Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted globally. The aim of this trial is to assess the clinical proof-of-principle of NNC0114-0006 and liraglutide on preservation of beta-cell function in adult subjects with newly diagnosed type 1 diabetes mellitus.
Interventions
DRUGNNC0114-0006
NNC0114-0006 12 mg/kg administered i.v (intravenously) every 6 weeks. Subjects will continue their pre-trial insulin treatment
DRUGliraglutide
Liraglutide 1.8 mg administered s.c. (subcutaneously) daily. Subjects will continue their pre-trial insulin treatment
DRUGplacebo
Placebo administered s.c (subcutaneously) or i.v ( intravenously). Subjects will continue their pre-trial insulin treatment
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * T1DM (type 1 diabetes mellitus) (as diagnosed clinically) for not more than 20 weeks prior to screening - Male or female, aged 18-45 (both inclusive) at the time of signing the informed consent form * Non-fasting peak C-peptide higher or equal to 0.2 nmol/l at visit 2 * BMI (body mass index) higher or equal to 18.5 kg/m\^2 * Presence of one or more islet specific auto antibodies (glutamic acid decarboxylase (GAD), islet antigen-2 (IA2) or zinc-transporter 8 (ZnT8)) at screening * Insulin dependence unless in temporary spontaneous remission (honeymoon period)
Exclusion criteria
* Daily insulin usage above 1 U/kg per day at screening or use of continuous subcutaneous insulin infusion (CSII) * History of recurrent (e.g. several times a year) of severe (e.g. pneumonia) or chronic infections or conditions predisposing to chronic infections (e.g., bronchiectasis and chronic osteomyelitis) * History of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate documented therapy * Vaccination within 4 weeks before randomisation, Visit 3 (V3) * Receipt of any other concomitant medications or herbal products that can influence the immune system within 90 days prior to screening (V1) * History of pancreatitis (acute or chronic) * Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC) * Any past or current diagnosis of malignant neoplasms * Known impairment of the immune system, except for T1DM, coeliac disease, alopecia, autoimmune antibodies not considered clinical important (e.g. thyroid antibodies without any clinically important thyroid disease), and vitiligo
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 54 Relative to Baseline | 0 - 4 hours post-dose on week 0 and week 54 | Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a mixed meal tolerance test (MMTT) stimulated C-peptide at week 54 is presented as ratio to baseline. AUC of C-peptide was measured as Nano moles\*hour per liter (nmol\*h/L). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of C-peptide at Week 54 Relative to Baseline | 0-4 hours post-dose on week 0 and week 54 | Maximum observed concentration (Cmax) of a MMTT stimulated C-peptide at week 54 is presented as ratio to baseline. Cmax of C-peptide was measured as nanomoles per liter (nmol/L). |
| AUC0-4h of Glucose at Week 54 Relative to Baseline | 0 - 4 hours post-dose on week 0 and week 54 | Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. AUC of glucose was measured as Milli moles\*hour per liter (mmol\*h/L). |
| AUC0-2h of Glucose at Week 54 Relative to Baseline | 0-2 hours post-dose on week 0 and week 54 | Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. AUC of glucose is measured as 'mmol\*h/L'. |
| Cmax of Glucose at Week 54 Relative to Baseline | 0-4 hours post-dose on week 0 and week 54 | Maximum observed concentration (Cmax) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. Cmax of C-peptide was measured as 'mmol/L'. |
| Number of Treatment Emergent Adverse Events | Week 0-54; Week 54-80 | An adverse event was any untoward medical occurrence in a participants administered a product, and which did not necessarily have a causal relationship with this treatment. An adverse event was defined as treatment emergent if the onset of the adverse event occurs on or after the first day of trial product administration. Number of treatment emergent adverse events from first dose of trial product to week 54 and week 80 are presented. Results are based on the on-treatment and on-observation period. On-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit. |
| Number of Treatment Emergent Hyperglycaemic Episodes | Week 0-54; Week 54-80 | Hyperglycaemic episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of treatment emergent episodes of hyperglycaemic episodes from first dose of trial product to week 54 and from week 54 to week 80 are presented. Results are based on the on-treatment and on-observation period. On-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit. |
| Number of Treatment Emergent Episodes of Diabetic Ketoacidosis | Weeks 0-54; Weeks 54-80 | Diabetic ketoacidosis episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of treatment emergent episodes of hyperglycaemic episodes from first dose of trial product to week 54 and from week 54 to week 80 are presented. Results are based on the on-treatment and on-observation period. On-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit. |
| Number of Participants Experiencing Treatment Emergent Injection/Infusion Site Reactions Caused by NNC0114-0006/Liraglutide/Placebo Injection/Infusion | Week 0-54 | Injection/infusion site reactions episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of participants experiencing treatment emergent episodes of injection/infusion site reactions episodes from first dose of trial product to week 54 (treatment period) is presented. |
| Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Weeks 0-54; Weeks 54-80 | Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 1 day after the date of last contact. Number of treatment-emergent hypoglycaemic episodes according to American Diabetes Association (ADA) classification from first dose of trial product to week 54 and from week 54 to week 80 are presented. Results presented hypoglycaemia episodes were recorded as per ADA definition: Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Pseudo-hypoglycaemia. |
| Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions | Weeks 0-54; Weeks 54-80 | Hypoglycaemia episodes were recorded as per Novo Nordisk definition: Symptomatic BG-confirmed: An episode that is blood glucose (BG) confirmed by plasma glucose (PG) value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Asymptomatic BG-confirmed: An episode that is BG-confirmed by PG value \<3.1 mmol/L without symptoms consistent with hypoglycaemia. Severe or BG-confirmed symptomatic: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. BG-confirmed: An episode that is BG-confirmed by a PG value \<3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Severe or BG-confirmed: An episode that is severe according to the International Society for Pediatric and Adolescent Diabetes (ISPAD) classification or BG-confirmed by a PG value \<3.1 mmol/L with or without symptoms consistent with hypoglycaemia. |
| Change in Body Weight (kg) | (Week 0, week 54) and (week 0, week 80) | Change in body weight is measured at week 54 and week 80 respective to baseline. Body weight was measured in unit 'Kg'. |
| Diabetes Retinopathy | Baseline, week 54 and week 80 | Number of participants evaluated for diabetic retinopathy at baseline (Day -28 to -14), week 54 and week 80 are presented as 'yes', 'no' or 'unknown'. |
| Estimated Glomerular Filtration Rate (eGFR)- Ratio to Baseline | (Week 0, week 54) and (week 0, week 80) | The eGFR was measured using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Change in eGFR (measured in milliliters per minute per 1.73 square meters) from baseline (week 0) at week 54 and week 80 is presented as ratio to baseline. |
| Change in Haematology: Erythrocytes | (Week 0, week 54) and (week 0, week 80) | Change in erythrocytes (measured in 10\^12 cells per liter) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Haematology: Haematocrit | (Week 0, week 54) and (week 0, week 80) | Change in haematocrit (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Haematology: Haemoglobin | (Week 0, week 54) and (week 0, week 80) | Change in haemoglobin (measured in millimoles per liter 'mmol/L') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Haematology: Leukocytes | (Week 0, week 54) and (week 0, week 80) | Change in leukocytes (measured in 10\^9 cells/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Haematology: Mean Corpuscular Hemoglobin | (Week 0, week 54) and (week 0, week 80) | Change in mean Corpuscular hemoglobin (measured in femtomole 'fmol') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Haematology: Mean Corpuscular Hemoglobin Concentration | (Week 0, week 54) and (week 0, week 80) | Change in mean corpuscular hemoglobin concentration (MCHC) (measured in gram per liter 'g/L') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Haematology: Mean Corpuscular Volume | (Week 0, week 54) and (week 0, week 80) | Change in Mean Corpuscular volume (measured in femtoliter 'fL') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Biochemistry: Alanine Aminotransferase (ALAT) | (Week 0, week 54) and (week 0, week 80) | Change in ALAT (measured in units per liter \[U/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Haematology: Thrombocytes | (Week 0, week 54) and (week 0, week 80) | Change in thrombocytes (measured in 10\^9 cells per liter) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Haematology: Eosinophil | (Week 0, week 54) and (week 0, week 80) | Change in eosinophil (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Haematology: Neutrophils | (Week 0, week 54) and (week 0, week 80) | Change in neutrophils (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Haematology: Basophils | (Week 0, week 54) and (week 0, week 80) | Change in basophils (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Biochemistry: Albumin | (Week 0, week 54) and (week 0, week 80) | Change in albumin (measured in gram per deciliter \[g/dL\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Haematology: Lymphocytes | (Week 0, week 54) and (week 0, week 80) | Change in lymphocytes (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Haematology: Monocytes | (Week 0, week 54) and (week 0, week 80) | Change in monocytes (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Biochemistry: Amylase | (Week 0, week 54) and (week 0, week 80) | Change in amylase (measured in units per liter \[U/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Biochemistry: Alkaline Phosphatase (ALP) | (Week 0, week 54) and (week 0, week 80) | Change in ALP (measured in units per liter \[U/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Biochemistry: Aspartate Aminotransferase (ASAT) | (Week 0, week 54) and (week 0, week 80) | Change in ASAT (measured in units per liter \[U/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Biochemistry: Total Bilirubin | (Week 0, week 54) and (week 0, week 80) | Change in Total bilirubin (measured in micromole per liter \[umol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Biochemistry: Calcium Corrected | (Week 0, week 54) and (week 0, week 80) | Change in calcium corrected (measured in millimole per liter \[mmol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Biochemistry: Chloride | (Week 0, week 54) and (week 0, week 80) | Change in chloride (measured in millimole per liter \[mmol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Biochemistry: Creatine Kinase | (Week 0, week 54) and (week 0, week 80) | Change in creatine kinase (measured in units per liter \[U/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Biochemistry: Creatinine | (Week 0, week 54) and (week 0, week 80) | Change in creatinine (measured in micromole per liter \[umol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Biochemistry: Gamma-glutamyl Transferase (GGT) | (Week 0, week 54) and (week 0, week 80) | Change in GGT (measured in units per liter \[U/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Biochemistry: C-reactive Protein Serum | (Week 0, week 54) and (week 0, week 80) | Change in C-reactive protein serum (measured in milligrams per liter \[mg/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Biochemistry: Lactate Dehydrogenase | (Week 0, week 54) and (week 0, week 80) | Change in Lactate Dehydrogenase (measured in units per liter \[U/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Biochemistry: Lipase | (Week 0, week 54) and (week 0, week 80) | Change in lipase (measured in units per liter \[U/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Biochemistry: Magnesium | (Week 0, week 54) and (week 0, week 80) | Change in magnesium (measured in millimole per liter \[mmol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Biochemistry: Phosphate | (Week 0, week 54) and (week 0, week 80) | Change in phosphate (measured in millimole per liter \[mmol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Biochemistry: Potassium | (Week 0, week 54) and (week 0, week 80) | Change in potassium (measured in millimole per liter \[mmol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Biochemistry: Sodium | (Week 0, week 54) and (week 0, week 80) | Change in sodium (measured in millimole per liter \[mmol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Biochemistry: Total Protein | (Week 0, week 54) and (week 0, week 80) | Change in total protein (measured in gram per liter \[g/dL\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Biochemistry: Blood Urea Nitrogen Serum | (Week 0, week 54) and (week 0, week 80) | Change in blood urea nitrogen serum (measured in milligram per deciliter \[mg/dL\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Biochemistry: Uric Acid | (Week 0, week 54) and (week 0, week 80) | Change in Uric Acid (measured in milligram per deciliter \[mg/dL\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in International Normalised Ratio (INR) | (Week 0, week 54) and (week 0, week 80) | Change in INR (measured in ratio\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in D-Dimer | (Week 0, week 54) and (week 0, week 80) | Change in D-Dimer (measured in mg/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Lipids: Total Cholesterol (Ratio to Baseline) | (Week 0, week 54) and (week 0, week 80) | Change in total cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Lipids: Free Fatty Acids (Ratio to Baseline) | (Week 0, week 54) and (week 0, week 80) | Change in total free fatty acids (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Lipids: HDL Cholesterol (Ratio to Baseline) | (Week 0, week 54) and (week 0, week 80) | Change in HDL cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Lipids: LDL Cholesterol (Ratio to Baseline) | (Week 0, week 54) and (week 0, week 80) | Change in LDL cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Lipids: Triglycerides (TG) (Ratio to Baseline) | (Week 0, week 54) and (week 0, week 80) | Change in Triglycerides (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Total Immunoglobulin E (IgE) | (Week 0, week 54) and (week 0, week 80) | Change in IgE (measured in kilo international units per liter \[kIU/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Urinalysis: Urine Dipsticks | Week 0, week 54 and week 80 | Urinalysis was performed by urine dipsticks for protein, glucose, erythrocytes, ketones leukocytes, nitrite, pH and specific gravity and categorised as normal, abnormal not clinically significant (NCS) and abnormal clinially significant (CS). Number of participants in each category at baseline (week 0), week 54 and 80 are presented. |
| Change in Cytokines: Interleukin (IL)-6 | Week 0, week 54 and week 80 | IL-6 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented. |
| Change in Cytokines- Interleukin (IL)-10 | Week 0, week 54 and week 80 | IL-10 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented. |
| Change in Cytokines: Interleukin (IL)-17 | Week 0, week 54 and week 80 | IL-17 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented. |
| Change in Cytokines: Interferon (IFN) Gamma | Week 0, week 54 and week 80 | IFN gamma levels at baseline (week 0), weeks 54 and 80 are evaluated and presented. |
| Change in Cytokines: TNF-alpha | Week 0, week 54 and week 80 | TNF-alpha levels at baseline (week 0), weeks 54 and 80 are evaluated and presented. |
| Change in Hormone Level: Thyroid Stimulating Hormone (TSH) | (Week 0, week 54) and (week 0, week 80) | Change in TSH (measured in milli international units per liter \[mIU/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Hormone Level: Calcitonin | (Week 0, week 54) and (week 0, week 80) | Change in Calcitonin (measured in nanogram per liter \[ng/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Systolic and Diastolic Blood Pressure | (Week 0, week 54) and (week 0, week 80) | Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) are evaluated from baseline (week 0) to weeks 54 and 80. |
| Change in Pulse | (Week 0, week 54) and (week 0, week 80) | Change in pulse is evaluated from baseline (week 0) to weeks 54 and 80 |
| Change in Body Temperature | Week 0, week 54) and (week 0, week 80) | Change in body temperature is evaluated from baseline (week 0) to weeks 54 and 80. |
| Change in Respiratory Rate | (Week 0, week 54) and (week 0, week 80) | Change in respiratory rate is evaluated from baseline (week 0) to weeks 54 and 80. |
| Change in Electrocardiogram (ECG) | Week 0, week 54 and week 80 | The ECG was assessed by the investigator at baseline (week 0), week 54 and week 80 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline, week 54 and week 80 are presented. |
| Change in Eye-examination | Week 0, week 54 and week 80 | Dilated fundoscopy or fundus photography was performed by the investigator at week 0, week 54 and week 80. The results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at week 0, week 54 and week 80 are presented. |
| Change in Physical Examination | Week 0, week 54 and week 80 | Physical examination parameters are categorised as general appearance; head, ears, eyes, nose, throat, neck; respiratory system;cardiovascular system; gastrointestinal system including mouth; musculoskeletal system; central and peripheral nervous system; skin; lymph node palpation and thyroid gland. Investigator assessed the participants with normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) findings at week 0, week 54 and week 80 are presented. |
| Occurrence of Anti-NNC0114-0006 Antibodies | Week 0, week 54 and week 80 | This outcome measure was applicable for NNC0114-0006 + Liraglutide treatment arm and NNC0114-0006 treatment arm. Participants was assessed for anti-NNC0114-0006 antibodies. Participant who reported anti-NNC0114-0006 antibodies were further analyzed for cross-reactivity. Number of participants who measured with anti-NNC0114-0006 antibodies at week 54 and week 80 are presented. |
| Occurrence of Anti-liraglutide Antibodies | Week 0, week 54 and week 80 | This outcome measure is applicable for NNC0114-0006 + Liraglutide treatment arm and Liraglutide treatment arm. Participants was assessed for anti-liraglutide antibodies. Participant who reported anti-liraglutide antibodies were further analyzed for cross-reactivity. Number of participants who measured with anti-liraglutide antibodies at week 54 and week 80 are presented. |
| Change in Insulin Dose | (Week 0, week 54) and (week 0, week 80) | The total daily insulin dose was derived as the average of the doses reported on the three days prior to the visit. Change in daily total insulin dose from baseline (week 0) after 54 weeks of treatment and week 80 are presented. |
| Change in Number of Insulin Injections | (Week 0, week 54) and (week 0, week 80) | The number of insulin injections was derived as the average of the reported number on the three days prior to the visit. The change in number of insulin injections per day (count) from baseline (week 0) after 54 weeks of treatment and week 80 are presented. |
| Number of Weeks Off Bolus Insulin | (Week 0 to week 54) and (week 0 to week 80) | The number of weeks off bolus insulin after 54 weeks of treatment and week 80 are presented. |
| Change in HbA1c | (Week 0, week 54) and (week 0, week 80) | Change in glycosylated haemoglobin (HbA1c) is evaluated from baseline (week 0) to weeks 54 and 80. |
| Change in Fasting Plasma Glucose | (Week 0, week 54) and (week 0, week 80) | Change in fasting plasma glucose is evaluated from baseline (week 0) to weeks 54 and 80. |
| Change in Fasting C-peptide- Ratio to Baseline | (Week 0, week 54) and (week 0, week 80) | Change in fasting C-peptide (measured in nanomole per liter \[nmol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| Change in Fasting Glucagon- Ratio to Baseline | (Week 0, week 54) and (week 0, week 80) | Change in fasting glucagon (measured in picogram per milliliter \[pg/mL\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. |
| 7-point SMPG Profiles | Week 54 and Week 80 | Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. 7-point SMPG profile values are presented for week 54 and week 80. |
| Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner | (Week 0, week 54) and (week 0, week 80) | Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Change from baseline (week 0) to week 54 and week 80 in 7-point SMPG postprandial glucose /prandial increment (breakfast, lunch and dinner) value are presented. |
| Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment (Average Over the Three Meals) | (Week 0, week 54) and (week 0, week 80) | Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. Change from baseline (week 0) to week 54 and week 80 in 7-point self-measured plasma glucose (SMPG) postprandial glucose /prandial increment (average over the three meals) value is presented. |
| Change in Mean of 7-point Profiles | (Week 0, week 54) and (week 0, week 80) | Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. Change from baseline (week 0) to week 54 and week 80 in mean of 7-point profiles value is presented. |
| Before Breakfast 7- Points Self Measured Plasma Glucose (SMPG) | Week 54 and week 80 | Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Before breakfast 7-point self-measured plasma glucose (SMPG) profile values are presented at week 54 and week 80. |
| Area Under the NNC0114-0006 Concentration-time Curve Over a Dosing Interval at Steady State (AUCtau, NNC0114-0006) | Pre-dose and 1 hour post-dose during week 48 to week 54 | AUCtau, NNC0114-0006 was derived as the area under the concentration-time curve using the linear trapezoidal technique based on observed values and actual measurement times between 0 and 6 weeks (after the last dose). This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms. |
| Terminal Half-life (t½) After Last Dose of NNC0114-0006 | Pre-dose and 1 hour post-dose during week 48 to week 80 | Terminal half life was calculated as log(2)/λz. The terminal rate constant λz was determined through linear regression with the logarithm to concentration as the response variable and actual measurement time as the explanatory variable. Valid observations from the terminal part of the curve, which is approximately linear, were used for the determination. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms. |
| Apparent Volume of Distribution of NNC0114-0006 at Steadystate (Vss, NNC0114-0006) | Pre-dose and 1 hour post-dose during week 48 to week 80 | The apparent volume of distribution of NNC0114-0006 at steady-state was calculated as mean residence time of (MRT) of NNC0114-0006 multiplied by clearance of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms. |
| Clearance of NNC0114-0006 at Steady State (CLss, NNC0114-0006) | Pre-dose and 1 hour post-dose during week 48 to week 54 | Clearance of NNC0114-0006 at steady state was calculated as dose/AUCtau, NNC0114-0006. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms. |
| Mean Residence Time of NNC0114-0006 (MRT, NNC0114-0006) | Pre-dose and 1 hour post-dose during week 48 to week 80 | This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms. Mean residence time of NNC0114-0006 is presented. |
| Accumulation Ratio of NNC114-0006 (RA,AUC, NNC0114-0006) | Pre-dose and 1 hour post-dose during (week 0 to week 6) and (week 48 to week 54) | Accumulation ratio of NNC114-0006 was defined as AUC48-54 weeks/AUC0-6 weeks. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms. |
| Observed NNC0114-0006 Concentration Prior to Dosing of NNC0114-0006 at Steady State (Ctrough, NNC0114-0006) | Week 48 (predose) | Ctrough of NNC0114-0006 was defined as concentration prior to dosing of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms. |
| Observed NNC0114-0006 Concentration 1 Hour After Dosing of NNC0114-0006 at Steady State (C1h, NNC0114-0006) | Week 48 (1 hour post-dose) | C1h, NNC0114-0006 was defined as concentration of NNC0114-0006 at 1 hour after dosing of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms. |
| Liraglutide Concentration at Steady State (C Liraglutide) | Week 54 (post-dose) | C liraglutide was defined as the liraglutide concentration at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and Liraglutide treatment arms. |
| Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0, week 54 and week 80 | B cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80. In below table CD refer to Cluster of Differentiation; IgMNeg refers to Immunoglobulin M negative; IgDNeg refers to Immunoglobulin D negative. |
| Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0, week 54 and week 80 | NK cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80. In below table ADCC refer to Antibody-dependent cellular cytotoxicity; CD refer to Cluster of Differentiation. |
| Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0, week 54 and week 80 | T cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80. In below table CD refer to Cluster of Differentiation; TEMRA refers to terminally differentiated effector memory cells re-expressing CD45RA; CCR refers to C-C chemokine receptor; TREG refers to Regulatory T cells. |
| Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0, week 54 and week 80 | TfH cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80. In below table CTFH refer to Circulating T follicular helper; ICOS refers to inducible T-cell co-stimulator; PD refers to Programmed cell death protein; CCR refers to C-C chemokine receptor; CXCR refers to C-X-C chemokine receptor; CD refer to Cluster of Differentiation; CM refers to central memory; EM refers to effector memory, TIGIT refers to T cell immunoreceptor with Ig and ITIM domains. |
| Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0, week 54 and week 80 | Myeloid panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80. In below table HLA refers to Human Leukocyte Antigen; MDSC refers to myeloid-derived suppressor cell; DC refers to Dendritic cells; MYDC refers to Myeloid Dendritic Cells; IMMYE\_MDSC refers to Immature myeloid cells & a subset of myeloid suppressor cells within the CD14-HLA class II- myeloid cell population. |
| Autoantibodies Against Glutamic Acid Decarboxylase (GAD) | Week 0, week 54 and week 80 | Participants were analyzed for autoantibodies against Glutamic acid decarboxylase (GAD) and were categorized as negative and positive. |
| AUC0-2h of C-peptide at Week 54 Relative to Baseline | 0-2 hours post-dose on week 0 and week 54 | Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated C-peptide at week 54 is presented as ratio to baseline. AUC of C-peptide was measured as 'nmol\*h/L'. |
| Autoantibodies Against Islet Antigen-2 (IA2) | Week 0, week 54 and week 80 | Participants were analyzed for autoantibodies against Islet antigen-2 (IA2) and were categorized as negative and positive. |
| Autoantibodies Against Insulin Autoantibodies (IAA) | Week 0, week 54 and week 80 | Participants were analyzed for autoantibodies against Insulin autoantibodies (IAA) and were categorized as negative and positive. |
| Change in Biomarker: Total Interleukin-21 (IL-21) | Week 0, week 54 and week 80 | IL-21 is evaluated at baseline (week 0), week 54 and week 80. |
| Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol) | Week 0, week 54 and week 80 | Serum vitamin D is evaluated at baseline (week 0), week 54 and week 80. |
| Change in Short Form 36 Health Survey (SF-36) | (Week 0, week 54) and (week 0, week 80) | SF-36v2™ questionnaire measured the HRQoL on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. Change from baseline (week 0) to week 54 and week 80 in SF-36 score is presented.The MCS measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The PCS measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicate an improvement since baseline. |
| Change in Experience of Treatment Benefits and Barriers (ETBB) | (Week 0, week 54) and (week 0, week 80) | Treatment Benefits and Barriers (ETBB) questionnaire measured diabetes-specific health beliefs on 2 categories: Total Score for Perceived Barriers and Perceived Benefits. The measurement of perceived benefits of, and barriers to, treatment was achieved by creating a pool 28 statements each with a 7-point scale ranging from strongly agree (6) to strongly disagree (0). ETBB benefits score was calculated using the responses from questions 1, 4, 7, 8, 10, and 12 and ETBB barriers score was calculated using the responses from questions 2, 3, 5, 6, 9, and 11. Both was calculated as the sum of responses divided by number of responses received multiplied by the maximum number of responses. Based on the responses used the maximum responses available was 6. The higher score indicates more perceived benefits or more perceived barrier. |
| Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) | (Week 0, week 54) and (week 0, week 80) | Change from baseline (week 0) in DTSQ is evaluated at week 54 and 80. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher score indicates a higher level of glycaemia/treatment satisfaction. |
| Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 80 Relative to Baseline | 0 - 4 hours post-dose on week 0 and week 80 | Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a mixed meal tolerance test (MMTT) stimulated C-peptide at week 80 is presented as ratio to baseline. AUC of C-peptide was measured as Nano moles\*hour per liter (nmol\*h/L). |
| AUC0-2h of C-peptide at Week 80 Relative to Baseline | 0-2 hours post-dose on week 0 and week 80 | Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated C-peptide at week 80 is presented as ratio to baseline. AUC of C-peptide was measured as 'nmol\*h/L'. |
| Cmax of C-peptide at Week 80 Relative to Baseline | 0-4 hours post-dose on week 0 and week 80 | Maximum observed concentration (Cmax) of a MMTT stimulated C-peptide at week 80 is presented as ratio to baseline. Cmax of C-peptide was measured as nanomoles per liter (nmol/L). |
| AUC0-4h of Glucose at Week 80 Relative to Baseline | 0 - 4 hours post-dose on week 0 and week 80 | Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. AUC of glucose was measured as Milli moles\*hour per liter (mmol\*h/L). |
| AUC0-2h of Glucose at Week 80 Relative to Baseline | 0-2 hours post-dose on week 0 and week 80 | Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. AUC of glucose was measured as 'mmol\*h/L'. |
| Cmax of Glucose at Week 80 Relative to Baseline | 0-4 hours post-dose on week 0 and week 80 | Maximum observed concentration (Cmax) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. Cmax of C-peptide was measured as 'mmol/L'. |
| Autoantibodies Against Zinc-transporter 8 (ZnT8) | Week 0, week 54 and week 80 | Participants were analyzed for autoantibodies against Zinc-transporter 8 (ZnT8) and were categorized as negative and positive. |
Countries
Austria, Belgium, Canada, Denmark, Finland, Ireland, Israel, Italy, Norway, Poland, Portugal, Russia, Serbia, Spain, Sweden, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
The trial was conducted at 94 sites in Austria, Belgium, Canada, Denmark, Finland, Ireland, Israel, Italy, Norway, Poland, Portugal, Russian Federation, Spain, Sweden, Ukraine, the United Kingdom (UK), and the United States (US).
Pre-assignment details
Participants were randomised in a 1:1:1:1 manner to one of the four treatment groups. One participant was randomised to liraglutide arm but was withdrawn from the trial before exposure to trial products as per investigator's decision.
Participants by arm
| Arm | Count |
|---|---|
| NNC0114-0006 + Liraglutide (Experimental) Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial. | 77 |
| NNC0114-0006 (Experimental) Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial. | 77 |
| Liraglutide (Experimental) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial. | 76 |
| Placebo (Placebo) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial. | 77 |
| Total | 307 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 4 | 1 | 2 |
| Overall Study | Death | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 2 | 0 | 1 |
| Overall Study | Pregnancy | 3 | 1 | 1 | 2 |
| Overall Study | Protocol Violation | 1 | 0 | 1 | 1 |
| Overall Study | Unclassified | 0 | 0 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 7 | 3 | 9 |
Baseline characteristics
| Characteristic | NNC0114-0006 + Liraglutide (Experimental) | NNC0114-0006 (Experimental) | Liraglutide (Experimental) | Placebo (Placebo) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 28.0 years STANDARD_DEVIATION 7.5 | 28.6 years STANDARD_DEVIATION 7.9 | 28.0 years STANDARD_DEVIATION 7.1 | 29.0 years STANDARD_DEVIATION 7 | 28.4 years STANDARD_DEVIATION 7.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 3 Participants | 2 Participants | 1 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 73 Participants | 74 Participants | 74 Participants | 76 Participants | 297 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 4 Participants | 2 Participants | 0 Participants | 10 Participants |
| Race (NIH/OMB) White | 73 Participants | 70 Participants | 73 Participants | 76 Participants | 292 Participants |
| Sex: Female, Male Female | 21 Participants | 32 Participants | 25 Participants | 28 Participants | 106 Participants |
| Sex: Female, Male Male | 56 Participants | 45 Participants | 51 Participants | 49 Participants | 201 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 77 | 0 / 77 | 1 / 76 | 0 / 77 |
| other Total, other adverse events | 57 / 77 | 55 / 77 | 62 / 76 | 54 / 77 |
| serious Total, serious adverse events | 7 / 77 | 5 / 77 | 9 / 76 | 11 / 77 |
Outcome results
Primary
Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 54 Relative to Baseline
Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a mixed meal tolerance test (MMTT) stimulated C-peptide at week 54 is presented as ratio to baseline. AUC of C-peptide was measured as Nano moles\*hour per liter (nmol\*h/L).
Time frame: 0 - 4 hours post-dose on week 0 and week 54
Population: The FAS included all randomised participants. Overall number of participants analysed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 54 Relative to Baseline | 0.934 Ratio of AUC | Geometric Coefficient of Variation 61.9 |
| NNC0114-0006 (Experimental) | Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 54 Relative to Baseline | 0.783 Ratio of AUC | Geometric Coefficient of Variation 45.5 |
| Liraglutide (Experimental) | Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 54 Relative to Baseline | 0.709 Ratio of AUC | Geometric Coefficient of Variation 104.8 |
| Placebo (Placebo) | Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 54 Relative to Baseline | 0.660 Ratio of AUC | Geometric Coefficient of Variation 86.3 |
Comparison: Ratio of week 54 to baseline are analysed using mixed model for repeated measurements (MMRM) with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.p-value: =0.001795% CI: [1.16, 1.89]Mixed model repeated measurements
Comparison: Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.p-value: =0.092795% CI: [0.97, 1.57]Mixed model repeated measurements
Comparison: Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.p-value: =0.37895% CI: [0.87, 1.42]Mixed model repeated measurements
Comparison: Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.p-value: =0.137795% CI: [0.94, 1.53]Mixed model repeated measurements
Comparison: Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.p-value: =0.021495% CI: [1.04, 1.69]Mixed model repeated measurements
Comparison: Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.p-value: =0.418795% CI: [0.87, 1.41]Mixed model repeated measurements
Secondary
7-point SMPG Profiles
Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. 7-point SMPG profile values are presented for week 54 and week 80.
Time frame: Week 54 and Week 80
Population: The FAS included all randomised participants. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | 7-point SMPG Profiles | Week 80: 90 minutes after start of dinner | 7.6 mmol/L | Standard Deviation 2.5 |
| NNC0114-0006 + Liraglutide (Experimental) | 7-point SMPG Profiles | Week 54: Before lunch | 5.5 mmol/L | Standard Deviation 1.8 |
| NNC0114-0006 + Liraglutide (Experimental) | 7-point SMPG Profiles | Week 80: 90 minutes after start of breakfast | 8.5 mmol/L | Standard Deviation 2.8 |
| NNC0114-0006 + Liraglutide (Experimental) | 7-point SMPG Profiles | Week 54: 90 minutes after start of dinner | 8.2 mmol/L | Standard Deviation 3.4 |
| NNC0114-0006 + Liraglutide (Experimental) | 7-point SMPG Profiles | Week 54: 90 minutes after start of breakfast | 8.9 mmol/L | Standard Deviation 3.7 |
| NNC0114-0006 + Liraglutide (Experimental) | 7-point SMPG Profiles | Week 54: Before dinner | 6.5 mmol/L | Standard Deviation 1.9 |
| NNC0114-0006 + Liraglutide (Experimental) | 7-point SMPG Profiles | Week 80: Bedtime | 7.8 mmol/L | Standard Deviation 3 |
| NNC0114-0006 + Liraglutide (Experimental) | 7-point SMPG Profiles | Week 80: Before dinner | 6.5 mmol/L | Standard Deviation 2.2 |
| NNC0114-0006 + Liraglutide (Experimental) | 7-point SMPG Profiles | Week 54: 90 minutes after start of lunch | 8.2 mmol/L | Standard Deviation 2.6 |
| NNC0114-0006 + Liraglutide (Experimental) | 7-point SMPG Profiles | Week 80: Before breakfast | 6.5 mmol/L | Standard Deviation 1.7 |
| NNC0114-0006 + Liraglutide (Experimental) | 7-point SMPG Profiles | Week 80: 90 minutes after start of lunch | 7.8 mmol/L | Standard Deviation 2.6 |
| NNC0114-0006 + Liraglutide (Experimental) | 7-point SMPG Profiles | Week 54: Before breakfast | 6.8 mmol/L | Standard Deviation 3.4 |
| NNC0114-0006 + Liraglutide (Experimental) | 7-point SMPG Profiles | Week 80: Before lunch | 6.2 mmol/L | Standard Deviation 2.2 |
| NNC0114-0006 + Liraglutide (Experimental) | 7-point SMPG Profiles | Week 54: Bedtime | 7.8 mmol/L | Standard Deviation 3.9 |
| NNC0114-0006 (Experimental) | 7-point SMPG Profiles | Week 54: Before breakfast | 6.8 mmol/L | Standard Deviation 2.7 |
| NNC0114-0006 (Experimental) | 7-point SMPG Profiles | Week 80: 90 minutes after start of lunch | 7.6 mmol/L | Standard Deviation 2.7 |
| NNC0114-0006 (Experimental) | 7-point SMPG Profiles | Week 80: Before dinner | 6.7 mmol/L | Standard Deviation 2.9 |
| NNC0114-0006 (Experimental) | 7-point SMPG Profiles | Week 80: 90 minutes after start of dinner | 7.0 mmol/L | Standard Deviation 2.1 |
| NNC0114-0006 (Experimental) | 7-point SMPG Profiles | Week 54: 90 minutes after start of breakfast | 7.5 mmol/L | Standard Deviation 2.4 |
| NNC0114-0006 (Experimental) | 7-point SMPG Profiles | Week 54: Before lunch | 6.4 mmol/L | Standard Deviation 2.3 |
| NNC0114-0006 (Experimental) | 7-point SMPG Profiles | Week 54: 90 minutes after start of lunch | 7.5 mmol/L | Standard Deviation 2.7 |
| NNC0114-0006 (Experimental) | 7-point SMPG Profiles | Week 54: Before dinner | 6.5 mmol/L | Standard Deviation 2.5 |
| NNC0114-0006 (Experimental) | 7-point SMPG Profiles | Week 80: Bedtime | 6.6 mmol/L | Standard Deviation 1.8 |
| NNC0114-0006 (Experimental) | 7-point SMPG Profiles | Week 54: 90 minutes after start of dinner | 7.0 mmol/L | Standard Deviation 2.5 |
| NNC0114-0006 (Experimental) | 7-point SMPG Profiles | Week 54: Bedtime | 7.4 mmol/L | Standard Deviation 2.6 |
| NNC0114-0006 (Experimental) | 7-point SMPG Profiles | Week 80: Before breakfast | 6.4 mmol/L | Standard Deviation 2 |
| NNC0114-0006 (Experimental) | 7-point SMPG Profiles | Week 80: Before lunch | 6.2 mmol/L | Standard Deviation 2 |
| NNC0114-0006 (Experimental) | 7-point SMPG Profiles | Week 80: 90 minutes after start of breakfast | 7.2 mmol/L | Standard Deviation 3 |
| Liraglutide (Experimental) | 7-point SMPG Profiles | Week 80: Bedtime | 7.8 mmol/L | Standard Deviation 4.4 |
| Liraglutide (Experimental) | 7-point SMPG Profiles | Week 54: 90 minutes after start of breakfast | 7.4 mmol/L | Standard Deviation 2.1 |
| Liraglutide (Experimental) | 7-point SMPG Profiles | Week 80: Before lunch | 6.9 mmol/L | Standard Deviation 3.3 |
| Liraglutide (Experimental) | 7-point SMPG Profiles | Week 54: Bedtime | 7.5 mmol/L | Standard Deviation 2.5 |
| Liraglutide (Experimental) | 7-point SMPG Profiles | Week 80: 90 minutes after start of dinner | 9.0 mmol/L | Standard Deviation 5 |
| Liraglutide (Experimental) | 7-point SMPG Profiles | Week 80: Before dinner | 7.6 mmol/L | Standard Deviation 4.1 |
| Liraglutide (Experimental) | 7-point SMPG Profiles | Week 80: 90 minutes after start of breakfast | 8.3 mmol/L | Standard Deviation 3.7 |
| Liraglutide (Experimental) | 7-point SMPG Profiles | Week 54: 90 minutes after start of lunch | 7.8 mmol/L | Standard Deviation 2.4 |
| Liraglutide (Experimental) | 7-point SMPG Profiles | Week 80: Before breakfast | 7.2 mmol/L | Standard Deviation 2.7 |
| Liraglutide (Experimental) | 7-point SMPG Profiles | Week 54: Before dinner | 6.6 mmol/L | Standard Deviation 2.2 |
| Liraglutide (Experimental) | 7-point SMPG Profiles | Week 54: Before breakfast | 6.4 mmol/L | Standard Deviation 2.2 |
| Liraglutide (Experimental) | 7-point SMPG Profiles | Week 54: Before lunch | 6.1 mmol/L | Standard Deviation 1.8 |
| Liraglutide (Experimental) | 7-point SMPG Profiles | Week 80: 90 minutes after start of lunch | 8.5 mmol/L | Standard Deviation 4.5 |
| Liraglutide (Experimental) | 7-point SMPG Profiles | Week 54: 90 minutes after start of dinner | 7.2 mmol/L | Standard Deviation 2.3 |
| Placebo (Placebo) | 7-point SMPG Profiles | Week 80: Bedtime | 7.4 mmol/L | Standard Deviation 2.2 |
| Placebo (Placebo) | 7-point SMPG Profiles | Week 54: Before lunch | 6.0 mmol/L | Standard Deviation 1.6 |
| Placebo (Placebo) | 7-point SMPG Profiles | Week 54: Before breakfast | 6.3 mmol/L | Standard Deviation 1.4 |
| Placebo (Placebo) | 7-point SMPG Profiles | Week 54: 90 minutes after start of breakfast | 7.6 mmol/L | Standard Deviation 2.4 |
| Placebo (Placebo) | 7-point SMPG Profiles | Week 54: 90 minutes after start of lunch | 7.7 mmol/L | Standard Deviation 2 |
| Placebo (Placebo) | 7-point SMPG Profiles | Week 54: Before dinner | 6.1 mmol/L | Standard Deviation 1.7 |
| Placebo (Placebo) | 7-point SMPG Profiles | Week 54: 90 minutes after start of dinner | 6.8 mmol/L | Standard Deviation 1.9 |
| Placebo (Placebo) | 7-point SMPG Profiles | Week 54: Bedtime | 7.2 mmol/L | Standard Deviation 2.1 |
| Placebo (Placebo) | 7-point SMPG Profiles | Week 80: Before breakfast | 6.8 mmol/L | Standard Deviation 2 |
| Placebo (Placebo) | 7-point SMPG Profiles | Week 80: 90 minutes after start of breakfast | 7.5 mmol/L | Standard Deviation 2.7 |
| Placebo (Placebo) | 7-point SMPG Profiles | Week 80: Before lunch | 6.1 mmol/L | Standard Deviation 1.8 |
| Placebo (Placebo) | 7-point SMPG Profiles | Week 80: 90 minutes after start of lunch | 8.0 mmol/L | Standard Deviation 3 |
| Placebo (Placebo) | 7-point SMPG Profiles | Week 80: 90 minutes after start of dinner | 7.6 mmol/L | Standard Deviation 2.5 |
| Placebo (Placebo) | 7-point SMPG Profiles | Week 80: Before dinner | 6.5 mmol/L | Standard Deviation 1.6 |
Secondary
Accumulation Ratio of NNC114-0006 (RA,AUC, NNC0114-0006)
Accumulation ratio of NNC114-0006 was defined as AUC48-54 weeks/AUC0-6 weeks. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.
Time frame: Pre-dose and 1 hour post-dose during (week 0 to week 6) and (week 48 to week 54)
Population: The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Accumulation Ratio of NNC114-0006 (RA,AUC, NNC0114-0006) | 1.24 Ratio of AUC | Geometric Coefficient of Variation 17.8 |
| NNC0114-0006 (Experimental) | Accumulation Ratio of NNC114-0006 (RA,AUC, NNC0114-0006) | 1.26 Ratio of AUC | Geometric Coefficient of Variation 17.4 |
Secondary
Apparent Volume of Distribution of NNC0114-0006 at Steadystate (Vss, NNC0114-0006)
The apparent volume of distribution of NNC0114-0006 at steady-state was calculated as mean residence time of (MRT) of NNC0114-0006 multiplied by clearance of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.
Time frame: Pre-dose and 1 hour post-dose during week 48 to week 80
Population: The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Apparent Volume of Distribution of NNC0114-0006 at Steadystate (Vss, NNC0114-0006) | 83.7 Milliliters per kilogram (mL/kg) | Geometric Coefficient of Variation 23.1 |
| NNC0114-0006 (Experimental) | Apparent Volume of Distribution of NNC0114-0006 at Steadystate (Vss, NNC0114-0006) | 79.3 Milliliters per kilogram (mL/kg) | Geometric Coefficient of Variation 17.6 |
Secondary
Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 80 Relative to Baseline
Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a mixed meal tolerance test (MMTT) stimulated C-peptide at week 80 is presented as ratio to baseline. AUC of C-peptide was measured as Nano moles\*hour per liter (nmol\*h/L).
Time frame: 0 - 4 hours post-dose on week 0 and week 80
Population: The FAS included all randomised participants. Overall number of participants analysed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 80 Relative to Baseline | 0.566 Ratio of AUC | Geometric Coefficient of Variation 71.3 |
| NNC0114-0006 (Experimental) | Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 80 Relative to Baseline | 0.598 Ratio of AUC | Geometric Coefficient of Variation 70.2 |
| Liraglutide (Experimental) | Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 80 Relative to Baseline | 0.373 Ratio of AUC | Geometric Coefficient of Variation 115.8 |
| Placebo (Placebo) | Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 80 Relative to Baseline | 0.571 Ratio of AUC | Geometric Coefficient of Variation 100.9 |
Secondary
Area Under the NNC0114-0006 Concentration-time Curve Over a Dosing Interval at Steady State (AUCtau, NNC0114-0006)
AUCtau, NNC0114-0006 was derived as the area under the concentration-time curve using the linear trapezoidal technique based on observed values and actual measurement times between 0 and 6 weeks (after the last dose). This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.
Time frame: Pre-dose and 1 hour post-dose during week 48 to week 54
Population: The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Area Under the NNC0114-0006 Concentration-time Curve Over a Dosing Interval at Steady State (AUCtau, NNC0114-0006) | 3969 day*microgram per milliliter (day*ug/mL) | Geometric Coefficient of Variation 17.9 |
| NNC0114-0006 (Experimental) | Area Under the NNC0114-0006 Concentration-time Curve Over a Dosing Interval at Steady State (AUCtau, NNC0114-0006) | 4115 day*microgram per milliliter (day*ug/mL) | Geometric Coefficient of Variation 23.1 |
Secondary
AUC0-2h of C-peptide at Week 54 Relative to Baseline
Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated C-peptide at week 54 is presented as ratio to baseline. AUC of C-peptide was measured as 'nmol\*h/L'.
Time frame: 0-2 hours post-dose on week 0 and week 54
Population: The FAS included all randomised participants. Overall number of participants analysed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | AUC0-2h of C-peptide at Week 54 Relative to Baseline | 0.961 Ratio of AUC | Geometric Coefficient of Variation 65.4 |
| NNC0114-0006 (Experimental) | AUC0-2h of C-peptide at Week 54 Relative to Baseline | 0.824 Ratio of AUC | Geometric Coefficient of Variation 53 |
| Liraglutide (Experimental) | AUC0-2h of C-peptide at Week 54 Relative to Baseline | 0.646 Ratio of AUC | Geometric Coefficient of Variation 97.4 |
| Placebo (Placebo) | AUC0-2h of C-peptide at Week 54 Relative to Baseline | 0.655 Ratio of AUC | Geometric Coefficient of Variation 87.3 |
Secondary
AUC0-2h of C-peptide at Week 80 Relative to Baseline
Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated C-peptide at week 80 is presented as ratio to baseline. AUC of C-peptide was measured as 'nmol\*h/L'.
Time frame: 0-2 hours post-dose on week 0 and week 80
Population: The FAS included all randomised participants. Overall number of participants analysed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | AUC0-2h of C-peptide at Week 80 Relative to Baseline | 0.590 Ratio of AUC | Geometric Coefficient of Variation 74.5 |
| NNC0114-0006 (Experimental) | AUC0-2h of C-peptide at Week 80 Relative to Baseline | 0.619 Ratio of AUC | Geometric Coefficient of Variation 71.2 |
| Liraglutide (Experimental) | AUC0-2h of C-peptide at Week 80 Relative to Baseline | 0.370 Ratio of AUC | Geometric Coefficient of Variation 111.5 |
| Placebo (Placebo) | AUC0-2h of C-peptide at Week 80 Relative to Baseline | 0.540 Ratio of AUC | Geometric Coefficient of Variation 120.6 |
Secondary
AUC0-2h of Glucose at Week 54 Relative to Baseline
Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. AUC of glucose is measured as 'mmol\*h/L'.
Time frame: 0-2 hours post-dose on week 0 and week 54
Population: The FAS included all randomised participants. Overall number of participants analysed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | AUC0-2h of Glucose at Week 54 Relative to Baseline | 0.939 Ratio of AUC | Geometric Coefficient of Variation 28.5 |
| NNC0114-0006 (Experimental) | AUC0-2h of Glucose at Week 54 Relative to Baseline | 1.066 Ratio of AUC | Geometric Coefficient of Variation 24.8 |
| Liraglutide (Experimental) | AUC0-2h of Glucose at Week 54 Relative to Baseline | 0.978 Ratio of AUC | Geometric Coefficient of Variation 31.9 |
| Placebo (Placebo) | AUC0-2h of Glucose at Week 54 Relative to Baseline | 1.057 Ratio of AUC | Geometric Coefficient of Variation 31.3 |
Secondary
AUC0-2h of Glucose at Week 80 Relative to Baseline
Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. AUC of glucose was measured as 'mmol\*h/L'.
Time frame: 0-2 hours post-dose on week 0 and week 80
Population: The FAS included all randomised participants. Overall number of participants analysed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | AUC0-2h of Glucose at Week 80 Relative to Baseline | 1.119 Ratio of AUC | Geometric Coefficient of Variation 28.6 |
| NNC0114-0006 (Experimental) | AUC0-2h of Glucose at Week 80 Relative to Baseline | 1.086 Ratio of AUC | Geometric Coefficient of Variation 28.1 |
| Liraglutide (Experimental) | AUC0-2h of Glucose at Week 80 Relative to Baseline | 1.070 Ratio of AUC | Geometric Coefficient of Variation 35.5 |
| Placebo (Placebo) | AUC0-2h of Glucose at Week 80 Relative to Baseline | 1.166 Ratio of AUC | Geometric Coefficient of Variation 21.7 |
Secondary
AUC0-4h of Glucose at Week 54 Relative to Baseline
Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. AUC of glucose was measured as Milli moles\*hour per liter (mmol\*h/L).
Time frame: 0 - 4 hours post-dose on week 0 and week 54
Population: The FAS included all randomised participants. Overall number of participants analysed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | AUC0-4h of Glucose at Week 54 Relative to Baseline | 0.904 Ratio of AUC | Geometric Coefficient of Variation 33.1 |
| NNC0114-0006 (Experimental) | AUC0-4h of Glucose at Week 54 Relative to Baseline | 1.078 Ratio of AUC | Geometric Coefficient of Variation 31.8 |
| Liraglutide (Experimental) | AUC0-4h of Glucose at Week 54 Relative to Baseline | 0.993 Ratio of AUC | Geometric Coefficient of Variation 34.2 |
| Placebo (Placebo) | AUC0-4h of Glucose at Week 54 Relative to Baseline | 1.089 Ratio of AUC | Geometric Coefficient of Variation 36.7 |
Secondary
AUC0-4h of Glucose at Week 80 Relative to Baseline
Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. AUC of glucose was measured as Milli moles\*hour per liter (mmol\*h/L).
Time frame: 0 - 4 hours post-dose on week 0 and week 80
Population: The FAS included all randomised participants. Overall number of participants analysed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | AUC0-4h of Glucose at Week 80 Relative to Baseline | 1.129 Ratio of AUC | Geometric Coefficient of Variation 33.3 |
| NNC0114-0006 (Experimental) | AUC0-4h of Glucose at Week 80 Relative to Baseline | 1.115 Ratio of AUC | Geometric Coefficient of Variation 32.6 |
| Liraglutide (Experimental) | AUC0-4h of Glucose at Week 80 Relative to Baseline | 1.136 Ratio of AUC | Geometric Coefficient of Variation 39 |
| Placebo (Placebo) | AUC0-4h of Glucose at Week 80 Relative to Baseline | 1.221 Ratio of AUC | Geometric Coefficient of Variation 26.6 |
Secondary
Autoantibodies Against Glutamic Acid Decarboxylase (GAD)
Participants were analyzed for autoantibodies against Glutamic acid decarboxylase (GAD) and were categorized as negative and positive.
Time frame: Week 0, week 54 and week 80
Population: The FAS included all randomised participants. Number analyzed = participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Autoantibodies Against Glutamic Acid Decarboxylase (GAD) | Week 0 | Negative | 3 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Autoantibodies Against Glutamic Acid Decarboxylase (GAD) | Week 0 | Positive | 74 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Autoantibodies Against Glutamic Acid Decarboxylase (GAD) | Week 54 | Negative | 5 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Autoantibodies Against Glutamic Acid Decarboxylase (GAD) | Week 54 | Positive | 62 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Autoantibodies Against Glutamic Acid Decarboxylase (GAD) | Week 80 | Negative | 4 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Autoantibodies Against Glutamic Acid Decarboxylase (GAD) | Week 80 | Positive | 61 Participants |
| NNC0114-0006 (Experimental) | Autoantibodies Against Glutamic Acid Decarboxylase (GAD) | Week 80 | Positive | 62 Participants |
| NNC0114-0006 (Experimental) | Autoantibodies Against Glutamic Acid Decarboxylase (GAD) | Week 54 | Positive | 61 Participants |
| NNC0114-0006 (Experimental) | Autoantibodies Against Glutamic Acid Decarboxylase (GAD) | Week 0 | Negative | 1 Participants |
| NNC0114-0006 (Experimental) | Autoantibodies Against Glutamic Acid Decarboxylase (GAD) | Week 54 | Negative | 4 Participants |
| NNC0114-0006 (Experimental) | Autoantibodies Against Glutamic Acid Decarboxylase (GAD) | Week 0 | Positive | 76 Participants |
| NNC0114-0006 (Experimental) | Autoantibodies Against Glutamic Acid Decarboxylase (GAD) | Week 80 | Negative | 2 Participants |
| Liraglutide (Experimental) | Autoantibodies Against Glutamic Acid Decarboxylase (GAD) | Week 0 | Positive | 71 Participants |
| Liraglutide (Experimental) | Autoantibodies Against Glutamic Acid Decarboxylase (GAD) | Week 54 | Negative | 4 Participants |
| Liraglutide (Experimental) | Autoantibodies Against Glutamic Acid Decarboxylase (GAD) | Week 54 | Positive | 64 Participants |
| Liraglutide (Experimental) | Autoantibodies Against Glutamic Acid Decarboxylase (GAD) | Week 80 | Positive | 63 Participants |
| Liraglutide (Experimental) | Autoantibodies Against Glutamic Acid Decarboxylase (GAD) | Week 80 | Negative | 5 Participants |
| Liraglutide (Experimental) | Autoantibodies Against Glutamic Acid Decarboxylase (GAD) | Week 0 | Negative | 5 Participants |
| Placebo (Placebo) | Autoantibodies Against Glutamic Acid Decarboxylase (GAD) | Week 80 | Negative | 1 Participants |
| Placebo (Placebo) | Autoantibodies Against Glutamic Acid Decarboxylase (GAD) | Week 80 | Positive | 61 Participants |
| Placebo (Placebo) | Autoantibodies Against Glutamic Acid Decarboxylase (GAD) | Week 0 | Positive | 74 Participants |
| Placebo (Placebo) | Autoantibodies Against Glutamic Acid Decarboxylase (GAD) | Week 54 | Positive | 63 Participants |
| Placebo (Placebo) | Autoantibodies Against Glutamic Acid Decarboxylase (GAD) | Week 0 | Negative | 3 Participants |
| Placebo (Placebo) | Autoantibodies Against Glutamic Acid Decarboxylase (GAD) | Week 54 | Negative | 3 Participants |
Secondary
Autoantibodies Against Insulin Autoantibodies (IAA)
Participants were analyzed for autoantibodies against Insulin autoantibodies (IAA) and were categorized as negative and positive.
Time frame: Week 0, week 54 and week 80
Population: The FAS included all randomised participants. Number analyzed = participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Autoantibodies Against Insulin Autoantibodies (IAA) | Week 0 | Negative | 35 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Autoantibodies Against Insulin Autoantibodies (IAA) | Week 0 | Positive | 42 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Autoantibodies Against Insulin Autoantibodies (IAA) | Week 54 | Negative | 30 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Autoantibodies Against Insulin Autoantibodies (IAA) | Week 54 | Positive | 38 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Autoantibodies Against Insulin Autoantibodies (IAA) | Week 80 | Negative | 18 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Autoantibodies Against Insulin Autoantibodies (IAA) | Week 80 | Positive | 48 Participants |
| NNC0114-0006 (Experimental) | Autoantibodies Against Insulin Autoantibodies (IAA) | Week 80 | Positive | 40 Participants |
| NNC0114-0006 (Experimental) | Autoantibodies Against Insulin Autoantibodies (IAA) | Week 54 | Positive | 37 Participants |
| NNC0114-0006 (Experimental) | Autoantibodies Against Insulin Autoantibodies (IAA) | Week 0 | Negative | 28 Participants |
| NNC0114-0006 (Experimental) | Autoantibodies Against Insulin Autoantibodies (IAA) | Week 54 | Negative | 28 Participants |
| NNC0114-0006 (Experimental) | Autoantibodies Against Insulin Autoantibodies (IAA) | Week 0 | Positive | 48 Participants |
| NNC0114-0006 (Experimental) | Autoantibodies Against Insulin Autoantibodies (IAA) | Week 80 | Negative | 24 Participants |
| Liraglutide (Experimental) | Autoantibodies Against Insulin Autoantibodies (IAA) | Week 0 | Positive | 49 Participants |
| Liraglutide (Experimental) | Autoantibodies Against Insulin Autoantibodies (IAA) | Week 54 | Negative | 22 Participants |
| Liraglutide (Experimental) | Autoantibodies Against Insulin Autoantibodies (IAA) | Week 54 | Positive | 46 Participants |
| Liraglutide (Experimental) | Autoantibodies Against Insulin Autoantibodies (IAA) | Week 80 | Positive | 55 Participants |
| Liraglutide (Experimental) | Autoantibodies Against Insulin Autoantibodies (IAA) | Week 80 | Negative | 13 Participants |
| Liraglutide (Experimental) | Autoantibodies Against Insulin Autoantibodies (IAA) | Week 0 | Negative | 26 Participants |
| Placebo (Placebo) | Autoantibodies Against Insulin Autoantibodies (IAA) | Week 80 | Negative | 15 Participants |
| Placebo (Placebo) | Autoantibodies Against Insulin Autoantibodies (IAA) | Week 80 | Positive | 47 Participants |
| Placebo (Placebo) | Autoantibodies Against Insulin Autoantibodies (IAA) | Week 0 | Positive | 40 Participants |
| Placebo (Placebo) | Autoantibodies Against Insulin Autoantibodies (IAA) | Week 54 | Positive | 55 Participants |
| Placebo (Placebo) | Autoantibodies Against Insulin Autoantibodies (IAA) | Week 0 | Negative | 36 Participants |
| Placebo (Placebo) | Autoantibodies Against Insulin Autoantibodies (IAA) | Week 54 | Negative | 11 Participants |
Secondary
Autoantibodies Against Islet Antigen-2 (IA2)
Participants were analyzed for autoantibodies against Islet antigen-2 (IA2) and were categorized as negative and positive.
Time frame: Week 0, week 54 and week 80
Population: The FAS included all randomised participants. Number analyzed = participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Autoantibodies Against Islet Antigen-2 (IA2) | Week 54 | Positive | 33 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Autoantibodies Against Islet Antigen-2 (IA2) | Week 54 | Negative | 35 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Autoantibodies Against Islet Antigen-2 (IA2) | Week 0 | Positive | 39 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Autoantibodies Against Islet Antigen-2 (IA2) | Week 80 | Positive | 33 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Autoantibodies Against Islet Antigen-2 (IA2) | Week 80 | Negative | 32 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Autoantibodies Against Islet Antigen-2 (IA2) | Week 0 | Negative | 38 Participants |
| NNC0114-0006 (Experimental) | Autoantibodies Against Islet Antigen-2 (IA2) | Week 0 | Positive | 40 Participants |
| NNC0114-0006 (Experimental) | Autoantibodies Against Islet Antigen-2 (IA2) | Week 0 | Negative | 37 Participants |
| NNC0114-0006 (Experimental) | Autoantibodies Against Islet Antigen-2 (IA2) | Week 80 | Positive | 26 Participants |
| NNC0114-0006 (Experimental) | Autoantibodies Against Islet Antigen-2 (IA2) | Week 80 | Negative | 38 Participants |
| NNC0114-0006 (Experimental) | Autoantibodies Against Islet Antigen-2 (IA2) | Week 54 | Negative | 33 Participants |
| NNC0114-0006 (Experimental) | Autoantibodies Against Islet Antigen-2 (IA2) | Week 54 | Positive | 32 Participants |
| Liraglutide (Experimental) | Autoantibodies Against Islet Antigen-2 (IA2) | Week 0 | Positive | 45 Participants |
| Liraglutide (Experimental) | Autoantibodies Against Islet Antigen-2 (IA2) | Week 0 | Negative | 31 Participants |
| Liraglutide (Experimental) | Autoantibodies Against Islet Antigen-2 (IA2) | Week 80 | Negative | 29 Participants |
| Liraglutide (Experimental) | Autoantibodies Against Islet Antigen-2 (IA2) | Week 54 | Positive | 40 Participants |
| Liraglutide (Experimental) | Autoantibodies Against Islet Antigen-2 (IA2) | Week 80 | Positive | 39 Participants |
| Liraglutide (Experimental) | Autoantibodies Against Islet Antigen-2 (IA2) | Week 54 | Negative | 28 Participants |
| Placebo (Placebo) | Autoantibodies Against Islet Antigen-2 (IA2) | Week 80 | Positive | 27 Participants |
| Placebo (Placebo) | Autoantibodies Against Islet Antigen-2 (IA2) | Week 0 | Positive | 32 Participants |
| Placebo (Placebo) | Autoantibodies Against Islet Antigen-2 (IA2) | Week 0 | Negative | 45 Participants |
| Placebo (Placebo) | Autoantibodies Against Islet Antigen-2 (IA2) | Week 54 | Negative | 38 Participants |
| Placebo (Placebo) | Autoantibodies Against Islet Antigen-2 (IA2) | Week 54 | Positive | 28 Participants |
| Placebo (Placebo) | Autoantibodies Against Islet Antigen-2 (IA2) | Week 80 | Negative | 35 Participants |
Secondary
Autoantibodies Against Zinc-transporter 8 (ZnT8)
Participants were analyzed for autoantibodies against Zinc-transporter 8 (ZnT8) and were categorized as negative and positive.
Time frame: Week 0, week 54 and week 80
Population: The FAS included all randomised participants. Number analyzed = participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Autoantibodies Against Zinc-transporter 8 (ZnT8) | Week 0 | Negative | 29 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Autoantibodies Against Zinc-transporter 8 (ZnT8) | Week 0 | Positive | 48 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Autoantibodies Against Zinc-transporter 8 (ZnT8) | Week 54 | Negative | 26 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Autoantibodies Against Zinc-transporter 8 (ZnT8) | Week 54 | Positive | 42 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Autoantibodies Against Zinc-transporter 8 (ZnT8) | Week 80 | Negative | 23 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Autoantibodies Against Zinc-transporter 8 (ZnT8) | Week 80 | Positive | 42 Participants |
| NNC0114-0006 (Experimental) | Autoantibodies Against Zinc-transporter 8 (ZnT8) | Week 80 | Positive | 34 Participants |
| NNC0114-0006 (Experimental) | Autoantibodies Against Zinc-transporter 8 (ZnT8) | Week 54 | Positive | 37 Participants |
| NNC0114-0006 (Experimental) | Autoantibodies Against Zinc-transporter 8 (ZnT8) | Week 0 | Negative | 30 Participants |
| NNC0114-0006 (Experimental) | Autoantibodies Against Zinc-transporter 8 (ZnT8) | Week 54 | Negative | 28 Participants |
| NNC0114-0006 (Experimental) | Autoantibodies Against Zinc-transporter 8 (ZnT8) | Week 0 | Positive | 47 Participants |
| NNC0114-0006 (Experimental) | Autoantibodies Against Zinc-transporter 8 (ZnT8) | Week 80 | Negative | 30 Participants |
| Liraglutide (Experimental) | Autoantibodies Against Zinc-transporter 8 (ZnT8) | Week 0 | Positive | 46 Participants |
| Liraglutide (Experimental) | Autoantibodies Against Zinc-transporter 8 (ZnT8) | Week 54 | Negative | 27 Participants |
| Liraglutide (Experimental) | Autoantibodies Against Zinc-transporter 8 (ZnT8) | Week 54 | Positive | 41 Participants |
| Liraglutide (Experimental) | Autoantibodies Against Zinc-transporter 8 (ZnT8) | Week 80 | Positive | 37 Participants |
| Liraglutide (Experimental) | Autoantibodies Against Zinc-transporter 8 (ZnT8) | Week 80 | Negative | 31 Participants |
| Liraglutide (Experimental) | Autoantibodies Against Zinc-transporter 8 (ZnT8) | Week 0 | Negative | 30 Participants |
| Placebo (Placebo) | Autoantibodies Against Zinc-transporter 8 (ZnT8) | Week 80 | Negative | 33 Participants |
| Placebo (Placebo) | Autoantibodies Against Zinc-transporter 8 (ZnT8) | Week 80 | Positive | 29 Participants |
| Placebo (Placebo) | Autoantibodies Against Zinc-transporter 8 (ZnT8) | Week 0 | Positive | 41 Participants |
| Placebo (Placebo) | Autoantibodies Against Zinc-transporter 8 (ZnT8) | Week 54 | Positive | 33 Participants |
| Placebo (Placebo) | Autoantibodies Against Zinc-transporter 8 (ZnT8) | Week 0 | Negative | 36 Participants |
| Placebo (Placebo) | Autoantibodies Against Zinc-transporter 8 (ZnT8) | Week 54 | Negative | 33 Participants |
Secondary
Before Breakfast 7- Points Self Measured Plasma Glucose (SMPG)
Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Before breakfast 7-point self-measured plasma glucose (SMPG) profile values are presented at week 54 and week 80.
Time frame: Week 54 and week 80
Population: The FAS included all randomised participants. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Before Breakfast 7- Points Self Measured Plasma Glucose (SMPG) | Week 54 | 6.8 mmol/L | Standard Deviation 3.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Before Breakfast 7- Points Self Measured Plasma Glucose (SMPG) | Week 80 | 6.5 mmol/L | Standard Deviation 1.7 |
| NNC0114-0006 (Experimental) | Before Breakfast 7- Points Self Measured Plasma Glucose (SMPG) | Week 80 | 6.4 mmol/L | Standard Deviation 2 |
| NNC0114-0006 (Experimental) | Before Breakfast 7- Points Self Measured Plasma Glucose (SMPG) | Week 54 | 6.8 mmol/L | Standard Deviation 2.7 |
| Liraglutide (Experimental) | Before Breakfast 7- Points Self Measured Plasma Glucose (SMPG) | Week 80 | 7.2 mmol/L | Standard Deviation 2.7 |
| Liraglutide (Experimental) | Before Breakfast 7- Points Self Measured Plasma Glucose (SMPG) | Week 54 | 6.4 mmol/L | Standard Deviation 2.2 |
| Placebo (Placebo) | Before Breakfast 7- Points Self Measured Plasma Glucose (SMPG) | Week 54 | 6.3 mmol/L | Standard Deviation 1.4 |
| Placebo (Placebo) | Before Breakfast 7- Points Self Measured Plasma Glucose (SMPG) | Week 80 | 6.8 mmol/L | Standard Deviation 2 |
Secondary
Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment (Average Over the Three Meals)
Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. Change from baseline (week 0) to week 54 and week 80 in 7-point self-measured plasma glucose (SMPG) postprandial glucose /prandial increment (average over the three meals) value is presented.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The FAS included all randomised participants. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment (Average Over the Three Meals) | Change from week 0 to week 54 | 0.9 mmol/L | Standard Deviation 2.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment (Average Over the Three Meals) | Change from week 0 to week 80 | 0.8 mmol/L | Standard Deviation 2.6 |
| NNC0114-0006 (Experimental) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment (Average Over the Three Meals) | Change from week 0 to week 80 | 0.4 mmol/L | Standard Deviation 2.2 |
| NNC0114-0006 (Experimental) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment (Average Over the Three Meals) | Change from week 0 to week 54 | 0.6 mmol/L | Standard Deviation 2.2 |
| Liraglutide (Experimental) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment (Average Over the Three Meals) | Change from week 0 to week 54 | 0.2 mmol/L | Standard Deviation 2 |
| Liraglutide (Experimental) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment (Average Over the Three Meals) | Change from week 0 to week 80 | 0.0 mmol/L | Standard Deviation 2.5 |
| Placebo (Placebo) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment (Average Over the Three Meals) | Change from week 0 to week 54 | -0.1 mmol/L | Standard Deviation 2 |
| Placebo (Placebo) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment (Average Over the Three Meals) | Change from week 0 to week 80 | -0.0 mmol/L | Standard Deviation 2.9 |
Secondary
Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner
Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Change from baseline (week 0) to week 54 and week 80 in 7-point SMPG postprandial glucose /prandial increment (breakfast, lunch and dinner) value are presented.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The FAS included all randomised participants. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner | Change from week 0 to week 54: Breakfast | 1.3 mmol/L | Standard Deviation 4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner | Change from week 0 to week 80: Breakfast | 1.9 mmol/L | Standard Deviation 4.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner | Change from week 0 to week 54: Lunch | 0.9 mmol/L | Standard Deviation 4.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner | Change from week 0 to week 80: Lunch | 0.0 mmol/L | Standard Deviation 4.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner | Change from week 0 to week 54: Dinner | 0.1 mmol/L | Standard Deviation 4.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner | Change from week 0 to week 80: Dinner | 0.5 mmol/L | Standard Deviation 5 |
| NNC0114-0006 (Experimental) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner | Change from week 0 to week 80: Dinner | 0.5 mmol/L | Standard Deviation 3.4 |
| NNC0114-0006 (Experimental) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner | Change from week 0 to week 80: Lunch | 0.1 mmol/L | Standard Deviation 3 |
| NNC0114-0006 (Experimental) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner | Change from week 0 to week 54: Breakfast | 0.4 mmol/L | Standard Deviation 3 |
| NNC0114-0006 (Experimental) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner | Change from week 0 to week 54: Lunch | 0.5 mmol/L | Standard Deviation 3.4 |
| NNC0114-0006 (Experimental) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner | Change from week 0 to week 80: Breakfast | 0.5 mmol/L | Standard Deviation 4 |
| NNC0114-0006 (Experimental) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner | Change from week 0 to week 54: Dinner | 1.1 mmol/L | Standard Deviation 4 |
| Liraglutide (Experimental) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner | Change from week 0 to week 80: Breakfast | -0.1 mmol/L | Standard Deviation 4.5 |
| Liraglutide (Experimental) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner | Change from week 0 to week 54: Lunch | 1.5 mmol/L | Standard Deviation 2.9 |
| Liraglutide (Experimental) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner | Change from week 0 to week 80: Lunch | 1.0 mmol/L | Standard Deviation 3.5 |
| Liraglutide (Experimental) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner | Change from week 0 to week 80: Dinner | -0.4 mmol/L | Standard Deviation 4.3 |
| Liraglutide (Experimental) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner | Change from week 0 to week 54: Dinner | -0.8 mmol/L | Standard Deviation 4.7 |
| Liraglutide (Experimental) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner | Change from week 0 to week 54: Breakfast | -0.1 mmol/L | Standard Deviation 3.8 |
| Placebo (Placebo) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner | Change from week 0 to week 54: Dinner | -0.3 mmol/L | Standard Deviation 3.1 |
| Placebo (Placebo) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner | Change from week 0 to week 80: Dinner | -0.4 mmol/L | Standard Deviation 3.2 |
| Placebo (Placebo) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner | Change from week 0 to week 80: Breakfast | -0.5 mmol/L | Standard Deviation 4.5 |
| Placebo (Placebo) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner | Change from week 0 to week 80: Lunch | 0.8 mmol/L | Standard Deviation 4.5 |
| Placebo (Placebo) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner | Change from week 0 to week 54: Breakfast | -0.6 mmol/L | Standard Deviation 2.4 |
| Placebo (Placebo) | Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner | Change from week 0 to week 54: Lunch | 0.7 mmol/L | Standard Deviation 2.7 |
Secondary
Change in Biochemistry: Alanine Aminotransferase (ALAT)
Change in ALAT (measured in units per liter \[U/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Alanine Aminotransferase (ALAT) | Change from week 0 to week 54 | 0.96 ratio of ALT | Geometric Coefficient of Variation 47.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Alanine Aminotransferase (ALAT) | Change from week 0 to week 80 | 0.95 ratio of ALT | Geometric Coefficient of Variation 54.7 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Alanine Aminotransferase (ALAT) | Change from week 0 to week 80 | 0.98 ratio of ALT | Geometric Coefficient of Variation 39.5 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Alanine Aminotransferase (ALAT) | Change from week 0 to week 54 | 0.98 ratio of ALT | Geometric Coefficient of Variation 35.9 |
| Liraglutide (Experimental) | Change in Biochemistry: Alanine Aminotransferase (ALAT) | Change from week 0 to week 54 | 0.97 ratio of ALT | Geometric Coefficient of Variation 46 |
| Liraglutide (Experimental) | Change in Biochemistry: Alanine Aminotransferase (ALAT) | Change from week 0 to week 80 | 1.06 ratio of ALT | Geometric Coefficient of Variation 40.7 |
| Placebo (Placebo) | Change in Biochemistry: Alanine Aminotransferase (ALAT) | Change from week 0 to week 54 | 0.90 ratio of ALT | Geometric Coefficient of Variation 44.1 |
| Placebo (Placebo) | Change in Biochemistry: Alanine Aminotransferase (ALAT) | Change from week 0 to week 80 | 0.92 ratio of ALT | Geometric Coefficient of Variation 40.6 |
Secondary
Change in Biochemistry: Albumin
Change in albumin (measured in gram per deciliter \[g/dL\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Albumin | Change from week 0 to week 80 | 1.00 ratio of albumin | Standard Deviation 6.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Albumin | Change from week 0 to week 54 | 0.99 ratio of albumin | Standard Deviation 7.3 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Albumin | Change from week 0 to week 54 | 1.00 ratio of albumin | Standard Deviation 6 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Albumin | Change from week 0 to week 80 | 1.01 ratio of albumin | Standard Deviation 6.9 |
| Liraglutide (Experimental) | Change in Biochemistry: Albumin | Change from week 0 to week 80 | 1.00 ratio of albumin | Standard Deviation 6.7 |
| Liraglutide (Experimental) | Change in Biochemistry: Albumin | Change from week 0 to week 54 | 1.02 ratio of albumin | Standard Deviation 7.4 |
| Placebo (Placebo) | Change in Biochemistry: Albumin | Change from week 0 to week 80 | 0.99 ratio of albumin | Standard Deviation 6.9 |
| Placebo (Placebo) | Change in Biochemistry: Albumin | Change from week 0 to week 54 | 0.99 ratio of albumin | Standard Deviation 7.5 |
Secondary
Change in Biochemistry: Alkaline Phosphatase (ALP)
Change in ALP (measured in units per liter \[U/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Alkaline Phosphatase (ALP) | Change from week 0 to week 54 | 1.03 Ratio of ALP | Geometric Coefficient of Variation 28.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Alkaline Phosphatase (ALP) | Change from week 0 to week 80 | 1.07 Ratio of ALP | Geometric Coefficient of Variation 30.3 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Alkaline Phosphatase (ALP) | Change from week 0 to week 80 | 1.05 Ratio of ALP | Geometric Coefficient of Variation 16.5 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Alkaline Phosphatase (ALP) | Change from week 0 to week 54 | 0.99 Ratio of ALP | Geometric Coefficient of Variation 17.8 |
| Liraglutide (Experimental) | Change in Biochemistry: Alkaline Phosphatase (ALP) | Change from week 0 to week 54 | 0.99 Ratio of ALP | Geometric Coefficient of Variation 18.1 |
| Liraglutide (Experimental) | Change in Biochemistry: Alkaline Phosphatase (ALP) | Change from week 0 to week 80 | 1.04 Ratio of ALP | Geometric Coefficient of Variation 22.1 |
| Placebo (Placebo) | Change in Biochemistry: Alkaline Phosphatase (ALP) | Change from week 0 to week 54 | 1.03 Ratio of ALP | Geometric Coefficient of Variation 17.9 |
| Placebo (Placebo) | Change in Biochemistry: Alkaline Phosphatase (ALP) | Change from week 0 to week 80 | 1.04 Ratio of ALP | Geometric Coefficient of Variation 21.7 |
Secondary
Change in Biochemistry: Amylase
Change in amylase (measured in units per liter \[U/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Amylase | Change from week 0 to week 54 | 1.07 ratio of Amylase | Geometric Coefficient of Variation 20.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Amylase | Change from week 0 to week 80 | 1.04 ratio of Amylase | Geometric Coefficient of Variation 24.3 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Amylase | Change from week 0 to week 80 | 0.99 ratio of Amylase | Geometric Coefficient of Variation 14.9 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Amylase | Change from week 0 to week 54 | 0.98 ratio of Amylase | Geometric Coefficient of Variation 16.6 |
| Liraglutide (Experimental) | Change in Biochemistry: Amylase | Change from week 0 to week 54 | 1.04 ratio of Amylase | Geometric Coefficient of Variation 18.9 |
| Liraglutide (Experimental) | Change in Biochemistry: Amylase | Change from week 0 to week 80 | 1.03 ratio of Amylase | Geometric Coefficient of Variation 19.8 |
| Placebo (Placebo) | Change in Biochemistry: Amylase | Change from week 0 to week 54 | 1.01 ratio of Amylase | Geometric Coefficient of Variation 19.2 |
| Placebo (Placebo) | Change in Biochemistry: Amylase | Change from week 0 to week 80 | 1.04 ratio of Amylase | Geometric Coefficient of Variation 26.1 |
Secondary
Change in Biochemistry: Aspartate Aminotransferase (ASAT)
Change in ASAT (measured in units per liter \[U/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Aspartate Aminotransferase (ASAT) | Change from week 0 to week 80 | 0.98 Ratio of AST | Geometric Coefficient of Variation 39.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Aspartate Aminotransferase (ASAT) | Change from week 0 to week 54 | 0.99 Ratio of AST | Geometric Coefficient of Variation 39.3 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Aspartate Aminotransferase (ASAT) | Change from week 0 to week 54 | 0.99 Ratio of AST | Geometric Coefficient of Variation 34.5 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Aspartate Aminotransferase (ASAT) | Change from week 0 to week 80 | 0.98 Ratio of AST | Geometric Coefficient of Variation 32.4 |
| Liraglutide (Experimental) | Change in Biochemistry: Aspartate Aminotransferase (ASAT) | Change from week 0 to week 80 | 1.09 Ratio of AST | Geometric Coefficient of Variation 34.6 |
| Liraglutide (Experimental) | Change in Biochemistry: Aspartate Aminotransferase (ASAT) | Change from week 0 to week 54 | 1.00 Ratio of AST | Geometric Coefficient of Variation 57 |
| Placebo (Placebo) | Change in Biochemistry: Aspartate Aminotransferase (ASAT) | Change from week 0 to week 80 | 0.99 Ratio of AST | Geometric Coefficient of Variation 39.3 |
| Placebo (Placebo) | Change in Biochemistry: Aspartate Aminotransferase (ASAT) | Change from week 0 to week 54 | 0.98 Ratio of AST | Geometric Coefficient of Variation 43.1 |
Secondary
Change in Biochemistry: Blood Urea Nitrogen Serum
Change in blood urea nitrogen serum (measured in milligram per deciliter \[mg/dL\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Blood Urea Nitrogen Serum | Change from week 0 to week 54 | 1.00 Ratio of Blood Urea Nitrogen serum | Geometric Coefficient of Variation 27 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Blood Urea Nitrogen Serum | Change from week 0 to week 80 | 0.97 Ratio of Blood Urea Nitrogen serum | Geometric Coefficient of Variation 33.2 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Blood Urea Nitrogen Serum | Change from week 0 to week 80 | 0.97 Ratio of Blood Urea Nitrogen serum | Geometric Coefficient of Variation 26.2 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Blood Urea Nitrogen Serum | Change from week 0 to week 54 | 1.05 Ratio of Blood Urea Nitrogen serum | Geometric Coefficient of Variation 22.4 |
| Liraglutide (Experimental) | Change in Biochemistry: Blood Urea Nitrogen Serum | Change from week 0 to week 80 | 0.98 Ratio of Blood Urea Nitrogen serum | Geometric Coefficient of Variation 28.9 |
| Liraglutide (Experimental) | Change in Biochemistry: Blood Urea Nitrogen Serum | Change from week 0 to week 54 | 0.98 Ratio of Blood Urea Nitrogen serum | Geometric Coefficient of Variation 22 |
| Placebo (Placebo) | Change in Biochemistry: Blood Urea Nitrogen Serum | Change from week 0 to week 80 | 0.97 Ratio of Blood Urea Nitrogen serum | Geometric Coefficient of Variation 28.2 |
| Placebo (Placebo) | Change in Biochemistry: Blood Urea Nitrogen Serum | Change from week 0 to week 54 | 0.94 Ratio of Blood Urea Nitrogen serum | Geometric Coefficient of Variation 23.3 |
Secondary
Change in Biochemistry: Calcium Corrected
Change in calcium corrected (measured in millimole per liter \[mmol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Calcium Corrected | Change from week 0 to week 54 | 0.99 ratio of calcium | Geometric Coefficient of Variation 3.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Calcium Corrected | Change from week 0 to week 80 | 0.96 ratio of calcium | Geometric Coefficient of Variation 3.5 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Calcium Corrected | Change from week 0 to week 80 | 0.97 ratio of calcium | Geometric Coefficient of Variation 4 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Calcium Corrected | Change from week 0 to week 54 | 0.98 ratio of calcium | Geometric Coefficient of Variation 3.6 |
| Liraglutide (Experimental) | Change in Biochemistry: Calcium Corrected | Change from week 0 to week 54 | 0.98 ratio of calcium | Geometric Coefficient of Variation 4 |
| Liraglutide (Experimental) | Change in Biochemistry: Calcium Corrected | Change from week 0 to week 80 | 0.98 ratio of calcium | Geometric Coefficient of Variation 3.9 |
| Placebo (Placebo) | Change in Biochemistry: Calcium Corrected | Change from week 0 to week 54 | 0.99 ratio of calcium | Geometric Coefficient of Variation 4.2 |
| Placebo (Placebo) | Change in Biochemistry: Calcium Corrected | Change from week 0 to week 80 | 0.98 ratio of calcium | Geometric Coefficient of Variation 4 |
Secondary
Change in Biochemistry: Chloride
Change in chloride (measured in millimole per liter \[mmol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Chloride | Change from week 0 to week 54 | 1.01 ratio of chloride | Geometric Coefficient of Variation 2.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Chloride | Change from week 0 to week 80 | 1.00 ratio of chloride | Geometric Coefficient of Variation 2.3 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Chloride | Change from week 0 to week 80 | 1.01 ratio of chloride | Geometric Coefficient of Variation 2.7 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Chloride | Change from week 0 to week 54 | 1.00 ratio of chloride | Geometric Coefficient of Variation 2.2 |
| Liraglutide (Experimental) | Change in Biochemistry: Chloride | Change from week 0 to week 54 | 1.00 ratio of chloride | Geometric Coefficient of Variation 2.8 |
| Liraglutide (Experimental) | Change in Biochemistry: Chloride | Change from week 0 to week 80 | 1.00 ratio of chloride | Geometric Coefficient of Variation 3 |
| Placebo (Placebo) | Change in Biochemistry: Chloride | Change from week 0 to week 54 | 1.00 ratio of chloride | Geometric Coefficient of Variation 3.1 |
| Placebo (Placebo) | Change in Biochemistry: Chloride | Change from week 0 to week 80 | 1.00 ratio of chloride | Geometric Coefficient of Variation 3 |
Secondary
Change in Biochemistry: C-reactive Protein Serum
Change in C-reactive protein serum (measured in milligrams per liter \[mg/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: C-reactive Protein Serum | Change from week 0 to week 54 | 0.92 Ratio of C-reactive protein | Geometric Coefficient of Variation 141.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: C-reactive Protein Serum | Change from week 0 to week 80 | 1.08 Ratio of C-reactive protein | Geometric Coefficient of Variation 103.8 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: C-reactive Protein Serum | Change from week 0 to week 80 | 0.94 Ratio of C-reactive protein | Geometric Coefficient of Variation 81 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: C-reactive Protein Serum | Change from week 0 to week 54 | 1.04 Ratio of C-reactive protein | Geometric Coefficient of Variation 93 |
| Liraglutide (Experimental) | Change in Biochemistry: C-reactive Protein Serum | Change from week 0 to week 54 | 0.89 Ratio of C-reactive protein | Geometric Coefficient of Variation 87.8 |
| Liraglutide (Experimental) | Change in Biochemistry: C-reactive Protein Serum | Change from week 0 to week 80 | 1.25 Ratio of C-reactive protein | Geometric Coefficient of Variation 134.7 |
| Placebo (Placebo) | Change in Biochemistry: C-reactive Protein Serum | Change from week 0 to week 54 | 1.06 Ratio of C-reactive protein | Geometric Coefficient of Variation 78 |
| Placebo (Placebo) | Change in Biochemistry: C-reactive Protein Serum | Change from week 0 to week 80 | 1.06 Ratio of C-reactive protein | Geometric Coefficient of Variation 70.1 |
Secondary
Change in Biochemistry: Creatine Kinase
Change in creatine kinase (measured in units per liter \[U/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Creatine Kinase | Change from week 0 to week 54 | 1.16 Ratio of Creatine Kinase | Geometric Coefficient of Variation 86.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Creatine Kinase | Change from week 0 to week 80 | 1.11 Ratio of Creatine Kinase | Geometric Coefficient of Variation 48.1 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Creatine Kinase | Change from week 0 to week 54 | 1.17 Ratio of Creatine Kinase | Geometric Coefficient of Variation 64.5 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Creatine Kinase | Change from week 0 to week 80 | 1.09 Ratio of Creatine Kinase | Geometric Coefficient of Variation 68.3 |
| Liraglutide (Experimental) | Change in Biochemistry: Creatine Kinase | Change from week 0 to week 80 | 1.24 Ratio of Creatine Kinase | Geometric Coefficient of Variation 87.2 |
| Liraglutide (Experimental) | Change in Biochemistry: Creatine Kinase | Change from week 0 to week 54 | 1.08 Ratio of Creatine Kinase | Geometric Coefficient of Variation 140.2 |
| Placebo (Placebo) | Change in Biochemistry: Creatine Kinase | Change from week 0 to week 54 | 1.02 Ratio of Creatine Kinase | Geometric Coefficient of Variation 72.8 |
| Placebo (Placebo) | Change in Biochemistry: Creatine Kinase | Change from week 0 to week 80 | 1.13 Ratio of Creatine Kinase | Geometric Coefficient of Variation 76.5 |
Secondary
Change in Biochemistry: Creatinine
Change in creatinine (measured in micromole per liter \[umol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Creatinine | Change from week 0 to week 54 | 1.01 Ratio of Creatinine | Geometric Coefficient of Variation 12 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Creatinine | Change from week 0 to week 80 | 1.02 Ratio of Creatinine | Geometric Coefficient of Variation 11.2 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Creatinine | Change from week 0 to week 80 | 1.05 Ratio of Creatinine | Geometric Coefficient of Variation 14.3 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Creatinine | Change from week 0 to week 54 | 1.05 Ratio of Creatinine | Geometric Coefficient of Variation 10.6 |
| Liraglutide (Experimental) | Change in Biochemistry: Creatinine | Change from week 0 to week 54 | 1.04 Ratio of Creatinine | Geometric Coefficient of Variation 12.8 |
| Liraglutide (Experimental) | Change in Biochemistry: Creatinine | Change from week 0 to week 80 | 1.05 Ratio of Creatinine | Geometric Coefficient of Variation 13.1 |
| Placebo (Placebo) | Change in Biochemistry: Creatinine | Change from week 0 to week 54 | 1.01 Ratio of Creatinine | Geometric Coefficient of Variation 9.9 |
| Placebo (Placebo) | Change in Biochemistry: Creatinine | Change from week 0 to week 80 | 1.02 Ratio of Creatinine | Geometric Coefficient of Variation 12.3 |
Secondary
Change in Biochemistry: Gamma-glutamyl Transferase (GGT)
Change in GGT (measured in units per liter \[U/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Gamma-glutamyl Transferase (GGT) | Change from week 0 to week 54 | 1.02 Ratio of GGT | Geometric Coefficient of Variation 38.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Gamma-glutamyl Transferase (GGT) | Change from week 0 to week 80 | 1.05 Ratio of GGT | Geometric Coefficient of Variation 41.9 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Gamma-glutamyl Transferase (GGT) | Change from week 0 to week 80 | 1.13 Ratio of GGT | Geometric Coefficient of Variation 29.4 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Gamma-glutamyl Transferase (GGT) | Change from week 0 to week 54 | 1.08 Ratio of GGT | Geometric Coefficient of Variation 27.7 |
| Liraglutide (Experimental) | Change in Biochemistry: Gamma-glutamyl Transferase (GGT) | Change from week 0 to week 54 | 1.03 Ratio of GGT | Geometric Coefficient of Variation 37.2 |
| Liraglutide (Experimental) | Change in Biochemistry: Gamma-glutamyl Transferase (GGT) | Change from week 0 to week 80 | 1.10 Ratio of GGT | Geometric Coefficient of Variation 41.1 |
| Placebo (Placebo) | Change in Biochemistry: Gamma-glutamyl Transferase (GGT) | Change from week 0 to week 54 | 1.02 Ratio of GGT | Geometric Coefficient of Variation 41.8 |
| Placebo (Placebo) | Change in Biochemistry: Gamma-glutamyl Transferase (GGT) | Change from week 0 to week 80 | 1.00 Ratio of GGT | Geometric Coefficient of Variation 36.8 |
Secondary
Change in Biochemistry: Lactate Dehydrogenase
Change in Lactate Dehydrogenase (measured in units per liter \[U/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Lactate Dehydrogenase | Change from week 0 to week 54 | 0.99 Ratio of Lactate Dehydrogenase | Geometric Coefficient of Variation 12.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Lactate Dehydrogenase | Change from week 0 to week 80 | 1.02 Ratio of Lactate Dehydrogenase | Geometric Coefficient of Variation 12.1 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Lactate Dehydrogenase | Change from week 0 to week 80 | 1.04 Ratio of Lactate Dehydrogenase | Geometric Coefficient of Variation 19.6 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Lactate Dehydrogenase | Change from week 0 to week 54 | 1.03 Ratio of Lactate Dehydrogenase | Geometric Coefficient of Variation 18.4 |
| Liraglutide (Experimental) | Change in Biochemistry: Lactate Dehydrogenase | Change from week 0 to week 54 | 1.04 Ratio of Lactate Dehydrogenase | Geometric Coefficient of Variation 23.3 |
| Liraglutide (Experimental) | Change in Biochemistry: Lactate Dehydrogenase | Change from week 0 to week 80 | 1.09 Ratio of Lactate Dehydrogenase | Geometric Coefficient of Variation 19.3 |
| Placebo (Placebo) | Change in Biochemistry: Lactate Dehydrogenase | Change from week 0 to week 54 | 1.03 Ratio of Lactate Dehydrogenase | Geometric Coefficient of Variation 16.5 |
| Placebo (Placebo) | Change in Biochemistry: Lactate Dehydrogenase | Change from week 0 to week 80 | 1.03 Ratio of Lactate Dehydrogenase | Geometric Coefficient of Variation 17.8 |
Secondary
Change in Biochemistry: Lipase
Change in lipase (measured in units per liter \[U/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Lipase | Change from week 0 to week 54 | 1.49 Ratio of lipase | Geometric Coefficient of Variation 36.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Lipase | Change from week 0 to week 80 | 1.05 Ratio of lipase | Geometric Coefficient of Variation 40.4 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Lipase | Change from week 0 to week 80 | 0.94 Ratio of lipase | Geometric Coefficient of Variation 27.2 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Lipase | Change from week 0 to week 54 | 1.00 Ratio of lipase | Geometric Coefficient of Variation 27.4 |
| Liraglutide (Experimental) | Change in Biochemistry: Lipase | Change from week 0 to week 54 | 1.34 Ratio of lipase | Geometric Coefficient of Variation 36.2 |
| Liraglutide (Experimental) | Change in Biochemistry: Lipase | Change from week 0 to week 80 | 1.02 Ratio of lipase | Geometric Coefficient of Variation 26.5 |
| Placebo (Placebo) | Change in Biochemistry: Lipase | Change from week 0 to week 54 | 1.01 Ratio of lipase | Geometric Coefficient of Variation 29.4 |
| Placebo (Placebo) | Change in Biochemistry: Lipase | Change from week 0 to week 80 | 0.96 Ratio of lipase | Geometric Coefficient of Variation 37.2 |
Secondary
Change in Biochemistry: Magnesium
Change in magnesium (measured in millimole per liter \[mmol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Magnesium | Change from week 0 to week 54 | 1.02 Ratio of magnesium | Geometric Coefficient of Variation 8.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Magnesium | Change from week 0 to week 80 | 1.01 Ratio of magnesium | Geometric Coefficient of Variation 10.7 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Magnesium | Change from week 0 to week 80 | 1.03 Ratio of magnesium | Geometric Coefficient of Variation 11.2 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Magnesium | Change from week 0 to week 54 | 1.01 Ratio of magnesium | Geometric Coefficient of Variation 7.6 |
| Liraglutide (Experimental) | Change in Biochemistry: Magnesium | Change from week 0 to week 54 | 1.02 Ratio of magnesium | Geometric Coefficient of Variation 7.8 |
| Liraglutide (Experimental) | Change in Biochemistry: Magnesium | Change from week 0 to week 80 | 1.02 Ratio of magnesium | Geometric Coefficient of Variation 9 |
| Placebo (Placebo) | Change in Biochemistry: Magnesium | Change from week 0 to week 54 | 0.99 Ratio of magnesium | Geometric Coefficient of Variation 8.1 |
| Placebo (Placebo) | Change in Biochemistry: Magnesium | Change from week 0 to week 80 | 0.98 Ratio of magnesium | Geometric Coefficient of Variation 9.2 |
Secondary
Change in Biochemistry: Phosphate
Change in phosphate (measured in millimole per liter \[mmol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Phosphate | Change from week 0 to week 54 | 0.99 Ratio of phosphate | Geometric Coefficient of Variation 16 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Phosphate | Change from week 0 to week 80 | 1.02 Ratio of phosphate | Geometric Coefficient of Variation 20.5 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Phosphate | Change from week 0 to week 80 | 1.01 Ratio of phosphate | Geometric Coefficient of Variation 16.9 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Phosphate | Change from week 0 to week 54 | 0.99 Ratio of phosphate | Geometric Coefficient of Variation 16.6 |
| Liraglutide (Experimental) | Change in Biochemistry: Phosphate | Change from week 0 to week 54 | 1.02 Ratio of phosphate | Geometric Coefficient of Variation 13.9 |
| Liraglutide (Experimental) | Change in Biochemistry: Phosphate | Change from week 0 to week 80 | 1.03 Ratio of phosphate | Geometric Coefficient of Variation 19.9 |
| Placebo (Placebo) | Change in Biochemistry: Phosphate | Change from week 0 to week 54 | 0.96 Ratio of phosphate | Geometric Coefficient of Variation 18.6 |
| Placebo (Placebo) | Change in Biochemistry: Phosphate | Change from week 0 to week 80 | 0.99 Ratio of phosphate | Geometric Coefficient of Variation 17.4 |
Secondary
Change in Biochemistry: Potassium
Change in potassium (measured in millimole per liter \[mmol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Potassium | Change from week 0 to week 54 | 1.01 Ratio of potassium | Geometric Coefficient of Variation 8.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Potassium | Change from week 0 to week 80 | 0.99 Ratio of potassium | Geometric Coefficient of Variation 8.3 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Potassium | Change from week 0 to week 80 | 0.99 Ratio of potassium | Geometric Coefficient of Variation 6.9 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Potassium | Change from week 0 to week 54 | 0.98 Ratio of potassium | Geometric Coefficient of Variation 6.9 |
| Liraglutide (Experimental) | Change in Biochemistry: Potassium | Change from week 0 to week 54 | 0.99 Ratio of potassium | Geometric Coefficient of Variation 8.3 |
| Liraglutide (Experimental) | Change in Biochemistry: Potassium | Change from week 0 to week 80 | 0.98 Ratio of potassium | Geometric Coefficient of Variation 8.5 |
| Placebo (Placebo) | Change in Biochemistry: Potassium | Change from week 0 to week 54 | 0.98 Ratio of potassium | Geometric Coefficient of Variation 10.4 |
| Placebo (Placebo) | Change in Biochemistry: Potassium | Change from week 0 to week 80 | 0.98 Ratio of potassium | Geometric Coefficient of Variation 10 |
Secondary
Change in Biochemistry: Sodium
Change in sodium (measured in millimole per liter \[mmol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Sodium | Change from week 0 to week 54 | 1.00 Ratio of sodium | Geometric Coefficient of Variation 1.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Sodium | Change from week 0 to week 80 | 0.99 Ratio of sodium | Geometric Coefficient of Variation 1.8 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Sodium | Change from week 0 to week 54 | 1.00 Ratio of sodium | Geometric Coefficient of Variation 1.4 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Sodium | Change from week 0 to week 80 | 1.00 Ratio of sodium | Geometric Coefficient of Variation 2.1 |
| Liraglutide (Experimental) | Change in Biochemistry: Sodium | Change from week 0 to week 80 | 1.00 Ratio of sodium | Geometric Coefficient of Variation 2.3 |
| Liraglutide (Experimental) | Change in Biochemistry: Sodium | Change from week 0 to week 54 | 1.00 Ratio of sodium | Geometric Coefficient of Variation 1.9 |
| Placebo (Placebo) | Change in Biochemistry: Sodium | Change from week 0 to week 80 | 1.00 Ratio of sodium | Geometric Coefficient of Variation 1.8 |
| Placebo (Placebo) | Change in Biochemistry: Sodium | Change from week 0 to week 54 | 1.00 Ratio of sodium | Geometric Coefficient of Variation 2 |
Secondary
Change in Biochemistry: Total Bilirubin
Change in Total bilirubin (measured in micromole per liter \[umol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Total Bilirubin | Change from week 0 to week 80 | 0.91 ratio of total bilirubin | Geometric Coefficient of Variation 44.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Total Bilirubin | Change from week 0 to week 54 | 0.81 ratio of total bilirubin | Geometric Coefficient of Variation 61.7 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Total Bilirubin | Change from week 0 to week 80 | 1.04 ratio of total bilirubin | Geometric Coefficient of Variation 74.8 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Total Bilirubin | Change from week 0 to week 54 | 1.10 ratio of total bilirubin | Geometric Coefficient of Variation 56.5 |
| Liraglutide (Experimental) | Change in Biochemistry: Total Bilirubin | Change from week 0 to week 80 | 0.98 ratio of total bilirubin | Geometric Coefficient of Variation 55.1 |
| Liraglutide (Experimental) | Change in Biochemistry: Total Bilirubin | Change from week 0 to week 54 | 0.99 ratio of total bilirubin | Geometric Coefficient of Variation 49.8 |
| Placebo (Placebo) | Change in Biochemistry: Total Bilirubin | Change from week 0 to week 54 | 1.01 ratio of total bilirubin | Geometric Coefficient of Variation 59.4 |
| Placebo (Placebo) | Change in Biochemistry: Total Bilirubin | Change from week 0 to week 80 | 0.99 ratio of total bilirubin | Geometric Coefficient of Variation 58.7 |
Secondary
Change in Biochemistry: Total Protein
Change in total protein (measured in gram per liter \[g/dL\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Total Protein | Change from week 0 to week 54 | 0.99 Ratio of total protein | Geometric Coefficient of Variation 6.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Total Protein | Change from week 0 to week 80 | 0.99 Ratio of total protein | Geometric Coefficient of Variation 6.5 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Total Protein | Change from week 0 to week 80 | 1.00 Ratio of total protein | Geometric Coefficient of Variation 6.4 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Total Protein | Change from week 0 to week 54 | 1.00 Ratio of total protein | Geometric Coefficient of Variation 6 |
| Liraglutide (Experimental) | Change in Biochemistry: Total Protein | Change from week 0 to week 54 | 1.01 Ratio of total protein | Geometric Coefficient of Variation 7.2 |
| Liraglutide (Experimental) | Change in Biochemistry: Total Protein | Change from week 0 to week 80 | 1.00 Ratio of total protein | Geometric Coefficient of Variation 6.6 |
| Placebo (Placebo) | Change in Biochemistry: Total Protein | Change from week 0 to week 54 | 1.00 Ratio of total protein | Geometric Coefficient of Variation 7.6 |
| Placebo (Placebo) | Change in Biochemistry: Total Protein | Change from week 0 to week 80 | 1.00 Ratio of total protein | Geometric Coefficient of Variation 7.4 |
Secondary
Change in Biochemistry: Uric Acid
Change in Uric Acid (measured in milligram per deciliter \[mg/dL\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Uric Acid | Change from week 0 to week 54 | 0.93 Ratio of uric acid | Geometric Coefficient of Variation 21.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biochemistry: Uric Acid | Change from week 0 to week 80 | 0.95 Ratio of uric acid | Geometric Coefficient of Variation 17.1 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Uric Acid | Change from week 0 to week 80 | 0.94 Ratio of uric acid | Geometric Coefficient of Variation 19.1 |
| NNC0114-0006 (Experimental) | Change in Biochemistry: Uric Acid | Change from week 0 to week 54 | 0.98 Ratio of uric acid | Geometric Coefficient of Variation 17.6 |
| Liraglutide (Experimental) | Change in Biochemistry: Uric Acid | Change from week 0 to week 54 | 0.98 Ratio of uric acid | Geometric Coefficient of Variation 18.8 |
| Liraglutide (Experimental) | Change in Biochemistry: Uric Acid | Change from week 0 to week 80 | 0.96 Ratio of uric acid | Geometric Coefficient of Variation 22.2 |
| Placebo (Placebo) | Change in Biochemistry: Uric Acid | Change from week 0 to week 54 | 0.96 Ratio of uric acid | Geometric Coefficient of Variation 18 |
| Placebo (Placebo) | Change in Biochemistry: Uric Acid | Change from week 0 to week 80 | 0.95 Ratio of uric acid | Geometric Coefficient of Variation 19.6 |
Secondary
Change in Biomarker: Immune Phenotyping- B Cell Panel
B cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80. In below table CD refer to Cluster of Differentiation; IgMNeg refers to Immunoglobulin M negative; IgDNeg refers to Immunoglobulin D negative.
Time frame: Week 0, week 54 and week 80
Population: The FAS included all randomised participants. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: IgMNeg IgDNeg Switched Memory B-cells | 0.1 Percentage of B cells (%) | Standard Deviation 0.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Activated Memory B-Cells | 1.3 Percentage of B cells (%) | Standard Deviation 0.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Transitional B-Cells | 10.8 Percentage of B cells (%) | Standard Deviation 6.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Non-Class Switched Memory B-Cells | 8.2 Percentage of B cells (%) | Standard Deviation 4.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: CD20Neg B-Cell | 0.5 Percentage of B cells (%) | Standard Deviation 0.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Transitional B-Cells | 10.2 Percentage of B cells (%) | Standard Deviation 5.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Transitional B-Cells | 11.4 Percentage of B cells (%) | Standard Deviation 6.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Total B-Cell Population | 72.5 Percentage of B cells (%) | Standard Deviation 9.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: CD20Neg B-Cell | 0.6 Percentage of B cells (%) | Standard Deviation 0.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Total B-Cell Population | 71.4 Percentage of B cells (%) | Standard Deviation 10.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Total B-Cell Population | 71.7 Percentage of B cells (%) | Standard Deviation 12.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: B-Cells Positive For Both CD19 & CD20 | 71.1 Percentage of B cells (%) | Standard Deviation 12.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: CD20Neg B-Cell | 0.6 Percentage of B cells (%) | Standard Deviation 0.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: CD24- B-Cells | 29.8 Percentage of B cells (%) | Standard Deviation 10.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Class-Switched Memory B Cells | 4.6 Percentage of B cells (%) | Standard Deviation 3.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: B-Cells Positive For Both CD19 & CD20 | 71.9 Percentage of B cells (%) | Standard Deviation 9.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Class-Switched Memory B Cells | 5.0 Percentage of B cells (%) | Standard Deviation 3.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Class-Switched Memory B Cells | 5.0 Percentage of B cells (%) | Standard Deviation 3.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Antibody-Secreting Cells | 0.5 Percentage of B cells (%) | Standard Deviation 0.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Antibody-Secreting Cells | 0.6 Percentage of B cells (%) | Standard Deviation 0.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: IgMNeg IgDNeg Switched Memory B-cells | 0.1 Percentage of B cells (%) | Standard Deviation 0.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: CD24- B-Cells | 30.0 Percentage of B cells (%) | Standard Deviation 8.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Antibody-Secreting Cells | 0.6 Percentage of B cells (%) | Standard Deviation 0.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Mature Naive B-Cells | 14.3 Percentage of B cells (%) | Standard Deviation 7.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: IgMNeg IgDNeg Switched Memory B-cells | 0.1 Percentage of B cells (%) | Standard Deviation 0.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: CD24- B-Cells | 30.2 Percentage of B cells (%) | Standard Deviation 9.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Mature Naive B-Cells | 14.0 Percentage of B cells (%) | Standard Deviation 6.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Mature Naive B-Cells | 15.1 Percentage of B cells (%) | Standard Deviation 6.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Non-Class Switched Memory B-Cells | 10.2 Percentage of B cells (%) | Standard Deviation 6.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: B-Cells Positive For Both CD19 & CD20 | 71.0 Percentage of B cells (%) | Standard Deviation 10.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Activated Memory B-Cells | 1.2 Percentage of B cells (%) | Standard Deviation 0.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Activated Memory B-Cells | 1.2 Percentage of B cells (%) | Standard Deviation 0.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Non-Class Switched Memory B-Cells | 8.5 Percentage of B cells (%) | Standard Deviation 4.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: B-Cells Positive For Both CD19 & CD20 | 70.8 Percentage of B cells (%) | Standard Deviation 12.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Antibody-Secreting Cells | 0.4 Percentage of B cells (%) | Standard Deviation 0.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: B-Cells Positive For Both CD19 & CD20 | 69.8 Percentage of B cells (%) | Standard Deviation 11.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: CD24- B-Cells | 31.0 Percentage of B cells (%) | Standard Deviation 11.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: IgMNeg IgDNeg Switched Memory B-cells | 0.1 Percentage of B cells (%) | Standard Deviation 0.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: IgMNeg IgDNeg Switched Memory B-cells | 0.1 Percentage of B cells (%) | Standard Deviation 0.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: IgMNeg IgDNeg Switched Memory B-cells | 0.2 Percentage of B cells (%) | Standard Deviation 0.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Non-Class Switched Memory B-Cells | 9.6 Percentage of B cells (%) | Standard Deviation 5.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Non-Class Switched Memory B-Cells | 9.0 Percentage of B cells (%) | Standard Deviation 5.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Non-Class Switched Memory B-Cells | 7.2 Percentage of B cells (%) | Standard Deviation 4.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Total B-Cell Population | 71.7 Percentage of B cells (%) | Standard Deviation 11.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Total B-Cell Population | 71.3 Percentage of B cells (%) | Standard Deviation 11.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Total B-Cell Population | 70.3 Percentage of B cells (%) | Standard Deviation 11.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Transitional B-Cells | 9.9 Percentage of B cells (%) | Standard Deviation 6.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Transitional B-Cells | 10.7 Percentage of B cells (%) | Standard Deviation 7.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Transitional B-Cells | 10.5 Percentage of B cells (%) | Standard Deviation 8.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Activated Memory B-Cells | 1.4 Percentage of B cells (%) | Standard Deviation 1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Activated Memory B-Cells | 1.1 Percentage of B cells (%) | Standard Deviation 1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Activated Memory B-Cells | 1.1 Percentage of B cells (%) | Standard Deviation 0.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Mature Naive B-Cells | 14.0 Percentage of B cells (%) | Standard Deviation 7.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Mature Naive B-Cells | 14.3 Percentage of B cells (%) | Standard Deviation 7.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Mature Naive B-Cells | 14.2 Percentage of B cells (%) | Standard Deviation 8.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Antibody-Secreting Cells | 0.5 Percentage of B cells (%) | Standard Deviation 0.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Antibody-Secreting Cells | 0.4 Percentage of B cells (%) | Standard Deviation 0.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: B-Cells Positive For Both CD19 & CD20 | 71.1 Percentage of B cells (%) | Standard Deviation 11.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: CD20Neg B-Cell | 0.6 Percentage of B cells (%) | Standard Deviation 0.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: CD20Neg B-Cell | 0.5 Percentage of B cells (%) | Standard Deviation 0.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: CD20Neg B-Cell | 0.5 Percentage of B cells (%) | Standard Deviation 0.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: CD24- B-Cells | 30.6 Percentage of B cells (%) | Standard Deviation 10.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: CD24- B-Cells | 31.6 Percentage of B cells (%) | Standard Deviation 10.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Class-Switched Memory B Cells | 4.6 Percentage of B cells (%) | Standard Deviation 2.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Class-Switched Memory B Cells | 4.2 Percentage of B cells (%) | Standard Deviation 2.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Class-Switched Memory B Cells | 3.6 Percentage of B cells (%) | Standard Deviation 2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Activated Memory B-Cells | 1.6 Percentage of B cells (%) | Standard Deviation 1.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: B-Cells Positive For Both CD19 & CD20 | 72.1 Percentage of B cells (%) | Standard Deviation 8.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Class-Switched Memory B Cells | 4.6 Percentage of B cells (%) | Standard Deviation 3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Mature Naive B-Cells | 12.0 Percentage of B cells (%) | Standard Deviation 5.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: CD20Neg B-Cell | 0.6 Percentage of B cells (%) | Standard Deviation 0.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Class-Switched Memory B Cells | 4.6 Percentage of B cells (%) | Standard Deviation 2.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: CD20Neg B-Cell | 0.5 Percentage of B cells (%) | Standard Deviation 0.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Non-Class Switched Memory B-Cells | 9.6 Percentage of B cells (%) | Standard Deviation 5.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: B-Cells Positive For Both CD19 & CD20 | 72.8 Percentage of B cells (%) | Standard Deviation 10.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: IgMNeg IgDNeg Switched Memory B-cells | 0.1 Percentage of B cells (%) | Standard Deviation 0.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: CD20Neg B-Cell | 0.6 Percentage of B cells (%) | Standard Deviation 1.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Class-Switched Memory B Cells | 4.8 Percentage of B cells (%) | Standard Deviation 3.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Antibody-Secreting Cells | 0.6 Percentage of B cells (%) | Standard Deviation 0.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Total B-Cell Population | 72.6 Percentage of B cells (%) | Standard Deviation 8.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Antibody-Secreting Cells | 0.5 Percentage of B cells (%) | Standard Deviation 0.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Total B-Cell Population | 72.7 Percentage of B cells (%) | Standard Deviation 9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: CD24- B-Cells | 31.5 Percentage of B cells (%) | Standard Deviation 11.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Total B-Cell Population | 73.5 Percentage of B cells (%) | Standard Deviation 9.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Mature Naive B-Cells | 13.6 Percentage of B cells (%) | Standard Deviation 6.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: B-Cells Positive For Both CD19 & CD20 | 72.1 Percentage of B cells (%) | Standard Deviation 8.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: IgMNeg IgDNeg Switched Memory B-cells | 0.1 Percentage of B cells (%) | Standard Deviation 0.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Transitional B-Cells | 9.5 Percentage of B cells (%) | Standard Deviation 5.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: IgMNeg IgDNeg Switched Memory B-cells | 0.1 Percentage of B cells (%) | Standard Deviation 0.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Non-Class Switched Memory B-Cells | 8.0 Percentage of B cells (%) | Standard Deviation 5.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: CD24- B-Cells | 33.4 Percentage of B cells (%) | Standard Deviation 12.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Transitional B-Cells | 9.5 Percentage of B cells (%) | Standard Deviation 6.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Mature Naive B-Cells | 13.6 Percentage of B cells (%) | Standard Deviation 7.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Activated Memory B-Cells | 1.5 Percentage of B cells (%) | Standard Deviation 1.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Antibody-Secreting Cells | 0.4 Percentage of B cells (%) | Standard Deviation 0.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Transitional B-Cells | 8.1 Percentage of B cells (%) | Standard Deviation 4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Activated Memory B-Cells | 1.5 Percentage of B cells (%) | Standard Deviation 1.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Non-Class Switched Memory B-Cells | 8.7 Percentage of B cells (%) | Standard Deviation 5.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: CD24- B-Cells | 31.3 Percentage of B cells (%) | Standard Deviation 11.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Activated Memory B-Cells | 1.3 Percentage of B cells (%) | Standard Deviation 0.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Activated Memory B-Cells | 1.5 Percentage of B cells (%) | Standard Deviation 1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Non-Class Switched Memory B-Cells | 10.1 Percentage of B cells (%) | Standard Deviation 6.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: CD24- B-Cells | 28.3 Percentage of B cells (%) | Standard Deviation 8.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Activated Memory B-Cells | 1.5 Percentage of B cells (%) | Standard Deviation 1.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: IgMNeg IgDNeg Switched Memory B-cells | 0.1 Percentage of B cells (%) | Standard Deviation 0.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Mature Naive B-Cells | 13.3 Percentage of B cells (%) | Standard Deviation 7.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Mature Naive B-Cells | 13.5 Percentage of B cells (%) | Standard Deviation 6.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: IgMNeg IgDNeg Switched Memory B-cells | 0.1 Percentage of B cells (%) | Standard Deviation 0.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Mature Naive B-Cells | 12.8 Percentage of B cells (%) | Standard Deviation 7.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Antibody-Secreting Cells | 0.6 Percentage of B cells (%) | Standard Deviation 0.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: IgMNeg IgDNeg Switched Memory B-cells | 0.1 Percentage of B cells (%) | Standard Deviation 0.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Antibody-Secreting Cells | 0.6 Percentage of B cells (%) | Standard Deviation 0.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: B-Cells Positive For Both CD19 & CD20 | 65.9 Percentage of B cells (%) | Standard Deviation 13.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Class-Switched Memory B Cells | 4.9 Percentage of B cells (%) | Standard Deviation 3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: CD24- B-Cells | 30.7 Percentage of B cells (%) | Standard Deviation 11.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Antibody-Secreting Cells | 0.6 Percentage of B cells (%) | Standard Deviation 0.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: CD20Neg B-Cell | 0.6 Percentage of B cells (%) | Standard Deviation 0.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: B-Cells Positive For Both CD19 & CD20 | 69.6 Percentage of B cells (%) | Standard Deviation 13.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Class-Switched Memory B Cells | 4.5 Percentage of B cells (%) | Standard Deviation 2.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: CD20Neg B-Cell | 0.6 Percentage of B cells (%) | Standard Deviation 0.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Class-Switched Memory B Cells | 4.8 Percentage of B cells (%) | Standard Deviation 2.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Total B-Cell Population | 72.8 Percentage of B cells (%) | Standard Deviation 8.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: CD20Neg B-Cell | 0.7 Percentage of B cells (%) | Standard Deviation 1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Total B-Cell Population | 66.5 Percentage of B cells (%) | Standard Deviation 13.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Total B-Cell Population | 70.4 Percentage of B cells (%) | Standard Deviation 13 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Non-Class Switched Memory B-Cells | 8.9 Percentage of B cells (%) | Standard Deviation 6.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: CD24- B-Cells | 32.0 Percentage of B cells (%) | Standard Deviation 11.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: Transitional B-Cells | 9.6 Percentage of B cells (%) | Standard Deviation 6.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 0: B-Cells Positive For Both CD19 & CD20 | 72.2 Percentage of B cells (%) | Standard Deviation 8.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Transitional B-Cells | 9.8 Percentage of B cells (%) | Standard Deviation 6.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 54: Non-Class Switched Memory B-Cells | 8.9 Percentage of B cells (%) | Standard Deviation 5.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- B Cell Panel | Week 80: Transitional B-Cells | 8.9 Percentage of B cells (%) | Standard Deviation 6.1 |
Secondary
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel
Myeloid panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80. In below table HLA refers to Human Leukocyte Antigen; MDSC refers to myeloid-derived suppressor cell; DC refers to Dendritic cells; MYDC refers to Myeloid Dendritic Cells; IMMYE\_MDSC refers to Immature myeloid cells & a subset of myeloid suppressor cells within the CD14-HLA class II- myeloid cell population.
Time frame: Week 0, week 54 and week 80
Population: The FAS included all randomised participants. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Non-Classical Monocytes | 1.2 Percentage of Myeloid cells (%) | Standard Deviation 1.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Total Percent Of Myeloid Cells | 95.1 Percentage of Myeloid cells (%) | Standard Deviation 3.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: CD16+ Dendritic Cells | 12.5 Percentage of Myeloid cells (%) | Standard Deviation 8.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Total MYDC | 28.7 Percentage of Myeloid cells (%) | Standard Deviation 10.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Non-Classical Monocytes | 1.5 Percentage of Myeloid cells (%) | Standard Deviation 1.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Intermediate Monocyte Subset | 6.0 Percentage of Myeloid cells (%) | Standard Deviation 5.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: CD16+ Dendritic Cells | 10.2 Percentage of Myeloid cells (%) | Standard Deviation 8.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: CD14+ HLA low Myeloid Cells | 1.0 Percentage of Myeloid cells (%) | Standard Deviation 2.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Intermediate Monocyte Subset | 6.5 Percentage of Myeloid cells (%) | Standard Deviation 4.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Intermediate Monocyte Subset | 8.6 Percentage of Myeloid cells (%) | Standard Deviation 8.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: CD16+ Dendritic Cells | 11.7 Percentage of Myeloid cells (%) | Standard Deviation 10.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: CD14+ HLA low Myeloid Cells | 1.1 Percentage of Myeloid cells (%) | Standard Deviation 1.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: IMMYE_MDSC | 0.2 Percentage of Myeloid cells (%) | Standard Deviation 0.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: IMMYE_MDSC | 0.2 Percentage of Myeloid cells (%) | Standard Deviation 0.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: IMMYE_MDSC | 0.3 Percentage of Myeloid cells (%) | Standard Deviation 0.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Total MYDC | 30.4 Percentage of Myeloid cells (%) | Standard Deviation 11.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Total MYDC | 30.4 Percentage of Myeloid cells (%) | Standard Deviation 9.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: CD14+ MDSC | 68.2 Percentage of Myeloid cells (%) | Standard Deviation 20.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Total Plasmacytoid Dendritic Cells (PDC) | 13.5 Percentage of Myeloid cells (%) | Standard Deviation 6.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Total Myeloid DC | 4.1 Percentage of Myeloid cells (%) | Standard Deviation 2.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Total Myeloid DC | 3.7 Percentage of Myeloid cells (%) | Standard Deviation 2.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: CD14+ MDSC | 64.0 Percentage of Myeloid cells (%) | Standard Deviation 23.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Total Plasmacytoid Dendritic Cells (PDC) | 14.3 Percentage of Myeloid cells (%) | Standard Deviation 5.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Total Myeloid DC | 3.8 Percentage of Myeloid cells (%) | Standard Deviation 2.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Total Monocytes in Myeloid Cells | 15.5 Percentage of Myeloid cells (%) | Standard Deviation 10.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: CD14+ MDSC | 65.7 Percentage of Myeloid cells (%) | Standard Deviation 22.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Total Percent Of Myeloid Cells | 94.8 Percentage of Myeloid cells (%) | Standard Deviation 5.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Total Monocytes in Myeloid Cells | 13.8 Percentage of Myeloid cells (%) | Standard Deviation 9.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Total Monocytes in Myeloid Cells | 14.2 Percentage of Myeloid cells (%) | Standard Deviation 8.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: CD14-HLA II- Myeloid Cells Total Myeloid | 80.4 Percentage of Myeloid cells (%) | Standard Deviation 11 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: CD14+ HLA low Myeloid Cells | 1.1 Percentage of Myeloid cells (%) | Standard Deviation 2.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Total Classical Monocytes | 89.3 Percentage of Myeloid cells (%) | Standard Deviation 6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Total Classical Monocytes | 87.8 Percentage of Myeloid cells (%) | Standard Deviation 7.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: CD14-HLA II- Myeloid Cells Total Myeloid | 80.9 Percentage of Myeloid cells (%) | Standard Deviation 11.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Total Plasmacytoid Dendritic Cells (PDC) | 14.4 Percentage of Myeloid cells (%) | Standard Deviation 6.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Total Classical Monocytes | 87.2 Percentage of Myeloid cells (%) | Standard Deviation 9.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Non-Classical Monocytes | 1.2 Percentage of Myeloid cells (%) | Standard Deviation 0.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: CD14-HLA II- Myeloid Cells Total Myeloid | 79.0 Percentage of Myeloid cells (%) | Standard Deviation 12.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Total Percent Of Myeloid Cells | 94.6 Percentage of Myeloid cells (%) | Standard Deviation 3.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Non-Classical Monocytes | 1.3 Percentage of Myeloid cells (%) | Standard Deviation 0.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Total Percent Of Myeloid Cells | 95.9 Percentage of Myeloid cells (%) | Standard Deviation 4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Total Percent Of Myeloid Cells | 95.6 Percentage of Myeloid cells (%) | Standard Deviation 4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: CD14+ HLA low Myeloid Cells | 1.0 Percentage of Myeloid cells (%) | Standard Deviation 1.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: CD14+ HLA low Myeloid Cells | 0.7 Percentage of Myeloid cells (%) | Standard Deviation 0.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: CD14+ HLA low Myeloid Cells | 0.6 Percentage of Myeloid cells (%) | Standard Deviation 0.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: CD14+ MDSC | 69.1 Percentage of Myeloid cells (%) | Standard Deviation 22.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: CD14+ MDSC | 67.0 Percentage of Myeloid cells (%) | Standard Deviation 23.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: CD14+ MDSC | 62.7 Percentage of Myeloid cells (%) | Standard Deviation 20.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: CD14-HLA II- Myeloid Cells Total Myeloid | 82.2 Percentage of Myeloid cells (%) | Standard Deviation 10.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: CD14-HLA II- Myeloid Cells Total Myeloid | 80.0 Percentage of Myeloid cells (%) | Standard Deviation 12 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: CD14-HLA II- Myeloid Cells Total Myeloid | 81.0 Percentage of Myeloid cells (%) | Standard Deviation 10.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: CD16+ Dendritic Cells | 11.3 Percentage of Myeloid cells (%) | Standard Deviation 7.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: CD16+ Dendritic Cells | 10.3 Percentage of Myeloid cells (%) | Standard Deviation 7.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: CD16+ Dendritic Cells | 9.4 Percentage of Myeloid cells (%) | Standard Deviation 6.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: IMMYE_MDSC | 0.2 Percentage of Myeloid cells (%) | Standard Deviation 0.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: IMMYE_MDSC | 0.2 Percentage of Myeloid cells (%) | Standard Deviation 0.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: IMMYE_MDSC | 0.1 Percentage of Myeloid cells (%) | Standard Deviation 0.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Intermediate Monocyte Subset | 9.0 Percentage of Myeloid cells (%) | Standard Deviation 7.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Intermediate Monocyte Subset | 7.3 Percentage of Myeloid cells (%) | Standard Deviation 6.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Intermediate Monocyte Subset | 6.6 Percentage of Myeloid cells (%) | Standard Deviation 6.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Non-Classical Monocytes | 1.3 Percentage of Myeloid cells (%) | Standard Deviation 0.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Non-Classical Monocytes | 1.2 Percentage of Myeloid cells (%) | Standard Deviation 0.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Total Classical Monocytes | 86.7 Percentage of Myeloid cells (%) | Standard Deviation 8.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Total Classical Monocytes | 88.1 Percentage of Myeloid cells (%) | Standard Deviation 7.6 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Total Classical Monocytes | 88.5 Percentage of Myeloid cells (%) | Standard Deviation 7.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Total Monocytes in Myeloid Cells | 12.6 Percentage of Myeloid cells (%) | Standard Deviation 7.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Total Monocytes in Myeloid Cells | 14.9 Percentage of Myeloid cells (%) | Standard Deviation 9.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Total Monocytes in Myeloid Cells | 13.8 Percentage of Myeloid cells (%) | Standard Deviation 9.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Total Myeloid DC | 3.6 Percentage of Myeloid cells (%) | Standard Deviation 2.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Total Myeloid DC | 3.9 Percentage of Myeloid cells (%) | Standard Deviation 2.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Total Myeloid DC | 4.1 Percentage of Myeloid cells (%) | Standard Deviation 2.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Total MYDC | 31.4 Percentage of Myeloid cells (%) | Standard Deviation 10.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Total MYDC | 31.3 Percentage of Myeloid cells (%) | Standard Deviation 8.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Total MYDC | 30.5 Percentage of Myeloid cells (%) | Standard Deviation 7.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Total Percent Of Myeloid Cells | 94.7 Percentage of Myeloid cells (%) | Standard Deviation 5.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Total Plasmacytoid Dendritic Cells (PDC) | 12.5 Percentage of Myeloid cells (%) | Standard Deviation 6.6 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Total Plasmacytoid Dendritic Cells (PDC) | 13.5 Percentage of Myeloid cells (%) | Standard Deviation 5.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Total Plasmacytoid Dendritic Cells (PDC) | 12.8 Percentage of Myeloid cells (%) | Standard Deviation 6.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Non-Classical Monocytes | 1.1 Percentage of Myeloid cells (%) | Standard Deviation 0.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Total Classical Monocytes | 88.6 Percentage of Myeloid cells (%) | Standard Deviation 7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Total Myeloid DC | 3.8 Percentage of Myeloid cells (%) | Standard Deviation 2.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: CD14-HLA II- Myeloid Cells Total Myeloid | 80.8 Percentage of Myeloid cells (%) | Standard Deviation 12.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: CD14+ MDSC | 73.5 Percentage of Myeloid cells (%) | Standard Deviation 19.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Total MYDC | 31.6 Percentage of Myeloid cells (%) | Standard Deviation 12 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Total Myeloid DC | 4.1 Percentage of Myeloid cells (%) | Standard Deviation 3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Total Percent Of Myeloid Cells | 95.0 Percentage of Myeloid cells (%) | Standard Deviation 3.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Total Classical Monocytes | 87.6 Percentage of Myeloid cells (%) | Standard Deviation 9.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Total Plasmacytoid Dendritic Cells (PDC) | 11.6 Percentage of Myeloid cells (%) | Standard Deviation 6.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Total MYDC | 32.7 Percentage of Myeloid cells (%) | Standard Deviation 9.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Total Monocytes in Myeloid Cells | 14.1 Percentage of Myeloid cells (%) | Standard Deviation 9.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: CD14+ HLA low Myeloid Cells | 0.9 Percentage of Myeloid cells (%) | Standard Deviation 1.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Total Plasmacytoid Dendritic Cells (PDC) | 12.0 Percentage of Myeloid cells (%) | Standard Deviation 6.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Total MYDC | 31.7 Percentage of Myeloid cells (%) | Standard Deviation 11.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Non-Classical Monocytes | 1.2 Percentage of Myeloid cells (%) | Standard Deviation 0.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: IMMYE_MDSC | 0.2 Percentage of Myeloid cells (%) | Standard Deviation 0.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: CD14+ MDSC | 64.1 Percentage of Myeloid cells (%) | Standard Deviation 23.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: CD14+ HLA low Myeloid Cells | 0.9 Percentage of Myeloid cells (%) | Standard Deviation 1.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Total Monocytes in Myeloid Cells | 14.3 Percentage of Myeloid cells (%) | Standard Deviation 10.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: IMMYE_MDSC | 0.2 Percentage of Myeloid cells (%) | Standard Deviation 0.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: CD14-HLA II- Myeloid Cells Total Myeloid | 80.9 Percentage of Myeloid cells (%) | Standard Deviation 9.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: CD16+ Dendritic Cells | 9.2 Percentage of Myeloid cells (%) | Standard Deviation 7.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Total Percent Of Myeloid Cells | 94.6 Percentage of Myeloid cells (%) | Standard Deviation 3.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: IMMYE_MDSC | 0.2 Percentage of Myeloid cells (%) | Standard Deviation 0.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Total Classical Monocytes | 88.0 Percentage of Myeloid cells (%) | Standard Deviation 8.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Total Monocytes in Myeloid Cells | 13.6 Percentage of Myeloid cells (%) | Standard Deviation 7.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Non-Classical Monocytes | 1.0 Percentage of Myeloid cells (%) | Standard Deviation 0.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Intermediate Monocyte Subset | 8.3 Percentage of Myeloid cells (%) | Standard Deviation 8.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: CD14+ MDSC | 69.3 Percentage of Myeloid cells (%) | Standard Deviation 21.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: CD16+ Dendritic Cells | 11.2 Percentage of Myeloid cells (%) | Standard Deviation 9.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: CD14+ HLA low Myeloid Cells | 0.7 Percentage of Myeloid cells (%) | Standard Deviation 1.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Intermediate Monocyte Subset | 6.3 Percentage of Myeloid cells (%) | Standard Deviation 7.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Total Plasmacytoid Dendritic Cells (PDC) | 12.0 Percentage of Myeloid cells (%) | Standard Deviation 6.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Total Myeloid DC | 3.8 Percentage of Myeloid cells (%) | Standard Deviation 2.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Total Percent Of Myeloid Cells | 94.6 Percentage of Myeloid cells (%) | Standard Deviation 4.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Intermediate Monocyte Subset | 5.7 Percentage of Myeloid cells (%) | Standard Deviation 5.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: CD14-HLA II- Myeloid Cells Total Myeloid | 80.8 Percentage of Myeloid cells (%) | Standard Deviation 12.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: CD16+ Dendritic Cells | 12.9 Percentage of Myeloid cells (%) | Standard Deviation 10.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: CD14+ MDSC | 70.3 Percentage of Myeloid cells (%) | Standard Deviation 18.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Non-Classical Monocytes | 1.3 Percentage of Myeloid cells (%) | Standard Deviation 1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Non-Classical Monocytes | 1.2 Percentage of Myeloid cells (%) | Standard Deviation 0.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: CD14-HLA II- Myeloid Cells Total Myeloid | 83.5 Percentage of Myeloid cells (%) | Standard Deviation 10.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Total Percent Of Myeloid Cells | 94.6 Percentage of Myeloid cells (%) | Standard Deviation 4.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Non-Classical Monocytes | 1.3 Percentage of Myeloid cells (%) | Standard Deviation 0.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Total Classical Monocytes | 88.0 Percentage of Myeloid cells (%) | Standard Deviation 8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: CD14-HLA II- Myeloid Cells Total Myeloid | 81.8 Percentage of Myeloid cells (%) | Standard Deviation 11 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Total Percent Of Myeloid Cells | 95.6 Percentage of Myeloid cells (%) | Standard Deviation 3.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Total Classical Monocytes | 89.3 Percentage of Myeloid cells (%) | Standard Deviation 6.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: CD14+ HLA low Myeloid Cells | 1.0 Percentage of Myeloid cells (%) | Standard Deviation 1.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Total Classical Monocytes | 89.7 Percentage of Myeloid cells (%) | Standard Deviation 5.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: CD14+ MDSC | 63.9 Percentage of Myeloid cells (%) | Standard Deviation 23.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Total Percent Of Myeloid Cells | 94.1 Percentage of Myeloid cells (%) | Standard Deviation 5.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Total Monocytes in Myeloid Cells | 13.4 Percentage of Myeloid cells (%) | Standard Deviation 8.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Total Monocytes in Myeloid Cells | 12.2 Percentage of Myeloid cells (%) | Standard Deviation 8.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: CD14+ MDSC | 65.9 Percentage of Myeloid cells (%) | Standard Deviation 20.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Total Plasmacytoid Dendritic Cells (PDC) | 12.5 Percentage of Myeloid cells (%) | Standard Deviation 6.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Total Monocytes in Myeloid Cells | 13.5 Percentage of Myeloid cells (%) | Standard Deviation 6.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Total Myeloid DC | 3.4 Percentage of Myeloid cells (%) | Standard Deviation 2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: CD14-HLA II- Myeloid Cells Total Myeloid | 81.3 Percentage of Myeloid cells (%) | Standard Deviation 8.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Total Plasmacytoid Dendritic Cells (PDC) | 12.9 Percentage of Myeloid cells (%) | Standard Deviation 7.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Total Myeloid DC | 3.2 Percentage of Myeloid cells (%) | Standard Deviation 2.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Total Myeloid DC | 3.9 Percentage of Myeloid cells (%) | Standard Deviation 2.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: CD14+ HLA low Myeloid Cells | 0.8 Percentage of Myeloid cells (%) | Standard Deviation 1.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Total MYDC | 31.0 Percentage of Myeloid cells (%) | Standard Deviation 9.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Total MYDC | 27.2 Percentage of Myeloid cells (%) | Standard Deviation 9.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: IMMYE_MDSC | 0.2 Percentage of Myeloid cells (%) | Standard Deviation 0.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: CD16+ Dendritic Cells | 12.1 Percentage of Myeloid cells (%) | Standard Deviation 8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: CD14+ HLA low Myeloid Cells | 0.6 Percentage of Myeloid cells (%) | Standard Deviation 1.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: IMMYE_MDSC | 0.1 Percentage of Myeloid cells (%) | Standard Deviation 0.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Total Plasmacytoid Dendritic Cells (PDC) | 11.8 Percentage of Myeloid cells (%) | Standard Deviation 6.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: IMMYE_MDSC | 0.2 Percentage of Myeloid cells (%) | Standard Deviation 0.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: CD16+ Dendritic Cells | 12.0 Percentage of Myeloid cells (%) | Standard Deviation 9.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Total MYDC | 31.9 Percentage of Myeloid cells (%) | Standard Deviation 10.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: Intermediate Monocyte Subset | 7.7 Percentage of Myeloid cells (%) | Standard Deviation 7.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 54: Intermediate Monocyte Subset | 5.8 Percentage of Myeloid cells (%) | Standard Deviation 5.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 0: CD16+ Dendritic Cells | 11.5 Percentage of Myeloid cells (%) | Standard Deviation 7.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel | Week 80: Intermediate Monocyte Subset | 5.8 Percentage of Myeloid cells (%) | Standard Deviation 4.5 |
Secondary
Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel
NK cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80. In below table ADCC refer to Antibody-dependent cellular cytotoxicity; CD refer to Cluster of Differentiation.
Time frame: Week 0, week 54 and week 80
Population: The FAS included all randomised participants. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Mature CD16+ Highly Functional NK Cells | 0.6 Percentage of NK cells (%) | Standard Deviation 0.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Mature CD16+ Highly Functional NK Cells | 0.6 Percentage of NK cells (%) | Standard Deviation 0.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: CD16+ Highly Functional NK Cells | 0.7 Percentage of NK cells (%) | Standard Deviation 0.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Mature CD16+ Highly Functional NK Cells | 0.7 Percentage of NK cells (%) | Standard Deviation 0.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: CD56- Cells | 34.8 Percentage of NK cells (%) | Standard Deviation 12.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Total Mature NK Cells; Highly Cytolytic | 58.6 Percentage of NK cells (%) | Standard Deviation 13.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Highly Cytolytic Subset Of NK Cells | 21.1 Percentage of NK cells (%) | Standard Deviation 9.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Highly Cytolytic Subset Of NK Cells | 22.2 Percentage of NK cells (%) | Standard Deviation 10.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: CD56- Cells | 36.2 Percentage of NK cells (%) | Standard Deviation 14.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Senescent Rapid Cytokine-Producing NK | 0.0 Percentage of NK cells (%) | Standard Deviation 0 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Highly Cytolytic Subset Of NK Cells | 18.8 Percentage of NK cells (%) | Standard Deviation 10.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Functional NK Cells; Efficient At ADCC | 13.3 Percentage of NK cells (%) | Standard Deviation 7.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: CD56High NK Pool | 4.9 Percentage of NK cells (%) | Standard Deviation 3.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Senescent Rapid Cytokine-Producing NK | 0.0 Percentage of NK cells (%) | Standard Deviation 0 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Functional NK Cells; Efficient At ADCC | 13.2 Percentage of NK cells (%) | Standard Deviation 8.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Senescent Cytolytic NK Cells | 9.4 Percentage of NK cells (%) | Standard Deviation 6.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: CD56High NK Pool | 4.5 Percentage of NK cells (%) | Standard Deviation 2.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Mature CD16- Terminally Differentiate NK | 0.3 Percentage of NK cells (%) | Standard Deviation 0.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Functional NK Cells; Efficient At ADCC | 14.5 Percentage of NK cells (%) | Standard Deviation 7.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: CD57+ MatNK Effectors | 20.0 Percentage of NK cells (%) | Standard Deviation 11.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: CD57+ MatNK Effectors | 22.6 Percentage of NK cells (%) | Standard Deviation 12.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Senescent Cytolytic NK Cells | 9.9 Percentage of NK cells (%) | Standard Deviation 6.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: CD57+ MatNK Effectors | 21.0 Percentage of NK cells (%) | Standard Deviation 12.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Senescent Cytolytic NK Cells | 8.7 Percentage of NK cells (%) | Standard Deviation 6.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Week 0: Total CD16- CD56- NK | 29.2 Percentage of NK cells (%) | Standard Deviation 12.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Senescent CD16- CD56- NK cells | 1.9 Percentage of NK cells (%) | Standard Deviation 2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Senescent CD16- CD56- NK cells | 1.5 Percentage of NK cells (%) | Standard Deviation 1.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Rapid Cytokine-Producing NK Cell Subset | 3.8 Percentage of NK cells (%) | Standard Deviation 2.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Senescent CD16+ CD56- NK cells | 1.3 Percentage of NK cells (%) | Standard Deviation 1.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: CD56- Cells | 34.5 Percentage of NK cells (%) | Standard Deviation 15.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Total Mature NK Cells; Highly Cytolytic | 59.6 Percentage of NK cells (%) | Standard Deviation 13.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Senescent CD16- CD56- NK cells | 1.3 Percentage of NK cells (%) | Standard Deviation 1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Week 0: Senescent CD16+CD56hi NK | 0.1 Percentage of NK cells (%) | Standard Deviation 0.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Week 0: Senescent CD16+CD56hi NK | 0.1 Percentage of NK cells (%) | Standard Deviation 0.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Senescent CD16+CD56hi NK | 0.1 Percentage of NK cells (%) | Standard Deviation 0.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Week 0: Total CD16- CD56- NK | 28.6 Percentage of NK cells (%) | Standard Deviation 12.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Senescent CD16+ CD56- NK cells | 1.1 Percentage of NK cells (%) | Standard Deviation 1.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Senescent CD16+ CD56- NK cells | 1.0 Percentage of NK cells (%) | Standard Deviation 1.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Senescent Rapid Cytokine-Producing NK | 0.1 Percentage of NK cells (%) | Standard Deviation 0.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Total CD16- CD56- NK | 27.6 Percentage of NK cells (%) | Standard Deviation 15.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Rapid Cytokine-Producing NK Cell Subset | 4.2 Percentage of NK cells (%) | Standard Deviation 2.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Rapid Cytokine-Producing NK Cell Subset | 4.1 Percentage of NK cells (%) | Standard Deviation 2.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: CD56High NK Pool | 4.9 Percentage of NK cells (%) | Standard Deviation 3.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Mature Rapid Cytokine-Producing NK Cell | 3.2 Percentage of NK cells (%) | Standard Deviation 2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Mature Rapid Cytokine-Producing NK Cell | 3.6 Percentage of NK cells (%) | Standard Deviation 2.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Mature Rapid Cytokine-Producing NK Cell | 3.6 Percentage of NK cells (%) | Standard Deviation 2.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Total Mature NK Cells; Highly Cytolytic | 58.5 Percentage of NK cells (%) | Standard Deviation 13.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Total CD16+ CD56- NK | 6.8 Percentage of NK cells (%) | Standard Deviation 5.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Mature Cytolytic NK Cells | 2.3 Percentage of NK cells (%) | Standard Deviation 1.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: ADCC-Competent NK | 39.5 Percentage of NK cells (%) | Standard Deviation 17.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Total CD16+ CD56- NK | 5.9 Percentage of NK cells (%) | Standard Deviation 2.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Mature Cytolytic NK Cells | 2.4 Percentage of NK cells (%) | Standard Deviation 1.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Mature Cytolytic NK Cells | 2.3 Percentage of NK cells (%) | Standard Deviation 1.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: ADCC-Competent NK | 37.1 Percentage of NK cells (%) | Standard Deviation 16.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: CD16+ Highly Functional NK Cells | 0.7 Percentage of NK cells (%) | Standard Deviation 0.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Mature CD16- Terminally Differentiate NK | 0.3 Percentage of NK cells (%) | Standard Deviation 0.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Mature CD16- Terminally Differentiate NK | 0.3 Percentage of NK cells (%) | Standard Deviation 0.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: ADCC-Competent NK | 37.1 Percentage of NK cells (%) | Standard Deviation 16 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Total CD16+ CD56- NK | 6.7 Percentage of NK cells (%) | Standard Deviation 3.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: CD16+ Highly Functional NK Cells | 0.8 Percentage of NK cells (%) | Standard Deviation 0.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Mature CD16+ Terminally Differentiated | 0.9 Percentage of NK cells (%) | Standard Deviation 0.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Mature CD16+ Terminally Differentiated | 1.1 Percentage of NK cells (%) | Standard Deviation 1.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Mature CD16+ Terminally Differentiated | 1.3 Percentage of NK cells (%) | Standard Deviation 1.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Senescent Rapid Cytokine-Producing NK | 0.0 Percentage of NK cells (%) | Standard Deviation 0 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: CD16+ Highly Functional NK Cells | 0.7 Percentage of NK cells (%) | Standard Deviation 0.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: CD16+ Highly Functional NK Cells | 0.6 Percentage of NK cells (%) | Standard Deviation 0.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: CD56- Cells | 36.8 Percentage of NK cells (%) | Standard Deviation 15.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Highly Cytolytic Subset Of NK Cells | 23.0 Percentage of NK cells (%) | Standard Deviation 9.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Mature CD16+ Terminally Differentiated | 0.8 Percentage of NK cells (%) | Standard Deviation 0.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Mature Rapid Cytokine-Producing NK Cell | 3.8 Percentage of NK cells (%) | Standard Deviation 2.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Senescent CD16+ CD56- NK cells | 1.2 Percentage of NK cells (%) | Standard Deviation 1.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Senescent CD16+ CD56- NK cells | 1.2 Percentage of NK cells (%) | Standard Deviation 1.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Senescent CD16+CD56hi NK | 0.1 Percentage of NK cells (%) | Standard Deviation 0.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Senescent Rapid Cytokine-Producing NK | 0.0 Percentage of NK cells (%) | Standard Deviation 0 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Total Mature NK Cells; Highly Cytolytic | 57.4 Percentage of NK cells (%) | Standard Deviation 15.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Total Mature NK Cells; Highly Cytolytic | 56.5 Percentage of NK cells (%) | Standard Deviation 13.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: ADCC-Competent NK | 36.3 Percentage of NK cells (%) | Standard Deviation 14.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: ADCC-Competent NK | 32.5 Percentage of NK cells (%) | Standard Deviation 14.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: ADCC-Competent NK | 33.2 Percentage of NK cells (%) | Standard Deviation 13.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: CD16+ Highly Functional NK Cells | 0.8 Percentage of NK cells (%) | Standard Deviation 0.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: CD56- Cells | 36.6 Percentage of NK cells (%) | Standard Deviation 12.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: CD56- Cells | 37.6 Percentage of NK cells (%) | Standard Deviation 13.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: CD56High NK Pool | 5.1 Percentage of NK cells (%) | Standard Deviation 3.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: CD56High NK Pool | 5.3 Percentage of NK cells (%) | Standard Deviation 3.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: CD56High NK Pool | 5.1 Percentage of NK cells (%) | Standard Deviation 3.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: CD57+ MatNK Effectors | 20.4 Percentage of NK cells (%) | Standard Deviation 10.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: CD57+ MatNK Effectors | 18.0 Percentage of NK cells (%) | Standard Deviation 10.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: CD57+ MatNK Effectors | 18.3 Percentage of NK cells (%) | Standard Deviation 9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Functional NK Cells; Efficient At ADCC | 13.3 Percentage of NK cells (%) | Standard Deviation 8.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Functional NK Cells; Efficient At ADCC | 11.1 Percentage of NK cells (%) | Standard Deviation 7.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Functional NK Cells; Efficient At ADCC | 11.3 Percentage of NK cells (%) | Standard Deviation 7.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Highly Cytolytic Subset Of NK Cells | 20.9 Percentage of NK cells (%) | Standard Deviation 10.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Highly Cytolytic Subset Of NK Cells | 24.5 Percentage of NK cells (%) | Standard Deviation 11 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Mature CD16+ Highly Functional NK Cells | 0.7 Percentage of NK cells (%) | Standard Deviation 0.6 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Mature CD16+ Highly Functional NK Cells | 0.6 Percentage of NK cells (%) | Standard Deviation 0.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Mature CD16+ Highly Functional NK Cells | 0.6 Percentage of NK cells (%) | Standard Deviation 0.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Mature CD16+ Terminally Differentiated | 1.1 Percentage of NK cells (%) | Standard Deviation 1.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Mature CD16+ Terminally Differentiated | 1.0 Percentage of NK cells (%) | Standard Deviation 1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Mature CD16- Terminally Differentiate NK | 0.3 Percentage of NK cells (%) | Standard Deviation 0.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Mature CD16- Terminally Differentiate NK | 0.3 Percentage of NK cells (%) | Standard Deviation 0.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Mature CD16- Terminally Differentiate NK | 0.3 Percentage of NK cells (%) | Standard Deviation 0.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Mature Cytolytic NK Cells | 2.2 Percentage of NK cells (%) | Standard Deviation 1.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Mature Cytolytic NK Cells | 2.7 Percentage of NK cells (%) | Standard Deviation 1.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Mature Cytolytic NK Cells | 2.9 Percentage of NK cells (%) | Standard Deviation 3.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Mature Rapid Cytokine-Producing NK Cell | 3.9 Percentage of NK cells (%) | Standard Deviation 2.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Mature Rapid Cytokine-Producing NK Cell | 3.7 Percentage of NK cells (%) | Standard Deviation 2.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Rapid Cytokine-Producing NK Cell Subset | 4.4 Percentage of NK cells (%) | Standard Deviation 3.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Rapid Cytokine-Producing NK Cell Subset | 4.5 Percentage of NK cells (%) | Standard Deviation 2.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Rapid Cytokine-Producing NK Cell Subset | 4.4 Percentage of NK cells (%) | Standard Deviation 2.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Senescent CD16+ CD56- NK cells | 1.4 Percentage of NK cells (%) | Standard Deviation 1.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Week 0: Senescent CD16+CD56hi NK | 0.0 Percentage of NK cells (%) | Standard Deviation 0.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Week 0: Senescent CD16+CD56hi NK | 0.0 Percentage of NK cells (%) | Standard Deviation 0 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Senescent CD16- CD56- NK cells | 1.5 Percentage of NK cells (%) | Standard Deviation 1.6 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Senescent CD16- CD56- NK cells | 1.8 Percentage of NK cells (%) | Standard Deviation 1.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Senescent CD16- CD56- NK cells | 2.4 Percentage of NK cells (%) | Standard Deviation 3.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Senescent Cytolytic NK Cells | 9.9 Percentage of NK cells (%) | Standard Deviation 7.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Senescent Cytolytic NK Cells | 11.3 Percentage of NK cells (%) | Standard Deviation 7.6 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Senescent Cytolytic NK Cells | 11.1 Percentage of NK cells (%) | Standard Deviation 7.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Senescent Rapid Cytokine-Producing NK | 0.0 Percentage of NK cells (%) | Standard Deviation 0 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Total CD16+ CD56- NK | 7.4 Percentage of NK cells (%) | Standard Deviation 5.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Total CD16+ CD56- NK | 6.2 Percentage of NK cells (%) | Standard Deviation 3.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Total CD16+ CD56- NK | 6.6 Percentage of NK cells (%) | Standard Deviation 4.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Total CD16- CD56- NK | 29.2 Percentage of NK cells (%) | Standard Deviation 13.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Week 0: Total CD16- CD56- NK | 30.1 Percentage of NK cells (%) | Standard Deviation 11.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Week 0: Total CD16- CD56- NK | 30.7 Percentage of NK cells (%) | Standard Deviation 13.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Total Mature NK Cells; Highly Cytolytic | 57.3 Percentage of NK cells (%) | Standard Deviation 12.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Senescent Rapid Cytokine-Producing NK | 0.0 Percentage of NK cells (%) | Standard Deviation 0 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Mature CD16+ Highly Functional NK Cells | 0.5 Percentage of NK cells (%) | Standard Deviation 0.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Mature CD16+ Terminally Differentiated | 1.1 Percentage of NK cells (%) | Standard Deviation 1.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: CD16+ Highly Functional NK Cells | 0.7 Percentage of NK cells (%) | Standard Deviation 0.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Highly Cytolytic Subset Of NK Cells | 25.5 Percentage of NK cells (%) | Standard Deviation 11.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Mature CD16+ Terminally Differentiated | 0.8 Percentage of NK cells (%) | Standard Deviation 0.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Week 0: Total CD16- CD56- NK | 30.7 Percentage of NK cells (%) | Standard Deviation 10.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Mature CD16- Terminally Differentiate NK | 0.4 Percentage of NK cells (%) | Standard Deviation 0.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Total CD16+ CD56- NK | 6.4 Percentage of NK cells (%) | Standard Deviation 3.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Mature CD16- Terminally Differentiate NK | 0.3 Percentage of NK cells (%) | Standard Deviation 0.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: ADCC-Competent NK | 33.9 Percentage of NK cells (%) | Standard Deviation 14 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Mature Cytolytic NK Cells | 2.4 Percentage of NK cells (%) | Standard Deviation 1.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: ADCC-Competent NK | 36.0 Percentage of NK cells (%) | Standard Deviation 16.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Mature Cytolytic NK Cells | 2.5 Percentage of NK cells (%) | Standard Deviation 1.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Total Mature NK Cells; Highly Cytolytic | 57.7 Percentage of NK cells (%) | Standard Deviation 12.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Total CD16+ CD56- NK | 6.0 Percentage of NK cells (%) | Standard Deviation 3.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Mature Cytolytic NK Cells | 2.6 Percentage of NK cells (%) | Standard Deviation 2.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Total Mature NK Cells; Highly Cytolytic | 56.9 Percentage of NK cells (%) | Standard Deviation 13.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Mature Rapid Cytokine-Producing NK Cell | 3.0 Percentage of NK cells (%) | Standard Deviation 2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Total Mature NK Cells; Highly Cytolytic | 56.8 Percentage of NK cells (%) | Standard Deviation 16.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: CD56High NK Pool | 4.2 Percentage of NK cells (%) | Standard Deviation 2.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Mature Rapid Cytokine-Producing NK Cell | 3.0 Percentage of NK cells (%) | Standard Deviation 1.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: CD16+ Highly Functional NK Cells | 0.6 Percentage of NK cells (%) | Standard Deviation 0.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Rapid Cytokine-Producing NK Cell Subset | 3.8 Percentage of NK cells (%) | Standard Deviation 2.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Senescent Rapid Cytokine-Producing NK | 0.0 Percentage of NK cells (%) | Standard Deviation 0 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Total CD16+ CD56- NK | 6.2 Percentage of NK cells (%) | Standard Deviation 3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Rapid Cytokine-Producing NK Cell Subset | 3.5 Percentage of NK cells (%) | Standard Deviation 2.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Rapid Cytokine-Producing NK Cell Subset | 3.7 Percentage of NK cells (%) | Standard Deviation 2.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Senescent CD16+ CD56- NK cells | 1.0 Percentage of NK cells (%) | Standard Deviation 1.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Senescent Cytolytic NK Cells | 9.8 Percentage of NK cells (%) | Standard Deviation 7.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Senescent CD16+CD56hi NK | 0.1 Percentage of NK cells (%) | Standard Deviation 0.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Week 0: Senescent CD16+CD56hi NK | 0.1 Percentage of NK cells (%) | Standard Deviation 0.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Senescent CD16+ CD56- NK cells | 0.9 Percentage of NK cells (%) | Standard Deviation 0.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Total CD16- CD56- NK | 31.4 Percentage of NK cells (%) | Standard Deviation 16.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Week 0: Senescent CD16+CD56hi NK | 0.1 Percentage of NK cells (%) | Standard Deviation 0.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Senescent CD16+ CD56- NK cells | 0.9 Percentage of NK cells (%) | Standard Deviation 0.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Senescent CD16- CD56- NK cells | 1.3 Percentage of NK cells (%) | Standard Deviation 1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: CD56- Cells | 38.0 Percentage of NK cells (%) | Standard Deviation 17.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Senescent CD16- CD56- NK cells | 1.6 Percentage of NK cells (%) | Standard Deviation 1.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Mature Rapid Cytokine-Producing NK Cell | 3.3 Percentage of NK cells (%) | Standard Deviation 2.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Senescent CD16- CD56- NK cells | 1.9 Percentage of NK cells (%) | Standard Deviation 1.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Week 0: Total CD16- CD56- NK | 31.9 Percentage of NK cells (%) | Standard Deviation 13.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Mature CD16- Terminally Differentiate NK | 0.4 Percentage of NK cells (%) | Standard Deviation 0.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Senescent Cytolytic NK Cells | 10.9 Percentage of NK cells (%) | Standard Deviation 7.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: CD57+ MatNK Effectors | 21.0 Percentage of NK cells (%) | Standard Deviation 11.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: CD57+ MatNK Effectors | 18.9 Percentage of NK cells (%) | Standard Deviation 10.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Senescent Cytolytic NK Cells | 11.5 Percentage of NK cells (%) | Standard Deviation 7.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: CD57+ MatNK Effectors | 17.5 Percentage of NK cells (%) | Standard Deviation 11.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: CD56High NK Pool | 4.3 Percentage of NK cells (%) | Standard Deviation 2.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Functional NK Cells; Efficient At ADCC | 13.1 Percentage of NK cells (%) | Standard Deviation 9.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: CD56High NK Pool | 4.5 Percentage of NK cells (%) | Standard Deviation 2.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Functional NK Cells; Efficient At ADCC | 12.1 Percentage of NK cells (%) | Standard Deviation 7.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Functional NK Cells; Efficient At ADCC | 10.9 Percentage of NK cells (%) | Standard Deviation 7.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: CD56- Cells | 37.1 Percentage of NK cells (%) | Standard Deviation 11.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Senescent Rapid Cytokine-Producing NK | 0.0 Percentage of NK cells (%) | Standard Deviation 0.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Highly Cytolytic Subset Of NK Cells | 20.6 Percentage of NK cells (%) | Standard Deviation 11 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Highly Cytolytic Subset Of NK Cells | 22.8 Percentage of NK cells (%) | Standard Deviation 11.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: CD56- Cells | 38.1 Percentage of NK cells (%) | Standard Deviation 14.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Mature CD16+ Terminally Differentiated | 1.0 Percentage of NK cells (%) | Standard Deviation 0.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Mature CD16+ Highly Functional NK Cells | 0.6 Percentage of NK cells (%) | Standard Deviation 0.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: ADCC-Competent NK | 31.9 Percentage of NK cells (%) | Standard Deviation 15.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Mature CD16+ Highly Functional NK Cells | 0.6 Percentage of NK cells (%) | Standard Deviation 0.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: CD16+ Highly Functional NK Cells | 0.7 Percentage of NK cells (%) | Standard Deviation 0.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: CD56- Cells | 41.1 Percentage of NK cells (%) | Standard Deviation 15.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Senescent Cytolytic NK Cells | 9.8 Percentage of NK cells (%) | Standard Deviation 7.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Mature CD16+ Highly Functional NK Cells | 0.7 Percentage of NK cells (%) | Standard Deviation 0.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: CD16+ Highly Functional NK Cells | 0.7 Percentage of NK cells (%) | Standard Deviation 0.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Senescent Rapid Cytokine-Producing NK | 0.0 Percentage of NK cells (%) | Standard Deviation 0.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Senescent Rapid Cytokine-Producing NK | 0.0 Percentage of NK cells (%) | Standard Deviation 0 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Mature CD16+ Terminally Differentiated | 1.3 Percentage of NK cells (%) | Standard Deviation 1.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Week 0: Senescent CD16+CD56hi NK | 0.1 Percentage of NK cells (%) | Standard Deviation 0.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Functional NK Cells; Efficient At ADCC | 12.1 Percentage of NK cells (%) | Standard Deviation 6.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Total CD16- CD56- NK | 30.5 Percentage of NK cells (%) | Standard Deviation 13 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Mature CD16+ Highly Functional NK Cells | 0.6 Percentage of NK cells (%) | Standard Deviation 0.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Senescent CD16- CD56- NK cells | 1.5 Percentage of NK cells (%) | Standard Deviation 1.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Mature CD16- Terminally Differentiate NK | 0.4 Percentage of NK cells (%) | Standard Deviation 0.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: ADCC-Competent NK | 31.5 Percentage of NK cells (%) | Standard Deviation 14 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Rapid Cytokine-Producing NK Cell Subset | 3.8 Percentage of NK cells (%) | Standard Deviation 2.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Mature CD16+ Terminally Differentiated | 1.1 Percentage of NK cells (%) | Standard Deviation 0.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Mature CD16- Terminally Differentiate NK | 0.4 Percentage of NK cells (%) | Standard Deviation 0.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Highly Cytolytic Subset Of NK Cells | 22.1 Percentage of NK cells (%) | Standard Deviation 11 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Total CD16+ CD56- NK | 7.3 Percentage of NK cells (%) | Standard Deviation 3.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: ADCC-Competent NK | 34.7 Percentage of NK cells (%) | Standard Deviation 14.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: CD56High NK Pool | 4.4 Percentage of NK cells (%) | Standard Deviation 3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Senescent CD16- CD56- NK cells | 2.0 Percentage of NK cells (%) | Standard Deviation 2.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Mature Cytolytic NK Cells | 2.3 Percentage of NK cells (%) | Standard Deviation 1.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Functional NK Cells; Efficient At ADCC | 11.0 Percentage of NK cells (%) | Standard Deviation 7.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Week 0: Total CD16- CD56- NK | 30.0 Percentage of NK cells (%) | Standard Deviation 12.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: ADCC-Competent NK | 34.1 Percentage of NK cells (%) | Standard Deviation 16.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Mature Cytolytic NK Cells | 2.4 Percentage of NK cells (%) | Standard Deviation 1.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: CD56- Cells | 37.6 Percentage of NK cells (%) | Standard Deviation 12.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Senescent CD16- CD56- NK cells | 2.2 Percentage of NK cells (%) | Standard Deviation 3.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Mature CD16- Terminally Differentiate NK | 1.0 Percentage of NK cells (%) | Standard Deviation 4.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Mature Cytolytic NK Cells | 2.5 Percentage of NK cells (%) | Standard Deviation 1.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Total Mature NK Cells; Highly Cytolytic | 53.7 Percentage of NK cells (%) | Standard Deviation 15 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Mature Rapid Cytokine-Producing NK Cell | 3.6 Percentage of NK cells (%) | Standard Deviation 2.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Total Mature NK Cells; Highly Cytolytic | 56.2 Percentage of NK cells (%) | Standard Deviation 11.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Total CD16+ CD56- NK | 6.8 Percentage of NK cells (%) | Standard Deviation 3.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Mature CD16+ Highly Functional NK Cells | 0.7 Percentage of NK cells (%) | Standard Deviation 0.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Mature Rapid Cytokine-Producing NK Cell | 3.3 Percentage of NK cells (%) | Standard Deviation 2.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Week 0: Total CD16- CD56- NK | 34.0 Percentage of NK cells (%) | Standard Deviation 14.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Functional NK Cells; Efficient At ADCC | 12.6 Percentage of NK cells (%) | Standard Deviation 9.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Senescent Cytolytic NK Cells | 9.6 Percentage of NK cells (%) | Standard Deviation 6.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Mature Rapid Cytokine-Producing NK Cell | 3.9 Percentage of NK cells (%) | Standard Deviation 3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Senescent Rapid Cytokine-Producing NK | 0.0 Percentage of NK cells (%) | Standard Deviation 0 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Mature CD16+ Terminally Differentiated | 1.3 Percentage of NK cells (%) | Standard Deviation 1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: CD57+ MatNK Effectors | 19.0 Percentage of NK cells (%) | Standard Deviation 10.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Rapid Cytokine-Producing NK Cell Subset | 4.1 Percentage of NK cells (%) | Standard Deviation 3.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Highly Cytolytic Subset Of NK Cells | 21.9 Percentage of NK cells (%) | Standard Deviation 9.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: CD16+ Highly Functional NK Cells | 0.8 Percentage of NK cells (%) | Standard Deviation 0.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: CD56- Cells | 38.0 Percentage of NK cells (%) | Standard Deviation 13.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Senescent CD16+ CD56- NK cells | 1.1 Percentage of NK cells (%) | Standard Deviation 1.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Total CD16+ CD56- NK | 7.3 Percentage of NK cells (%) | Standard Deviation 3.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: CD57+ MatNK Effectors | 16.6 Percentage of NK cells (%) | Standard Deviation 9.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Rapid Cytokine-Producing NK Cell Subset | 4.6 Percentage of NK cells (%) | Standard Deviation 3.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: CD56High NK Pool | 5.4 Percentage of NK cells (%) | Standard Deviation 4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Senescent CD16+ CD56- NK cells | 1.2 Percentage of NK cells (%) | Standard Deviation 1.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Senescent Cytolytic NK Cells | 9.9 Percentage of NK cells (%) | Standard Deviation 6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: CD16+ Highly Functional NK Cells | 0.6 Percentage of NK cells (%) | Standard Deviation 0.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: CD56High NK Pool | 4.9 Percentage of NK cells (%) | Standard Deviation 3.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Highly Cytolytic Subset Of NK Cells | 21.4 Percentage of NK cells (%) | Standard Deviation 9.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Senescent CD16+CD56hi NK | 0.1 Percentage of NK cells (%) | Standard Deviation 0.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: Senescent CD16+ CD56- NK cells | 1.2 Percentage of NK cells (%) | Standard Deviation 1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 0: Total Mature NK Cells; Highly Cytolytic | 56.3 Percentage of NK cells (%) | Standard Deviation 13.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 80: CD57+ MatNK Effectors | 17.3 Percentage of NK cells (%) | Standard Deviation 9.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel | Week 54: Week 0: Senescent CD16+CD56hi NK | 0.0 Percentage of NK cells (%) | Standard Deviation 0.1 |
Secondary
Change in Biomarker: Immune Phenotyping- T Cell Panel
T cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80. In below table CD refer to Cluster of Differentiation; TEMRA refers to terminally differentiated effector memory cells re-expressing CD45RA; CCR refers to C-C chemokine receptor; TREG refers to Regulatory T cells.
Time frame: Week 0, week 54 and week 80
Population: The FAS included all randomised participants. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Naive CD4 T-Cells | 2.0 Percentage of T cells (%) | Standard Deviation 1.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent CD8 Central Memory Cells | 12.7 Percentage of T cells (%) | Standard Deviation 9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total Viable CD4 T-Cells | 54.7 Percentage of T cells (%) | Standard Deviation 10.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Conventional Central Memory CD4 T-Cells | 20.4 Percentage of T cells (%) | Standard Deviation 8.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CD8 Central Memory | 1.8 Percentage of T cells (%) | Standard Deviation 1.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent CD8 Effector Memory Cells | 27.3 Percentage of T cells (%) | Standard Deviation 14.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ CD4 TEMRA | 18.4 Percentage of T cells (%) | Standard Deviation 12.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Effector Memory Regulatory T-Cells | 4.7 Percentage of T cells (%) | Standard Deviation 3.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Naive CD4 T-Cells | 1.9 Percentage of T cells (%) | Standard Deviation 1.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent CD8 Effector Memory Cells | 25.2 Percentage of T cells (%) | Standard Deviation 13.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ CD8 EM | 37.9 Percentage of T cells (%) | Standard Deviation 14.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated Mature Naive CD4 T-Cells | 4.0 Percentage of T cells (%) | Standard Deviation 2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Effector Memory Regulatory T-Cells | 5.2 Percentage of T cells (%) | Standard Deviation 3.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent CD8 Effector Memory Cells | 27.5 Percentage of T cells (%) | Standard Deviation 14.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Central Memory CD4 Cells | 4.1 Percentage of T cells (%) | Standard Deviation 2.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Effector Memory Regulatory T-Cells | 4.8 Percentage of T cells (%) | Standard Deviation 3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total Viable T-Cells | 52.7 Percentage of T cells (%) | Standard Deviation 8.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent Naive CD4 T-Cells | 2.6 Percentage of T cells (%) | Standard Deviation 2.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CD4 TEMRA | 3.8 Percentage of T cells (%) | Standard Deviation 5.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ CD4 TEMRA | 17.7 Percentage of T cells (%) | Standard Deviation 12.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Central Memory CD4 Cells | 4.5 Percentage of T cells (%) | Standard Deviation 2.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent Naive CD4 T-Cells | 2.5 Percentage of T cells (%) | Standard Deviation 2.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total Viable CD8 T-Cells | 26.1 Percentage of T cells (%) | Standard Deviation 8.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated CD4 TEMRA | 9.1 Percentage of T cells (%) | Standard Deviation 5.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Naive CD4 T-Cells | 55.4 Percentage of T cells (%) | Standard Deviation 11.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent Naive CD4 T-Cells | 3.1 Percentage of T cells (%) | Standard Deviation 3.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Conventional Effector Memory CD4 T-Cells | 20.3 Percentage of T cells (%) | Standard Deviation 9.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Naive CD8 T-Cells | 3.7 Percentage of T cells (%) | Standard Deviation 2.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total TREG EM | 30.7 Percentage of T cells (%) | Standard Deviation 13.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent Naive CD8 T-Cells | 3.9 Percentage of T cells (%) | Standard Deviation 3.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent TREG EM | 0.5 Percentage of T cells (%) | Standard Deviation 0.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent Naive CD8 T-Cells | 3.5 Percentage of T cells (%) | Standard Deviation 2.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated Mature Naive CD8 T-Cells | 2.7 Percentage of T cells (%) | Standard Deviation 2.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Central Memory CD4 Cells | 4.9 Percentage of T cells (%) | Standard Deviation 2.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent Naive TREG | 6.3 Percentage of T cells (%) | Standard Deviation 5.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent Naive CD8 T-Cells | 4.4 Percentage of T cells (%) | Standard Deviation 4.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total TREG TEMRA | 7.3 Percentage of T cells (%) | Standard Deviation 8.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Naive Regulatory T-Cells | 6.1 Percentage of T cells (%) | Standard Deviation 6.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated Effector Memory CD8 | 1.9 Percentage of T cells (%) | Standard Deviation 3.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent Naive TREG | 6.9 Percentage of T cells (%) | Standard Deviation 7.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated CD4 TEMRA | 10.1 Percentage of T cells (%) | Standard Deviation 7.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CD8 Effector Memory | 15.1 Percentage of T cells (%) | Standard Deviation 8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent Naive TREG | 7.2 Percentage of T cells (%) | Standard Deviation 10.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent TEMRA CD4 | 23.3 Percentage of T cells (%) | Standard Deviation 19.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated Mature Naive CD8 T-Cells | 3.0 Percentage of T cells (%) | Standard Deviation 3.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated Mature Naive CD4 T-Cells | 3.9 Percentage of T cells (%) | Standard Deviation 2.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Central Memory Regulatory T-Cells | 2.1 Percentage of T cells (%) | Standard Deviation 1.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent TEMRA CD4 | 20.0 Percentage of T cells (%) | Standard Deviation 17.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated Mature Naive CD8 T-Cells | 3.4 Percentage of T cells (%) | Standard Deviation 3.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Naive Regulatory T-Cells | 6.7 Percentage of T cells (%) | Standard Deviation 10.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated Mature Naive CD4 T-Cells | 4.0 Percentage of T cells (%) | Standard Deviation 2.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent TEMRA CD4 | 21.0 Percentage of T cells (%) | Standard Deviation 19.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Central Memory CD8 Cells | 16.8 Percentage of T cells (%) | Standard Deviation 9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated CD4 TEMRA | 10.3 Percentage of T cells (%) | Standard Deviation 5.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated Effector Memory CD4 | 10.2 Percentage of T cells (%) | Standard Deviation 6.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent TEMRA CD8 | 42.8 Percentage of T cells (%) | Standard Deviation 20.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ CD8 EM | 35.3 Percentage of T cells (%) | Standard Deviation 14.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Naive CD4 T-Cells | 56.1 Percentage of T cells (%) | Standard Deviation 11.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total Viable CD8 T-Cells | 25.0 Percentage of T cells (%) | Standard Deviation 7.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent TEMRA CD8 | 39.2 Percentage of T cells (%) | Standard Deviation 19.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Central Memory Regulatory T-Cells | 1.9 Percentage of T cells (%) | Standard Deviation 1.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CD4 TEMRA | 3.7 Percentage of T cells (%) | Standard Deviation 4.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Naive CD8 T-Cells | 52.0 Percentage of T cells (%) | Standard Deviation 15.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent TEMRA CD8 | 42.7 Percentage of T cells (%) | Standard Deviation 21.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total Viable CD4 T-Cells | 54.3 Percentage of T cells (%) | Standard Deviation 11.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CD4 TEMRA | 4.4 Percentage of T cells (%) | Standard Deviation 5.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated Effector Memory CD4 | 10.3 Percentage of T cells (%) | Standard Deviation 5.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent TEMRA TREG | 3.6 Percentage of T cells (%) | Standard Deviation 19.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Conventional Effector Memory CD4 T-Cells | 20.0 Percentage of T cells (%) | Standard Deviation 9.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Conventional Central Memory CD4 T-Cells | 20.0 Percentage of T cells (%) | Standard Deviation 9.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Naive Regulatory T-Cells | 5.8 Percentage of T cells (%) | Standard Deviation 4.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent TEMRA TREG | 3.9 Percentage of T cells (%) | Standard Deviation 9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated Effector Memory CD4 | 10.1 Percentage of T cells (%) | Standard Deviation 5.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CD8 Central Memory | 2.0 Percentage of T cells (%) | Standard Deviation 1.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated Central Memory CD8 | 2.2 Percentage of T cells (%) | Standard Deviation 6.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent TEMRA TREG | 2.6 Percentage of T cells (%) | Standard Deviation 4.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total TREG TEMRA | 8.5 Percentage of T cells (%) | Standard Deviation 11.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Naive CD8 T-Cells | 51.1 Percentage of T cells (%) | Standard Deviation 16 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated CD8 TEMRA | 0.9 Percentage of T cells (%) | Standard Deviation 1.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent TREG CM | 0.1 Percentage of T cells (%) | Standard Deviation 0.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ CD8 EM | 38.8 Percentage of T cells (%) | Standard Deviation 15.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total Viable CD8 T-Cells | 24.2 Percentage of T cells (%) | Standard Deviation 8.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated Central Memory CD8 | 1.4 Percentage of T cells (%) | Standard Deviation 1.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent TREG CM | 0.1 Percentage of T cells (%) | Standard Deviation 0.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent CD4 Central Memory Cells | 2.3 Percentage of T cells (%) | Standard Deviation 1.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CD8 Central Memory | 1.8 Percentage of T cells (%) | Standard Deviation 1.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ CD4 Treg TEMRA | 4.2 Percentage of T cells (%) | Standard Deviation 9.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent TREG CM | 0.2 Percentage of T cells (%) | Standard Deviation 0.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Naive CD8 T-Cells | 53.2 Percentage of T cells (%) | Standard Deviation 14.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Naive CD8 T-Cells | 3.8 Percentage of T cells (%) | Standard Deviation 1.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated Central Memory CD8 | 1.1 Percentage of T cells (%) | Standard Deviation 1.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent TREG EM | 0.4 Percentage of T cells (%) | Standard Deviation 0.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent CD4 Central Memory Cells | 1.9 Percentage of T cells (%) | Standard Deviation 1.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated CD8 TEMRA | 0.7 Percentage of T cells (%) | Standard Deviation 0.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated Effector Memory CD8 | 2.0 Percentage of T cells (%) | Standard Deviation 3.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent TREG EM | 0.4 Percentage of T cells (%) | Standard Deviation 0.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated Effector Memory CD8 | 1.9 Percentage of T cells (%) | Standard Deviation 3.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CD8 TEMRA | 29.8 Percentage of T cells (%) | Standard Deviation 12.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Conventional Central Memory CD4 T-Cells | 19.4 Percentage of T cells (%) | Standard Deviation 8.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent CD4 Central Memory Cells | 2.3 Percentage of T cells (%) | Standard Deviation 1.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ CD8 TEMRA | 25.9 Percentage of T cells (%) | Standard Deviation 11.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total Naive TREG | 46.8 Percentage of T cells (%) | Standard Deviation 18.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Conventional Effector Memory CD4 T-Cells | 19.2 Percentage of T cells (%) | Standard Deviation 10.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CD8 Effector Memory | 14.3 Percentage of T cells (%) | Standard Deviation 7.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ CD4 Treg TEMRA | 3.7 Percentage of T cells (%) | Standard Deviation 10.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total Naive TREG | 43.7 Percentage of T cells (%) | Standard Deviation 15.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Naive CD8 T-Cells | 3.4 Percentage of T cells (%) | Standard Deviation 1.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent CD4 Effector Memory Cells | 6.9 Percentage of T cells (%) | Standard Deviation 5.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated Central Memory CD4 | 6.5 Percentage of T cells (%) | Standard Deviation 3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total Naive TREG | 46.8 Percentage of T cells (%) | Standard Deviation 15.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Central Memory CD8 Cells | 16.8 Percentage of T cells (%) | Standard Deviation 8.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Central Memory Regulatory T-Cells | 2.0 Percentage of T cells (%) | Standard Deviation 1.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Effector Memory CD4 | 16.2 Percentage of T cells (%) | Standard Deviation 7.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total TREG | 3.9 Percentage of T cells (%) | Standard Deviation 1.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated CD8 TEMRA | 0.9 Percentage of T cells (%) | Standard Deviation 1.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CD8 Effector Memory | 15.1 Percentage of T cells (%) | Standard Deviation 7.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent CD4 Effector Memory Cells | 5.9 Percentage of T cells (%) | Standard Deviation 5.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total TREG | 3.8 Percentage of T cells (%) | Standard Deviation 1.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total Viable T-Cells | 55.6 Percentage of T cells (%) | Standard Deviation 7.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total Viable CD4 T-Cells | 51.9 Percentage of T cells (%) | Standard Deviation 13.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total TREG | 3.7 Percentage of T cells (%) | Standard Deviation 1.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Naive CD4 T-Cells | 2.3 Percentage of T cells (%) | Standard Deviation 1.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ CD4 Treg TEMRA | 2.8 Percentage of T cells (%) | Standard Deviation 4.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated Central Memory CD4 | 6.3 Percentage of T cells (%) | Standard Deviation 3.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total TREG CM | 14.8 Percentage of T cells (%) | Standard Deviation 9.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent CD4 Effector Memory Cells | 6.9 Percentage of T cells (%) | Standard Deviation 5.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CD8 TEMRA | 31.6 Percentage of T cells (%) | Standard Deviation 12.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ CD4 TEMRA | 18.3 Percentage of T cells (%) | Standard Deviation 11 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total TREG CM | 15.5 Percentage of T cells (%) | Standard Deviation 9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Central Memory CD8 Cells | 15.0 Percentage of T cells (%) | Standard Deviation 10.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent CD8 Central Memory Cells | 12.1 Percentage of T cells (%) | Standard Deviation 10.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ CD8 TEMRA | 25.9 Percentage of T cells (%) | Standard Deviation 10.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total TREG CM | 15.3 Percentage of T cells (%) | Standard Deviation 8.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Naive CD4 T-Cells | 57.0 Percentage of T cells (%) | Standard Deviation 14.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated Central Memory CD4 | 6.3 Percentage of T cells (%) | Standard Deviation 3.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Effector Memory CD4 | 17.5 Percentage of T cells (%) | Standard Deviation 7.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total TREG EM | 30.8 Percentage of T cells (%) | Standard Deviation 14.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Effector Memory CD4 | 15.5 Percentage of T cells (%) | Standard Deviation 7.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent CD8 Central Memory Cells | 11.7 Percentage of T cells (%) | Standard Deviation 9.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ CD8 TEMRA | 22.8 Percentage of T cells (%) | Standard Deviation 10.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total TREG EM | 32.4 Percentage of T cells (%) | Standard Deviation 14.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total Viable T-Cells | 53.6 Percentage of T cells (%) | Standard Deviation 7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total TREG TEMRA | 7.6 Percentage of T cells (%) | Standard Deviation 11.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CD8 TEMRA | 31.9 Percentage of T cells (%) | Standard Deviation 14.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total TREG TEMRA | 5.5 Percentage of T cells (%) | Standard Deviation 3.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Effector Memory CD4 | 14.5 Percentage of T cells (%) | Standard Deviation 7.6 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total TREG TEMRA | 7.7 Percentage of T cells (%) | Standard Deviation 10.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CD8 TEMRA | 33.5 Percentage of T cells (%) | Standard Deviation 13.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total TREG TEMRA | 7.4 Percentage of T cells (%) | Standard Deviation 10.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Central Memory Regulatory T-Cells | 1.8 Percentage of T cells (%) | Standard Deviation 1.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total Viable CD4 T-Cells | 53.2 Percentage of T cells (%) | Standard Deviation 8.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total Viable CD4 T-Cells | 52.1 Percentage of T cells (%) | Standard Deviation 12.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total Viable CD4 T-Cells | 50.3 Percentage of T cells (%) | Standard Deviation 13.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Conventional Central Memory CD4 T-Cells | 21.7 Percentage of T cells (%) | Standard Deviation 7.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ CD8 EM | 34.7 Percentage of T cells (%) | Standard Deviation 12.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total Viable CD8 T-Cells | 28.2 Percentage of T cells (%) | Standard Deviation 8.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated Central Memory CD4 | 6.1 Percentage of T cells (%) | Standard Deviation 3.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Central Memory CD8 Cells | 14.2 Percentage of T cells (%) | Standard Deviation 9.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total Viable CD8 T-Cells | 26.7 Percentage of T cells (%) | Standard Deviation 9.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CD8 Central Memory | 1.9 Percentage of T cells (%) | Standard Deviation 2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total Viable CD8 T-Cells | 25.4 Percentage of T cells (%) | Standard Deviation 9.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Central Memory CD8 Cells | 14.4 Percentage of T cells (%) | Standard Deviation 9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total Viable T-Cells | 55.2 Percentage of T cells (%) | Standard Deviation 8.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Naive CD8 T-Cells | 52.1 Percentage of T cells (%) | Standard Deviation 18.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ CD8 EM | 36.4 Percentage of T cells (%) | Standard Deviation 13.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total Viable T-Cells | 55.9 Percentage of T cells (%) | Standard Deviation 6.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total Viable T-Cells | 55.3 Percentage of T cells (%) | Standard Deviation 7.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ CD8 EM | 35.5 Percentage of T cells (%) | Standard Deviation 13.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Conventional Effector Memory CD4 T-Cells | 22.9 Percentage of T cells (%) | Standard Deviation 11 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated CD4 TEMRA | 9.7 Percentage of T cells (%) | Standard Deviation 5.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CD4 TEMRA | 3.2 Percentage of T cells (%) | Standard Deviation 2.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ CD4 Treg TEMRA | 4.4 Percentage of T cells (%) | Standard Deviation 10.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ CD4 Treg TEMRA | 4.2 Percentage of T cells (%) | Standard Deviation 10.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated CD8 TEMRA | 0.8 Percentage of T cells (%) | Standard Deviation 1.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated Effector Memory CD8 | 1.7 Percentage of T cells (%) | Standard Deviation 2.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated Effector Memory CD8 | 1.6 Percentage of T cells (%) | Standard Deviation 2.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Conventional Effector Memory CD4 T-Cells | 24.4 Percentage of T cells (%) | Standard Deviation 11.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ CD4 TEMRA | 19.5 Percentage of T cells (%) | Standard Deviation 13.6 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated CD8 TEMRA | 0.6 Percentage of T cells (%) | Standard Deviation 0.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CD4 TEMRA | 2.9 Percentage of T cells (%) | Standard Deviation 2.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated CD8 TEMRA | 0.6 Percentage of T cells (%) | Standard Deviation 0.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ CD4 TEMRA | 17.7 Percentage of T cells (%) | Standard Deviation 10.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Naive CD4 T-Cells | 52.4 Percentage of T cells (%) | Standard Deviation 14.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated Effector Memory CD8 | 1.5 Percentage of T cells (%) | Standard Deviation 2.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Central Memory CD8 Cells | 15.5 Percentage of T cells (%) | Standard Deviation 8.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ CD4 TEMRA | 16.4 Percentage of T cells (%) | Standard Deviation 8.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Central Memory CD4 Cells | 4.3 Percentage of T cells (%) | Standard Deviation 2.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Central Memory CD4 Cells | 4.1 Percentage of T cells (%) | Standard Deviation 2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated Mature Naive CD8 T-Cells | 2.6 Percentage of T cells (%) | Standard Deviation 2.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Central Memory CD4 Cells | 4.9 Percentage of T cells (%) | Standard Deviation 3.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated Mature Naive CD4 T-Cells | 4.0 Percentage of T cells (%) | Standard Deviation 1.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Naive CD4 T-Cells | 51.8 Percentage of T cells (%) | Standard Deviation 15 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated Mature Naive CD8 T-Cells | 2.6 Percentage of T cells (%) | Standard Deviation 3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated Mature Naive CD4 T-Cells | 3.8 Percentage of T cells (%) | Standard Deviation 1.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated Mature Naive CD4 T-Cells | 3.8 Percentage of T cells (%) | Standard Deviation 1.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CD4 TEMRA | 2.6 Percentage of T cells (%) | Standard Deviation 1.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Naive CD4 T-Cells | 50.6 Percentage of T cells (%) | Standard Deviation 16.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Naive CD8 T-Cells | 52.5 Percentage of T cells (%) | Standard Deviation 19.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Central Memory Regulatory T-Cells | 1.8 Percentage of T cells (%) | Standard Deviation 1.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Naive Regulatory T-Cells | 5.0 Percentage of T cells (%) | Standard Deviation 3.6 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Naive CD8 T-Cells | 48.1 Percentage of T cells (%) | Standard Deviation 19.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Central Memory Regulatory T-Cells | 1.5 Percentage of T cells (%) | Standard Deviation 1.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Naive CD8 T-Cells | 4.0 Percentage of T cells (%) | Standard Deviation 4.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent CD4 Central Memory Cells | 2.2 Percentage of T cells (%) | Standard Deviation 1.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent CD4 Central Memory Cells | 2.1 Percentage of T cells (%) | Standard Deviation 1.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Naive CD8 T-Cells | 3.5 Percentage of T cells (%) | Standard Deviation 2.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent CD4 Central Memory Cells | 2.3 Percentage of T cells (%) | Standard Deviation 1.6 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Conventional Effector Memory CD4 T-Cells | 22.8 Percentage of T cells (%) | Standard Deviation 10.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent CD4 Effector Memory Cells | 6.3 Percentage of T cells (%) | Standard Deviation 5.6 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated CD4 TEMRA | 8.7 Percentage of T cells (%) | Standard Deviation 5.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Naive CD4 T-Cells | 2.9 Percentage of T cells (%) | Standard Deviation 3.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent CD4 Effector Memory Cells | 6.7 Percentage of T cells (%) | Standard Deviation 6 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Conventional Central Memory CD4 T-Cells | 22.2 Percentage of T cells (%) | Standard Deviation 9.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent CD4 Effector Memory Cells | 7.0 Percentage of T cells (%) | Standard Deviation 5.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Effector Memory CD4 | 15.7 Percentage of T cells (%) | Standard Deviation 7.6 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent CD8 Central Memory Cells | 11.5 Percentage of T cells (%) | Standard Deviation 9.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Naive CD4 T-Cells | 2.1 Percentage of T cells (%) | Standard Deviation 2.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated Mature Naive CD8 T-Cells | 2.8 Percentage of T cells (%) | Standard Deviation 2.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent CD8 Central Memory Cells | 12.7 Percentage of T cells (%) | Standard Deviation 9.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Naive CD4 T-Cells | 2.0 Percentage of T cells (%) | Standard Deviation 1.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent CD8 Effector Memory Cells | 27.2 Percentage of T cells (%) | Standard Deviation 15.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent CD8 Effector Memory Cells | 25.1 Percentage of T cells (%) | Standard Deviation 14.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Effector Memory Regulatory T-Cells | 5.1 Percentage of T cells (%) | Standard Deviation 3.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent CD8 Effector Memory Cells | 28.6 Percentage of T cells (%) | Standard Deviation 15.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Effector Memory Regulatory T-Cells | 4.6 Percentage of T cells (%) | Standard Deviation 3.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent Naive CD4 T-Cells | 2.9 Percentage of T cells (%) | Standard Deviation 3.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Effector Memory Regulatory T-Cells | 5.2 Percentage of T cells (%) | Standard Deviation 4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Effector Memory CD4 | 16.8 Percentage of T cells (%) | Standard Deviation 9.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent Naive CD4 T-Cells | 3.0 Percentage of T cells (%) | Standard Deviation 3.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total TREG EM | 33.5 Percentage of T cells (%) | Standard Deviation 13.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent Naive CD4 T-Cells | 3.3 Percentage of T cells (%) | Standard Deviation 3.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent Naive CD8 T-Cells | 3.8 Percentage of T cells (%) | Standard Deviation 4.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Naive CD8 T-Cells | 3.5 Percentage of T cells (%) | Standard Deviation 1.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent Naive CD8 T-Cells | 4.3 Percentage of T cells (%) | Standard Deviation 4.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent Naive TREG | 6.8 Percentage of T cells (%) | Standard Deviation 7.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent Naive TREG | 7.0 Percentage of T cells (%) | Standard Deviation 8.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated CD4 TEMRA | 8.1 Percentage of T cells (%) | Standard Deviation 5.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent TEMRA CD4 | 21.7 Percentage of T cells (%) | Standard Deviation 18.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Conventional Central Memory CD4 T-Cells | 22.1 Percentage of T cells (%) | Standard Deviation 8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent Naive TREG | 5.5 Percentage of T cells (%) | Standard Deviation 3.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent TEMRA CD4 | 22.8 Percentage of T cells (%) | Standard Deviation 18.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated Effector Memory CD4 | 8.9 Percentage of T cells (%) | Standard Deviation 4.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent TEMRA CD4 | 24.2 Percentage of T cells (%) | Standard Deviation 18.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Naive Regulatory T-Cells | 6.3 Percentage of T cells (%) | Standard Deviation 7.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent TEMRA CD8 | 40.3 Percentage of T cells (%) | Standard Deviation 21 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent Naive CD8 T-Cells | 3.6 Percentage of T cells (%) | Standard Deviation 3.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated Effector Memory CD4 | 9.6 Percentage of T cells (%) | Standard Deviation 5.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent TEMRA CD8 | 40.7 Percentage of T cells (%) | Standard Deviation 21.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Naive Regulatory T-Cells | 6.5 Percentage of T cells (%) | Standard Deviation 8.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated Effector Memory CD4 | 10.9 Percentage of T cells (%) | Standard Deviation 5.6 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent TEMRA CD8 | 44.8 Percentage of T cells (%) | Standard Deviation 20.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent TEMRA TREG | 1.8 Percentage of T cells (%) | Standard Deviation 1.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated Central Memory CD8 | 1.4 Percentage of T cells (%) | Standard Deviation 1.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent TEMRA TREG | 4.2 Percentage of T cells (%) | Standard Deviation 10.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent TEMRA TREG | 4.4 Percentage of T cells (%) | Standard Deviation 10.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CD8 Central Memory | 2.0 Percentage of T cells (%) | Standard Deviation 2.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated Central Memory CD8 | 1.6 Percentage of T cells (%) | Standard Deviation 1.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent TREG CM | 0.1 Percentage of T cells (%) | Standard Deviation 0.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ CD4 Treg TEMRA | 1.7 Percentage of T cells (%) | Standard Deviation 1.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent TREG CM | 0.1 Percentage of T cells (%) | Standard Deviation 0.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated Central Memory CD8 | 1.7 Percentage of T cells (%) | Standard Deviation 1.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent TREG CM | 0.2 Percentage of T cells (%) | Standard Deviation 0.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CD8 Central Memory | 2.1 Percentage of T cells (%) | Standard Deviation 2.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent TREG EM | 0.4 Percentage of T cells (%) | Standard Deviation 0.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ CD8 TEMRA | 24.4 Percentage of T cells (%) | Standard Deviation 11.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent TREG EM | 0.3 Percentage of T cells (%) | Standard Deviation 0.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent TREG EM | 0.5 Percentage of T cells (%) | Standard Deviation 0.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CD8 TEMRA | 30.9 Percentage of T cells (%) | Standard Deviation 13.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total Naive TREG | 42.4 Percentage of T cells (%) | Standard Deviation 14.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated Central Memory CD4 | 6.0 Percentage of T cells (%) | Standard Deviation 2.6 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total Naive TREG | 44.3 Percentage of T cells (%) | Standard Deviation 15.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CD8 Effector Memory | 14.7 Percentage of T cells (%) | Standard Deviation 7.6 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total Naive TREG | 44.1 Percentage of T cells (%) | Standard Deviation 18.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent CD8 Central Memory Cells | 10.4 Percentage of T cells (%) | Standard Deviation 9.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total TREG | 3.8 Percentage of T cells (%) | Standard Deviation 1.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated Central Memory CD4 | 6.7 Percentage of T cells (%) | Standard Deviation 3.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total TREG | 3.5 Percentage of T cells (%) | Standard Deviation 1.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CD8 Effector Memory | 14.8 Percentage of T cells (%) | Standard Deviation 7.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total TREG | 3.5 Percentage of T cells (%) | Standard Deviation 1.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total TREG CM | 15.8 Percentage of T cells (%) | Standard Deviation 8.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ CD8 TEMRA | 25.0 Percentage of T cells (%) | Standard Deviation 9.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total TREG CM | 15.6 Percentage of T cells (%) | Standard Deviation 9.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CD8 TEMRA | 31.0 Percentage of T cells (%) | Standard Deviation 13.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total TREG CM | 15.0 Percentage of T cells (%) | Standard Deviation 8.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ CD8 TEMRA | 22.9 Percentage of T cells (%) | Standard Deviation 10.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total TREG EM | 36.4 Percentage of T cells (%) | Standard Deviation 11.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CD8 Effector Memory | 16.5 Percentage of T cells (%) | Standard Deviation 9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total TREG EM | 32.6 Percentage of T cells (%) | Standard Deviation 12.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent Naive CD8 T-Cells | 3.5 Percentage of T cells (%) | Standard Deviation 3.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated Mature Naive CD4 T-Cells | 4.5 Percentage of T cells (%) | Standard Deviation 2.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated Mature Naive CD8 T-Cells | 3.3 Percentage of T cells (%) | Standard Deviation 3.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated Mature Naive CD8 T-Cells | 2.6 Percentage of T cells (%) | Standard Deviation 2.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ CD4 Treg TEMRA | 2.7 Percentage of T cells (%) | Standard Deviation 4.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Central Memory CD4 Cells | 5.1 Percentage of T cells (%) | Standard Deviation 3.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Central Memory CD8 Cells | 16.9 Percentage of T cells (%) | Standard Deviation 10.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Central Memory CD8 Cells | 15.8 Percentage of T cells (%) | Standard Deviation 9.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Central Memory Regulatory T-Cells | 1.8 Percentage of T cells (%) | Standard Deviation 1.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Central Memory Regulatory T-Cells | 1.9 Percentage of T cells (%) | Standard Deviation 1.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Effector Memory CD4 | 15.5 Percentage of T cells (%) | Standard Deviation 8.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Effector Memory CD4 | 16.4 Percentage of T cells (%) | Standard Deviation 8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Naive CD4 T-Cells | 2.1 Percentage of T cells (%) | Standard Deviation 1.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Naive Regulatory T-Cells | 6.5 Percentage of T cells (%) | Standard Deviation 8.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Naive Regulatory T-Cells | 4.8 Percentage of T cells (%) | Standard Deviation 5.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CD8 Central Memory | 1.8 Percentage of T cells (%) | Standard Deviation 1.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CD8 Central Memory | 1.7 Percentage of T cells (%) | Standard Deviation 1.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CD8 Effector Memory | 13.4 Percentage of T cells (%) | Standard Deviation 7.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CD8 Effector Memory | 11.3 Percentage of T cells (%) | Standard Deviation 6.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CD8 TEMRA | 30.3 Percentage of T cells (%) | Standard Deviation 12.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CD8 TEMRA | 30.4 Percentage of T cells (%) | Standard Deviation 13 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Conventional Central Memory CD4 T-Cells | 19.9 Percentage of T cells (%) | Standard Deviation 8.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Conventional Effector Memory CD4 T-Cells | 19.5 Percentage of T cells (%) | Standard Deviation 9.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Conventional Effector Memory CD4 T-Cells | 20.5 Percentage of T cells (%) | Standard Deviation 10.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Conventional Effector Memory CD4 T-Cells | 20.9 Percentage of T cells (%) | Standard Deviation 11.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Naive CD4 T-Cells | 57.0 Percentage of T cells (%) | Standard Deviation 12.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Naive CD4 T-Cells | 56.3 Percentage of T cells (%) | Standard Deviation 13.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Naive CD4 T-Cells | 55.6 Percentage of T cells (%) | Standard Deviation 15.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Naive CD8 T-Cells | 55.8 Percentage of T cells (%) | Standard Deviation 17 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Naive CD8 T-Cells | 54.7 Percentage of T cells (%) | Standard Deviation 15.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Naive CD8 T-Cells | 53.9 Percentage of T cells (%) | Standard Deviation 17.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent CD4 Central Memory Cells | 2.4 Percentage of T cells (%) | Standard Deviation 2.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent CD4 Central Memory Cells | 2.2 Percentage of T cells (%) | Standard Deviation 1.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent CD4 Central Memory Cells | 2.1 Percentage of T cells (%) | Standard Deviation 1.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent CD4 Effector Memory Cells | 6.9 Percentage of T cells (%) | Standard Deviation 5.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent CD4 Effector Memory Cells | 6.6 Percentage of T cells (%) | Standard Deviation 4.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent CD4 Effector Memory Cells | 6.4 Percentage of T cells (%) | Standard Deviation 4.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent CD8 Central Memory Cells | 12.9 Percentage of T cells (%) | Standard Deviation 9.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent CD8 Central Memory Cells | 12.0 Percentage of T cells (%) | Standard Deviation 10.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent CD8 Central Memory Cells | 11.3 Percentage of T cells (%) | Standard Deviation 9.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent CD8 Effector Memory Cells | 27.7 Percentage of T cells (%) | Standard Deviation 13.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent CD8 Effector Memory Cells | 26.1 Percentage of T cells (%) | Standard Deviation 12.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent CD8 Effector Memory Cells | 26.5 Percentage of T cells (%) | Standard Deviation 14.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent Naive CD4 T-Cells | 2.6 Percentage of T cells (%) | Standard Deviation 2.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent Naive CD4 T-Cells | 2.8 Percentage of T cells (%) | Standard Deviation 3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent Naive CD4 T-Cells | 3.1 Percentage of T cells (%) | Standard Deviation 3.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent Naive CD8 T-Cells | 3.7 Percentage of T cells (%) | Standard Deviation 4.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent Naive CD8 T-Cells | 3.8 Percentage of T cells (%) | Standard Deviation 3.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent Naive TREG | 6.0 Percentage of T cells (%) | Standard Deviation 7.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent TEMRA CD4 | 21.9 Percentage of T cells (%) | Standard Deviation 21.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent TEMRA CD4 | 23.1 Percentage of T cells (%) | Standard Deviation 22.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent TEMRA CD4 | 21.7 Percentage of T cells (%) | Standard Deviation 21.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent TEMRA CD8 | 37.7 Percentage of T cells (%) | Standard Deviation 19.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent TEMRA CD8 | 38.3 Percentage of T cells (%) | Standard Deviation 18.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent TEMRA CD8 | 38.7 Percentage of T cells (%) | Standard Deviation 20.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent TEMRA TREG | 2.8 Percentage of T cells (%) | Standard Deviation 4.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent TEMRA TREG | 4.6 Percentage of T cells (%) | Standard Deviation 10.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent TEMRA TREG | 3.2 Percentage of T cells (%) | Standard Deviation 5.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent TREG CM | 0.1 Percentage of T cells (%) | Standard Deviation 0.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent TREG CM | 0.1 Percentage of T cells (%) | Standard Deviation 0.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent TREG CM | 0.1 Percentage of T cells (%) | Standard Deviation 0.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent TREG EM | 0.4 Percentage of T cells (%) | Standard Deviation 0.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent TREG EM | 0.3 Percentage of T cells (%) | Standard Deviation 0.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent TREG EM | 0.5 Percentage of T cells (%) | Standard Deviation 0.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total Naive TREG | 50.3 Percentage of T cells (%) | Standard Deviation 14.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total Naive TREG | 49.4 Percentage of T cells (%) | Standard Deviation 15.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total Naive TREG | 48.7 Percentage of T cells (%) | Standard Deviation 17 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total TREG | 4.1 Percentage of T cells (%) | Standard Deviation 1.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total TREG | 4.0 Percentage of T cells (%) | Standard Deviation 1.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total TREG | 3.4 Percentage of T cells (%) | Standard Deviation 1.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total TREG CM | 14.4 Percentage of T cells (%) | Standard Deviation 7.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total TREG CM | 13.8 Percentage of T cells (%) | Standard Deviation 7.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total TREG CM | 13.8 Percentage of T cells (%) | Standard Deviation 7.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total TREG EM | 28.8 Percentage of T cells (%) | Standard Deviation 12.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total TREG TEMRA | 6.7 Percentage of T cells (%) | Standard Deviation 5.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total TREG TEMRA | 8.6 Percentage of T cells (%) | Standard Deviation 10.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total TREG TEMRA | 7.5 Percentage of T cells (%) | Standard Deviation 6.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total Viable CD4 T-Cells | 54.6 Percentage of T cells (%) | Standard Deviation 11.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total Viable CD4 T-Cells | 54.6 Percentage of T cells (%) | Standard Deviation 12.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total Viable CD4 T-Cells | 53.1 Percentage of T cells (%) | Standard Deviation 12.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total Viable CD8 T-Cells | 25.8 Percentage of T cells (%) | Standard Deviation 7.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total Viable CD8 T-Cells | 24.6 Percentage of T cells (%) | Standard Deviation 7.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total Viable CD8 T-Cells | 23.5 Percentage of T cells (%) | Standard Deviation 8.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total Viable T-Cells | 55.3 Percentage of T cells (%) | Standard Deviation 8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total Viable T-Cells | 57.4 Percentage of T cells (%) | Standard Deviation 7.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total Viable T-Cells | 56.2 Percentage of T cells (%) | Standard Deviation 8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated Effector Memory CD8 | 1.2 Percentage of T cells (%) | Standard Deviation 1.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated CD4 TEMRA | 10.8 Percentage of T cells (%) | Standard Deviation 6.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated CD4 TEMRA | 9.7 Percentage of T cells (%) | Standard Deviation 5.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated CD4 TEMRA | 8.1 Percentage of T cells (%) | Standard Deviation 4.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated Effector Memory CD8 | 1.2 Percentage of T cells (%) | Standard Deviation 1.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated CD8 TEMRA | 0.6 Percentage of T cells (%) | Standard Deviation 0.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated CD8 TEMRA | 0.6 Percentage of T cells (%) | Standard Deviation 0.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated CD8 TEMRA | 0.6 Percentage of T cells (%) | Standard Deviation 0.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ CD8 TEMRA | 26.8 Percentage of T cells (%) | Standard Deviation 13.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated Effector Memory CD8 | 1.4 Percentage of T cells (%) | Standard Deviation 2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Central Memory CD4 Cells | 4.5 Percentage of T cells (%) | Standard Deviation 2.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Central Memory CD4 Cells | 4.1 Percentage of T cells (%) | Standard Deviation 2.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated Mature Naive CD4 T-Cells | 4.7 Percentage of T cells (%) | Standard Deviation 2.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated Mature Naive CD4 T-Cells | 4.0 Percentage of T cells (%) | Standard Deviation 1.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated Mature Naive CD8 T-Cells | 2.5 Percentage of T cells (%) | Standard Deviation 2.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ CD4 TEMRA | 16.9 Percentage of T cells (%) | Standard Deviation 11.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ CD4 TEMRA | 18.8 Percentage of T cells (%) | Standard Deviation 13.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ CD4 TEMRA | 18.6 Percentage of T cells (%) | Standard Deviation 11.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ CD4 Treg TEMRA | 4.6 Percentage of T cells (%) | Standard Deviation 10.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ CD4 Treg TEMRA | 3.2 Percentage of T cells (%) | Standard Deviation 5.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ CD8 EM | 38.2 Percentage of T cells (%) | Standard Deviation 14.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ CD8 EM | 38.0 Percentage of T cells (%) | Standard Deviation 14.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Central Memory CD8 Cells | 15.8 Percentage of T cells (%) | Standard Deviation 9.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ CD8 EM | 37.5 Percentage of T cells (%) | Standard Deviation 14.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Central Memory Regulatory T-Cells | 1.7 Percentage of T cells (%) | Standard Deviation 1.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ CD8 TEMRA | 25.9 Percentage of T cells (%) | Standard Deviation 12.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated Central Memory CD4 | 7.1 Percentage of T cells (%) | Standard Deviation 3.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ CD8 TEMRA | 26.3 Percentage of T cells (%) | Standard Deviation 12.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated Central Memory CD4 | 6.3 Percentage of T cells (%) | Standard Deviation 2.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Effector Memory CD4 | 14.9 Percentage of T cells (%) | Standard Deviation 7.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated Central Memory CD4 | 6.0 Percentage of T cells (%) | Standard Deviation 2.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Effector Memory Regulatory T-Cells | 4.4 Percentage of T cells (%) | Standard Deviation 3.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated Central Memory CD8 | 1.6 Percentage of T cells (%) | Standard Deviation 1.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated Central Memory CD8 | 1.5 Percentage of T cells (%) | Standard Deviation 1.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated Central Memory CD8 | 1.6 Percentage of T cells (%) | Standard Deviation 2.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated Effector Memory CD4 | 11.3 Percentage of T cells (%) | Standard Deviation 6.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated Effector Memory CD4 | 10.0 Percentage of T cells (%) | Standard Deviation 4.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated Effector Memory CD4 | 9.5 Percentage of T cells (%) | Standard Deviation 4.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent Naive TREG | 7.1 Percentage of T cells (%) | Standard Deviation 8.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent Naive TREG | 5.0 Percentage of T cells (%) | Standard Deviation 5.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total TREG EM | 28.3 Percentage of T cells (%) | Standard Deviation 12.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total TREG EM | 30.2 Percentage of T cells (%) | Standard Deviation 15 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Effector Memory Regulatory T-Cells | 4.5 Percentage of T cells (%) | Standard Deviation 3.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Effector Memory Regulatory T-Cells | 5.4 Percentage of T cells (%) | Standard Deviation 5.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Naive CD4 T-Cells | 2.1 Percentage of T cells (%) | Standard Deviation 1.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Naive CD4 T-Cells | 2.8 Percentage of T cells (%) | Standard Deviation 3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Naive CD8 T-Cells | 4.1 Percentage of T cells (%) | Standard Deviation 2.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Naive CD8 T-Cells | 3.5 Percentage of T cells (%) | Standard Deviation 2.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Naive CD8 T-Cells | 4.3 Percentage of T cells (%) | Standard Deviation 3.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Naive Regulatory T-Cells | 5.7 Percentage of T cells (%) | Standard Deviation 6.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CD4 TEMRA | 3.1 Percentage of T cells (%) | Standard Deviation 2.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CD4 TEMRA | 3.3 Percentage of T cells (%) | Standard Deviation 2.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CD4 TEMRA | 3.6 Percentage of T cells (%) | Standard Deviation 3.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CD8 Central Memory | 1.8 Percentage of T cells (%) | Standard Deviation 1.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CD8 Effector Memory | 13.9 Percentage of T cells (%) | Standard Deviation 7.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CD8 TEMRA | 29.0 Percentage of T cells (%) | Standard Deviation 12.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Conventional Central Memory CD4 T-Cells | 20.3 Percentage of T cells (%) | Standard Deviation 8.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Conventional Central Memory CD4 T-Cells | 19.9 Percentage of T cells (%) | Standard Deviation 7.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Central Memory CD8 Cells | 19.3 Percentage of T cells (%) | Standard Deviation 13.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Central Memory Regulatory T-Cells | 1.5 Percentage of T cells (%) | Standard Deviation 1.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total Viable CD4 T-Cells | 52.7 Percentage of T cells (%) | Standard Deviation 12.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Conventional Effector Memory CD4 T-Cells | 23.2 Percentage of T cells (%) | Standard Deviation 10 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total Viable CD4 T-Cells | 54.6 Percentage of T cells (%) | Standard Deviation 11.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total TREG TEMRA | 7.8 Percentage of T cells (%) | Standard Deviation 9.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total TREG TEMRA | 8.2 Percentage of T cells (%) | Standard Deviation 10.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total TREG TEMRA | 7.5 Percentage of T cells (%) | Standard Deviation 9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total TREG EM | 30.7 Percentage of T cells (%) | Standard Deviation 15.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total TREG CM | 15.9 Percentage of T cells (%) | Standard Deviation 8.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Central Memory Regulatory T-Cells | 2.2 Percentage of T cells (%) | Standard Deviation 2.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ CD8 TEMRA | 24.3 Percentage of T cells (%) | Standard Deviation 12.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total TREG CM | 15.0 Percentage of T cells (%) | Standard Deviation 6.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total TREG CM | 14.2 Percentage of T cells (%) | Standard Deviation 7.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total TREG | 3.4 Percentage of T cells (%) | Standard Deviation 1.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total TREG | 3.5 Percentage of T cells (%) | Standard Deviation 1.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CD4 TEMRA | 3.1 Percentage of T cells (%) | Standard Deviation 3.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated Central Memory CD4 | 6.1 Percentage of T cells (%) | Standard Deviation 3.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Conventional Effector Memory CD4 T-Cells | 21.3 Percentage of T cells (%) | Standard Deviation 9.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Central Memory Regulatory T-Cells | 1.7 Percentage of T cells (%) | Standard Deviation 1.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated Central Memory CD4 | 6.2 Percentage of T cells (%) | Standard Deviation 3.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total Naive TREG | 43.4 Percentage of T cells (%) | Standard Deviation 15.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ CD8 TEMRA | 25.4 Percentage of T cells (%) | Standard Deviation 11.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CD8 Central Memory | 1.9 Percentage of T cells (%) | Standard Deviation 1.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Effector Memory CD4 | 16.9 Percentage of T cells (%) | Standard Deviation 9.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total Naive TREG | 45.1 Percentage of T cells (%) | Standard Deviation 13.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total Naive TREG | 47.7 Percentage of T cells (%) | Standard Deviation 17.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Conventional Effector Memory CD4 T-Cells | 20.7 Percentage of T cells (%) | Standard Deviation 9.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated Central Memory CD4 | 6.5 Percentage of T cells (%) | Standard Deviation 2.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent TREG EM | 0.5 Percentage of T cells (%) | Standard Deviation 0.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent TREG EM | 0.4 Percentage of T cells (%) | Standard Deviation 0.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Conventional Central Memory CD4 T-Cells | 21.1 Percentage of T cells (%) | Standard Deviation 8.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent TREG CM | 0.3 Percentage of T cells (%) | Standard Deviation 0.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent TREG CM | 0.2 Percentage of T cells (%) | Standard Deviation 0.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Central Memory CD8 Cells | 16.7 Percentage of T cells (%) | Standard Deviation 11.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated Central Memory CD8 | 1.1 Percentage of T cells (%) | Standard Deviation 1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent TREG CM | 0.2 Percentage of T cells (%) | Standard Deviation 0.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent TEMRA TREG | 4.4 Percentage of T cells (%) | Standard Deviation 9.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CD8 Effector Memory | 15.7 Percentage of T cells (%) | Standard Deviation 6.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent TEMRA TREG | 4.6 Percentage of T cells (%) | Standard Deviation 9.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent TEMRA TREG | 4.0 Percentage of T cells (%) | Standard Deviation 8.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CD8 Effector Memory | 16.4 Percentage of T cells (%) | Standard Deviation 7.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated Central Memory CD8 | 1.9 Percentage of T cells (%) | Standard Deviation 4.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent TEMRA CD8 | 43.5 Percentage of T cells (%) | Standard Deviation 23.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent TEMRA CD8 | 40.4 Percentage of T cells (%) | Standard Deviation 22.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Conventional Central Memory CD4 T-Cells | 21.1 Percentage of T cells (%) | Standard Deviation 8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated Effector Memory CD4 | 9.4 Percentage of T cells (%) | Standard Deviation 4.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent TEMRA CD8 | 42.0 Percentage of T cells (%) | Standard Deviation 23 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CD8 TEMRA | 30.4 Percentage of T cells (%) | Standard Deviation 13.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated Effector Memory CD4 | 9.2 Percentage of T cells (%) | Standard Deviation 4.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent TEMRA CD4 | 25.4 Percentage of T cells (%) | Standard Deviation 21.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent TEMRA CD4 | 23.5 Percentage of T cells (%) | Standard Deviation 21.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent CD4 Effector Memory Cells | 7.6 Percentage of T cells (%) | Standard Deviation 7.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated Effector Memory CD4 | 9.1 Percentage of T cells (%) | Standard Deviation 4.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent TEMRA CD4 | 22.0 Percentage of T cells (%) | Standard Deviation 20.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CD8 Effector Memory | 17.4 Percentage of T cells (%) | Standard Deviation 7.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent Naive TREG | 7.3 Percentage of T cells (%) | Standard Deviation 9.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent Naive TREG | 7.4 Percentage of T cells (%) | Standard Deviation 8.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent Naive CD8 T-Cells | 4.5 Percentage of T cells (%) | Standard Deviation 4.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CD8 Central Memory | 2.2 Percentage of T cells (%) | Standard Deviation 2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent Naive TREG | 5.6 Percentage of T cells (%) | Standard Deviation 5.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent Naive CD8 T-Cells | 4.2 Percentage of T cells (%) | Standard Deviation 3.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent TREG EM | 0.5 Percentage of T cells (%) | Standard Deviation 0.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent Naive CD8 T-Cells | 4.2 Percentage of T cells (%) | Standard Deviation 4.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total TREG | 3.5 Percentage of T cells (%) | Standard Deviation 1.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ CD4 Treg TEMRA | 3.9 Percentage of T cells (%) | Standard Deviation 8.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total TREG EM | 31.9 Percentage of T cells (%) | Standard Deviation 13.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent Naive CD4 T-Cells | 3.9 Percentage of T cells (%) | Standard Deviation 5.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent Naive CD4 T-Cells | 2.7 Percentage of T cells (%) | Standard Deviation 2.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CD8 TEMRA | 32.3 Percentage of T cells (%) | Standard Deviation 13.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total TREG EM | 32.9 Percentage of T cells (%) | Standard Deviation 13.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent Naive CD4 T-Cells | 2.5 Percentage of T cells (%) | Standard Deviation 2.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CD8 Central Memory | 2.1 Percentage of T cells (%) | Standard Deviation 1.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Effector Memory Regulatory T-Cells | 4.1 Percentage of T cells (%) | Standard Deviation 2.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent CD8 Effector Memory Cells | 26.6 Percentage of T cells (%) | Standard Deviation 15.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Effector Memory Regulatory T-Cells | 4.5 Percentage of T cells (%) | Standard Deviation 2.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent CD8 Effector Memory Cells | 25.8 Percentage of T cells (%) | Standard Deviation 14.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CD8 TEMRA | 33.4 Percentage of T cells (%) | Standard Deviation 14.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Effector Memory Regulatory T-Cells | 5.2 Percentage of T cells (%) | Standard Deviation 3.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent CD8 Effector Memory Cells | 29.1 Percentage of T cells (%) | Standard Deviation 17.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent CD8 Central Memory Cells | 12.2 Percentage of T cells (%) | Standard Deviation 11.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Naive CD4 T-Cells | 2.0 Percentage of T cells (%) | Standard Deviation 1.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent CD8 Central Memory Cells | 12.2 Percentage of T cells (%) | Standard Deviation 14.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent CD8 Central Memory Cells | 12.4 Percentage of T cells (%) | Standard Deviation 12.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CD4 TEMRA | 3.5 Percentage of T cells (%) | Standard Deviation 2.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Naive CD4 T-Cells | 2.3 Percentage of T cells (%) | Standard Deviation 2.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent CD4 Effector Memory Cells | 7.5 Percentage of T cells (%) | Standard Deviation 9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent CD4 Effector Memory Cells | 6.7 Percentage of T cells (%) | Standard Deviation 6.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Naive Regulatory T-Cells | 6.5 Percentage of T cells (%) | Standard Deviation 8.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Naive CD4 T-Cells | 3.5 Percentage of T cells (%) | Standard Deviation 5.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated Mature Naive CD8 T-Cells | 3.1 Percentage of T cells (%) | Standard Deviation 3.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Naive CD8 T-Cells | 4.2 Percentage of T cells (%) | Standard Deviation 3.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Senescent CD4 Central Memory Cells | 2.6 Percentage of T cells (%) | Standard Deviation 2.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Senescent CD4 Central Memory Cells | 2.4 Percentage of T cells (%) | Standard Deviation 2.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Conventional Central Memory CD4 T-Cells | 21.6 Percentage of T cells (%) | Standard Deviation 8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Naive CD8 T-Cells | 4.1 Percentage of T cells (%) | Standard Deviation 2.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Senescent CD4 Central Memory Cells | 2.3 Percentage of T cells (%) | Standard Deviation 2.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Naive CD8 T-Cells | 46.9 Percentage of T cells (%) | Standard Deviation 17.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Effector Memory CD4 | 18.4 Percentage of T cells (%) | Standard Deviation 10.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Naive CD8 T-Cells | 4.9 Percentage of T cells (%) | Standard Deviation 4.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated Mature Naive CD4 T-Cells | 3.9 Percentage of T cells (%) | Standard Deviation 1.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated Mature Naive CD4 T-Cells | 3.7 Percentage of T cells (%) | Standard Deviation 1.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated Mature Naive CD8 T-Cells | 3.5 Percentage of T cells (%) | Standard Deviation 3.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated Mature Naive CD4 T-Cells | 3.9 Percentage of T cells (%) | Standard Deviation 1.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Central Memory CD4 Cells | 5.7 Percentage of T cells (%) | Standard Deviation 4.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ CD4 TEMRA | 21.4 Percentage of T cells (%) | Standard Deviation 15.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Central Memory CD4 Cells | 4.9 Percentage of T cells (%) | Standard Deviation 3.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Naive CD8 T-Cells | 51.1 Percentage of T cells (%) | Standard Deviation 17.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated Mature Naive CD8 T-Cells | 3.1 Percentage of T cells (%) | Standard Deviation 3.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Central Memory CD4 Cells | 4.5 Percentage of T cells (%) | Standard Deviation 3.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ CD8 TEMRA | 26.9 Percentage of T cells (%) | Standard Deviation 13.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Naive Regulatory T-Cells | 5.3 Percentage of T cells (%) | Standard Deviation 5.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ CD4 TEMRA | 18.9 Percentage of T cells (%) | Standard Deviation 12.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated Effector Memory CD8 | 1.1 Percentage of T cells (%) | Standard Deviation 1.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated CD8 TEMRA | 1.1 Percentage of T cells (%) | Standard Deviation 2.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Naive CD8 T-Cells | 50.1 Percentage of T cells (%) | Standard Deviation 17.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ CD4 TEMRA | 21.0 Percentage of T cells (%) | Standard Deviation 17.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated CD8 TEMRA | 0.7 Percentage of T cells (%) | Standard Deviation 1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated CD8 TEMRA | 1.0 Percentage of T cells (%) | Standard Deviation 1.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ Effector Memory CD4 | 15.3 Percentage of T cells (%) | Standard Deviation 7.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated Effector Memory CD8 | 1.1 Percentage of T cells (%) | Standard Deviation 1.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated Effector Memory CD8 | 0.9 Percentage of T cells (%) | Standard Deviation 1.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Activated CD4 TEMRA | 8.7 Percentage of T cells (%) | Standard Deviation 5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ Naive Regulatory T-Cells | 7.1 Percentage of T cells (%) | Standard Deviation 8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ CD4 Treg TEMRA | 4.6 Percentage of T cells (%) | Standard Deviation 9.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated CD4 TEMRA | 9.3 Percentage of T cells (%) | Standard Deviation 6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Naive CD4 T-Cells | 52.1 Percentage of T cells (%) | Standard Deviation 14.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ CD4 Treg TEMRA | 4.4 Percentage of T cells (%) | Standard Deviation 9.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Activated CD4 TEMRA | 9.7 Percentage of T cells (%) | Standard Deviation 6.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total Viable T-Cells | 55.8 Percentage of T cells (%) | Standard Deviation 7.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Naive CD4 T-Cells | 54.5 Percentage of T cells (%) | Standard Deviation 12.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CCR5+ CD8 EM | 37.7 Percentage of T cells (%) | Standard Deviation 15.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total Viable T-Cells | 55.5 Percentage of T cells (%) | Standard Deviation 8.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total Viable T-Cells | 55.0 Percentage of T cells (%) | Standard Deviation 7.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Activated Central Memory CD8 | 3.1 Percentage of T cells (%) | Standard Deviation 13.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total Viable CD8 T-Cells | 23.9 Percentage of T cells (%) | Standard Deviation 9.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ CD8 EM | 38.8 Percentage of T cells (%) | Standard Deviation 15.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: Total Viable CD8 T-Cells | 24.0 Percentage of T cells (%) | Standard Deviation 9.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Total Viable CD8 T-Cells | 26.6 Percentage of T cells (%) | Standard Deviation 8.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: CD4 TEMRA | 2.7 Percentage of T cells (%) | Standard Deviation 2.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 54: CCR5+ Central Memory CD8 Cells | 18.5 Percentage of T cells (%) | Standard Deviation 15.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: Total Viable CD4 T-Cells | 52.2 Percentage of T cells (%) | Standard Deviation 13.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 0: Naive CD4 T-Cells | 54.9 Percentage of T cells (%) | Standard Deviation 13.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Cell Panel | Week 80: CCR5+ CD8 EM | 40.0 Percentage of T cells (%) | Standard Deviation 16.3 |
Secondary
Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel
TfH cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80. In below table CTFH refer to Circulating T follicular helper; ICOS refers to inducible T-cell co-stimulator; PD refers to Programmed cell death protein; CCR refers to C-C chemokine receptor; CXCR refers to C-X-C chemokine receptor; CD refer to Cluster of Differentiation; CM refers to central memory; EM refers to effector memory, TIGIT refers to T cell immunoreceptor with Ig and ITIM domains.
Time frame: Week 0, week 54 and week 80
Population: The FAS included all randomised participants. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Circulating TFH-Cells (cTfh) | 5.7 Percentage of TfH cells (%) | Standard Deviation 3.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ CD4 Effector Memory | 3.7 Percentage of TfH cells (%) | Standard Deviation 3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: TH2-Like Circulating T-Follicular Cells | 3.6 Percentage of TfH cells (%) | Standard Deviation 2.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1- ICOS- cTfh17 | 77.4 Percentage of TfH cells (%) | Standard Deviation 17.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Circulating TFH-Cells (cTfh) | 5.8 Percentage of TfH cells (%) | Standard Deviation 3.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ICOSNeg cTfh17 | 26.8 Percentage of TfH cells (%) | Standard Deviation 19.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Activated cTfh17 Cells | 0.8 Percentage of TfH cells (%) | Standard Deviation 2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Th1-Like Circulating T-Follicular Cells | 1.3 Percentage of TfH cells (%) | Standard Deviation 1.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ CD4 CM | 0.5 Percentage of TfH cells (%) | Standard Deviation 0.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ICOSNeg cTfh1 | 30.5 Percentage of TfH cells (%) | Standard Deviation 16.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ Naive TREG | 8.4 Percentage of TfH cells (%) | Standard Deviation 6.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Potentially Anergic TEMRA CD4 | 0.8 Percentage of TfH cells (%) | Standard Deviation 3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ CD4 CM | 0.3 Percentage of TfH cells (%) | Standard Deviation 0.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1- ICOS- cTfh17 | 72.1 Percentage of TfH cells (%) | Standard Deviation 20.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: CCR7+ cTfh1 Cells | 97.1 Percentage of TfH cells (%) | Standard Deviation 2.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: TOTAL ICOS+ TREG | 8.3 Percentage of TfH cells (%) | Standard Deviation 4.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ CD4 CM | 0.3 Percentage of TfH cells (%) | Standard Deviation 0.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ TREG EM | 20.6 Percentage of TfH cells (%) | Standard Deviation 12.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ CD4 Effector Memory | 3.9 Percentage of TfH cells (%) | Standard Deviation 2.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Regulatory T-Follicular Subset | 0.2 Percentage of TfH cells (%) | Standard Deviation 0.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ CD4 EM | 0.2 Percentage of TfH cells (%) | Standard Deviation 0.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1- ICOS- cTfh2 | 80.1 Percentage of TfH cells (%) | Standard Deviation 12.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ICOSNeg cTfh2 | 19.1 Percentage of TfH cells (%) | Standard Deviation 12 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: TOTAL ICOS+ TREG | 8.3 Percentage of TfH cells (%) | Standard Deviation 4.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ CD4 EM | 0.2 Percentage of TfH cells (%) | Standard Deviation 0.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: CXCR4+ cTfh1 Cells | 59.4 Percentage of TfH cells (%) | Standard Deviation 27.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Potentially Anergic TEMRA CD4 | 0.7 Percentage of TfH cells (%) | Standard Deviation 2.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1- ICOS- cTfh2 | 81.0 Percentage of TfH cells (%) | Standard Deviation 13.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ CD4 EM | 0.2 Percentage of TfH cells (%) | Standard Deviation 0.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: TH17-Like Circulating T-Follicular cells | 0.4 Percentage of TfH cells (%) | Standard Deviation 0.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: CCR7+ cTfh1 Cells | 97.0 Percentage of TfH cells (%) | Standard Deviation 3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: TOTAL ICOS+ TREG | 8.6 Percentage of TfH cells (%) | Standard Deviation 4.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ CD4 TEMRA | 0.0 Percentage of TfH cells (%) | Standard Deviation 0 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Activated cTfh2 Cells | 0.6 Percentage of TfH cells (%) | Standard Deviation 0.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ICOSNeg cTfh1 | 32.4 Percentage of TfH cells (%) | Standard Deviation 18.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1- ICOS- cTfh2 | 79.1 Percentage of TfH cells (%) | Standard Deviation 16.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ CD4 TEMRA | 0.0 Percentage of TfH cells (%) | Standard Deviation 0 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ICOSNeg cTfh2 | 18.4 Percentage of TfH cells (%) | Standard Deviation 13.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ CD4 Effector Memory | 4.0 Percentage of TfH cells (%) | Standard Deviation 3.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: TIGIT+ cTfh2 | 40.7 Percentage of TfH cells (%) | Standard Deviation 10.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ CD4 TEMRA | 0.0 Percentage of TfH cells (%) | Standard Deviation 0 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ TREG EM | 19.3 Percentage of TfH cells (%) | Standard Deviation 10.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ CD4 Central Memory | 6.2 Percentage of TfH cells (%) | Standard Deviation 4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: CCR7+ cTfh1 Cells | 96.9 Percentage of TfH cells (%) | Standard Deviation 2.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ NAIVE CD4 T-Cells | 0.1 Percentage of TfH cells (%) | Standard Deviation 0.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ Naive CD4 | 4.2 Percentage of TfH cells (%) | Standard Deviation 6.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: CCR7+ cTfh17 Cells | 97.4 Percentage of TfH cells (%) | Standard Deviation 11.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: TIGIT+ cTfh2 | 41.1 Percentage of TfH cells (%) | Standard Deviation 11 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ NAIVE CD4 T-Cells | 0.0 Percentage of TfH cells (%) | Standard Deviation 0.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Regulatory T-Follicular Subset | 0.2 Percentage of TfH cells (%) | Standard Deviation 0.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: CXCR4+ cTfh1 Cells | 64.5 Percentage of TfH cells (%) | Standard Deviation 28.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ICOSNeg cTfh2 | 20.2 Percentage of TfH cells (%) | Standard Deviation 16.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ NAIVE CD4 T-Cells | 0.0 Percentage of TfH cells (%) | Standard Deviation 0.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Activated cTfh2 Cells | 0.4 Percentage of TfH cells (%) | Standard Deviation 0.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ CD4 Central Memory | 6.7 Percentage of TfH cells (%) | Standard Deviation 5.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: TIGIT+ cTfh2 | 44.4 Percentage of TfH cells (%) | Standard Deviation 9.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ NAIVE TREG | 2.3 Percentage of TfH cells (%) | Standard Deviation 1.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Total PD1+ TREG | 16.0 Percentage of TfH cells (%) | Standard Deviation 10.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: CXCR4+ cTfh1 Cells | 70.8 Percentage of TfH cells (%) | Standard Deviation 24.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ CD4 Central Memory | 6.4 Percentage of TfH cells (%) | Standard Deviation 4.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ NAIVE TREG | 2.1 Percentage of TfH cells (%) | Standard Deviation 2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0:Activated PD1+ICOS+ cTfh1 | 1.3 Percentage of TfH cells (%) | Standard Deviation 1.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: CCR7+ cTfh17 Cells | 98.1 Percentage of TfH cells (%) | Standard Deviation 2.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: TIGIT+ cTfh17 | 39.4 Percentage of TfH cells (%) | Standard Deviation 14.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ NAIVE TREG | 2.2 Percentage of TfH cells (%) | Standard Deviation 2.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: TH17-Like Circulating T-Follicular cells | 0.4 Percentage of TfH cells (%) | Standard Deviation 0.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: CXCR4+ cTfh17 Cells | 50.9 Percentage of TfH cells (%) | Standard Deviation 30.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1- ICOS- cTfh1 | 68.4 Percentage of TfH cells (%) | Standard Deviation 15.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ TREG CM | 10.9 Percentage of TfH cells (%) | Standard Deviation 5.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ICOSNeg cTfh17 | 21.8 Percentage of TfH cells (%) | Standard Deviation 16.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Activated cTfh2 Cells | 0.6 Percentage of TfH cells (%) | Standard Deviation 0.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: TIGIT+ cTfh17 | 37.0 Percentage of TfH cells (%) | Standard Deviation 13.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ TREG CM | 10.0 Percentage of TfH cells (%) | Standard Deviation 5.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Total PD1+ TREG | 14.8 Percentage of TfH cells (%) | Standard Deviation 9.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: CXCR4+ cTfh17 Cells | 56.1 Percentage of TfH cells (%) | Standard Deviation 31.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ICOSNeg cTfh1 | 30.0 Percentage of TfH cells (%) | Standard Deviation 14.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ TREG CM | 10.1 Percentage of TfH cells (%) | Standard Deviation 4.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ Naive TREG | 9.8 Percentage of TfH cells (%) | Standard Deviation 7.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: CCR7+ cTfh17 Cells | 98.7 Percentage of TfH cells (%) | Standard Deviation 1.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: TIGIT+ cTfh17 | 40.5 Percentage of TfH cells (%) | Standard Deviation 16.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ TREG EM | 12.8 Percentage of TfH cells (%) | Standard Deviation 6.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Regulatory T-Follicular Subset | 0.2 Percentage of TfH cells (%) | Standard Deviation 0.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: CXCR4+ cTfh17 Cells | 60.0 Percentage of TfH cells (%) | Standard Deviation 27.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1- ICOS- cTfh1 | 68.6 Percentage of TfH cells (%) | Standard Deviation 16.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ TREG EM | 11.9 Percentage of TfH cells (%) | Standard Deviation 5.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Activated PD1+ICOS+ cTfh1 | 0.7 Percentage of TfH cells (%) | Standard Deviation 0.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Total PD1+ TREG | 14.5 Percentage of TfH cells (%) | Standard Deviation 7.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ TREG TEMRA | 8.8 Percentage of TfH cells (%) | Standard Deviation 10.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: TIGIT+ cTfh1 | 51.4 Percentage of TfH cells (%) | Standard Deviation 11.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ TREG TEMRA | 9.9 Percentage of TfH cells (%) | Standard Deviation 9.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: CXCR4+ Ctfh2 Cells | 58.8 Percentage of TfH cells (%) | Standard Deviation 26.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ TREG TEMRA | 10.2 Percentage of TfH cells (%) | Standard Deviation 10.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ TREG EM | 20.1 Percentage of TfH cells (%) | Standard Deviation 9.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: CCR7+ cTfh2 Cells | 98.1 Percentage of TfH cells (%) | Standard Deviation 1.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: TIGIT+ cTfh1 | 51.1 Percentage of TfH cells (%) | Standard Deviation 13.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: TH17-Like Circulating T-Follicular cells | 0.5 Percentage of TfH cells (%) | Standard Deviation 0.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ Naive TREG | 11.0 Percentage of TfH cells (%) | Standard Deviation 9.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ICOSNeg cTfh17 | 21.8 Percentage of TfH cells (%) | Standard Deviation 17.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: CXCR4+ Ctfh2 Cells | 63.3 Percentage of TfH cells (%) | Standard Deviation 28.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: TIGIT+ cTfh1 | 53.0 Percentage of TfH cells (%) | Standard Deviation 11.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ TEMRA TREG | 22.5 Percentage of TfH cells (%) | Standard Deviation 19 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1- ICOS- cTfh1 | 66.7 Percentage of TfH cells (%) | Standard Deviation 18.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Activated cTfh17 Cells | 0.6 Percentage of TfH cells (%) | Standard Deviation 1.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: CCR7+ cTfh2 Cells | 98.3 Percentage of TfH cells (%) | Standard Deviation 1.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ TEMRA TREG | 20.5 Percentage of TfH cells (%) | Standard Deviation 13.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Th1-Like Circulating T-Follicular Cells | 1.5 Percentage of TfH cells (%) | Standard Deviation 1.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ Naive CD4 | 5.0 Percentage of TfH cells (%) | Standard Deviation 8.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: TH2-Like Circulating T-Follicular Cells | 3.8 Percentage of TfH cells (%) | Standard Deviation 2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ TEMRA TREG | 22.5 Percentage of TfH cells (%) | Standard Deviation 15 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: CXCR4+ Ctfh2 Cells | 69.3 Percentage of TfH cells (%) | Standard Deviation 23.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: CCR7+ cTfh2 Cells | 98.1 Percentage of TfH cells (%) | Standard Deviation 1.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ Naive CD4 | 3.8 Percentage of TfH cells (%) | Standard Deviation 6.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ TREG CM | 16.8 Percentage of TfH cells (%) | Standard Deviation 10 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Potentially Anergic TEMRA CD4 | 0.8 Percentage of TfH cells (%) | Standard Deviation 2.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1- ICOS- cTfh17 | 75.6 Percentage of TfH cells (%) | Standard Deviation 18.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: TH2-Like Circulating T-Follicular Cells | 3.9 Percentage of TfH cells (%) | Standard Deviation 2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ TREG CM | 16.5 Percentage of TfH cells (%) | Standard Deviation 10.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Circulating TFH-Cells (cTfh) | 5.5 Percentage of TfH cells (%) | Standard Deviation 3.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ TREG EM | 12.0 Percentage of TfH cells (%) | Standard Deviation 5.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Activated cTfh17 Cells | 0.8 Percentage of TfH cells (%) | Standard Deviation 1.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ TREG CM | 18.1 Percentage of TfH cells (%) | Standard Deviation 13 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Activated PD1+ICOS+ cTfh1 | 0.7 Percentage of TfH cells (%) | Standard Deviation 0.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Th1-Like Circulating T-Follicular Cells | 1.4 Percentage of TfH cells (%) | Standard Deviation 1.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ TREG TEMRA | 9.7 Percentage of TfH cells (%) | Standard Deviation 10.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ TREG EM | 21.1 Percentage of TfH cells (%) | Standard Deviation 11.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ TREG EM | 19.8 Percentage of TfH cells (%) | Standard Deviation 10.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: CCR7+ cTfh2 Cells | 98.3 Percentage of TfH cells (%) | Standard Deviation 1.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: TH17-Like Circulating T-Follicular cells | 0.4 Percentage of TfH cells (%) | Standard Deviation 0.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ TREG EM | 21.1 Percentage of TfH cells (%) | Standard Deviation 10.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ICOSNeg cTfh1 | 28.8 Percentage of TfH cells (%) | Standard Deviation 15.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ Naive CD4 | 2.9 Percentage of TfH cells (%) | Standard Deviation 4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: TH17-Like Circulating T-Follicular cells | 0.4 Percentage of TfH cells (%) | Standard Deviation 0.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ICOSNeg cTfh1 | 29.1 Percentage of TfH cells (%) | Standard Deviation 13.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ICOSNeg cTfh1 | 30.7 Percentage of TfH cells (%) | Standard Deviation 16 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: CXCR4+ cTfh1 Cells | 58.0 Percentage of TfH cells (%) | Standard Deviation 25.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: TH17-Like Circulating T-Follicular cells | 0.4 Percentage of TfH cells (%) | Standard Deviation 0.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ICOSNeg cTfh17 | 22.5 Percentage of TfH cells (%) | Standard Deviation 16.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Activated cTfh2 Cells | 0.4 Percentage of TfH cells (%) | Standard Deviation 0.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ICOSNeg cTfh17 | 21.1 Percentage of TfH cells (%) | Standard Deviation 16.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Regulatory T-Follicular Subset | 0.2 Percentage of TfH cells (%) | Standard Deviation 0.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ICOSNeg cTfh17 | 24.7 Percentage of TfH cells (%) | Standard Deviation 16 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ TREG EM | 11.3 Percentage of TfH cells (%) | Standard Deviation 5.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ICOSNeg cTfh2 | 18.4 Percentage of TfH cells (%) | Standard Deviation 12.6 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Activated cTfh17 Cells | 0.4 Percentage of TfH cells (%) | Standard Deviation 0.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Regulatory T-Follicular Subset | 0.2 Percentage of TfH cells (%) | Standard Deviation 0.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ICOSNeg cTfh2 | 18.1 Percentage of TfH cells (%) | Standard Deviation 13.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ICOSNeg cTfh2 | 19.6 Percentage of TfH cells (%) | Standard Deviation 13.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Regulatory T-Follicular Subset | 0.2 Percentage of TfH cells (%) | Standard Deviation 0.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1- ICOS- cTfh1 | 69.0 Percentage of TfH cells (%) | Standard Deviation 16.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ Naive CD4 | 3.0 Percentage of TfH cells (%) | Standard Deviation 4.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1- ICOS- cTfh1 | 68.0 Percentage of TfH cells (%) | Standard Deviation 16.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ CD4 Effector Memory | 4.2 Percentage of TfH cells (%) | Standard Deviation 2.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Potentially Anergic TEMRA CD4 | 0.2 Percentage of TfH cells (%) | Standard Deviation 0.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1- ICOS- cTfh1 | 68.1 Percentage of TfH cells (%) | Standard Deviation 16.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1- ICOS- cTfh17 | 74.7 Percentage of TfH cells (%) | Standard Deviation 18.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Potentially Anergic TEMRA CD4 | 0.2 Percentage of TfH cells (%) | Standard Deviation 0.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1- ICOS- cTfh17 | 72.9 Percentage of TfH cells (%) | Standard Deviation 23.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ CD4 Effector Memory | 3.9 Percentage of TfH cells (%) | Standard Deviation 2.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1- ICOS- cTfh17 | 74.0 Percentage of TfH cells (%) | Standard Deviation 16.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Potentially Anergic TEMRA CD4 | 0.2 Percentage of TfH cells (%) | Standard Deviation 0.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1- ICOS- cTfh2 | 80.8 Percentage of TfH cells (%) | Standard Deviation 12.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ CD4 Effector Memory | 4.3 Percentage of TfH cells (%) | Standard Deviation 2.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1- ICOS- cTfh2 | 81.3 Percentage of TfH cells (%) | Standard Deviation 13.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1- ICOS- cTfh2 | 79.8 Percentage of TfH cells (%) | Standard Deviation 13.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: CCR7+ cTfh1 Cells | 97.1 Percentage of TfH cells (%) | Standard Deviation 3.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Activated cTfh2 Cells | 0.5 Percentage of TfH cells (%) | Standard Deviation 0.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Activated cTfh17 Cells | 1.0 Percentage of TfH cells (%) | Standard Deviation 2.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Total PD1+ TREG | 15.9 Percentage of TfH cells (%) | Standard Deviation 8.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: CXCR4+ cTfh1 Cells | 64.5 Percentage of TfH cells (%) | Standard Deviation 28.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ Naive TREG | 9.4 Percentage of TfH cells (%) | Standard Deviation 9.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: CXCR4+ cTfh1 Cells | 66.4 Percentage of TfH cells (%) | Standard Deviation 27.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Total PD1+ TREG | 14.3 Percentage of TfH cells (%) | Standard Deviation 8.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: CXCR4+ cTfh17 Cells | 45.8 Percentage of TfH cells (%) | Standard Deviation 27.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0:Activated PD1+ICOS+ cTfh1 | 1.9 Percentage of TfH cells (%) | Standard Deviation 7.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: CXCR4+ cTfh17 Cells | 54.0 Percentage of TfH cells (%) | Standard Deviation 29.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Total PD1+ TREG | 15.1 Percentage of TfH cells (%) | Standard Deviation 8.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: CXCR4+ cTfh17 Cells | 57.2 Percentage of TfH cells (%) | Standard Deviation 30.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: CXCR4+ Ctfh2 Cells | 56.3 Percentage of TfH cells (%) | Standard Deviation 25.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Activated PD1+ICOS+ cTfh1 | 1.0 Percentage of TfH cells (%) | Standard Deviation 1.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Th1-Like Circulating T-Follicular Cells | 1.8 Percentage of TfH cells (%) | Standard Deviation 1.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: CXCR4+ Ctfh2 Cells | 65.2 Percentage of TfH cells (%) | Standard Deviation 27.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ CD4 Central Memory | 7.5 Percentage of TfH cells (%) | Standard Deviation 5.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: CXCR4+ Ctfh2 Cells | 65.8 Percentage of TfH cells (%) | Standard Deviation 27.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ Naive TREG | 8.7 Percentage of TfH cells (%) | Standard Deviation 7.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Th1-Like Circulating T-Follicular Cells | 1.6 Percentage of TfH cells (%) | Standard Deviation 1.7 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Circulating TFH-Cells (cTfh) | 5.4 Percentage of TfH cells (%) | Standard Deviation 3.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Circulating TFH-Cells (cTfh) | 5.6 Percentage of TfH cells (%) | Standard Deviation 3.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Activated PD1+ICOS+ cTfh1 | 0.9 Percentage of TfH cells (%) | Standard Deviation 1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Th1-Like Circulating T-Follicular Cells | 1.3 Percentage of TfH cells (%) | Standard Deviation 1.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Circulating TFH-Cells (cTfh) | 5.9 Percentage of TfH cells (%) | Standard Deviation 4.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ CD4 CM | 0.5 Percentage of TfH cells (%) | Standard Deviation 0.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: TOTAL ICOS+ TREG | 7.4 Percentage of TfH cells (%) | Standard Deviation 3.6 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ CD4 CM | 0.3 Percentage of TfH cells (%) | Standard Deviation 0.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ CD4 CM | 0.3 Percentage of TfH cells (%) | Standard Deviation 0.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: CCR7+ cTfh1 Cells | 95.8 Percentage of TfH cells (%) | Standard Deviation 13.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: TOTAL ICOS+ TREG | 7.5 Percentage of TfH cells (%) | Standard Deviation 3.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ CD4 EM | 0.3 Percentage of TfH cells (%) | Standard Deviation 0.6 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Activated cTfh17 Cells | 1.1 Percentage of TfH cells (%) | Standard Deviation 2.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ CD4 EM | 0.2 Percentage of TfH cells (%) | Standard Deviation 0.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ CD4 Central Memory | 6.7 Percentage of TfH cells (%) | Standard Deviation 4.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: TOTAL ICOS+ TREG | 9.6 Percentage of TfH cells (%) | Standard Deviation 5.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ CD4 EM | 0.2 Percentage of TfH cells (%) | Standard Deviation 0.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ CD4 TEMRA | 0.0 Percentage of TfH cells (%) | Standard Deviation 0 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: CCR7+ cTfh1 Cells | 96.8 Percentage of TfH cells (%) | Standard Deviation 3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: TIGIT+ cTfh2 | 38.4 Percentage of TfH cells (%) | Standard Deviation 9.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ CD4 TEMRA | 0.0 Percentage of TfH cells (%) | Standard Deviation 0 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ CD4 TEMRA | 0.0 Percentage of TfH cells (%) | Standard Deviation 0 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: TIGIT+ cTfh2 | 37.9 Percentage of TfH cells (%) | Standard Deviation 10.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ NAIVE CD4 T-Cells | 0.1 Percentage of TfH cells (%) | Standard Deviation 0.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ NAIVE CD4 T-Cells | 0.0 Percentage of TfH cells (%) | Standard Deviation 0 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: CCR7+ cTfh17 Cells | 97.4 Percentage of TfH cells (%) | Standard Deviation 11.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: TIGIT+ cTfh2 | 40.9 Percentage of TfH cells (%) | Standard Deviation 9.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ NAIVE CD4 T-Cells | 0.0 Percentage of TfH cells (%) | Standard Deviation 0 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ NAIVE TREG | 2.7 Percentage of TfH cells (%) | Standard Deviation 3.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ TREG TEMRA | 9.6 Percentage of TfH cells (%) | Standard Deviation 10.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: TIGIT+ cTfh17 | 35.9 Percentage of TfH cells (%) | Standard Deviation 13.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ NAIVE TREG | 2.0 Percentage of TfH cells (%) | Standard Deviation 2.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ NAIVE TREG | 2.1 Percentage of TfH cells (%) | Standard Deviation 2.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: CCR7+ cTfh17 Cells | 93.9 Percentage of TfH cells (%) | Standard Deviation 22.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: TIGIT+ cTfh17 | 31.4 Percentage of TfH cells (%) | Standard Deviation 16.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ TREG CM | 11.3 Percentage of TfH cells (%) | Standard Deviation 5.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ TREG CM | 9.2 Percentage of TfH cells (%) | Standard Deviation 4.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ Naive CD4 | 3.3 Percentage of TfH cells (%) | Standard Deviation 4.6 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: TIGIT+ cTfh17 | 36.2 Percentage of TfH cells (%) | Standard Deviation 13.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ TREG CM | 9.0 Percentage of TfH cells (%) | Standard Deviation 4.3 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ TREG EM | 13.3 Percentage of TfH cells (%) | Standard Deviation 6.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: CCR7+ cTfh17 Cells | 97.3 Percentage of TfH cells (%) | Standard Deviation 5.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: TIGIT+ cTfh1 | 48.1 Percentage of TfH cells (%) | Standard Deviation 14.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ TREG EM | 11.6 Percentage of TfH cells (%) | Standard Deviation 5.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Activated cTfh2 Cells | 0.6 Percentage of TfH cells (%) | Standard Deviation 0.6 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: TIGIT+ cTfh1 | 47.6 Percentage of TfH cells (%) | Standard Deviation 13.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ TREG TEMRA | 13.0 Percentage of TfH cells (%) | Standard Deviation 18.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: TIGIT+ cTfh1 | 48.5 Percentage of TfH cells (%) | Standard Deviation 13.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ Naive TREG | 10.1 Percentage of TfH cells (%) | Standard Deviation 9.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: CCR7+ cTfh2 Cells | 98.2 Percentage of TfH cells (%) | Standard Deviation 1.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ TEMRA TREG | 23.5 Percentage of TfH cells (%) | Standard Deviation 17.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: TH2-Like Circulating T-Follicular Cells | 3.7 Percentage of TfH cells (%) | Standard Deviation 2.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ TEMRA TREG | 19.7 Percentage of TfH cells (%) | Standard Deviation 16.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ TEMRA TREG | 25.7 Percentage of TfH cells (%) | Standard Deviation 19.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: TH2-Like Circulating T-Follicular Cells | 3.6 Percentage of TfH cells (%) | Standard Deviation 2.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ TREG CM | 17.5 Percentage of TfH cells (%) | Standard Deviation 11.5 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: CCR7+ cTfh2 Cells | 98.5 Percentage of TfH cells (%) | Standard Deviation 1.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ TREG CM | 16.7 Percentage of TfH cells (%) | Standard Deviation 10.9 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ CD4 Central Memory | 6.8 Percentage of TfH cells (%) | Standard Deviation 5.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ TREG CM | 18.7 Percentage of TfH cells (%) | Standard Deviation 11.2 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: TH2-Like Circulating T-Follicular Cells | 3.6 Percentage of TfH cells (%) | Standard Deviation 2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: TH2-Like Circulating T-Follicular Cells | 4.0 Percentage of TfH cells (%) | Standard Deviation 2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Activated cTfh17 Cells | 0.8 Percentage of TfH cells (%) | Standard Deviation 1.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Activated cTfh17 Cells | 0.7 Percentage of TfH cells (%) | Standard Deviation 1.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Activated cTfh17 Cells | 0.6 Percentage of TfH cells (%) | Standard Deviation 0.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Activated cTfh2 Cells | 0.6 Percentage of TfH cells (%) | Standard Deviation 0.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Activated cTfh2 Cells | 0.7 Percentage of TfH cells (%) | Standard Deviation 1.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Activated cTfh2 Cells | 0.5 Percentage of TfH cells (%) | Standard Deviation 0.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Activated PD1+ICOS+ cTfh1 | 1.2 Percentage of TfH cells (%) | Standard Deviation 2.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: CCR7+ cTfh1 Cells | 94.7 Percentage of TfH cells (%) | Standard Deviation 13.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: CCR7+ cTfh1 Cells | 97.1 Percentage of TfH cells (%) | Standard Deviation 4.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: CCR7+ cTfh1 Cells | 97.4 Percentage of TfH cells (%) | Standard Deviation 2.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: CCR7+ cTfh17 Cells | 97.4 Percentage of TfH cells (%) | Standard Deviation 12.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: CCR7+ cTfh17 Cells | 96.9 Percentage of TfH cells (%) | Standard Deviation 12.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: CCR7+ cTfh17 Cells | 96.8 Percentage of TfH cells (%) | Standard Deviation 13.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: CCR7+ cTfh2 Cells | 98.2 Percentage of TfH cells (%) | Standard Deviation 1.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: CCR7+ cTfh2 Cells | 98.3 Percentage of TfH cells (%) | Standard Deviation 1.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: CCR7+ cTfh2 Cells | 98.4 Percentage of TfH cells (%) | Standard Deviation 1.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: CXCR4+ cTfh1 Cells | 54.9 Percentage of TfH cells (%) | Standard Deviation 27.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ TREG TEMRA | 8.2 Percentage of TfH cells (%) | Standard Deviation 9.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ CD4 Effector Memory | 3.6 Percentage of TfH cells (%) | Standard Deviation 2.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ Naive CD4 | 4.2 Percentage of TfH cells (%) | Standard Deviation 6.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ Naive CD4 | 4.4 Percentage of TfH cells (%) | Standard Deviation 6.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: CXCR4+ cTfh1 Cells | 64.4 Percentage of TfH cells (%) | Standard Deviation 29.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: CXCR4+ cTfh1 Cells | 63.5 Percentage of TfH cells (%) | Standard Deviation 30.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: CXCR4+ cTfh17 Cells | 43.7 Percentage of TfH cells (%) | Standard Deviation 29.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: CXCR4+ cTfh17 Cells | 53.1 Percentage of TfH cells (%) | Standard Deviation 31.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: CXCR4+ cTfh17 Cells | 54.6 Percentage of TfH cells (%) | Standard Deviation 31.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: CXCR4+ Ctfh2 Cells | 54.0 Percentage of TfH cells (%) | Standard Deviation 26.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: CXCR4+ Ctfh2 Cells | 63.7 Percentage of TfH cells (%) | Standard Deviation 28.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: CXCR4+ Ctfh2 Cells | 62.7 Percentage of TfH cells (%) | Standard Deviation 29.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Circulating TFH-Cells (cTfh) | 6.2 Percentage of TfH cells (%) | Standard Deviation 3.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Circulating TFH-Cells (cTfh) | 6.2 Percentage of TfH cells (%) | Standard Deviation 4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Circulating TFH-Cells (cTfh) | 6.1 Percentage of TfH cells (%) | Standard Deviation 4.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ CD4 CM | 0.4 Percentage of TfH cells (%) | Standard Deviation 0.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ CD4 CM | 0.4 Percentage of TfH cells (%) | Standard Deviation 0.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ CD4 CM | 0.3 Percentage of TfH cells (%) | Standard Deviation 0.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ CD4 EM | 0.2 Percentage of TfH cells (%) | Standard Deviation 0.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ CD4 EM | 0.2 Percentage of TfH cells (%) | Standard Deviation 0.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ CD4 EM | 0.2 Percentage of TfH cells (%) | Standard Deviation 0.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ CD4 TEMRA | 0.0 Percentage of TfH cells (%) | Standard Deviation 0 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ CD4 TEMRA | 0.0 Percentage of TfH cells (%) | Standard Deviation 0 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ CD4 TEMRA | 0.0 Percentage of TfH cells (%) | Standard Deviation 0.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ NAIVE CD4 T-Cells | 0.1 Percentage of TfH cells (%) | Standard Deviation 0.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ NAIVE CD4 T-Cells | 0.0 Percentage of TfH cells (%) | Standard Deviation 0.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ NAIVE CD4 T-Cells | 0.0 Percentage of TfH cells (%) | Standard Deviation 0.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ NAIVE TREG | 1.9 Percentage of TfH cells (%) | Standard Deviation 2.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ NAIVE TREG | 1.9 Percentage of TfH cells (%) | Standard Deviation 2.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ NAIVE TREG | 1.9 Percentage of TfH cells (%) | Standard Deviation 2.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ TREG CM | 10.4 Percentage of TfH cells (%) | Standard Deviation 5.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ TREG CM | 9.7 Percentage of TfH cells (%) | Standard Deviation 4.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ TREG CM | 8.8 Percentage of TfH cells (%) | Standard Deviation 5.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ TREG EM | 13.0 Percentage of TfH cells (%) | Standard Deviation 6.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ TREG EM | 12.8 Percentage of TfH cells (%) | Standard Deviation 6.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ TREG EM | 10.5 Percentage of TfH cells (%) | Standard Deviation 5.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ TREG TEMRA | 10.5 Percentage of TfH cells (%) | Standard Deviation 11.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ Naive TREG | 9.3 Percentage of TfH cells (%) | Standard Deviation 8.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ TEMRA TREG | 19.8 Percentage of TfH cells (%) | Standard Deviation 15 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ TEMRA TREG | 18.6 Percentage of TfH cells (%) | Standard Deviation 14 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ TEMRA TREG | 22.4 Percentage of TfH cells (%) | Standard Deviation 16.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ TREG CM | 17.3 Percentage of TfH cells (%) | Standard Deviation 11 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ TREG CM | 16.8 Percentage of TfH cells (%) | Standard Deviation 11.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ TREG CM | 16.6 Percentage of TfH cells (%) | Standard Deviation 11 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ TREG EM | 21.6 Percentage of TfH cells (%) | Standard Deviation 10.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ TREG EM | 21.1 Percentage of TfH cells (%) | Standard Deviation 11.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ TREG EM | 19.4 Percentage of TfH cells (%) | Standard Deviation 10.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ICOSNeg cTfh1 | 32.4 Percentage of TfH cells (%) | Standard Deviation 16.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ICOSNeg cTfh1 | 34.2 Percentage of TfH cells (%) | Standard Deviation 19 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ICOSNeg cTfh1 | 31.3 Percentage of TfH cells (%) | Standard Deviation 14 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ICOSNeg cTfh17 | 23.7 Percentage of TfH cells (%) | Standard Deviation 17.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ICOSNeg cTfh17 | 26.2 Percentage of TfH cells (%) | Standard Deviation 19.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ICOSNeg cTfh17 | 23.6 Percentage of TfH cells (%) | Standard Deviation 15.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ICOSNeg cTfh2 | 20.8 Percentage of TfH cells (%) | Standard Deviation 14.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ICOSNeg cTfh2 | 20.2 Percentage of TfH cells (%) | Standard Deviation 14.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ICOSNeg cTfh2 | 18.9 Percentage of TfH cells (%) | Standard Deviation 11.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1- ICOS- cTfh1 | 64.6 Percentage of TfH cells (%) | Standard Deviation 17.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1- ICOS- cTfh1 | 64.1 Percentage of TfH cells (%) | Standard Deviation 19.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1- ICOS- cTfh1 | 67.4 Percentage of TfH cells (%) | Standard Deviation 14.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1- ICOS- cTfh17 | 73.4 Percentage of TfH cells (%) | Standard Deviation 19.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1- ICOS- cTfh17 | 70.9 Percentage of TfH cells (%) | Standard Deviation 21.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1- ICOS- cTfh17 | 73.6 Percentage of TfH cells (%) | Standard Deviation 18.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1- ICOS- cTfh2 | 78.3 Percentage of TfH cells (%) | Standard Deviation 14.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1- ICOS- cTfh2 | 78.8 Percentage of TfH cells (%) | Standard Deviation 14.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1- ICOS- cTfh2 | 80.4 Percentage of TfH cells (%) | Standard Deviation 11.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Potentially Anergic TEMRA CD4 | 0.4 Percentage of TfH cells (%) | Standard Deviation 1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Potentially Anergic TEMRA CD4 | 0.5 Percentage of TfH cells (%) | Standard Deviation 1.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Potentially Anergic TEMRA CD4 | 0.5 Percentage of TfH cells (%) | Standard Deviation 1.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Regulatory T-Follicular Subset | 0.2 Percentage of TfH cells (%) | Standard Deviation 0.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Regulatory T-Follicular Subset | 0.2 Percentage of TfH cells (%) | Standard Deviation 0.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Regulatory T-Follicular Subset | 0.2 Percentage of TfH cells (%) | Standard Deviation 0.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: TH17-Like Circulating T-Follicular cells | 0.5 Percentage of TfH cells (%) | Standard Deviation 0.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: TH17-Like Circulating T-Follicular cells | 0.4 Percentage of TfH cells (%) | Standard Deviation 0.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: TH17-Like Circulating T-Follicular cells | 0.3 Percentage of TfH cells (%) | Standard Deviation 0.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: TH2-Like Circulating T-Follicular Cells | 4.0 Percentage of TfH cells (%) | Standard Deviation 2.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: TH2-Like Circulating T-Follicular Cells | 3.9 Percentage of TfH cells (%) | Standard Deviation 2.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: TIGIT+ cTfh1 | 53.4 Percentage of TfH cells (%) | Standard Deviation 12.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: TIGIT+ cTfh1 | 52.2 Percentage of TfH cells (%) | Standard Deviation 14.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: TIGIT+ cTfh1 | 49.6 Percentage of TfH cells (%) | Standard Deviation 10.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: TIGIT+ cTfh17 | 39.3 Percentage of TfH cells (%) | Standard Deviation 14.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: TIGIT+ cTfh17 | 40.7 Percentage of TfH cells (%) | Standard Deviation 14.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: TIGIT+ cTfh17 | 35.3 Percentage of TfH cells (%) | Standard Deviation 12.7 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: TIGIT+ cTfh2 | 44.8 Percentage of TfH cells (%) | Standard Deviation 7.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: TIGIT+ cTfh2 | 42.0 Percentage of TfH cells (%) | Standard Deviation 9.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: TIGIT+ cTfh2 | 40.5 Percentage of TfH cells (%) | Standard Deviation 8.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: TOTAL ICOS+ TREG | 8.0 Percentage of TfH cells (%) | Standard Deviation 3.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: TOTAL ICOS+ TREG | 7.6 Percentage of TfH cells (%) | Standard Deviation 3.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: TOTAL ICOS+ TREG | 6.6 Percentage of TfH cells (%) | Standard Deviation 3.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Th1-Like Circulating T-Follicular Cells | 1.6 Percentage of TfH cells (%) | Standard Deviation 1.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Th1-Like Circulating T-Follicular Cells | 1.8 Percentage of TfH cells (%) | Standard Deviation 1.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Th1-Like Circulating T-Follicular Cells | 1.9 Percentage of TfH cells (%) | Standard Deviation 2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Total PD1+ TREG | 14.7 Percentage of TfH cells (%) | Standard Deviation 8.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Total PD1+ TREG | 14.5 Percentage of TfH cells (%) | Standard Deviation 9.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Total PD1+ TREG | 14.2 Percentage of TfH cells (%) | Standard Deviation 9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0:Activated PD1+ICOS+ cTfh1 | 1.1 Percentage of TfH cells (%) | Standard Deviation 1.2 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Activated PD1+ICOS+ cTfh1 | 1.0 Percentage of TfH cells (%) | Standard Deviation 2.1 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ CD4 Effector Memory | 3.6 Percentage of TfH cells (%) | Standard Deviation 2.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ TREG TEMRA | 11.0 Percentage of TfH cells (%) | Standard Deviation 12.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ Naive CD4 | 4.2 Percentage of TfH cells (%) | Standard Deviation 6.6 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ CD4 Central Memory | 7.2 Percentage of TfH cells (%) | Standard Deviation 5.3 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ Naive TREG | 8.4 Percentage of TfH cells (%) | Standard Deviation 7.9 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ Naive TREG | 9.1 Percentage of TfH cells (%) | Standard Deviation 8.5 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ CD4 Central Memory | 7.2 Percentage of TfH cells (%) | Standard Deviation 5.4 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ CD4 Central Memory | 6.8 Percentage of TfH cells (%) | Standard Deviation 4.8 |
| Liraglutide (Experimental) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ CD4 Effector Memory | 4.0 Percentage of TfH cells (%) | Standard Deviation 2.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ TREG CM | 18.0 Percentage of TfH cells (%) | Standard Deviation 10.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: TH2-Like Circulating T-Follicular Cells | 4.1 Percentage of TfH cells (%) | Standard Deviation 2.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ TREG CM | 17.2 Percentage of TfH cells (%) | Standard Deviation 10.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ TEMRA TREG | 22.7 Percentage of TfH cells (%) | Standard Deviation 13 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ TREG TEMRA | 11.0 Percentage of TfH cells (%) | Standard Deviation 10.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: TH2-Like Circulating T-Follicular Cells | 3.9 Percentage of TfH cells (%) | Standard Deviation 2.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ TEMRA TREG | 21.4 Percentage of TfH cells (%) | Standard Deviation 13.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ TEMRA TREG | 19.5 Percentage of TfH cells (%) | Standard Deviation 13.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: CCR7+ cTfh2 Cells | 98.3 Percentage of TfH cells (%) | Standard Deviation 1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: TH2-Like Circulating T-Follicular Cells | 3.8 Percentage of TfH cells (%) | Standard Deviation 2.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ Naive TREG | 10.7 Percentage of TfH cells (%) | Standard Deviation 9.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ Naive TREG | 9.4 Percentage of TfH cells (%) | Standard Deviation 8.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: CCR7+ cTfh2 Cells | 98.1 Percentage of TfH cells (%) | Standard Deviation 1.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: TIGIT+ cTfh1 | 51.6 Percentage of TfH cells (%) | Standard Deviation 13.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ TREG TEMRA | 9.3 Percentage of TfH cells (%) | Standard Deviation 8.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ TREG EM | 12.0 Percentage of TfH cells (%) | Standard Deviation 5.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Activated cTfh2 Cells | 0.6 Percentage of TfH cells (%) | Standard Deviation 0.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: TIGIT+ cTfh1 | 50.2 Percentage of TfH cells (%) | Standard Deviation 14.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ TREG EM | 12.7 Percentage of TfH cells (%) | Standard Deviation 5.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ TREG EM | 12.8 Percentage of TfH cells (%) | Standard Deviation 6.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ Naive CD4 | 3.5 Percentage of TfH cells (%) | Standard Deviation 4.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: TIGIT+ cTfh1 | 52.7 Percentage of TfH cells (%) | Standard Deviation 12.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ TREG CM | 10.5 Percentage of TfH cells (%) | Standard Deviation 4.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ TREG CM | 10.6 Percentage of TfH cells (%) | Standard Deviation 5.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: CCR7+ cTfh2 Cells | 98.3 Percentage of TfH cells (%) | Standard Deviation 1.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: TIGIT+ cTfh17 | 38.7 Percentage of TfH cells (%) | Standard Deviation 14.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ TREG CM | 11.0 Percentage of TfH cells (%) | Standard Deviation 5.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ NAIVE TREG | 2.7 Percentage of TfH cells (%) | Standard Deviation 2.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ TREG TEMRA | 12.8 Percentage of TfH cells (%) | Standard Deviation 15.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: TIGIT+ cTfh17 | 35.8 Percentage of TfH cells (%) | Standard Deviation 15.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ NAIVE TREG | 2.4 Percentage of TfH cells (%) | Standard Deviation 2.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ NAIVE TREG | 2.5 Percentage of TfH cells (%) | Standard Deviation 2.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: CCR7+ cTfh17 Cells | 98.7 Percentage of TfH cells (%) | Standard Deviation 1.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: TIGIT+ cTfh17 | 36.8 Percentage of TfH cells (%) | Standard Deviation 13.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ NAIVE CD4 T-Cells | 0.0 Percentage of TfH cells (%) | Standard Deviation 0 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ NAIVE CD4 T-Cells | 0.1 Percentage of TfH cells (%) | Standard Deviation 0.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: CCR7+ cTfh17 Cells | 95.3 Percentage of TfH cells (%) | Standard Deviation 18.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: TIGIT+ cTfh2 | 43.4 Percentage of TfH cells (%) | Standard Deviation 9.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ NAIVE CD4 T-Cells | 0.1 Percentage of TfH cells (%) | Standard Deviation 0.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ CD4 TEMRA | 0.0 Percentage of TfH cells (%) | Standard Deviation 0 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Activated cTfh17 Cells | 0.6 Percentage of TfH cells (%) | Standard Deviation 0.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: TIGIT+ cTfh2 | 41.0 Percentage of TfH cells (%) | Standard Deviation 11.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ CD4 TEMRA | 0.0 Percentage of TfH cells (%) | Standard Deviation 0 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ CD4 TEMRA | 0.0 Percentage of TfH cells (%) | Standard Deviation 0 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: CCR7+ cTfh17 Cells | 97.3 Percentage of TfH cells (%) | Standard Deviation 11.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: TIGIT+ cTfh2 | 41.9 Percentage of TfH cells (%) | Standard Deviation 9.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ CD4 EM | 0.2 Percentage of TfH cells (%) | Standard Deviation 0.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ CD4 EM | 0.2 Percentage of TfH cells (%) | Standard Deviation 0.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: CCR7+ cTfh1 Cells | 97.0 Percentage of TfH cells (%) | Standard Deviation 2.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: TOTAL ICOS+ TREG | 8.9 Percentage of TfH cells (%) | Standard Deviation 4.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ CD4 EM | 0.2 Percentage of TfH cells (%) | Standard Deviation 0.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: ICOS+ CD4 CM | 0.3 Percentage of TfH cells (%) | Standard Deviation 0.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: CCR7+ cTfh1 Cells | 97.3 Percentage of TfH cells (%) | Standard Deviation 2.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: TOTAL ICOS+ TREG | 8.6 Percentage of TfH cells (%) | Standard Deviation 3.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: ICOS+ CD4 CM | 0.4 Percentage of TfH cells (%) | Standard Deviation 0.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: ICOS+ CD4 CM | 0.5 Percentage of TfH cells (%) | Standard Deviation 0.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ Naive CD4 | 3.8 Percentage of TfH cells (%) | Standard Deviation 6.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: TOTAL ICOS+ TREG | 8.6 Percentage of TfH cells (%) | Standard Deviation 3.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Circulating TFH-Cells (cTfh) | 5.8 Percentage of TfH cells (%) | Standard Deviation 3.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Circulating TFH-Cells (cTfh) | 6.2 Percentage of TfH cells (%) | Standard Deviation 4.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: CCR7+ cTfh1 Cells | 97.2 Percentage of TfH cells (%) | Standard Deviation 2.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Th1-Like Circulating T-Follicular Cells | 1.5 Percentage of TfH cells (%) | Standard Deviation 1.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Circulating TFH-Cells (cTfh) | 6.1 Percentage of TfH cells (%) | Standard Deviation 3.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: CXCR4+ Ctfh2 Cells | 66.7 Percentage of TfH cells (%) | Standard Deviation 24.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Activated PD1+ICOS+ cTfh1 | 1.2 Percentage of TfH cells (%) | Standard Deviation 1.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Th1-Like Circulating T-Follicular Cells | 1.8 Percentage of TfH cells (%) | Standard Deviation 1.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: CXCR4+ Ctfh2 Cells | 67.7 Percentage of TfH cells (%) | Standard Deviation 25.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: CXCR4+ Ctfh2 Cells | 54.5 Percentage of TfH cells (%) | Standard Deviation 28.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ CD4 Central Memory | 6.7 Percentage of TfH cells (%) | Standard Deviation 3.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Th1-Like Circulating T-Follicular Cells | 1.6 Percentage of TfH cells (%) | Standard Deviation 1.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: CXCR4+ cTfh17 Cells | 57.6 Percentage of TfH cells (%) | Standard Deviation 28.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: CXCR4+ cTfh17 Cells | 56.4 Percentage of TfH cells (%) | Standard Deviation 29.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ CD4 Central Memory | 6.6 Percentage of TfH cells (%) | Standard Deviation 4.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Total PD1+ TREG | 14.4 Percentage of TfH cells (%) | Standard Deviation 7.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: CXCR4+ cTfh17 Cells | 45.1 Percentage of TfH cells (%) | Standard Deviation 31.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: CXCR4+ cTfh1 Cells | 66.8 Percentage of TfH cells (%) | Standard Deviation 25.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Activated cTfh17 Cells | 0.9 Percentage of TfH cells (%) | Standard Deviation 1.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Total PD1+ TREG | 15.0 Percentage of TfH cells (%) | Standard Deviation 7.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: CXCR4+ cTfh1 Cells | 69.4 Percentage of TfH cells (%) | Standard Deviation 25 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: CXCR4+ cTfh1 Cells | 55.6 Percentage of TfH cells (%) | Standard Deviation 29.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ Naive TREG | 8.5 Percentage of TfH cells (%) | Standard Deviation 8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Total PD1+ TREG | 16.1 Percentage of TfH cells (%) | Standard Deviation 8.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1- ICOS- cTfh2 | 80.3 Percentage of TfH cells (%) | Standard Deviation 11.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Activated cTfh2 Cells | 0.6 Percentage of TfH cells (%) | Standard Deviation 0.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1- ICOS- cTfh2 | 79.0 Percentage of TfH cells (%) | Standard Deviation 13.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1- ICOS- cTfh2 | 80.7 Percentage of TfH cells (%) | Standard Deviation 11.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1- ICOS- cTfh17 | 74.6 Percentage of TfH cells (%) | Standard Deviation 15.8 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0:Activated PD1+ICOS+ cTfh1 | 1.0 Percentage of TfH cells (%) | Standard Deviation 1.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Potentially Anergic TEMRA CD4 | 0.3 Percentage of TfH cells (%) | Standard Deviation 0.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1- ICOS- cTfh17 | 73.5 Percentage of TfH cells (%) | Standard Deviation 20.9 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1- ICOS- cTfh17 | 75.3 Percentage of TfH cells (%) | Standard Deviation 18.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Activated cTfh2 Cells | 0.6 Percentage of TfH cells (%) | Standard Deviation 0.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Potentially Anergic TEMRA CD4 | 0.3 Percentage of TfH cells (%) | Standard Deviation 0.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1- ICOS- cTfh1 | 65.9 Percentage of TfH cells (%) | Standard Deviation 14 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1- ICOS- cTfh1 | 67.5 Percentage of TfH cells (%) | Standard Deviation 14.1 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Activated PD1+ICOS+ cTfh1 | 1.1 Percentage of TfH cells (%) | Standard Deviation 2.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Potentially Anergic TEMRA CD4 | 0.3 Percentage of TfH cells (%) | Standard Deviation 0.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1- ICOS- cTfh1 | 68.9 Percentage of TfH cells (%) | Standard Deviation 13.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ICOSNeg cTfh2 | 20.2 Percentage of TfH cells (%) | Standard Deviation 13.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ Naive CD4 | 3.2 Percentage of TfH cells (%) | Standard Deviation 4.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: Regulatory T-Follicular Subset | 0.2 Percentage of TfH cells (%) | Standard Deviation 0.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ICOSNeg cTfh2 | 18.8 Percentage of TfH cells (%) | Standard Deviation 11.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ICOSNeg cTfh2 | 18.5 Percentage of TfH cells (%) | Standard Deviation 11.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ CD4 Effector Memory | 4.3 Percentage of TfH cells (%) | Standard Deviation 2.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Regulatory T-Follicular Subset | 0.3 Percentage of TfH cells (%) | Standard Deviation 0.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ICOSNeg cTfh17 | 24.3 Percentage of TfH cells (%) | Standard Deviation 15.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ICOSNeg cTfh17 | 21.7 Percentage of TfH cells (%) | Standard Deviation 15.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: Activated cTfh17 Cells | 0.9 Percentage of TfH cells (%) | Standard Deviation 2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: Regulatory T-Follicular Subset | 0.3 Percentage of TfH cells (%) | Standard Deviation 0.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ICOSNeg cTfh17 | 22.3 Percentage of TfH cells (%) | Standard Deviation 15.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ICOSNeg cTfh1 | 32.8 Percentage of TfH cells (%) | Standard Deviation 13.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ CD4 Effector Memory | 4.0 Percentage of TfH cells (%) | Standard Deviation 2.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: TH17-Like Circulating T-Follicular cells | 0.5 Percentage of TfH cells (%) | Standard Deviation 0.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ICOSNeg cTfh1 | 31.0 Percentage of TfH cells (%) | Standard Deviation 13.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ICOSNeg cTfh1 | 29.7 Percentage of TfH cells (%) | Standard Deviation 13.2 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ CD4 Effector Memory | 4.1 Percentage of TfH cells (%) | Standard Deviation 2.6 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: TH17-Like Circulating T-Follicular cells | 0.4 Percentage of TfH cells (%) | Standard Deviation 0.4 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ TREG EM | 21.9 Percentage of TfH cells (%) | Standard Deviation 10 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 54: PD1+ TREG EM | 21.6 Percentage of TfH cells (%) | Standard Deviation 10.7 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ CD4 Central Memory | 7.2 Percentage of TfH cells (%) | Standard Deviation 5.3 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: TH17-Like Circulating T-Follicular cells | 0.4 Percentage of TfH cells (%) | Standard Deviation 0.5 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 0: PD1+ TREG EM | 20.9 Percentage of TfH cells (%) | Standard Deviation 10 |
| Placebo (Placebo) | Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel | Week 80: PD1+ TREG CM | 18.8 Percentage of TfH cells (%) | Standard Deviation 11.6 |
Secondary
Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol)
Serum vitamin D is evaluated at baseline (week 0), week 54 and week 80.
Time frame: Week 0, week 54 and week 80
Population: The FAS included all randomised participants. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol) | Week 80 | 119 picomole per liter | Standard Deviation 41 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol) | Week 0 | 123 picomole per liter | Standard Deviation 30 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol) | Week 54 | 117 picomole per liter | Standard Deviation 31 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol) | Week 54 | 125 picomole per liter | Standard Deviation 36 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol) | Week 0 | 122 picomole per liter | Standard Deviation 39 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol) | Week 80 | 124 picomole per liter | Standard Deviation 49 |
| Liraglutide (Experimental) | Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol) | Week 54 | 113 picomole per liter | Standard Deviation 30 |
| Liraglutide (Experimental) | Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol) | Week 0 | 122 picomole per liter | Standard Deviation 29 |
| Liraglutide (Experimental) | Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol) | Week 80 | 121 picomole per liter | Standard Deviation 38 |
| Placebo (Placebo) | Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol) | Week 0 | 120 picomole per liter | Standard Deviation 33 |
| Placebo (Placebo) | Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol) | Week 80 | 115 picomole per liter | Standard Deviation 33 |
| Placebo (Placebo) | Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol) | Week 54 | 119 picomole per liter | Standard Deviation 32 |
Secondary
Change in Biomarker: Total Interleukin-21 (IL-21)
IL-21 is evaluated at baseline (week 0), week 54 and week 80.
Time frame: Week 0, week 54 and week 80
Population: The FAS included all randomised participants. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Total Interleukin-21 (IL-21) | Week 0 | 28.8 picogram per milliliter | Standard Deviation 10.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Total Interleukin-21 (IL-21) | Week 80 | 540.9 picogram per milliliter | Standard Deviation 495.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Biomarker: Total Interleukin-21 (IL-21) | Week 54 | 3993.5 picogram per milliliter | Standard Deviation 2145.4 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Total Interleukin-21 (IL-21) | Week 0 | 31.1 picogram per milliliter | Standard Deviation 10.8 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Total Interleukin-21 (IL-21) | Week 80 | 674.1 picogram per milliliter | Standard Deviation 648.1 |
| NNC0114-0006 (Experimental) | Change in Biomarker: Total Interleukin-21 (IL-21) | Week 54 | 4368.2 picogram per milliliter | Standard Deviation 2374.9 |
| Liraglutide (Experimental) | Change in Biomarker: Total Interleukin-21 (IL-21) | Week 54 | 25.0 picogram per milliliter | Standard Deviation 0 |
| Liraglutide (Experimental) | Change in Biomarker: Total Interleukin-21 (IL-21) | Week 0 | 30.9 picogram per milliliter | Standard Deviation 10.7 |
| Liraglutide (Experimental) | Change in Biomarker: Total Interleukin-21 (IL-21) | Week 80 | 28.0 picogram per milliliter | Standard Deviation 8.2 |
| Placebo (Placebo) | Change in Biomarker: Total Interleukin-21 (IL-21) | Week 0 | 30.2 picogram per milliliter | Standard Deviation 10.2 |
| Placebo (Placebo) | Change in Biomarker: Total Interleukin-21 (IL-21) | Week 80 | 30.7 picogram per milliliter | Standard Deviation 17.2 |
| Placebo (Placebo) | Change in Biomarker: Total Interleukin-21 (IL-21) | Week 54 | 34.1 picogram per milliliter | Standard Deviation 68.1 |
Secondary
Change in Body Temperature
Change in body temperature is evaluated from baseline (week 0) to weeks 54 and 80.
Time frame: Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Body Temperature | Change from week 0 to week 54 | -0.1 Degree celsius (C) | Standard Deviation 0.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Body Temperature | Change from week 0 to week 80 | -0.0 Degree celsius (C) | Standard Deviation 0.4 |
| NNC0114-0006 (Experimental) | Change in Body Temperature | Change from week 0 to week 80 | 0.1 Degree celsius (C) | Standard Deviation 0.5 |
| NNC0114-0006 (Experimental) | Change in Body Temperature | Change from week 0 to week 54 | 0.0 Degree celsius (C) | Standard Deviation 0.6 |
| Liraglutide (Experimental) | Change in Body Temperature | Change from week 0 to week 80 | 0.0 Degree celsius (C) | Standard Deviation 0.5 |
| Liraglutide (Experimental) | Change in Body Temperature | Change from week 0 to week 54 | -0.1 Degree celsius (C) | Standard Deviation 0.5 |
| Placebo (Placebo) | Change in Body Temperature | Change from week 0 to week 80 | 0.0 Degree celsius (C) | Standard Deviation 0.4 |
| Placebo (Placebo) | Change in Body Temperature | Change from week 0 to week 54 | -0.0 Degree celsius (C) | Standard Deviation 0.3 |
Secondary
Change in Body Weight (kg)
Change in body weight is measured at week 54 and week 80 respective to baseline. Body weight was measured in unit 'Kg'.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Body Weight (kg) | Change from week 0 to week 80 | 1.9 Kilogram (Kg) | Standard Deviation 4.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Body Weight (kg) | Change from week 0 to week 54 | -1.8 Kilogram (Kg) | Standard Deviation 4.2 |
| NNC0114-0006 (Experimental) | Change in Body Weight (kg) | Change from week 0 to week 54 | 1.2 Kilogram (Kg) | Standard Deviation 5 |
| NNC0114-0006 (Experimental) | Change in Body Weight (kg) | Change from week 0 to week 80 | 1.6 Kilogram (Kg) | Standard Deviation 5.2 |
| Liraglutide (Experimental) | Change in Body Weight (kg) | Change from week 0 to week 80 | 0.4 Kilogram (Kg) | Standard Deviation 4.7 |
| Liraglutide (Experimental) | Change in Body Weight (kg) | Change from week 0 to week 54 | -2.5 Kilogram (Kg) | Standard Deviation 4 |
| Placebo (Placebo) | Change in Body Weight (kg) | Change from week 0 to week 54 | 1.1 Kilogram (Kg) | Standard Deviation 6.1 |
| Placebo (Placebo) | Change in Body Weight (kg) | Change from week 0 to week 80 | 2.8 Kilogram (Kg) | Standard Deviation 5.5 |
Secondary
Change in Cytokines: Interferon (IFN) Gamma
IFN gamma levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.
Time frame: Week 0, week 54 and week 80
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Cytokines: Interferon (IFN) Gamma | Week 0 | 7.3 pg/mL | Standard Deviation 16.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Cytokines: Interferon (IFN) Gamma | Week 80 | 4.4 pg/mL | Standard Deviation 2.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Cytokines: Interferon (IFN) Gamma | Week 54 | 4.6 pg/mL | Standard Deviation 4.2 |
| NNC0114-0006 (Experimental) | Change in Cytokines: Interferon (IFN) Gamma | Week 0 | 7.8 pg/mL | Standard Deviation 24 |
| NNC0114-0006 (Experimental) | Change in Cytokines: Interferon (IFN) Gamma | Week 80 | 4.9 pg/mL | Standard Deviation 6.4 |
| NNC0114-0006 (Experimental) | Change in Cytokines: Interferon (IFN) Gamma | Week 54 | 7.5 pg/mL | Standard Deviation 19.6 |
| Liraglutide (Experimental) | Change in Cytokines: Interferon (IFN) Gamma | Week 54 | 5.0 pg/mL | Standard Deviation 6.8 |
| Liraglutide (Experimental) | Change in Cytokines: Interferon (IFN) Gamma | Week 0 | 5.8 pg/mL | Standard Deviation 11.6 |
| Liraglutide (Experimental) | Change in Cytokines: Interferon (IFN) Gamma | Week 80 | 13.0 pg/mL | Standard Deviation 57.5 |
| Placebo (Placebo) | Change in Cytokines: Interferon (IFN) Gamma | Week 0 | 4.3 pg/mL | Standard Deviation 2.8 |
| Placebo (Placebo) | Change in Cytokines: Interferon (IFN) Gamma | Week 80 | 4.5 pg/mL | Standard Deviation 3.4 |
| Placebo (Placebo) | Change in Cytokines: Interferon (IFN) Gamma | Week 54 | 5.8 pg/mL | Standard Deviation 7 |
Secondary
Change in Cytokines- Interleukin (IL)-10
IL-10 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.
Time frame: Week 0, week 54 and week 80
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Cytokines- Interleukin (IL)-10 | Week 0 | 0.7 pg/mL | Standard Deviation 1.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Cytokines- Interleukin (IL)-10 | Week 54 | 0.4 pg/mL | Standard Deviation 0.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Cytokines- Interleukin (IL)-10 | Week 80 | 0.4 pg/mL | Standard Deviation 0.5 |
| NNC0114-0006 (Experimental) | Change in Cytokines- Interleukin (IL)-10 | Week 0 | 0.5 pg/mL | Standard Deviation 1.1 |
| NNC0114-0006 (Experimental) | Change in Cytokines- Interleukin (IL)-10 | Week 54 | 0.4 pg/mL | Standard Deviation 0.1 |
| NNC0114-0006 (Experimental) | Change in Cytokines- Interleukin (IL)-10 | Week 80 | 0.4 pg/mL | Standard Deviation 0.2 |
| Liraglutide (Experimental) | Change in Cytokines- Interleukin (IL)-10 | Week 0 | 0.4 pg/mL | Standard Deviation 0.3 |
| Liraglutide (Experimental) | Change in Cytokines- Interleukin (IL)-10 | Week 54 | 0.4 pg/mL | Standard Deviation 0.3 |
| Liraglutide (Experimental) | Change in Cytokines- Interleukin (IL)-10 | Week 80 | 0.5 pg/mL | Standard Deviation 0.7 |
| Placebo (Placebo) | Change in Cytokines- Interleukin (IL)-10 | Week 54 | 0.4 pg/mL | Standard Deviation 0.3 |
| Placebo (Placebo) | Change in Cytokines- Interleukin (IL)-10 | Week 80 | 0.4 pg/mL | Standard Deviation 0.1 |
| Placebo (Placebo) | Change in Cytokines- Interleukin (IL)-10 | Week 0 | 0.4 pg/mL | Standard Deviation 0.2 |
Secondary
Change in Cytokines: Interleukin (IL)-17
IL-17 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.
Time frame: Week 0, week 54 and week 80
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Cytokines: Interleukin (IL)-17 | Week 0 | 4.9 pg/mL | Standard Deviation 2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Cytokines: Interleukin (IL)-17 | Week 80 | 4.9 pg/mL | Standard Deviation 1.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Cytokines: Interleukin (IL)-17 | Week 54 | 4.9 pg/mL | Standard Deviation 1.9 |
| NNC0114-0006 (Experimental) | Change in Cytokines: Interleukin (IL)-17 | Week 0 | 4.7 pg/mL | Standard Deviation 0.7 |
| NNC0114-0006 (Experimental) | Change in Cytokines: Interleukin (IL)-17 | Week 80 | 4.7 pg/mL | Standard Deviation 0 |
| NNC0114-0006 (Experimental) | Change in Cytokines: Interleukin (IL)-17 | Week 54 | 4.8 pg/mL | Standard Deviation 1.3 |
| Liraglutide (Experimental) | Change in Cytokines: Interleukin (IL)-17 | Week 54 | 5.1 pg/mL | Standard Deviation 3.5 |
| Liraglutide (Experimental) | Change in Cytokines: Interleukin (IL)-17 | Week 0 | 4.7 pg/mL | Standard Deviation 0 |
| Liraglutide (Experimental) | Change in Cytokines: Interleukin (IL)-17 | Week 80 | 4.8 pg/mL | Standard Deviation 1.2 |
| Placebo (Placebo) | Change in Cytokines: Interleukin (IL)-17 | Week 0 | 4.8 pg/mL | Standard Deviation 0.9 |
| Placebo (Placebo) | Change in Cytokines: Interleukin (IL)-17 | Week 80 | 4.8 pg/mL | Standard Deviation 1 |
| Placebo (Placebo) | Change in Cytokines: Interleukin (IL)-17 | Week 54 | 5.4 pg/mL | Standard Deviation 5 |
Secondary
Change in Cytokines: Interleukin (IL)-6
IL-6 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.
Time frame: Week 0, week 54 and week 80
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Cytokines: Interleukin (IL)-6 | Week 80 | 0.9 picogram per milliliter (pg/mL) | Standard Deviation 0.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Cytokines: Interleukin (IL)-6 | Week 54 | 0.8 picogram per milliliter (pg/mL) | Standard Deviation 0.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Cytokines: Interleukin (IL)-6 | Week 0 | 0.9 picogram per milliliter (pg/mL) | Standard Deviation 0.6 |
| NNC0114-0006 (Experimental) | Change in Cytokines: Interleukin (IL)-6 | Week 54 | 0.8 picogram per milliliter (pg/mL) | Standard Deviation 0.4 |
| NNC0114-0006 (Experimental) | Change in Cytokines: Interleukin (IL)-6 | Week 0 | 0.8 picogram per milliliter (pg/mL) | Standard Deviation 0.1 |
| NNC0114-0006 (Experimental) | Change in Cytokines: Interleukin (IL)-6 | Week 80 | 0.8 picogram per milliliter (pg/mL) | Standard Deviation 0.2 |
| Liraglutide (Experimental) | Change in Cytokines: Interleukin (IL)-6 | Week 0 | 1.2 picogram per milliliter (pg/mL) | Standard Deviation 1.8 |
| Liraglutide (Experimental) | Change in Cytokines: Interleukin (IL)-6 | Week 80 | 0.9 picogram per milliliter (pg/mL) | Standard Deviation 0.8 |
| Liraglutide (Experimental) | Change in Cytokines: Interleukin (IL)-6 | Week 54 | 1.0 picogram per milliliter (pg/mL) | Standard Deviation 0.8 |
| Placebo (Placebo) | Change in Cytokines: Interleukin (IL)-6 | Week 54 | 0.8 picogram per milliliter (pg/mL) | Standard Deviation 0.2 |
| Placebo (Placebo) | Change in Cytokines: Interleukin (IL)-6 | Week 0 | 0.8 picogram per milliliter (pg/mL) | Standard Deviation 0.3 |
| Placebo (Placebo) | Change in Cytokines: Interleukin (IL)-6 | Week 80 | 0.9 picogram per milliliter (pg/mL) | Standard Deviation 0.4 |
Secondary
Change in Cytokines: TNF-alpha
TNF-alpha levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.
Time frame: Week 0, week 54 and week 80
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Cytokines: TNF-alpha | Week 54 | 2.36 pg/mL | Standard Deviation 0.75 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Cytokines: TNF-alpha | Week 80 | 2.43 pg/mL | Standard Deviation 0.66 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Cytokines: TNF-alpha | Week 0 | 2.60 pg/mL | Standard Deviation 1.69 |
| NNC0114-0006 (Experimental) | Change in Cytokines: TNF-alpha | Week 54 | 2.33 pg/mL | Standard Deviation 0.59 |
| NNC0114-0006 (Experimental) | Change in Cytokines: TNF-alpha | Week 80 | 2.36 pg/mL | Standard Deviation 0.68 |
| NNC0114-0006 (Experimental) | Change in Cytokines: TNF-alpha | Week 0 | 2.32 pg/mL | Standard Deviation 0.82 |
| Liraglutide (Experimental) | Change in Cytokines: TNF-alpha | Week 0 | 2.70 pg/mL | Standard Deviation 1.73 |
| Liraglutide (Experimental) | Change in Cytokines: TNF-alpha | Week 54 | 2.56 pg/mL | Standard Deviation 1.11 |
| Liraglutide (Experimental) | Change in Cytokines: TNF-alpha | Week 80 | 2.96 pg/mL | Standard Deviation 2.39 |
| Placebo (Placebo) | Change in Cytokines: TNF-alpha | Week 54 | 2.43 pg/mL | Standard Deviation 0.65 |
| Placebo (Placebo) | Change in Cytokines: TNF-alpha | Week 80 | 2.75 pg/mL | Standard Deviation 2.47 |
| Placebo (Placebo) | Change in Cytokines: TNF-alpha | Week 0 | 3.06 pg/mL | Standard Deviation 3.75 |
Secondary
Change in D-Dimer
Change in D-Dimer (measured in mg/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in D-Dimer | Change from week 0 to week 54 | 0.96 Ratio of D-dimer | Geometric Coefficient of Variation 37.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in D-Dimer | Change from week 0 to week 80 | 0.96 Ratio of D-dimer | Geometric Coefficient of Variation 43.7 |
| NNC0114-0006 (Experimental) | Change in D-Dimer | Change from week 0 to week 80 | 0.92 Ratio of D-dimer | Geometric Coefficient of Variation 61.3 |
| NNC0114-0006 (Experimental) | Change in D-Dimer | Change from week 0 to week 54 | 0.98 Ratio of D-dimer | Geometric Coefficient of Variation 53.9 |
| Liraglutide (Experimental) | Change in D-Dimer | Change from week 0 to week 54 | 0.98 Ratio of D-dimer | Geometric Coefficient of Variation 56.8 |
| Liraglutide (Experimental) | Change in D-Dimer | Change from week 0 to week 80 | 1.05 Ratio of D-dimer | Geometric Coefficient of Variation 60 |
| Placebo (Placebo) | Change in D-Dimer | Change from week 0 to week 54 | 1.15 Ratio of D-dimer | Geometric Coefficient of Variation 107.1 |
| Placebo (Placebo) | Change in D-Dimer | Change from week 0 to week 80 | 1.10 Ratio of D-dimer | Geometric Coefficient of Variation 74.3 |
Secondary
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Change from baseline (week 0) in DTSQ is evaluated at week 54 and 80. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher score indicates a higher level of glycaemia/treatment satisfaction.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The FAS included all randomised participants. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) | Week 80: Treatment satisfaction | 1.3 Score on a scale | Standard Deviation 6.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) | Week 80: Perceived frequency of hypoglycaemia | -0.9 Score on a scale | Standard Deviation 1.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) | Week 80: Perceived frequency of hyperglycaemia | 0.9 Score on a scale | Standard Deviation 1.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) | Week 54: Perceived frequency of hyperglycaemia | 0.6 Score on a scale | Standard Deviation 1.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) | Week 54: Treatment satisfaction | 1.5 Score on a scale | Standard Deviation 4.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) | Week 54: Perceived frequency of hypoglycaemia | -0.7 Score on a scale | Standard Deviation 2.1 |
| NNC0114-0006 (Experimental) | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) | Week 54: Perceived frequency of hypoglycaemia | -0.6 Score on a scale | Standard Deviation 1.6 |
| NNC0114-0006 (Experimental) | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) | Week 80: Perceived frequency of hypoglycaemia | -0.3 Score on a scale | Standard Deviation 1.7 |
| NNC0114-0006 (Experimental) | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) | Week 80: Perceived frequency of hyperglycaemia | 0.5 Score on a scale | Standard Deviation 1.8 |
| NNC0114-0006 (Experimental) | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) | Week 54: Perceived frequency of hyperglycaemia | 0.0 Score on a scale | Standard Deviation 1.5 |
| NNC0114-0006 (Experimental) | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) | Week 80: Treatment satisfaction | 1.2 Score on a scale | Standard Deviation 5.7 |
| NNC0114-0006 (Experimental) | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) | Week 54: Treatment satisfaction | 0.9 Score on a scale | Standard Deviation 5.2 |
| Liraglutide (Experimental) | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) | Week 54: Perceived frequency of hypoglycaemia | -0.4 Score on a scale | Standard Deviation 2.1 |
| Liraglutide (Experimental) | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) | Week 54: Perceived frequency of hyperglycaemia | 0.0 Score on a scale | Standard Deviation 1.9 |
| Liraglutide (Experimental) | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) | Week 80: Perceived frequency of hyperglycaemia | 0.6 Score on a scale | Standard Deviation 2 |
| Liraglutide (Experimental) | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) | Week 80: Perceived frequency of hypoglycaemia | -0.4 Score on a scale | Standard Deviation 1.8 |
| Liraglutide (Experimental) | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) | Week 54: Treatment satisfaction | 1.3 Score on a scale | Standard Deviation 4.8 |
| Liraglutide (Experimental) | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) | Week 80: Treatment satisfaction | 0.0 Score on a scale | Standard Deviation 5.1 |
| Placebo (Placebo) | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) | Week 80: Perceived frequency of hyperglycaemia | 0.7 Score on a scale | Standard Deviation 1.9 |
| Placebo (Placebo) | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) | Week 54: Perceived frequency of hyperglycaemia | 0.5 Score on a scale | Standard Deviation 1.7 |
| Placebo (Placebo) | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) | Week 80: Treatment satisfaction | 0.2 Score on a scale | Standard Deviation 6.2 |
| Placebo (Placebo) | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) | Week 54: Perceived frequency of hypoglycaemia | -0.2 Score on a scale | Standard Deviation 1.5 |
| Placebo (Placebo) | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) | Week 54: Treatment satisfaction | 0.2 Score on a scale | Standard Deviation 5.5 |
| Placebo (Placebo) | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) | Week 80: Perceived frequency of hypoglycaemia | -0.1 Score on a scale | Standard Deviation 1.5 |
Secondary
Change in Electrocardiogram (ECG)
The ECG was assessed by the investigator at baseline (week 0), week 54 and week 80 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline, week 54 and week 80 are presented.
Time frame: Week 0, week 54 and week 80
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Electrocardiogram (ECG) | Week 0 | Abnormal, NCS | 15 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Electrocardiogram (ECG) | Week 80 | Abnormal, NCS | 15 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Electrocardiogram (ECG) | Week 54 | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Electrocardiogram (ECG) | Week 0 | Normal | 62 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Electrocardiogram (ECG) | Week 80 | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Electrocardiogram (ECG) | Week 54 | Normal | 54 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Electrocardiogram (ECG) | Week 80 | Normal | 51 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Electrocardiogram (ECG) | Week 54 | Abnormal, NCS | 14 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Electrocardiogram (ECG) | Week 0 | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Electrocardiogram (ECG) | Week 54 | Abnormal, NCS | 17 Participants |
| NNC0114-0006 (Experimental) | Change in Electrocardiogram (ECG) | Week 54 | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Electrocardiogram (ECG) | Week 80 | Normal | 48 Participants |
| NNC0114-0006 (Experimental) | Change in Electrocardiogram (ECG) | Week 80 | Abnormal, NCS | 16 Participants |
| NNC0114-0006 (Experimental) | Change in Electrocardiogram (ECG) | Week 0 | Normal | 65 Participants |
| NNC0114-0006 (Experimental) | Change in Electrocardiogram (ECG) | Week 0 | Abnormal, NCS | 12 Participants |
| NNC0114-0006 (Experimental) | Change in Electrocardiogram (ECG) | Week 0 | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Electrocardiogram (ECG) | Week 54 | Normal | 48 Participants |
| NNC0114-0006 (Experimental) | Change in Electrocardiogram (ECG) | Week 80 | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Electrocardiogram (ECG) | Week 54 | Normal | 55 Participants |
| Liraglutide (Experimental) | Change in Electrocardiogram (ECG) | Week 80 | Normal | 53 Participants |
| Liraglutide (Experimental) | Change in Electrocardiogram (ECG) | Week 54 | Abnormal, NCS | 12 Participants |
| Liraglutide (Experimental) | Change in Electrocardiogram (ECG) | Week 0 | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Electrocardiogram (ECG) | Week 0 | Abnormal, NCS | 16 Participants |
| Liraglutide (Experimental) | Change in Electrocardiogram (ECG) | Week 80 | Abnormal, NCS | 15 Participants |
| Liraglutide (Experimental) | Change in Electrocardiogram (ECG) | Week 0 | Normal | 60 Participants |
| Liraglutide (Experimental) | Change in Electrocardiogram (ECG) | Week 54 | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Electrocardiogram (ECG) | Week 80 | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Electrocardiogram (ECG) | Week 80 | Normal | 50 Participants |
| Placebo (Placebo) | Change in Electrocardiogram (ECG) | Week 0 | Abnormal, NCS | 13 Participants |
| Placebo (Placebo) | Change in Electrocardiogram (ECG) | Week 0 | Abnormal, CS | 1 Participants |
| Placebo (Placebo) | Change in Electrocardiogram (ECG) | Week 54 | Normal | 46 Participants |
| Placebo (Placebo) | Change in Electrocardiogram (ECG) | Week 54 | Abnormal, NCS | 19 Participants |
| Placebo (Placebo) | Change in Electrocardiogram (ECG) | Week 54 | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Electrocardiogram (ECG) | Week 80 | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Electrocardiogram (ECG) | Week 0 | Normal | 63 Participants |
| Placebo (Placebo) | Change in Electrocardiogram (ECG) | Week 80 | Abnormal, NCS | 12 Participants |
Secondary
Change in Experience of Treatment Benefits and Barriers (ETBB)
Treatment Benefits and Barriers (ETBB) questionnaire measured diabetes-specific health beliefs on 2 categories: Total Score for Perceived Barriers and Perceived Benefits. The measurement of perceived benefits of, and barriers to, treatment was achieved by creating a pool 28 statements each with a 7-point scale ranging from strongly agree (6) to strongly disagree (0). ETBB benefits score was calculated using the responses from questions 1, 4, 7, 8, 10, and 12 and ETBB barriers score was calculated using the responses from questions 2, 3, 5, 6, 9, and 11. Both was calculated as the sum of responses divided by number of responses received multiplied by the maximum number of responses. Based on the responses used the maximum responses available was 6. The higher score indicates more perceived benefits or more perceived barrier.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The FAS included all randomised participants. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Experience of Treatment Benefits and Barriers (ETBB) | Week 54: Total Score for Perceived Barriers | -1.2 score on a scale | Standard Deviation 8.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Experience of Treatment Benefits and Barriers (ETBB) | Week 80: Total Score for Perceived Barriers | -2.0 score on a scale | Standard Deviation 7.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Experience of Treatment Benefits and Barriers (ETBB) | Week 54: Total Score for Perceived Benefits | 0.6 score on a scale | Standard Deviation 5.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Experience of Treatment Benefits and Barriers (ETBB) | Week 80: Total Score for Perceived Benefits | 0.1 score on a scale | Standard Deviation 5.8 |
| NNC0114-0006 (Experimental) | Change in Experience of Treatment Benefits and Barriers (ETBB) | Week 80: Total Score for Perceived Barriers | -2.0 score on a scale | Standard Deviation 7.5 |
| NNC0114-0006 (Experimental) | Change in Experience of Treatment Benefits and Barriers (ETBB) | Week 54: Total Score for Perceived Benefits | 1.1 score on a scale | Standard Deviation 4.2 |
| NNC0114-0006 (Experimental) | Change in Experience of Treatment Benefits and Barriers (ETBB) | Week 80: Total Score for Perceived Benefits | 1.1 score on a scale | Standard Deviation 4.8 |
| NNC0114-0006 (Experimental) | Change in Experience of Treatment Benefits and Barriers (ETBB) | Week 54: Total Score for Perceived Barriers | -1.8 score on a scale | Standard Deviation 7.7 |
| Liraglutide (Experimental) | Change in Experience of Treatment Benefits and Barriers (ETBB) | Week 54: Total Score for Perceived Benefits | 0.2 score on a scale | Standard Deviation 5.7 |
| Liraglutide (Experimental) | Change in Experience of Treatment Benefits and Barriers (ETBB) | Week 80: Total Score for Perceived Barriers | -0.1 score on a scale | Standard Deviation 6.7 |
| Liraglutide (Experimental) | Change in Experience of Treatment Benefits and Barriers (ETBB) | Week 80: Total Score for Perceived Benefits | 1.3 score on a scale | Standard Deviation 6.2 |
| Liraglutide (Experimental) | Change in Experience of Treatment Benefits and Barriers (ETBB) | Week 54: Total Score for Perceived Barriers | -0.2 score on a scale | Standard Deviation 8.2 |
| Placebo (Placebo) | Change in Experience of Treatment Benefits and Barriers (ETBB) | Week 80: Total Score for Perceived Benefits | -0.4 score on a scale | Standard Deviation 5.1 |
| Placebo (Placebo) | Change in Experience of Treatment Benefits and Barriers (ETBB) | Week 80: Total Score for Perceived Barriers | 0.1 score on a scale | Standard Deviation 8.3 |
| Placebo (Placebo) | Change in Experience of Treatment Benefits and Barriers (ETBB) | Week 54: Total Score for Perceived Barriers | -0.3 score on a scale | Standard Deviation 6.3 |
| Placebo (Placebo) | Change in Experience of Treatment Benefits and Barriers (ETBB) | Week 54: Total Score for Perceived Benefits | -0.5 score on a scale | Standard Deviation 6.3 |
Secondary
Change in Eye-examination
Dilated fundoscopy or fundus photography was performed by the investigator at week 0, week 54 and week 80. The results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at week 0, week 54 and week 80 are presented.
Time frame: Week 0, week 54 and week 80
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Eye-examination | Week 80: Right eye ophthalmoscopy | Normal | 52 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Eye-examination | Week 0: Left eye ophthalmoscopy | Abnormal, NCS | 13 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Eye-examination | Week 0: Left eye ophthalmoscopy | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Eye-examination | Week 54: Left eye ophthalmoscopy | Normal | 55 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Eye-examination | Week 54: Left eye ophthalmoscopy | Abnormal, NCS | 12 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Eye-examination | Week 54: Left eye ophthalmoscopy | Abnormal, CS | 1 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Eye-examination | Week 80: Left eye ophthalmoscopy | Normal | 52 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Eye-examination | Week 80: Left eye ophthalmoscopy | Abnormal, NCS | 11 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Eye-examination | Week 80: Left eye ophthalmoscopy | Abnormal, CS | 3 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Eye-examination | Week 0: Right eye ophthalmoscopy | Normal | 58 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Eye-examination | Week 0: Right eye ophthalmoscopy | Abnormal, CS | 1 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Eye-examination | Week 54: Right eye ophthalmoscopy | Abnormal, NCS | 13 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Eye-examination | Week 54: Right eye ophthalmoscopy | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Eye-examination | Week 0: Left eye ophthalmoscopy | Normal | 64 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Eye-examination | Week 80: Right eye ophthalmoscopy | Abnormal, CS | 2 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Eye-examination | Week 0: Right eye ophthalmoscopy | Abnormal, NCS | 18 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Eye-examination | Week 54: Right eye ophthalmoscopy | Normal | 55 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Eye-examination | Week 80: Right eye ophthalmoscopy | Abnormal, NCS | 12 Participants |
| NNC0114-0006 (Experimental) | Change in Eye-examination | Week 80: Left eye ophthalmoscopy | Normal | 54 Participants |
| NNC0114-0006 (Experimental) | Change in Eye-examination | Week 0: Left eye ophthalmoscopy | Normal | 68 Participants |
| NNC0114-0006 (Experimental) | Change in Eye-examination | Week 0: Right eye ophthalmoscopy | Normal | 66 Participants |
| NNC0114-0006 (Experimental) | Change in Eye-examination | Week 0: Right eye ophthalmoscopy | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Eye-examination | Week 54: Left eye ophthalmoscopy | Normal | 56 Participants |
| NNC0114-0006 (Experimental) | Change in Eye-examination | Week 54: Right eye ophthalmoscopy | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Eye-examination | Week 54: Right eye ophthalmoscopy | Normal | 55 Participants |
| NNC0114-0006 (Experimental) | Change in Eye-examination | Week 0: Left eye ophthalmoscopy | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Eye-examination | Week 54: Right eye ophthalmoscopy | Abnormal, NCS | 8 Participants |
| NNC0114-0006 (Experimental) | Change in Eye-examination | Week 80: Right eye ophthalmoscopy | Normal | 53 Participants |
| NNC0114-0006 (Experimental) | Change in Eye-examination | Week 80: Left eye ophthalmoscopy | Abnormal, NCS | 8 Participants |
| NNC0114-0006 (Experimental) | Change in Eye-examination | Week 54: Left eye ophthalmoscopy | Abnormal, NCS | 7 Participants |
| NNC0114-0006 (Experimental) | Change in Eye-examination | Week 0: Left eye ophthalmoscopy | Abnormal, NCS | 9 Participants |
| NNC0114-0006 (Experimental) | Change in Eye-examination | Week 80: Right eye ophthalmoscopy | Abnormal, NCS | 9 Participants |
| NNC0114-0006 (Experimental) | Change in Eye-examination | Week 80: Left eye ophthalmoscopy | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Eye-examination | Week 54: Left eye ophthalmoscopy | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Eye-examination | Week 80: Right eye ophthalmoscopy | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Eye-examination | Week 0: Right eye ophthalmoscopy | Abnormal, NCS | 11 Participants |
| Liraglutide (Experimental) | Change in Eye-examination | Week 0: Left eye ophthalmoscopy | Abnormal, NCS | 6 Participants |
| Liraglutide (Experimental) | Change in Eye-examination | Week 54: Left eye ophthalmoscopy | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Eye-examination | Week 0: Right eye ophthalmoscopy | Normal | 69 Participants |
| Liraglutide (Experimental) | Change in Eye-examination | Week 80: Left eye ophthalmoscopy | Normal | 59 Participants |
| Liraglutide (Experimental) | Change in Eye-examination | Week 80: Left eye ophthalmoscopy | Abnormal, NCS | 6 Participants |
| Liraglutide (Experimental) | Change in Eye-examination | Week 80: Left eye ophthalmoscopy | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Eye-examination | Week 0: Right eye ophthalmoscopy | Abnormal, NCS | 7 Participants |
| Liraglutide (Experimental) | Change in Eye-examination | Week 80: Right eye ophthalmoscopy | Abnormal, NCS | 7 Participants |
| Liraglutide (Experimental) | Change in Eye-examination | Week 0: Right eye ophthalmoscopy | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Eye-examination | Week 54: Right eye ophthalmoscopy | Normal | 60 Participants |
| Liraglutide (Experimental) | Change in Eye-examination | Week 54: Right eye ophthalmoscopy | Abnormal, NCS | 9 Participants |
| Liraglutide (Experimental) | Change in Eye-examination | Week 80: Right eye ophthalmoscopy | Normal | 58 Participants |
| Liraglutide (Experimental) | Change in Eye-examination | Week 54: Right eye ophthalmoscopy | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Eye-examination | Week 0: Left eye ophthalmoscopy | Normal | 70 Participants |
| Liraglutide (Experimental) | Change in Eye-examination | Week 80: Right eye ophthalmoscopy | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Eye-examination | Week 0: Left eye ophthalmoscopy | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Eye-examination | Week 54: Left eye ophthalmoscopy | Normal | 60 Participants |
| Liraglutide (Experimental) | Change in Eye-examination | Week 54: Left eye ophthalmoscopy | Abnormal, NCS | 9 Participants |
| Placebo (Placebo) | Change in Eye-examination | Week 80: Right eye ophthalmoscopy | Abnormal, NCS | 8 Participants |
| Placebo (Placebo) | Change in Eye-examination | Week 0: Right eye ophthalmoscopy | Abnormal, NCS | 10 Participants |
| Placebo (Placebo) | Change in Eye-examination | Week 54: Left eye ophthalmoscopy | Abnormal, CS | 1 Participants |
| Placebo (Placebo) | Change in Eye-examination | Week 80: Left eye ophthalmoscopy | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Eye-examination | Week 80: Left eye ophthalmoscopy | Abnormal, NCS | 8 Participants |
| Placebo (Placebo) | Change in Eye-examination | Week 54: Left eye ophthalmoscopy | Abnormal, NCS | 9 Participants |
| Placebo (Placebo) | Change in Eye-examination | Week 0: Left eye ophthalmoscopy | Abnormal, NCS | 11 Participants |
| Placebo (Placebo) | Change in Eye-examination | Week 54: Left eye ophthalmoscopy | Normal | 54 Participants |
| Placebo (Placebo) | Change in Eye-examination | Week 0: Right eye ophthalmoscopy | Normal | 67 Participants |
| Placebo (Placebo) | Change in Eye-examination | Week 0: Left eye ophthalmoscopy | Normal | 66 Participants |
| Placebo (Placebo) | Change in Eye-examination | Week 54: Right eye ophthalmoscopy | Normal | 55 Participants |
| Placebo (Placebo) | Change in Eye-examination | Week 0: Left eye ophthalmoscopy | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Eye-examination | Week 54: Right eye ophthalmoscopy | Abnormal, NCS | 8 Participants |
| Placebo (Placebo) | Change in Eye-examination | Week 80: Right eye ophthalmoscopy | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Eye-examination | Week 0: Right eye ophthalmoscopy | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Eye-examination | Week 80: Left eye ophthalmoscopy | Normal | 51 Participants |
| Placebo (Placebo) | Change in Eye-examination | Week 54: Right eye ophthalmoscopy | Abnormal, CS | 1 Participants |
| Placebo (Placebo) | Change in Eye-examination | Week 80: Right eye ophthalmoscopy | Normal | 51 Participants |
Secondary
Change in Fasting C-peptide- Ratio to Baseline
Change in fasting C-peptide (measured in nanomole per liter \[nmol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The FAS included all randomised participants. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Fasting C-peptide- Ratio to Baseline | Ratio from week 0 to week 54 | 1.01 Ratio of C-peptide | Geometric Coefficient of Variation 76.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Fasting C-peptide- Ratio to Baseline | Ratio from week 0 to week 80 | 0.58 Ratio of C-peptide | Geometric Coefficient of Variation 112.9 |
| NNC0114-0006 (Experimental) | Change in Fasting C-peptide- Ratio to Baseline | Ratio from week 0 to week 80 | 0.53 Ratio of C-peptide | Geometric Coefficient of Variation 106.2 |
| NNC0114-0006 (Experimental) | Change in Fasting C-peptide- Ratio to Baseline | Ratio from week 0 to week 54 | 0.70 Ratio of C-peptide | Geometric Coefficient of Variation 71.1 |
| Liraglutide (Experimental) | Change in Fasting C-peptide- Ratio to Baseline | Ratio from week 0 to week 54 | 0.65 Ratio of C-peptide | Geometric Coefficient of Variation 102.4 |
| Liraglutide (Experimental) | Change in Fasting C-peptide- Ratio to Baseline | Ratio from week 0 to week 80 | 0.42 Ratio of C-peptide | Geometric Coefficient of Variation 132.5 |
| Placebo (Placebo) | Change in Fasting C-peptide- Ratio to Baseline | Ratio from week 0 to week 54 | 0.66 Ratio of C-peptide | Geometric Coefficient of Variation 116.3 |
| Placebo (Placebo) | Change in Fasting C-peptide- Ratio to Baseline | Ratio from week 0 to week 80 | 0.54 Ratio of C-peptide | Geometric Coefficient of Variation 154.4 |
Secondary
Change in Fasting Glucagon- Ratio to Baseline
Change in fasting glucagon (measured in picogram per milliliter \[pg/mL\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The FAS included all randomised participants. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Fasting Glucagon- Ratio to Baseline | Ratio from week 0 to week 54 | 1.01 Ratio of glucagon | Geometric Coefficient of Variation 32.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Fasting Glucagon- Ratio to Baseline | Ratio from week 0 to week 80 | 0.89 Ratio of glucagon | Geometric Coefficient of Variation 36.2 |
| NNC0114-0006 (Experimental) | Change in Fasting Glucagon- Ratio to Baseline | Ratio from week 0 to week 80 | 0.85 Ratio of glucagon | Geometric Coefficient of Variation 30.7 |
| NNC0114-0006 (Experimental) | Change in Fasting Glucagon- Ratio to Baseline | Ratio from week 0 to week 54 | 0.95 Ratio of glucagon | Geometric Coefficient of Variation 32.5 |
| Liraglutide (Experimental) | Change in Fasting Glucagon- Ratio to Baseline | Ratio from week 0 to week 54 | 0.96 Ratio of glucagon | Geometric Coefficient of Variation 31.3 |
| Liraglutide (Experimental) | Change in Fasting Glucagon- Ratio to Baseline | Ratio from week 0 to week 80 | 0.96 Ratio of glucagon | Geometric Coefficient of Variation 32.8 |
| Placebo (Placebo) | Change in Fasting Glucagon- Ratio to Baseline | Ratio from week 0 to week 54 | 1.00 Ratio of glucagon | Geometric Coefficient of Variation 31.4 |
| Placebo (Placebo) | Change in Fasting Glucagon- Ratio to Baseline | Ratio from week 0 to week 80 | 0.93 Ratio of glucagon | Geometric Coefficient of Variation 37.8 |
Secondary
Change in Fasting Plasma Glucose
Change in fasting plasma glucose is evaluated from baseline (week 0) to weeks 54 and 80.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The FAS included all randomised participants. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Fasting Plasma Glucose | Change from week 0 to week 54 | 0.5 mmol/L | Standard Deviation 3.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Fasting Plasma Glucose | Change from week 0 to week 80 | 1.1 mmol/L | Standard Deviation 3.3 |
| NNC0114-0006 (Experimental) | Change in Fasting Plasma Glucose | Change from week 0 to week 80 | 0.3 mmol/L | Standard Deviation 2.4 |
| NNC0114-0006 (Experimental) | Change in Fasting Plasma Glucose | Change from week 0 to week 54 | 0.2 mmol/L | Standard Deviation 2.4 |
| Liraglutide (Experimental) | Change in Fasting Plasma Glucose | Change from week 0 to week 54 | -0.3 mmol/L | Standard Deviation 3.1 |
| Liraglutide (Experimental) | Change in Fasting Plasma Glucose | Change from week 0 to week 80 | 0.2 mmol/L | Standard Deviation 4 |
| Placebo (Placebo) | Change in Fasting Plasma Glucose | Change from week 0 to week 54 | 0.5 mmol/L | Standard Deviation 2.4 |
| Placebo (Placebo) | Change in Fasting Plasma Glucose | Change from week 0 to week 80 | 1.0 mmol/L | Standard Deviation 2.4 |
Secondary
Change in Haematology: Basophils
Change in basophils (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Haematology: Basophils | Change from week 0 to week 54 | 1.73 Ratio of basophils | Standard Deviation 2.11 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Haematology: Basophils | Change from week 0 to week 80 | 2.17 Ratio of basophils | Standard Deviation 2.17 |
| NNC0114-0006 (Experimental) | Change in Haematology: Basophils | Change from week 0 to week 80 | 1.73 Ratio of basophils | Standard Deviation 1.41 |
| NNC0114-0006 (Experimental) | Change in Haematology: Basophils | Change from week 0 to week 54 | 1.58 Ratio of basophils | Standard Deviation 1.52 |
| Liraglutide (Experimental) | Change in Haematology: Basophils | Change from week 0 to week 54 | 1.52 Ratio of basophils | Standard Deviation 1.47 |
| Liraglutide (Experimental) | Change in Haematology: Basophils | Change from week 0 to week 80 | 2.09 Ratio of basophils | Standard Deviation 1.86 |
| Placebo (Placebo) | Change in Haematology: Basophils | Change from week 0 to week 54 | 1.43 Ratio of basophils | Standard Deviation 1.06 |
| Placebo (Placebo) | Change in Haematology: Basophils | Change from week 0 to week 80 | 1.96 Ratio of basophils | Standard Deviation 1.27 |
Secondary
Change in Haematology: Eosinophil
Change in eosinophil (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Haematology: Eosinophil | Change from week 0 to week 80 | 1.31 Ratio of eosinophils | Standard Deviation 1.24 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Haematology: Eosinophil | Change from week 0 to week 54 | 1.15 Ratio of eosinophils | Standard Deviation 0.65 |
| NNC0114-0006 (Experimental) | Change in Haematology: Eosinophil | Change from week 0 to week 80 | 1.23 Ratio of eosinophils | Standard Deviation 1.03 |
| NNC0114-0006 (Experimental) | Change in Haematology: Eosinophil | Change from week 0 to week 54 | 1.30 Ratio of eosinophils | Standard Deviation 1.71 |
| Liraglutide (Experimental) | Change in Haematology: Eosinophil | Change from week 0 to week 54 | 3.10 Ratio of eosinophils | Standard Deviation 13.79 |
| Liraglutide (Experimental) | Change in Haematology: Eosinophil | Change from week 0 to week 80 | 1.54 Ratio of eosinophils | Standard Deviation 1.78 |
| Placebo (Placebo) | Change in Haematology: Eosinophil | Change from week 0 to week 80 | 1.36 Ratio of eosinophils | Standard Deviation 1.27 |
| Placebo (Placebo) | Change in Haematology: Eosinophil | Change from week 0 to week 54 | 1.37 Ratio of eosinophils | Standard Deviation 1.15 |
Secondary
Change in Haematology: Erythrocytes
Change in erythrocytes (measured in 10\^12 cells per liter) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Haematology: Erythrocytes | Change from week 0 to week 80 | 0.99 ratio of erythrocytes | Geometric Coefficient of Variation 6.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Haematology: Erythrocytes | Change from week 0 to week 54 | 0.99 ratio of erythrocytes | Geometric Coefficient of Variation 6 |
| NNC0114-0006 (Experimental) | Change in Haematology: Erythrocytes | Change from week 0 to week 80 | 1.00 ratio of erythrocytes | Geometric Coefficient of Variation 6.7 |
| NNC0114-0006 (Experimental) | Change in Haematology: Erythrocytes | Change from week 0 to week 54 | 1.01 ratio of erythrocytes | Geometric Coefficient of Variation 6.3 |
| Liraglutide (Experimental) | Change in Haematology: Erythrocytes | Change from week 0 to week 80 | 0.99 ratio of erythrocytes | Geometric Coefficient of Variation 7 |
| Liraglutide (Experimental) | Change in Haematology: Erythrocytes | Change from week 0 to week 54 | 0.99 ratio of erythrocytes | Geometric Coefficient of Variation 7.2 |
| Placebo (Placebo) | Change in Haematology: Erythrocytes | Change from week 0 to week 80 | 1.00 ratio of erythrocytes | Geometric Coefficient of Variation 5.5 |
| Placebo (Placebo) | Change in Haematology: Erythrocytes | Change from week 0 to week 54 | 1.00 ratio of erythrocytes | Geometric Coefficient of Variation 6 |
Secondary
Change in Haematology: Haematocrit
Change in haematocrit (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Haematology: Haematocrit | Change from week 0 to week 80 | 0.98 ratio of haematocrit | Geometric Coefficient of Variation 7.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Haematology: Haematocrit | Change from week 0 to week 54 | 0.99 ratio of haematocrit | Geometric Coefficient of Variation 6.6 |
| NNC0114-0006 (Experimental) | Change in Haematology: Haematocrit | Change from week 0 to week 80 | 1.00 ratio of haematocrit | Geometric Coefficient of Variation 7.3 |
| NNC0114-0006 (Experimental) | Change in Haematology: Haematocrit | Change from week 0 to week 54 | 1.00 ratio of haematocrit | Geometric Coefficient of Variation 7 |
| Liraglutide (Experimental) | Change in Haematology: Haematocrit | Change from week 0 to week 54 | 0.99 ratio of haematocrit | Geometric Coefficient of Variation 7.8 |
| Liraglutide (Experimental) | Change in Haematology: Haematocrit | Change from week 0 to week 80 | 0.98 ratio of haematocrit | Geometric Coefficient of Variation 7.2 |
| Placebo (Placebo) | Change in Haematology: Haematocrit | Change from week 0 to week 80 | 0.99 ratio of haematocrit | Geometric Coefficient of Variation 5.8 |
| Placebo (Placebo) | Change in Haematology: Haematocrit | Change from week 0 to week 54 | 1.00 ratio of haematocrit | Geometric Coefficient of Variation 5.9 |
Secondary
Change in Haematology: Haemoglobin
Change in haemoglobin (measured in millimoles per liter 'mmol/L') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Haematology: Haemoglobin | Change from week 0 to week 54 | 1.01 ratio of haemoglobin | Geometric Coefficient of Variation 6.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Haematology: Haemoglobin | Change from week 0 to week 80 | 1.00 ratio of haemoglobin | Geometric Coefficient of Variation 7.5 |
| NNC0114-0006 (Experimental) | Change in Haematology: Haemoglobin | Change from week 0 to week 80 | 1.02 ratio of haemoglobin | Geometric Coefficient of Variation 8.2 |
| NNC0114-0006 (Experimental) | Change in Haematology: Haemoglobin | Change from week 0 to week 54 | 1.02 ratio of haemoglobin | Geometric Coefficient of Variation 7.2 |
| Liraglutide (Experimental) | Change in Haematology: Haemoglobin | Change from week 0 to week 54 | 1.00 ratio of haemoglobin | Geometric Coefficient of Variation 7.9 |
| Liraglutide (Experimental) | Change in Haematology: Haemoglobin | Change from week 0 to week 80 | 1.00 ratio of haemoglobin | Geometric Coefficient of Variation 7.4 |
| Placebo (Placebo) | Change in Haematology: Haemoglobin | Change from week 0 to week 54 | 1.01 ratio of haemoglobin | Geometric Coefficient of Variation 5.6 |
| Placebo (Placebo) | Change in Haematology: Haemoglobin | Change from week 0 to week 80 | 1.01 ratio of haemoglobin | Geometric Coefficient of Variation 5.6 |
Secondary
Change in Haematology: Leukocytes
Change in leukocytes (measured in 10\^9 cells/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Haematology: Leukocytes | Change from week 0 to week 54 | 0.96 ratio of leukocytes | Geometric Coefficient of Variation 27.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Haematology: Leukocytes | Change from week 0 to week 80 | 0.99 ratio of leukocytes | Geometric Coefficient of Variation 33 |
| NNC0114-0006 (Experimental) | Change in Haematology: Leukocytes | Change from week 0 to week 80 | 0.95 ratio of leukocytes | Geometric Coefficient of Variation 19.9 |
| NNC0114-0006 (Experimental) | Change in Haematology: Leukocytes | Change from week 0 to week 54 | 0.98 ratio of leukocytes | Geometric Coefficient of Variation 21.9 |
| Liraglutide (Experimental) | Change in Haematology: Leukocytes | Change from week 0 to week 80 | 0.99 ratio of leukocytes | Geometric Coefficient of Variation 29.5 |
| Liraglutide (Experimental) | Change in Haematology: Leukocytes | Change from week 0 to week 54 | 0.97 ratio of leukocytes | Geometric Coefficient of Variation 23.2 |
| Placebo (Placebo) | Change in Haematology: Leukocytes | Change from week 0 to week 80 | 1.00 ratio of leukocytes | Geometric Coefficient of Variation 24.9 |
| Placebo (Placebo) | Change in Haematology: Leukocytes | Change from week 0 to week 54 | 1.02 ratio of leukocytes | Geometric Coefficient of Variation 24.8 |
Secondary
Change in Haematology: Lymphocytes
Change in lymphocytes (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Haematology: Lymphocytes | Change from week 0 to week 80 | 1.01 ratio of lymphocytes | Geometric Coefficient of Variation 28 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Haematology: Lymphocytes | Change from week 0 to week 54 | 1.00 ratio of lymphocytes | Geometric Coefficient of Variation 28.5 |
| NNC0114-0006 (Experimental) | Change in Haematology: Lymphocytes | Change from week 0 to week 80 | 0.98 ratio of lymphocytes | Geometric Coefficient of Variation 21.8 |
| NNC0114-0006 (Experimental) | Change in Haematology: Lymphocytes | Change from week 0 to week 54 | 1.00 ratio of lymphocytes | Geometric Coefficient of Variation 28.3 |
| Liraglutide (Experimental) | Change in Haematology: Lymphocytes | Change from week 0 to week 54 | 1.02 ratio of lymphocytes | Geometric Coefficient of Variation 28.4 |
| Liraglutide (Experimental) | Change in Haematology: Lymphocytes | Change from week 0 to week 80 | 0.99 ratio of lymphocytes | Geometric Coefficient of Variation 35.1 |
| Placebo (Placebo) | Change in Haematology: Lymphocytes | Change from week 0 to week 80 | 0.91 ratio of lymphocytes | Geometric Coefficient of Variation 30.6 |
| Placebo (Placebo) | Change in Haematology: Lymphocytes | Change from week 0 to week 54 | 0.91 ratio of lymphocytes | Geometric Coefficient of Variation 30.7 |
Secondary
Change in Haematology: Mean Corpuscular Hemoglobin
Change in mean Corpuscular hemoglobin (measured in femtomole 'fmol') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Haematology: Mean Corpuscular Hemoglobin | Change from week 0 to week 80 | 1.02 ratio of mean Corpuscular hemoglobin | Standard Deviation 5.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Haematology: Mean Corpuscular Hemoglobin | Change from week 0 to week 54 | 1.02 ratio of mean Corpuscular hemoglobin | Standard Deviation 3.6 |
| NNC0114-0006 (Experimental) | Change in Haematology: Mean Corpuscular Hemoglobin | Change from week 0 to week 80 | 1.01 ratio of mean Corpuscular hemoglobin | Standard Deviation 6.6 |
| NNC0114-0006 (Experimental) | Change in Haematology: Mean Corpuscular Hemoglobin | Change from week 0 to week 54 | 1.01 ratio of mean Corpuscular hemoglobin | Standard Deviation 4.8 |
| Liraglutide (Experimental) | Change in Haematology: Mean Corpuscular Hemoglobin | Change from week 0 to week 54 | 1.01 ratio of mean Corpuscular hemoglobin | Standard Deviation 4 |
| Liraglutide (Experimental) | Change in Haematology: Mean Corpuscular Hemoglobin | Change from week 0 to week 80 | 1.01 ratio of mean Corpuscular hemoglobin | Standard Deviation 5.4 |
| Placebo (Placebo) | Change in Haematology: Mean Corpuscular Hemoglobin | Change from week 0 to week 80 | 1.02 ratio of mean Corpuscular hemoglobin | Standard Deviation 4.3 |
| Placebo (Placebo) | Change in Haematology: Mean Corpuscular Hemoglobin | Change from week 0 to week 54 | 1.01 ratio of mean Corpuscular hemoglobin | Standard Deviation 4.1 |
Secondary
Change in Haematology: Mean Corpuscular Hemoglobin Concentration
Change in mean corpuscular hemoglobin concentration (MCHC) (measured in gram per liter 'g/L') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Haematology: Mean Corpuscular Hemoglobin Concentration | Change from week 0 to week 54 | 1.02 Ratio of MCHC | Geometric Coefficient of Variation 2.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Haematology: Mean Corpuscular Hemoglobin Concentration | Change from week 0 to week 80 | 1.02 Ratio of MCHC | Geometric Coefficient of Variation 3.5 |
| NNC0114-0006 (Experimental) | Change in Haematology: Mean Corpuscular Hemoglobin Concentration | Change from week 0 to week 80 | 1.02 Ratio of MCHC | Geometric Coefficient of Variation 3.1 |
| NNC0114-0006 (Experimental) | Change in Haematology: Mean Corpuscular Hemoglobin Concentration | Change from week 0 to week 54 | 1.01 Ratio of MCHC | Geometric Coefficient of Variation 2.1 |
| Liraglutide (Experimental) | Change in Haematology: Mean Corpuscular Hemoglobin Concentration | Change from week 0 to week 54 | 1.02 Ratio of MCHC | Geometric Coefficient of Variation 2.6 |
| Liraglutide (Experimental) | Change in Haematology: Mean Corpuscular Hemoglobin Concentration | Change from week 0 to week 80 | 1.02 Ratio of MCHC | Geometric Coefficient of Variation 3 |
| Placebo (Placebo) | Change in Haematology: Mean Corpuscular Hemoglobin Concentration | Change from week 0 to week 54 | 1.02 Ratio of MCHC | Geometric Coefficient of Variation 3 |
| Placebo (Placebo) | Change in Haematology: Mean Corpuscular Hemoglobin Concentration | Change from week 0 to week 80 | 1.02 Ratio of MCHC | Geometric Coefficient of Variation 0.29 |
Secondary
Change in Haematology: Mean Corpuscular Volume
Change in Mean Corpuscular volume (measured in femtoliter 'fL') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Haematology: Mean Corpuscular Volume | Change from week 0 to week 80 | 1.00 ratio of mean corpuscular volume | Geometric Coefficient of Variation 4.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Haematology: Mean Corpuscular Volume | Change from week 0 to week 54 | 1.00 ratio of mean corpuscular volume | Geometric Coefficient of Variation 2.8 |
| NNC0114-0006 (Experimental) | Change in Haematology: Mean Corpuscular Volume | Change from week 0 to week 80 | 1.00 ratio of mean corpuscular volume | Geometric Coefficient of Variation 5.2 |
| NNC0114-0006 (Experimental) | Change in Haematology: Mean Corpuscular Volume | Change from week 0 to week 54 | 0.99 ratio of mean corpuscular volume | Geometric Coefficient of Variation 3.8 |
| Liraglutide (Experimental) | Change in Haematology: Mean Corpuscular Volume | Change from week 0 to week 80 | 1.00 ratio of mean corpuscular volume | Geometric Coefficient of Variation 4.3 |
| Liraglutide (Experimental) | Change in Haematology: Mean Corpuscular Volume | Change from week 0 to week 54 | 1.00 ratio of mean corpuscular volume | Geometric Coefficient of Variation 3.3 |
| Placebo (Placebo) | Change in Haematology: Mean Corpuscular Volume | Change from week 0 to week 54 | 0.99 ratio of mean corpuscular volume | Geometric Coefficient of Variation 3.3 |
| Placebo (Placebo) | Change in Haematology: Mean Corpuscular Volume | Change from week 0 to week 80 | 0.99 ratio of mean corpuscular volume | Geometric Coefficient of Variation 3.7 |
Secondary
Change in Haematology: Monocytes
Change in monocytes (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Haematology: Monocytes | Change from week 0 to week 54 | 1.05 ratio of monocytes | Geometric Coefficient of Variation 40.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Haematology: Monocytes | Change from week 0 to week 80 | 1.12 ratio of monocytes | Geometric Coefficient of Variation 44 |
| NNC0114-0006 (Experimental) | Change in Haematology: Monocytes | Change from week 0 to week 80 | 1.07 ratio of monocytes | Geometric Coefficient of Variation 37.5 |
| NNC0114-0006 (Experimental) | Change in Haematology: Monocytes | Change from week 0 to week 54 | 1.02 ratio of monocytes | Geometric Coefficient of Variation 34.8 |
| Liraglutide (Experimental) | Change in Haematology: Monocytes | Change from week 0 to week 54 | 1.01 ratio of monocytes | Geometric Coefficient of Variation 41.1 |
| Liraglutide (Experimental) | Change in Haematology: Monocytes | Change from week 0 to week 80 | 1.04 ratio of monocytes | Geometric Coefficient of Variation 42.9 |
| Placebo (Placebo) | Change in Haematology: Monocytes | Change from week 0 to week 54 | 1.01 ratio of monocytes | Geometric Coefficient of Variation 34.9 |
| Placebo (Placebo) | Change in Haematology: Monocytes | Change from week 0 to week 80 | 1.12 ratio of monocytes | Geometric Coefficient of Variation 35.4 |
Secondary
Change in Haematology: Neutrophils
Change in neutrophils (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Haematology: Neutrophils | Change from week 0 to week 54 | 0.98 ratio of neutrophils | Geometric Coefficient of Variation 18.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Haematology: Neutrophils | Change from week 0 to week 80 | 0.97 ratio of neutrophils | Geometric Coefficient of Variation 17.5 |
| NNC0114-0006 (Experimental) | Change in Haematology: Neutrophils | Change from week 0 to week 80 | 0.99 ratio of neutrophils | Geometric Coefficient of Variation 14.2 |
| NNC0114-0006 (Experimental) | Change in Haematology: Neutrophils | Change from week 0 to week 54 | 0.99 ratio of neutrophils | Geometric Coefficient of Variation 17.6 |
| Liraglutide (Experimental) | Change in Haematology: Neutrophils | Change from week 0 to week 54 | 0.97 ratio of neutrophils | Geometric Coefficient of Variation 18.5 |
| Liraglutide (Experimental) | Change in Haematology: Neutrophils | Change from week 0 to week 80 | 0.98 ratio of neutrophils | Geometric Coefficient of Variation 20.7 |
| Placebo (Placebo) | Change in Haematology: Neutrophils | Change from week 0 to week 54 | 1.04 ratio of neutrophils | Geometric Coefficient of Variation 17.8 |
| Placebo (Placebo) | Change in Haematology: Neutrophils | Change from week 0 to week 80 | 1.04 ratio of neutrophils | Geometric Coefficient of Variation 17.2 |
Secondary
Change in Haematology: Thrombocytes
Change in thrombocytes (measured in 10\^9 cells per liter) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Haematology: Thrombocytes | Change from week 0 to week 54 | 0.98 ratio of thrombocytes | Geometric Coefficient of Variation 14.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Haematology: Thrombocytes | Change from week 0 to week 80 | 1.00 ratio of thrombocytes | Geometric Coefficient of Variation 15 |
| NNC0114-0006 (Experimental) | Change in Haematology: Thrombocytes | Change from week 0 to week 80 | 1.03 ratio of thrombocytes | Geometric Coefficient of Variation 15.7 |
| NNC0114-0006 (Experimental) | Change in Haematology: Thrombocytes | Change from week 0 to week 54 | 0.98 ratio of thrombocytes | Geometric Coefficient of Variation 15 |
| Liraglutide (Experimental) | Change in Haematology: Thrombocytes | Change from week 0 to week 54 | 1.03 ratio of thrombocytes | Geometric Coefficient of Variation 13.2 |
| Liraglutide (Experimental) | Change in Haematology: Thrombocytes | Change from week 0 to week 80 | 1.04 ratio of thrombocytes | Geometric Coefficient of Variation 15.6 |
| Placebo (Placebo) | Change in Haematology: Thrombocytes | Change from week 0 to week 54 | 0.98 ratio of thrombocytes | Geometric Coefficient of Variation 14.1 |
| Placebo (Placebo) | Change in Haematology: Thrombocytes | Change from week 0 to week 80 | 1.00 ratio of thrombocytes | Geometric Coefficient of Variation 17.3 |
Secondary
Change in HbA1c
Change in glycosylated haemoglobin (HbA1c) is evaluated from baseline (week 0) to weeks 54 and 80.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The FAS included all randomised participants. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in HbA1c | Change from week 0 to week 54 | -0.7 Percentage point of HbA1c | Standard Deviation 1.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in HbA1c | Change from week 0 to week 80 | -0.1 Percentage point of HbA1c | Standard Deviation 1.6 |
| NNC0114-0006 (Experimental) | Change in HbA1c | Change from week 0 to week 80 | -0.2 Percentage point of HbA1c | Standard Deviation 1.5 |
| NNC0114-0006 (Experimental) | Change in HbA1c | Change from week 0 to week 54 | -0.5 Percentage point of HbA1c | Standard Deviation 1.4 |
| Liraglutide (Experimental) | Change in HbA1c | Change from week 0 to week 54 | -0.3 Percentage point of HbA1c | Standard Deviation 1.5 |
| Liraglutide (Experimental) | Change in HbA1c | Change from week 0 to week 80 | 0.5 Percentage point of HbA1c | Standard Deviation 2.1 |
| Placebo (Placebo) | Change in HbA1c | Change from week 0 to week 54 | -0.3 Percentage point of HbA1c | Standard Deviation 1.9 |
| Placebo (Placebo) | Change in HbA1c | Change from week 0 to week 80 | -0.4 Percentage point of HbA1c | Standard Deviation 1.8 |
Secondary
Change in Hormone Level: Calcitonin
Change in Calcitonin (measured in nanogram per liter \[ng/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Hormone Level: Calcitonin | Change from week 0 to week 54 | 1.00 Ratio of Calcitonin | Geometric Coefficient of Variation 43.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Hormone Level: Calcitonin | Change from week 0 to week 80 | 0.85 Ratio of Calcitonin | Geometric Coefficient of Variation 50.9 |
| NNC0114-0006 (Experimental) | Change in Hormone Level: Calcitonin | Change from week 0 to week 80 | 0.93 Ratio of Calcitonin | Geometric Coefficient of Variation 41.8 |
| NNC0114-0006 (Experimental) | Change in Hormone Level: Calcitonin | Change from week 0 to week 54 | 0.90 Ratio of Calcitonin | Geometric Coefficient of Variation 48.5 |
| Liraglutide (Experimental) | Change in Hormone Level: Calcitonin | Change from week 0 to week 54 | 0.89 Ratio of Calcitonin | Geometric Coefficient of Variation 57.2 |
| Liraglutide (Experimental) | Change in Hormone Level: Calcitonin | Change from week 0 to week 80 | 0.82 Ratio of Calcitonin | Geometric Coefficient of Variation 71.5 |
| Placebo (Placebo) | Change in Hormone Level: Calcitonin | Change from week 0 to week 54 | 0.88 Ratio of Calcitonin | Geometric Coefficient of Variation 47.4 |
| Placebo (Placebo) | Change in Hormone Level: Calcitonin | Change from week 0 to week 80 | 0.90 Ratio of Calcitonin | Geometric Coefficient of Variation 64.5 |
Secondary
Change in Hormone Level: Thyroid Stimulating Hormone (TSH)
Change in TSH (measured in milli international units per liter \[mIU/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) | Change from week 0 to week 54 | 1.00 Ratio of Thyroid Stimulating Hormone | Geometric Coefficient of Variation 49.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) | Change from week 0 to week 80 | 1.04 Ratio of Thyroid Stimulating Hormone | Geometric Coefficient of Variation 46.7 |
| NNC0114-0006 (Experimental) | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) | Change from week 0 to week 54 | 1.12 Ratio of Thyroid Stimulating Hormone | Geometric Coefficient of Variation 54.1 |
| NNC0114-0006 (Experimental) | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) | Change from week 0 to week 80 | 0.99 Ratio of Thyroid Stimulating Hormone | Geometric Coefficient of Variation 116.1 |
| Liraglutide (Experimental) | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) | Change from week 0 to week 54 | 0.89 Ratio of Thyroid Stimulating Hormone | Geometric Coefficient of Variation 46.6 |
| Liraglutide (Experimental) | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) | Change from week 0 to week 80 | 0.99 Ratio of Thyroid Stimulating Hormone | Geometric Coefficient of Variation 48.5 |
| Placebo (Placebo) | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) | Change from week 0 to week 80 | 0.93 Ratio of Thyroid Stimulating Hormone | Geometric Coefficient of Variation 84.5 |
| Placebo (Placebo) | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) | Change from week 0 to week 54 | 0.91 Ratio of Thyroid Stimulating Hormone | Geometric Coefficient of Variation 66.1 |
Secondary
Change in Insulin Dose
The total daily insulin dose was derived as the average of the doses reported on the three days prior to the visit. Change in daily total insulin dose from baseline (week 0) after 54 weeks of treatment and week 80 are presented.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The FAS included all randomised participants. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Insulin Dose | Change from week 0 to week 54 | -0.05 Units per kilograms | Standard Deviation 0.18 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Insulin Dose | Change from week 0 to week 80 | 0.10 Units per kilograms | Standard Deviation 0.2 |
| NNC0114-0006 (Experimental) | Change in Insulin Dose | Change from week 0 to week 54 | 0.02 Units per kilograms | Standard Deviation 0.18 |
| NNC0114-0006 (Experimental) | Change in Insulin Dose | Change from week 0 to week 80 | 0.05 Units per kilograms | Standard Deviation 0.19 |
| Liraglutide (Experimental) | Change in Insulin Dose | Change from week 0 to week 54 | 0.01 Units per kilograms | Standard Deviation 0.23 |
| Liraglutide (Experimental) | Change in Insulin Dose | Change from week 0 to week 80 | 0.11 Units per kilograms | Standard Deviation 0.22 |
| Placebo (Placebo) | Change in Insulin Dose | Change from week 0 to week 80 | 0.12 Units per kilograms | Standard Deviation 0.18 |
| Placebo (Placebo) | Change in Insulin Dose | Change from week 0 to week 54 | 0.09 Units per kilograms | Standard Deviation 0.19 |
Secondary
Change in International Normalised Ratio (INR)
Change in INR (measured in ratio\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in International Normalised Ratio (INR) | Change from week 0 to week 80 | 0.98 Ratio of INR | Geometric Coefficient of Variation 12.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in International Normalised Ratio (INR) | Change from week 0 to week 54 | 0.97 Ratio of INR | Geometric Coefficient of Variation 9.5 |
| NNC0114-0006 (Experimental) | Change in International Normalised Ratio (INR) | Change from week 0 to week 54 | 0.96 Ratio of INR | Geometric Coefficient of Variation 10.4 |
| NNC0114-0006 (Experimental) | Change in International Normalised Ratio (INR) | Change from week 0 to week 80 | 0.99 Ratio of INR | Geometric Coefficient of Variation 12.9 |
| Liraglutide (Experimental) | Change in International Normalised Ratio (INR) | Change from week 0 to week 54 | 0.95 Ratio of INR | Geometric Coefficient of Variation 9.8 |
| Liraglutide (Experimental) | Change in International Normalised Ratio (INR) | Change from week 0 to week 80 | 0.96 Ratio of INR | Geometric Coefficient of Variation 9.2 |
| Placebo (Placebo) | Change in International Normalised Ratio (INR) | Change from week 0 to week 80 | 0.97 Ratio of INR | Geometric Coefficient of Variation 11.5 |
| Placebo (Placebo) | Change in International Normalised Ratio (INR) | Change from week 0 to week 54 | 0.96 Ratio of INR | Geometric Coefficient of Variation 13.7 |
Secondary
Change in Lipids: Free Fatty Acids (Ratio to Baseline)
Change in total free fatty acids (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Lipids: Free Fatty Acids (Ratio to Baseline) | Change from week 0 to week 54 | 0.86 Ratio of free fatty acids | Geometric Coefficient of Variation 94.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Lipids: Free Fatty Acids (Ratio to Baseline) | Change from week 0 to week 80 | 0.89 Ratio of free fatty acids | Geometric Coefficient of Variation 85.3 |
| NNC0114-0006 (Experimental) | Change in Lipids: Free Fatty Acids (Ratio to Baseline) | Change from week 0 to week 80 | 1.06 Ratio of free fatty acids | Geometric Coefficient of Variation 112.8 |
| NNC0114-0006 (Experimental) | Change in Lipids: Free Fatty Acids (Ratio to Baseline) | Change from week 0 to week 54 | 1.01 Ratio of free fatty acids | Geometric Coefficient of Variation 114.4 |
| Liraglutide (Experimental) | Change in Lipids: Free Fatty Acids (Ratio to Baseline) | Change from week 0 to week 54 | 1.18 Ratio of free fatty acids | Geometric Coefficient of Variation 82.5 |
| Liraglutide (Experimental) | Change in Lipids: Free Fatty Acids (Ratio to Baseline) | Change from week 0 to week 80 | 1.19 Ratio of free fatty acids | Geometric Coefficient of Variation 92.8 |
| Placebo (Placebo) | Change in Lipids: Free Fatty Acids (Ratio to Baseline) | Change from week 0 to week 54 | 0.97 Ratio of free fatty acids | Geometric Coefficient of Variation 68.7 |
| Placebo (Placebo) | Change in Lipids: Free Fatty Acids (Ratio to Baseline) | Change from week 0 to week 80 | 0.94 Ratio of free fatty acids | Geometric Coefficient of Variation 84 |
Secondary
Change in Lipids: HDL Cholesterol (Ratio to Baseline)
Change in HDL cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Lipids: HDL Cholesterol (Ratio to Baseline) | Change from week 0 to week 54 | 1.04 Ratio of HDL cholesterol | Geometric Coefficient of Variation 17.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Lipids: HDL Cholesterol (Ratio to Baseline) | Change from week 0 to week 80 | 1.04 Ratio of HDL cholesterol | Geometric Coefficient of Variation 18.7 |
| NNC0114-0006 (Experimental) | Change in Lipids: HDL Cholesterol (Ratio to Baseline) | Change from week 0 to week 54 | 1.08 Ratio of HDL cholesterol | Geometric Coefficient of Variation 18.2 |
| NNC0114-0006 (Experimental) | Change in Lipids: HDL Cholesterol (Ratio to Baseline) | Change from week 0 to week 80 | 1.06 Ratio of HDL cholesterol | Geometric Coefficient of Variation 16.7 |
| Liraglutide (Experimental) | Change in Lipids: HDL Cholesterol (Ratio to Baseline) | Change from week 0 to week 54 | 1.12 Ratio of HDL cholesterol | Geometric Coefficient of Variation 19.6 |
| Liraglutide (Experimental) | Change in Lipids: HDL Cholesterol (Ratio to Baseline) | Change from week 0 to week 80 | 1.14 Ratio of HDL cholesterol | Geometric Coefficient of Variation 21.5 |
| Placebo (Placebo) | Change in Lipids: HDL Cholesterol (Ratio to Baseline) | Change from week 0 to week 80 | 1.07 Ratio of HDL cholesterol | Geometric Coefficient of Variation 22.2 |
| Placebo (Placebo) | Change in Lipids: HDL Cholesterol (Ratio to Baseline) | Change from week 0 to week 54 | 1.10 Ratio of HDL cholesterol | Geometric Coefficient of Variation 20.2 |
Secondary
Change in Lipids: LDL Cholesterol (Ratio to Baseline)
Change in LDL cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Lipids: LDL Cholesterol (Ratio to Baseline) | Change from week 0 to week 54 | 0.96 Ratio of LDL cholesterol | Geometric Coefficient of Variation 17.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Lipids: LDL Cholesterol (Ratio to Baseline) | Change from week 0 to week 80 | 0.99 Ratio of LDL cholesterol | Geometric Coefficient of Variation 22.2 |
| NNC0114-0006 (Experimental) | Change in Lipids: LDL Cholesterol (Ratio to Baseline) | Change from week 0 to week 80 | 1.02 Ratio of LDL cholesterol | Geometric Coefficient of Variation 21.2 |
| NNC0114-0006 (Experimental) | Change in Lipids: LDL Cholesterol (Ratio to Baseline) | Change from week 0 to week 54 | 0.97 Ratio of LDL cholesterol | Geometric Coefficient of Variation 20.9 |
| Liraglutide (Experimental) | Change in Lipids: LDL Cholesterol (Ratio to Baseline) | Change from week 0 to week 80 | 1.02 Ratio of LDL cholesterol | Geometric Coefficient of Variation 21.2 |
| Liraglutide (Experimental) | Change in Lipids: LDL Cholesterol (Ratio to Baseline) | Change from week 0 to week 54 | 0.98 Ratio of LDL cholesterol | Geometric Coefficient of Variation 24 |
| Placebo (Placebo) | Change in Lipids: LDL Cholesterol (Ratio to Baseline) | Change from week 0 to week 54 | 1.01 Ratio of LDL cholesterol | Geometric Coefficient of Variation 23.6 |
| Placebo (Placebo) | Change in Lipids: LDL Cholesterol (Ratio to Baseline) | Change from week 0 to week 80 | 1.03 Ratio of LDL cholesterol | Geometric Coefficient of Variation 29.2 |
Secondary
Change in Lipids: Total Cholesterol (Ratio to Baseline)
Change in total cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Lipids: Total Cholesterol (Ratio to Baseline) | Change from week 0 to week 54 | 1.00 Ratio of total cholesterol | Geometric Coefficient of Variation 13.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Lipids: Total Cholesterol (Ratio to Baseline) | Change from week 0 to week 80 | 1.02 Ratio of total cholesterol | Geometric Coefficient of Variation 15.5 |
| NNC0114-0006 (Experimental) | Change in Lipids: Total Cholesterol (Ratio to Baseline) | Change from week 0 to week 80 | 1.03 Ratio of total cholesterol | Geometric Coefficient of Variation 14.1 |
| NNC0114-0006 (Experimental) | Change in Lipids: Total Cholesterol (Ratio to Baseline) | Change from week 0 to week 54 | 1.02 Ratio of total cholesterol | Geometric Coefficient of Variation 14.1 |
| Liraglutide (Experimental) | Change in Lipids: Total Cholesterol (Ratio to Baseline) | Change from week 0 to week 54 | 1.03 Ratio of total cholesterol | Geometric Coefficient of Variation 16.2 |
| Liraglutide (Experimental) | Change in Lipids: Total Cholesterol (Ratio to Baseline) | Change from week 0 to week 80 | 1.07 Ratio of total cholesterol | Geometric Coefficient of Variation 15 |
| Placebo (Placebo) | Change in Lipids: Total Cholesterol (Ratio to Baseline) | Change from week 0 to week 54 | 1.04 Ratio of total cholesterol | Geometric Coefficient of Variation 16.8 |
| Placebo (Placebo) | Change in Lipids: Total Cholesterol (Ratio to Baseline) | Change from week 0 to week 80 | 1.03 Ratio of total cholesterol | Geometric Coefficient of Variation 18.4 |
Secondary
Change in Lipids: Triglycerides (TG) (Ratio to Baseline)
Change in Triglycerides (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Lipids: Triglycerides (TG) (Ratio to Baseline) | Change from week 0 to week 54 | 1.03 Ratio of TG | Geometric Coefficient of Variation 46.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Lipids: Triglycerides (TG) (Ratio to Baseline) | Change from week 0 to week 80 | 1.08 Ratio of TG | Geometric Coefficient of Variation 45.6 |
| NNC0114-0006 (Experimental) | Change in Lipids: Triglycerides (TG) (Ratio to Baseline) | Change from week 0 to week 54 | 0.96 Ratio of TG | Geometric Coefficient of Variation 39.5 |
| NNC0114-0006 (Experimental) | Change in Lipids: Triglycerides (TG) (Ratio to Baseline) | Change from week 0 to week 80 | 0.94 Ratio of TG | Geometric Coefficient of Variation 45.1 |
| Liraglutide (Experimental) | Change in Lipids: Triglycerides (TG) (Ratio to Baseline) | Change from week 0 to week 54 | 1.03 Ratio of TG | Geometric Coefficient of Variation 49.2 |
| Liraglutide (Experimental) | Change in Lipids: Triglycerides (TG) (Ratio to Baseline) | Change from week 0 to week 80 | 1.09 Ratio of TG | Geometric Coefficient of Variation 51.5 |
| Placebo (Placebo) | Change in Lipids: Triglycerides (TG) (Ratio to Baseline) | Change from week 0 to week 80 | 0.95 Ratio of TG | Geometric Coefficient of Variation 50.4 |
| Placebo (Placebo) | Change in Lipids: Triglycerides (TG) (Ratio to Baseline) | Change from week 0 to week 54 | 1.02 Ratio of TG | Geometric Coefficient of Variation 54.7 |
Secondary
Change in Mean of 7-point Profiles
Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. Change from baseline (week 0) to week 54 and week 80 in mean of 7-point profiles value is presented.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The FAS included all randomised participants. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Mean of 7-point Profiles | Change from week 0 to week 80 | 0.1 mmol/L | Standard Deviation 2.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Mean of 7-point Profiles | Change from week 0 to week 54 | 0.5 mmol/L | Standard Deviation 2 |
| NNC0114-0006 (Experimental) | Change in Mean of 7-point Profiles | Change from week 0 to week 80 | 0.0 mmol/L | Standard Deviation 2.3 |
| NNC0114-0006 (Experimental) | Change in Mean of 7-point Profiles | Change from week 0 to week 54 | 0.3 mmol/L | Standard Deviation 2.4 |
| Liraglutide (Experimental) | Change in Mean of 7-point Profiles | Change from week 0 to week 54 | -0.1 mmol/L | Standard Deviation 1.9 |
| Liraglutide (Experimental) | Change in Mean of 7-point Profiles | Change from week 0 to week 80 | 0.7 mmol/L | Standard Deviation 1.6 |
| Placebo (Placebo) | Change in Mean of 7-point Profiles | Change from week 0 to week 80 | 0.3 mmol/L | Standard Deviation 1.7 |
| Placebo (Placebo) | Change in Mean of 7-point Profiles | Change from week 0 to week 54 | 0.0 mmol/L | Standard Deviation 1.2 |
Secondary
Change in Number of Insulin Injections
The number of insulin injections was derived as the average of the reported number on the three days prior to the visit. The change in number of insulin injections per day (count) from baseline (week 0) after 54 weeks of treatment and week 80 are presented.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The FAS included all randomised participants. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Number of Insulin Injections | Change from week 0 to week 80 | 0.2 Injections per day | Standard Deviation 1.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Number of Insulin Injections | Change from week 0 to week 54 | -0.3 Injections per day | Standard Deviation 1.5 |
| NNC0114-0006 (Experimental) | Change in Number of Insulin Injections | Change from week 0 to week 80 | -0.3 Injections per day | Standard Deviation 1.3 |
| NNC0114-0006 (Experimental) | Change in Number of Insulin Injections | Change from week 0 to week 54 | -0.1 Injections per day | Standard Deviation 1.2 |
| Liraglutide (Experimental) | Change in Number of Insulin Injections | Change from week 0 to week 54 | -0.5 Injections per day | Standard Deviation 1.7 |
| Liraglutide (Experimental) | Change in Number of Insulin Injections | Change from week 0 to week 80 | -0.2 Injections per day | Standard Deviation 1.5 |
| Placebo (Placebo) | Change in Number of Insulin Injections | Change from week 0 to week 54 | 0.2 Injections per day | Standard Deviation 1.4 |
| Placebo (Placebo) | Change in Number of Insulin Injections | Change from week 0 to week 80 | 0.2 Injections per day | Standard Deviation 1.3 |
Secondary
Change in Physical Examination
Physical examination parameters are categorised as general appearance; head, ears, eyes, nose, throat, neck; respiratory system;cardiovascular system; gastrointestinal system including mouth; musculoskeletal system; central and peripheral nervous system; skin; lymph node palpation and thyroid gland. Investigator assessed the participants with normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) findings at week 0, week 54 and week 80 are presented.
Time frame: Week 0, week 54 and week 80
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Gastrointestinal System incl. Mouth | Abnormal, NCS | 2 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Gastrointestinal System incl. Mouth | Normal | 75 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Head, Ears, Eyes, Nose, Throat, Neck | Abnormal, NCS | 2 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: General Appearance | Abnormal, NCS | 1 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Cardiovascular System | Abnormal, NCS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Cardiovascular System | Normal | 67 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Head, Ears, Eyes, Nose, Throat, Neck | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Lymph Node Palpation | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Cardiovascular System | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Cardiovascular System | Abnormal, NCS | 1 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Head, Ears, Eyes, Nose, Throat, Neck | Normal | 66 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Respiratory System | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Cardiovascular System | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Cardiovascular System | Abnormal, NCS | 3 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Head, Ears, Eyes, Nose, Throat, Neck | Abnormal, NCS | 1 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Lymph Node Palpation | Abnormal, NCS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Respiratory System | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Respiratory System | Abnormal, NCS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Head, Ears, Eyes, Nose, Throat, Neck | Abnormal, CS | 1 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Lymph Node Palpation | Normal | 77 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Respiratory System | Abnormal, NCS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Respiratory System | Normal | 68 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Respiratory System | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Respiratory System | Abnormal, NCS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Respiratory System | Normal | 67 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Respiratory System | Normal | 77 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Head, Ears, Eyes, Nose, Throat, Neck | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Skin | Abnormal, NCS | 6 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Skin | Normal | 61 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Skin | Abnormal, CS | 2 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Cardiovascular System | Normal | 74 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Skin | Abnormal, NCS | 5 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Skin | Normal | 61 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Cardiovascular System | Normal | 67 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: General Appearance | Normal | 76 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Skin | Abnormal, CS | 1 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Cardiovascular System | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Skin | Abnormal, NCS | 6 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Gastrointestinal System incl. Mouth | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Thyroid Gland | Normal | 67 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Skin | Normal | 70 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Central and Peripheral Nervous System | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Central and Peripheral Nervous System | Normal | 66 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Central and Peripheral Nervous System | Abnormal, NCS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Central and Peripheral Nervous System | Normal | 68 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Musculoskeletal System | Normal | 65 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Thyroid Gland | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Thyroid Gland | Abnormal, NCS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Central and Peripheral Nervous System | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Central and Peripheral Nervous System | Abnormal, NCS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Central and Peripheral Nervous System | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: General Appearance | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Central and Peripheral Nervous System | Abnormal, NCS | 1 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Thyroid Gland | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Central and Peripheral Nervous System | Normal | 77 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Skin | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Lymph Node Palpation | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Musculoskeletal System | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Musculoskeletal System | Abnormal, NCS | 1 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Musculoskeletal System | Normal | 66 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Lymph Node Palpation | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Musculoskeletal System | Abnormal, CS | 2 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Thyroid Gland | Normal | 77 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Lymph Node Palpation | Abnormal, NCS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Thyroid Gland | Normal | 67 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Lymph Node Palpation | Normal | 67 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Thyroid Gland | Abnormal, NCS | 1 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Thyroid Gland | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: General Appearance | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: General Appearance | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Musculoskeletal System | Abnormal, NCS | 1 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Musculoskeletal System | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: General Appearance | Normal | 68 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Head, Ears, Eyes, Nose, Throat, Neck | Normal | 65 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Musculoskeletal System | Abnormal, NCS | 1 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Musculoskeletal System | Normal | 76 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: General Appearance | Abnormal, NCS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Thyroid Gland | Abnormal, NCS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Gastrointestinal System incl. Mouth | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Gastrointestinal System incl. Mouth | Abnormal, NCS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Gastrointestinal System incl. Mouth | Normal | 67 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: General Appearance | Normal | 67 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: Head, Ears, Eyes, Nose, Throat, Neck | Abnormal, NCS | 2 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Gastrointestinal System incl. Mouth | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 80: General Appearance | Abnormal, NCS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Lymph Node Palpation | Abnormal, NCS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Gastrointestinal System incl. Mouth | Abnormal, NCS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Gastrointestinal System incl. Mouth | Normal | 68 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 0: Head, Ears, Eyes, Nose, Throat, Neck | Normal | 75 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Physical Examination | Week 54: Lymph Node Palpation | Normal | 68 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: General Appearance | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: General Appearance | Normal | 77 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: General Appearance | Abnormal, NCS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: General Appearance | Abnormal, CS | 1 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Head, Ears, Eyes, Nose, Throat, Neck | Normal | 64 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Respiratory System | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Cardiovascular System | Normal | 65 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Gastrointestinal System incl. Mouth | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Musculoskeletal System | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Musculoskeletal System | Normal | 64 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Central and Peripheral Nervous System | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Central and Peripheral Nervous System | Abnormal, NCS | 1 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Lymph Node Palpation | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Thyroid Gland | Normal | 76 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Thyroid Gland | Normal | 65 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: General Appearance | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: General Appearance | Normal | 64 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: General Appearance | Abnormal, NCS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: General Appearance | Normal | 64 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: General Appearance | Abnormal, NCS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Head, Ears, Eyes, Nose, Throat, Neck | Normal | 77 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Head, Ears, Eyes, Nose, Throat, Neck | Abnormal, NCS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Head, Ears, Eyes, Nose, Throat, Neck | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Head, Ears, Eyes, Nose, Throat, Neck | Normal | 65 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Head, Ears, Eyes, Nose, Throat, Neck | Abnormal, NCS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Head, Ears, Eyes, Nose, Throat, Neck | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Head, Ears, Eyes, Nose, Throat, Neck | Abnormal, NCS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Head, Ears, Eyes, Nose, Throat, Neck | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Respiratory System | Normal | 77 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Respiratory System | Abnormal, NCS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Respiratory System | Normal | 65 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Respiratory System | Abnormal, NCS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Respiratory System | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Respiratory System | Normal | 64 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Respiratory System | Abnormal, NCS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Respiratory System | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Cardiovascular System | Normal | 76 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Cardiovascular System | Abnormal, NCS | 1 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Cardiovascular System | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Cardiovascular System | Abnormal, NCS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Cardiovascular System | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Cardiovascular System | Normal | 64 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Cardiovascular System | Abnormal, NCS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Cardiovascular System | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Gastrointestinal System incl. Mouth | Normal | 76 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Gastrointestinal System incl. Mouth | Abnormal, NCS | 1 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Gastrointestinal System incl. Mouth | Normal | 64 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Gastrointestinal System incl. Mouth | Abnormal, NCS | 1 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Gastrointestinal System incl. Mouth | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Gastrointestinal System incl. Mouth | Normal | 63 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Gastrointestinal System incl. Mouth | Abnormal, NCS | 1 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Gastrointestinal System incl. Mouth | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Musculoskeletal System | Normal | 75 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Musculoskeletal System | Abnormal, NCS | 2 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Musculoskeletal System | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Musculoskeletal System | Normal | 63 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Musculoskeletal System | Abnormal, NCS | 2 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Musculoskeletal System | Abnormal, NCS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Musculoskeletal System | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Central and Peripheral Nervous System | Normal | 76 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Central and Peripheral Nervous System | Abnormal, NCS | 1 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Central and Peripheral Nervous System | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Central and Peripheral Nervous System | Normal | 64 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Central and Peripheral Nervous System | Abnormal, NCS | 1 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Central and Peripheral Nervous System | Normal | 63 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Central and Peripheral Nervous System | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Skin | Normal | 75 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Skin | Abnormal, NCS | 2 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Skin | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Skin | Normal | 63 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Skin | Abnormal, NCS | 1 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Skin | Abnormal, CS | 1 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Skin | Normal | 62 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Skin | Abnormal, NCS | 2 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Skin | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Lymph Node Palpation | Normal | 76 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Lymph Node Palpation | Abnormal, NCS | 1 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Lymph Node Palpation | Normal | 65 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Lymph Node Palpation | Abnormal, NCS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Lymph Node Palpation | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Lymph Node Palpation | Normal | 63 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Lymph Node Palpation | Abnormal, NCS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Lymph Node Palpation | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Thyroid Gland | Abnormal, NCS | 1 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 0: Thyroid Gland | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Thyroid Gland | Abnormal, NCS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 54: Thyroid Gland | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Thyroid Gland | Normal | 64 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Thyroid Gland | Abnormal, NCS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Physical Examination | Week 80: Thyroid Gland | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: General Appearance | Normal | 76 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Gastrointestinal System incl. Mouth | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: General Appearance | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Lymph Node Palpation | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Gastrointestinal System incl. Mouth | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: General Appearance | Normal | 68 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Gastrointestinal System incl. Mouth | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Gastrointestinal System incl. Mouth | Normal | 68 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: General Appearance | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Thyroid Gland | Normal | 68 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: General Appearance | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Gastrointestinal System incl. Mouth | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: General Appearance | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Musculoskeletal System | Normal | 74 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: General Appearance | Normal | 66 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Lymph Node Palpation | Abnormal, NCS | 1 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Musculoskeletal System | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Musculoskeletal System | Normal | 66 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: General Appearance | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Musculoskeletal System | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Lymph Node Palpation | Normal | 67 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Musculoskeletal System | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Lymph Node Palpation | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Musculoskeletal System | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Lymph Node Palpation | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Musculoskeletal System | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Skin | Normal | 63 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Central and Peripheral Nervous System | Normal | 76 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Thyroid Gland | Normal | 76 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Central and Peripheral Nervous System | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Musculoskeletal System | Normal | 68 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Central and Peripheral Nervous System | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Central and Peripheral Nervous System | Normal | 66 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Musculoskeletal System | Abnormal, NCS | 2 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Thyroid Gland | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Central and Peripheral Nervous System | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Central and Peripheral Nervous System | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Gastrointestinal System incl. Mouth | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Thyroid Gland | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Central and Peripheral Nervous System | Normal | 68 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Central and Peripheral Nervous System | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Central and Peripheral Nervous System | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Gastrointestinal System incl. Mouth | Normal | 66 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Skin | Normal | 69 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Gastrointestinal System incl. Mouth | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Thyroid Gland | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Skin | Abnormal, NCS | 7 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Thyroid Gland | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Skin | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Cardiovascular System | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Thyroid Gland | Normal | 66 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Skin | Abnormal, NCS | 3 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Skin | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Skin | Normal | 65 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Respiratory System | Normal | 68 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Thyroid Gland | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Skin | Abnormal, NCS | 3 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Head, Ears, Eyes, Nose, Throat, Neck | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Head, Ears, Eyes, Nose, Throat, Neck | Abnormal, NCS | 2 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Skin | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Respiratory System | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Head, Ears, Eyes, Nose, Throat, Neck | Normal | 66 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Respiratory System | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Respiratory System | Normal | 66 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Head, Ears, Eyes, Nose, Throat, Neck | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: General Appearance | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Respiratory System | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Lymph Node Palpation | Normal | 76 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Respiratory System | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Respiratory System | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Head, Ears, Eyes, Nose, Throat, Neck | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Thyroid Gland | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Respiratory System | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Lymph Node Palpation | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Cardiovascular System | Normal | 76 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Head, Ears, Eyes, Nose, Throat, Neck | Normal | 66 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Cardiovascular System | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Cardiovascular System | Normal | 65 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Lymph Node Palpation | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Cardiovascular System | Abnormal, NCS | 1 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Head, Ears, Eyes, Nose, Throat, Neck | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Cardiovascular System | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Cardiovascular System | Normal | 67 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Head, Ears, Eyes, Nose, Throat, Neck | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Cardiovascular System | Abnormal, NCS | 1 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 54: Lymph Node Palpation | Normal | 66 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 80: Cardiovascular System | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Respiratory System | Normal | 76 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Gastrointestinal System incl. Mouth | Normal | 76 Participants |
| Liraglutide (Experimental) | Change in Physical Examination | Week 0: Head, Ears, Eyes, Nose, Throat, Neck | Normal | 76 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Cardiovascular System | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Gastrointestinal System incl. Mouth | Abnormal, NCS | 1 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Head, Ears, Eyes, Nose, Throat, Neck | Normal | 76 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Gastrointestinal System incl. Mouth | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: General Appearance | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Thyroid Gland | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Cardiovascular System | Normal | 66 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Skin | Abnormal, NCS | 3 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Cardiovascular System | Abnormal, NCS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Gastrointestinal System incl. Mouth | Abnormal, NCS | 1 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Head, Ears, Eyes, Nose, Throat, Neck | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Lymph Node Palpation | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Lymph Node Palpation | Normal | 77 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Gastrointestinal System incl. Mouth | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: General Appearance | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: General Appearance | Abnormal, NCS | 1 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Skin | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Gastrointestinal System incl. Mouth | Normal | 61 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Cardiovascular System | Abnormal, NCS | 4 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Thyroid Gland | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Gastrointestinal System incl. Mouth | Abnormal, NCS | 1 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Skin | Normal | 66 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Lymph Node Palpation | Normal | 62 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Head, Ears, Eyes, Nose, Throat, Neck | Abnormal, NCS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Gastrointestinal System incl. Mouth | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: General Appearance | Normal | 65 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Cardiovascular System | Normal | 62 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Gastrointestinal System incl. Mouth | Normal | 76 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Musculoskeletal System | Normal | 77 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Skin | Abnormal, NCS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Thyroid Gland | Normal | 62 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: General Appearance | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Respiratory System | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Thyroid Gland | Normal | 65 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Musculoskeletal System | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Lymph Node Palpation | Abnormal, NCS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Respiratory System | Abnormal, NCS | 1 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Musculoskeletal System | Normal | 65 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Skin | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: General Appearance | Normal | 61 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Respiratory System | Normal | 61 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Musculoskeletal System | Abnormal, NCS | 1 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Thyroid Gland | Abnormal, NCS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Cardiovascular System | Abnormal, NCS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Musculoskeletal System | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Lymph Node Palpation | Abnormal, NCS | 1 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Musculoskeletal System | Normal | 62 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Skin | Normal | 62 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: General Appearance | Normal | 76 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Thyroid Gland | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Musculoskeletal System | Abnormal, NCS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Lymph Node Palpation | Normal | 64 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Lymph Node Palpation | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Cardiovascular System | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Skin | Abnormal, NCS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Lymph Node Palpation | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Head, Ears, Eyes, Nose, Throat, Neck | Abnormal, NCS | 2 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Central and Peripheral Nervous System | Normal | 76 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Musculoskeletal System | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Thyroid Gland | Abnormal, NCS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Cardiovascular System | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Central and Peripheral Nervous System | Abnormal, NCS | 1 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Head, Ears, Eyes, Nose, Throat, Neck | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Thyroid Gland | Normal | 75 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Cardiovascular System | Normal | 73 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Central and Peripheral Nervous System | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Musculoskeletal System | Abnormal, NCS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: General Appearance | Abnormal, NCS | 1 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Head, Ears, Eyes, Nose, Throat, Neck | Normal | 66 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Central and Peripheral Nervous System | Normal | 65 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Head, Ears, Eyes, Nose, Throat, Neck | Normal | 60 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Skin | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Lymph Node Palpation | Abnormal, NCS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Central and Peripheral Nervous System | Abnormal, NCS | 1 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Respiratory System | Abnormal, NCS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Central and Peripheral Nervous System | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Head, Ears, Eyes, Nose, Throat, Neck | Abnormal, NCS | 1 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Respiratory System | Abnormal, NCS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Respiratory System | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Central and Peripheral Nervous System | Normal | 62 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Head, Ears, Eyes, Nose, Throat, Neck | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Central and Peripheral Nervous System | Abnormal, NCS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Gastrointestinal System incl. Mouth | Normal | 65 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Thyroid Gland | Abnormal, NCS | 2 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Respiratory System | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 80: Central and Peripheral Nervous System | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Respiratory System | Normal | 77 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: General Appearance | Abnormal, NCS | 1 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 54: Respiratory System | Normal | 66 Participants |
| Placebo (Placebo) | Change in Physical Examination | Week 0: Skin | Normal | 74 Participants |
Secondary
Change in Pulse
Change in pulse is evaluated from baseline (week 0) to weeks 54 and 80
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Pulse | Change from week 0 to week 54 | 3 Beats/min | Standard Deviation 12 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Pulse | Change from week 0 to week 80 | -1 Beats/min | Standard Deviation 10 |
| NNC0114-0006 (Experimental) | Change in Pulse | Change from week 0 to week 80 | -1 Beats/min | Standard Deviation 10 |
| NNC0114-0006 (Experimental) | Change in Pulse | Change from week 0 to week 54 | 0 Beats/min | Standard Deviation 12 |
| Liraglutide (Experimental) | Change in Pulse | Change from week 0 to week 80 | 2 Beats/min | Standard Deviation 10 |
| Liraglutide (Experimental) | Change in Pulse | Change from week 0 to week 54 | 6 Beats/min | Standard Deviation 9 |
| Placebo (Placebo) | Change in Pulse | Change from week 0 to week 80 | 1 Beats/min | Standard Deviation 9 |
| Placebo (Placebo) | Change in Pulse | Change from week 0 to week 54 | 2 Beats/min | Standard Deviation 8 |
Secondary
Change in Respiratory Rate
Change in respiratory rate is evaluated from baseline (week 0) to weeks 54 and 80.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Respiratory Rate | Change from week 0 to week 54 | -0.3 Breaths per minute | Standard Deviation 2.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Respiratory Rate | Change from week 0 to week 80 | -0.3 Breaths per minute | Standard Deviation 2 |
| NNC0114-0006 (Experimental) | Change in Respiratory Rate | Change from week 0 to week 80 | -0.2 Breaths per minute | Standard Deviation 2.7 |
| NNC0114-0006 (Experimental) | Change in Respiratory Rate | Change from week 0 to week 54 | 0.1 Breaths per minute | Standard Deviation 3 |
| Liraglutide (Experimental) | Change in Respiratory Rate | Change from week 0 to week 54 | 0.1 Breaths per minute | Standard Deviation 2.5 |
| Liraglutide (Experimental) | Change in Respiratory Rate | Change from week 0 to week 80 | 0.1 Breaths per minute | Standard Deviation 2.5 |
| Placebo (Placebo) | Change in Respiratory Rate | Change from week 0 to week 54 | 0.6 Breaths per minute | Standard Deviation 2.4 |
| Placebo (Placebo) | Change in Respiratory Rate | Change from week 0 to week 80 | 0.1 Breaths per minute | Standard Deviation 2.2 |
Secondary
Change in Short Form 36 Health Survey (SF-36)
SF-36v2™ questionnaire measured the HRQoL on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. Change from baseline (week 0) to week 54 and week 80 in SF-36 score is presented.The MCS measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The PCS measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicate an improvement since baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The FAS included all randomised participants. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Lim. Phy Health | 0.8 Score on a scale | Standard Deviation 6.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Physical Functioning | 0.5 Score on a scale | Standard Deviation 2.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: General Health Perception | -0.9 Score on a scale | Standard Deviation 7.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Lim. Phy Health | 0.3 Score on a scale | Standard Deviation 5.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54:Lim Emotion Prob | 0.3 Score on a scale | Standard Deviation 10.7 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Bodily pain | -0.8 Score on a scale | Standard Deviation 8.5 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Lim Emotion Prob | 1.2 Score on a scale | Standard Deviation 10.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Bodily Pain | 0.8 Score on a scale | Standard Deviation 7.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Vitality | -0.5 Score on a scale | Standard Deviation 8.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Mental Component Sum | 0.5 Score on a scale | Standard Deviation 9.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Mental Component Sum | 1.7 Score on a scale | Standard Deviation 9.8 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Social Functioning | 2.3 Score on a scale | Standard Deviation 9.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | week 54: Mental Health | 0.7 Score on a scale | Standard Deviation 8.4 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Vitality | 0.5 Score on a scale | Standard Deviation 7.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Mental Health | 1.5 Score on a scale | Standard Deviation 8.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54: General Health Perception | -1.1 Score on a scale | Standard Deviation 7.1 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Social Functioning | 0.8 Score on a scale | Standard Deviation 10.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Physical Component Sum | -0.4 Score on a scale | Standard Deviation 4.2 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Physical Component Sum | -0.1 Score on a scale | Standard Deviation 3.9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Physical Functioning | 0.6 Score on a scale | Standard Deviation 2.5 |
| NNC0114-0006 (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Lim. Phy Health | 0.9 Score on a scale | Standard Deviation 7 |
| NNC0114-0006 (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Physical Functioning | 0.9 Score on a scale | Standard Deviation 4.4 |
| NNC0114-0006 (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Vitality | 0.5 Score on a scale | Standard Deviation 7.9 |
| NNC0114-0006 (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Lim. Phy Health | 0.7 Score on a scale | Standard Deviation 6.9 |
| NNC0114-0006 (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Mental Component Sum | -0.4 Score on a scale | Standard Deviation 8.9 |
| NNC0114-0006 (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Physical Functioning | 1.1 Score on a scale | Standard Deviation 4.6 |
| NNC0114-0006 (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Bodily pain | -2.2 Score on a scale | Standard Deviation 7.6 |
| NNC0114-0006 (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Vitality | -1.4 Score on a scale | Standard Deviation 6.9 |
| NNC0114-0006 (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Physical Component Sum | 0.5 Score on a scale | Standard Deviation 5.4 |
| NNC0114-0006 (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54:Lim Emotion Prob | 0.5 Score on a scale | Standard Deviation 8.9 |
| NNC0114-0006 (Experimental) | Change in Short Form 36 Health Survey (SF-36) | week 54: Mental Health | 0.6 Score on a scale | Standard Deviation 7.9 |
| NNC0114-0006 (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Lim Emotion Prob | -0.1 Score on a scale | Standard Deviation 9.8 |
| NNC0114-0006 (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Physical Component Sum | -0.4 Score on a scale | Standard Deviation 5.3 |
| NNC0114-0006 (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: General Health Perception | 0.6 Score on a scale | Standard Deviation 9 |
| NNC0114-0006 (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Social Functioning | 0.1 Score on a scale | Standard Deviation 10 |
| NNC0114-0006 (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54: General Health Perception | -0.3 Score on a scale | Standard Deviation 8.4 |
| NNC0114-0006 (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Mental Health | -0.2 Score on a scale | Standard Deviation 8 |
| NNC0114-0006 (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Mental Component Sum | 0.6 Score on a scale | Standard Deviation 9.3 |
| NNC0114-0006 (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Bodily Pain | -1.4 Score on a scale | Standard Deviation 7 |
| NNC0114-0006 (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Social Functioning | 1.0 Score on a scale | Standard Deviation 8.3 |
| Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54:Lim Emotion Prob | -1.4 Score on a scale | Standard Deviation 9 |
| Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Bodily pain | 0.1 Score on a scale | Standard Deviation 5.2 |
| Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Bodily Pain | -0.5 Score on a scale | Standard Deviation 6.4 |
| Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54: General Health Perception | -1.6 Score on a scale | Standard Deviation 7.3 |
| Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: General Health Perception | -1.7 Score on a scale | Standard Deviation 7.9 |
| Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Mental Component Sum | -2.1 Score on a scale | Standard Deviation 9 |
| Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Mental Component Sum | -2.4 Score on a scale | Standard Deviation 9.6 |
| Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | week 54: Mental Health | -1.5 Score on a scale | Standard Deviation 8.6 |
| Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Mental Health | -1.5 Score on a scale | Standard Deviation 9 |
| Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Physical Component Sum | -0.1 Score on a scale | Standard Deviation 3.8 |
| Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Physical Component Sum | 0.0 Score on a scale | Standard Deviation 4.3 |
| Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Physical Functioning | 0.0 Score on a scale | Standard Deviation 2.6 |
| Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Physical Functioning | -0.1 Score on a scale | Standard Deviation 2.4 |
| Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Lim Emotion Prob | -2.2 Score on a scale | Standard Deviation 9.4 |
| Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Lim. Phy Health | -0.6 Score on a scale | Standard Deviation 5.7 |
| Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Lim. Phy Health | -0.2 Score on a scale | Standard Deviation 5.2 |
| Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Social Functioning | -1.4 Score on a scale | Standard Deviation 7.4 |
| Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Social Functioning | -1.2 Score on a scale | Standard Deviation 7.3 |
| Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Vitality | -2.2 Score on a scale | Standard Deviation 5.9 |
| Liraglutide (Experimental) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Vitality | -2.2 Score on a scale | Standard Deviation 7.1 |
| Placebo (Placebo) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Physical Component Sum | 0.0 Score on a scale | Standard Deviation 6.9 |
| Placebo (Placebo) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Physical Component Sum | 0.3 Score on a scale | Standard Deviation 5.7 |
| Placebo (Placebo) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Vitality | -2.3 Score on a scale | Standard Deviation 6.9 |
| Placebo (Placebo) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Lim. Phy Health | 0.0 Score on a scale | Standard Deviation 7.3 |
| Placebo (Placebo) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Mental Health | -0.7 Score on a scale | Standard Deviation 7.6 |
| Placebo (Placebo) | Change in Short Form 36 Health Survey (SF-36) | week 54: Mental Health | -1.3 Score on a scale | Standard Deviation 6.9 |
| Placebo (Placebo) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Bodily Pain | 0.8 Score on a scale | Standard Deviation 10.2 |
| Placebo (Placebo) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Social Functioning | 0.0 Score on a scale | Standard Deviation 8.5 |
| Placebo (Placebo) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Mental Component Sum | -0.7 Score on a scale | Standard Deviation 8.7 |
| Placebo (Placebo) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Mental Component Sum | -1.3 Score on a scale | Standard Deviation 7.6 |
| Placebo (Placebo) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Bodily pain | 0.6 Score on a scale | Standard Deviation 9.1 |
| Placebo (Placebo) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Social Functioning | -0.4 Score on a scale | Standard Deviation 8.4 |
| Placebo (Placebo) | Change in Short Form 36 Health Survey (SF-36) | Week 80: General Health Perception | -1.8 Score on a scale | Standard Deviation 8.6 |
| Placebo (Placebo) | Change in Short Form 36 Health Survey (SF-36) | Week 54:Lim Emotion Prob | -0.1 Score on a scale | Standard Deviation 8.5 |
| Placebo (Placebo) | Change in Short Form 36 Health Survey (SF-36) | Week 54: General Health Perception | -1.0 Score on a scale | Standard Deviation 7.1 |
| Placebo (Placebo) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Lim Emotion Prob | 0.0 Score on a scale | Standard Deviation 8.3 |
| Placebo (Placebo) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Physical Functioning | 0.1 Score on a scale | Standard Deviation 6.4 |
| Placebo (Placebo) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Physical Functioning | 0.3 Score on a scale | Standard Deviation 5.8 |
| Placebo (Placebo) | Change in Short Form 36 Health Survey (SF-36) | Week 80: Vitality | -0.7 Score on a scale | Standard Deviation 6.9 |
| Placebo (Placebo) | Change in Short Form 36 Health Survey (SF-36) | Week 54: Lim. Phy Health | -0.2 Score on a scale | Standard Deviation 6.9 |
Secondary
Change in Systolic and Diastolic Blood Pressure
Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) are evaluated from baseline (week 0) to weeks 54 and 80.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Systolic and Diastolic Blood Pressure | Week 54: Diastolic blood pressure | -0 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Systolic and Diastolic Blood Pressure | Week 80: Systolic blood pressure | -1 Millimeters of mercury (mmHg) | Standard Deviation 10 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Systolic and Diastolic Blood Pressure | Week 54: Systolic blood pressure | -3 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Systolic and Diastolic Blood Pressure | Week 80: Diastolic blood pressure | -0 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| NNC0114-0006 (Experimental) | Change in Systolic and Diastolic Blood Pressure | Week 54: Systolic blood pressure | 3 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| NNC0114-0006 (Experimental) | Change in Systolic and Diastolic Blood Pressure | Week 54: Diastolic blood pressure | 2 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| NNC0114-0006 (Experimental) | Change in Systolic and Diastolic Blood Pressure | Week 80: Systolic blood pressure | 2 Millimeters of mercury (mmHg) | Standard Deviation 11 |
| NNC0114-0006 (Experimental) | Change in Systolic and Diastolic Blood Pressure | Week 80: Diastolic blood pressure | 2 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| Liraglutide (Experimental) | Change in Systolic and Diastolic Blood Pressure | Week 80: Diastolic blood pressure | 1 Millimeters of mercury (mmHg) | Standard Deviation 10 |
| Liraglutide (Experimental) | Change in Systolic and Diastolic Blood Pressure | Week 54: Systolic blood pressure | -2 Millimeters of mercury (mmHg) | Standard Deviation 14 |
| Liraglutide (Experimental) | Change in Systolic and Diastolic Blood Pressure | Week 80: Systolic blood pressure | 1 Millimeters of mercury (mmHg) | Standard Deviation 12 |
| Liraglutide (Experimental) | Change in Systolic and Diastolic Blood Pressure | Week 54: Diastolic blood pressure | -1 Millimeters of mercury (mmHg) | Standard Deviation 10 |
| Placebo (Placebo) | Change in Systolic and Diastolic Blood Pressure | Week 54: Diastolic blood pressure | -1 Millimeters of mercury (mmHg) | Standard Deviation 8 |
| Placebo (Placebo) | Change in Systolic and Diastolic Blood Pressure | Week 80: Systolic blood pressure | 4 Millimeters of mercury (mmHg) | Standard Deviation 10 |
| Placebo (Placebo) | Change in Systolic and Diastolic Blood Pressure | Week 80: Diastolic blood pressure | 1 Millimeters of mercury (mmHg) | Standard Deviation 10 |
| Placebo (Placebo) | Change in Systolic and Diastolic Blood Pressure | Week 54: Systolic blood pressure | 1 Millimeters of mercury (mmHg) | Standard Deviation 11 |
Secondary
Change in Total Immunoglobulin E (IgE)
Change in IgE (measured in kilo international units per liter \[kIU/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Total Immunoglobulin E (IgE) | Change from week 0 to week 54 | 1.31 Ratio of IgE | Geometric Coefficient of Variation 71.6 |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Total Immunoglobulin E (IgE) | Change from week 0 to week 80 | 1.32 Ratio of IgE | Geometric Coefficient of Variation 65.4 |
| NNC0114-0006 (Experimental) | Change in Total Immunoglobulin E (IgE) | Change from week 0 to week 80 | 1.18 Ratio of IgE | Geometric Coefficient of Variation 38.5 |
| NNC0114-0006 (Experimental) | Change in Total Immunoglobulin E (IgE) | Change from week 0 to week 54 | 1.05 Ratio of IgE | Geometric Coefficient of Variation 63.1 |
| Liraglutide (Experimental) | Change in Total Immunoglobulin E (IgE) | Change from week 0 to week 54 | 1.08 Ratio of IgE | Geometric Coefficient of Variation 45.7 |
| Liraglutide (Experimental) | Change in Total Immunoglobulin E (IgE) | Change from week 0 to week 80 | 1.16 Ratio of IgE | Geometric Coefficient of Variation 55.1 |
| Placebo (Placebo) | Change in Total Immunoglobulin E (IgE) | Change from week 0 to week 54 | 1.02 Ratio of IgE | Geometric Coefficient of Variation 41.8 |
| Placebo (Placebo) | Change in Total Immunoglobulin E (IgE) | Change from week 0 to week 80 | 0.94 Ratio of IgE | Geometric Coefficient of Variation 61.2 |
Secondary
Change in Urinalysis: Urine Dipsticks
Urinalysis was performed by urine dipsticks for protein, glucose, erythrocytes, ketones leukocytes, nitrite, pH and specific gravity and categorised as normal, abnormal not clinically significant (NCS) and abnormal clinially significant (CS). Number of participants in each category at baseline (week 0), week 54 and 80 are presented.
Time frame: Week 0, week 54 and week 80
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Glucose dipstick | Abnormal, NCS | 5 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Leukocytes in urine | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Erythrocytes in urine | Normal | 74 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Leukocytes in urine | Abnormal, NCS | 4 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Leukocytes in urine | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Erythrocytes in urine | Abnormal, NCS | 2 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Glucose dipstick | Abnormal, CS | 2 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Leukocytes in urine | Abnormal, NCS | 4 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Leukocytes in urine | Normal | 64 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Erythrocytes in urine | Abnormal, CS | 1 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Specific Gravity | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Leukocytes in urine | Normal | 77 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Erythrocytes in urine | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Erythrocytes in urine | Normal | 66 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Protein urine | Abnormal, NCS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Erythrocytes in urine | Abnormal, NCS | 3 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Erythrocytes in urine | Normal | 63 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Erythrocytes in urine | Abnormal, NCS | 2 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Protein urine | Normal | 77 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Erythrocytes in urine | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Glucose dipstick | Normal | 54 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Nitrite | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Glucose dipstick | Abnormal, NCS | 12 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Specific Gravity | Abnormal, NCS | 2 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Specific Gravity | Normal | 75 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Nitrite | Abnormal, NCS | 1 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Nitrite | Normal | 65 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Ketone dipstick | Normal | 74 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Nitrite | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Glucose dipstick | Normal | 57 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Nitrite | Abnormal, NCS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Nitrite | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Ketone dipstick | Abnormal, NCS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Nitrite | Abnormal, NCS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Nitrite | Normal | 77 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Ketone dipstick | Abnormal, NCS | 1 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Specific Gravity | Abnormal, NCS | 1 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Leukocytes in urine | Normal | 62 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Leukocytes in urine | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Ketone dipstick | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Leukocytes in urine | Abnormal, NCS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: pH dipstick | Normal | 75 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Protein urine | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Ketone dipstick | Normal | 65 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Ketone dipstick | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: pH dipstick | Abnormal, NCS | 2 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Protein urine | Normal | 63 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Ketone dipstick | Normal | 68 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Ketone dipstick | Abnormal, CS | 1 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: pH dipstick | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Glucose dipstick | Abnormal, NCS | 9 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Ketone dipstick | Abnormal, NCS | 2 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Glucose dipstick | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: pH dipstick | Normal | 67 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Glucose dipstick | Normal | 72 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Specific Gravity | Abnormal, NCS | 1 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: pH dipstick | Abnormal, NCS | 1 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Glucose dipstick | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Specific Gravity | Normal | 65 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Specific Gravity | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: pH dipstick | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Protein urine | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Specific Gravity | Normal | 67 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Specific Gravity | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: pH dipstick | Normal | 66 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Protein urine | Abnormal, CS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Protein urine | Abnormal, NCS | 3 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Protein urine | Abnormal, NCS | 1 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: pH dipstick | Abnormal, NCS | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Protein urine | Normal | 67 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Nitrite | Normal | 68 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: pH dipstick | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: pH dipstick | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Glucose dipstick | Abnormal, NCS | 6 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Glucose dipstick | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Glucose dipstick | Normal | 56 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Glucose dipstick | Abnormal, NCS | 9 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Glucose dipstick | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Glucose dipstick | Abnormal, NCS | 10 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Glucose dipstick | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Ketone dipstick | Abnormal, NCS | 4 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Ketone dipstick | Abnormal, NCS | 3 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: pH dipstick | Normal | 77 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: pH dipstick | Abnormal, NCS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: pH dipstick | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: pH dipstick | Abnormal, NCS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: pH dipstick | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: pH dipstick | Normal | 64 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Erythrocytes in urine | Abnormal, NCS | 3 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Erythrocytes in urine | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Erythrocytes in urine | Normal | 63 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Erythrocytes in urine | Abnormal, NCS | 2 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Erythrocytes in urine | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Erythrocytes in urine | Normal | 61 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Erythrocytes in urine | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Leukocytes in urine | Normal | 73 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Leukocytes in urine | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Leukocytes in urine | Normal | 62 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Leukocytes in urine | Abnormal, NCS | 3 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Leukocytes in urine | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Leukocytes in urine | Abnormal, NCS | 3 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Leukocytes in urine | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Nitrite | Normal | 65 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Protein urine | Normal | 64 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Protein urine | Abnormal, NCS | 1 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Specific Gravity | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Specific Gravity | Normal | 65 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Specific Gravity | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Specific Gravity | Normal | 64 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Glucose dipstick | Normal | 71 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Glucose dipstick | Normal | 54 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Ketone dipstick | Normal | 73 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Ketone dipstick | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Ketone dipstick | Normal | 64 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Ketone dipstick | Abnormal, NCS | 1 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Ketone dipstick | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Ketone dipstick | Normal | 61 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Ketone dipstick | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: pH dipstick | Normal | 65 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: pH dipstick | Abnormal, NCS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Erythrocytes in urine | Normal | 74 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Erythrocytes in urine | Abnormal, NCS | 3 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Leukocytes in urine | Abnormal, NCS | 4 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Leukocytes in urine | Normal | 61 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Nitrite | Normal | 77 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Nitrite | Abnormal, NCS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Nitrite | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Nitrite | Abnormal, NCS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Protein urine | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Nitrite | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Nitrite | Normal | 64 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Nitrite | Abnormal, NCS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Nitrite | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Protein urine | Normal | 71 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Protein urine | Abnormal, NCS | 6 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Protein urine | Abnormal, CS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Protein urine | Normal | 62 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Protein urine | Abnormal, NCS | 1 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Protein urine | Abnormal, CS | 1 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Specific Gravity | Normal | 77 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Specific Gravity | Abnormal, NCS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Specific Gravity | Abnormal, NCS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Specific Gravity | Abnormal, NCS | 0 Participants |
| NNC0114-0006 (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Specific Gravity | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Specific Gravity | Normal | 68 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Glucose dipstick | Normal | 63 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Nitrite | Normal | 76 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Glucose dipstick | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Ketone dipstick | Normal | 66 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Specific Gravity | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Nitrite | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Ketone dipstick | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Specific Gravity | Normal | 68 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Protein urine | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Nitrite | Normal | 68 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: pH dipstick | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Ketone dipstick | Abnormal, NCS | 3 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Protein urine | Abnormal, NCS | 6 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Nitrite | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Ketone dipstick | Normal | 65 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: pH dipstick | Normal | 68 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Ketone dipstick | Abnormal, NCS | 3 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Specific Gravity | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Nitrite | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: pH dipstick | Normal | 68 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Erythrocytes in urine | Abnormal, NCS | 2 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Specific Gravity | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Erythrocytes in urine | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Glucose dipstick | Abnormal, NCS | 5 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Ketone dipstick | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Glucose dipstick | Normal | 67 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Erythrocytes in urine | Normal | 65 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: pH dipstick | Normal | 76 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Erythrocytes in urine | Normal | 66 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Specific Gravity | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Protein urine | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Specific Gravity | Normal | 76 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Erythrocytes in urine | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Ketone dipstick | Abnormal, CS | 1 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Erythrocytes in urine | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Nitrite | Normal | 68 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Specific Gravity | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Leukocytes in urine | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Glucose dipstick | Normal | 54 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: pH dipstick | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Glucose dipstick | Abnormal, CS | 1 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Leukocytes in urine | Normal | 67 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Glucose dipstick | Abnormal, NCS | 9 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Erythrocytes in urine | Abnormal, NCS | 2 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Specific Gravity | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Leukocytes in urine | Abnormal, NCS | 1 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Erythrocytes in urine | Abnormal, NCS | 3 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Leukocytes in urine | Normal | 76 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Nitrite | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Leukocytes in urine | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Glucose dipstick | Abnormal, NCS | 13 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Erythrocytes in urine | Normal | 74 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: pH dipstick | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Leukocytes in urine | Abnormal, NCS | 1 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Protein urine | Abnormal, NCS | 3 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Leukocytes in urine | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Glucose dipstick | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Nitrite | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: pH dipstick | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Protein urine | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Ketone dipstick | Abnormal, NCS | 1 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Ketone dipstick | Normal | 73 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Nitrite | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Leukocytes in urine | Normal | 67 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: pH dipstick | Abnormal, NCS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: pH dipstick | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 54: Protein urine | Normal | 62 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Leukocytes in urine | Abnormal, CS | 0 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Protein urine | Abnormal, NCS | 1 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 0: Protein urine | Normal | 75 Participants |
| Liraglutide (Experimental) | Change in Urinalysis: Urine Dipsticks | Week 80: Protein urine | Normal | 65 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 80: Ketone dipstick | Normal | 61 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 0: Specific Gravity | Abnormal, NCS | 2 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 54: pH dipstick | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 0: Protein urine | Normal | 76 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 0: Specific Gravity | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 54: Specific Gravity | Abnormal, NCS | 1 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 54: pH dipstick | Abnormal, NCS | 1 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 54: Specific Gravity | Normal | 64 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 54: Specific Gravity | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 80: Specific Gravity | Normal | 62 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 54: pH dipstick | Normal | 64 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 80: Specific Gravity | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 0: Protein urine | Abnormal, NCS | 1 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 0: Glucose dipstick | Normal | 71 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 54: Glucose dipstick | Abnormal, NCS | 6 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 80: Glucose dipstick | Abnormal, NCS | 11 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 0: pH dipstick | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 0: Ketone dipstick | Abnormal, NCS | 1 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 0: pH dipstick | Abnormal, NCS | 2 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 0: Protein urine | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 0: Ketone dipstick | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 54: Protein urine | Abnormal, NCS | 4 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 54: Ketone dipstick | Abnormal, NCS | 1 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 0: pH dipstick | Normal | 75 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 54: Ketone dipstick | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 0: Glucose dipstick | Abnormal, NCS | 6 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 54: Protein urine | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 54: Glucose dipstick | Normal | 59 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 0: Leukocytes in urine | Normal | 77 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 80: Ketone dipstick | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 0: Leukocytes in urine | Abnormal, NCS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 80: Ketone dipstick | Abnormal, NCS | 1 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 80: Protein urine | Abnormal, NCS | 2 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 80: Leukocytes in urine | Normal | 60 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 80: Leukocytes in urine | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 80: Protein urine | Normal | 59 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 0: Nitrite | Normal | 77 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 0: Nitrite | Abnormal, NCS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 54: Ketone dipstick | Normal | 64 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 54: Nitrite | Normal | 65 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 80: Protein urine | Abnormal, CS | 1 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 54: Nitrite | Abnormal, NCS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 0: Glucose dipstick | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 0: Ketone dipstick | Normal | 76 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 54: Erythrocytes in urine | Abnormal, NCS | 2 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 54: Nitrite | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 54: Erythrocytes in urine | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 54: Erythrocytes in urine | Normal | 63 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 80: Glucose dipstick | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 80: Erythrocytes in urine | Normal | 60 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 80: Erythrocytes in urine | Abnormal, NCS | 2 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 0: Erythrocytes in urine | Abnormal, CS | 1 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 80: Erythrocytes in urine | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 80: Nitrite | Normal | 61 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 0: Leukocytes in urine | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 0: Erythrocytes in urine | Abnormal, NCS | 4 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 54: Leukocytes in urine | Normal | 64 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 0: Specific Gravity | Normal | 75 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 54: Leukocytes in urine | Abnormal, NCS | 1 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 0: Erythrocytes in urine | Normal | 72 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 54: Leukocytes in urine | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 80: Glucose dipstick | Normal | 51 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 80: Leukocytes in urine | Abnormal, NCS | 2 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 80: pH dipstick | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 0: Nitrite | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 80: pH dipstick | Abnormal, NCS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 54: Glucose dipstick | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 80: Nitrite | Abnormal, NCS | 1 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 80: Nitrite | Abnormal, CS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 80: Specific Gravity | Abnormal, NCS | 0 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 54: Protein urine | Normal | 61 Participants |
| Placebo (Placebo) | Change in Urinalysis: Urine Dipsticks | Week 80: pH dipstick | Normal | 62 Participants |
Secondary
Clearance of NNC0114-0006 at Steady State (CLss, NNC0114-0006)
Clearance of NNC0114-0006 at steady state was calculated as dose/AUCtau, NNC0114-0006. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.
Time frame: Pre-dose and 1 hour post-dose during week 48 to week 54
Population: The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Clearance of NNC0114-0006 at Steady State (CLss, NNC0114-0006) | 3.02 (Milliliters/day)/kilogram ([mL/day]/kg) | Geometric Coefficient of Variation 17.9 |
| NNC0114-0006 (Experimental) | Clearance of NNC0114-0006 at Steady State (CLss, NNC0114-0006) | 2.92 (Milliliters/day)/kilogram ([mL/day]/kg) | Geometric Coefficient of Variation 23.1 |
Secondary
Cmax of C-peptide at Week 54 Relative to Baseline
Maximum observed concentration (Cmax) of a MMTT stimulated C-peptide at week 54 is presented as ratio to baseline. Cmax of C-peptide was measured as nanomoles per liter (nmol/L).
Time frame: 0-4 hours post-dose on week 0 and week 54
Population: The FAS included all randomised participants. Overall number of participants analysed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Cmax of C-peptide at Week 54 Relative to Baseline | 0.978 Ratio of Cmax | Geometric Coefficient of Variation 70.3 |
| NNC0114-0006 (Experimental) | Cmax of C-peptide at Week 54 Relative to Baseline | 0.779 Ratio of Cmax | Geometric Coefficient of Variation 47.6 |
| Liraglutide (Experimental) | Cmax of C-peptide at Week 54 Relative to Baseline | 0.733 Ratio of Cmax | Geometric Coefficient of Variation 110.4 |
| Placebo (Placebo) | Cmax of C-peptide at Week 54 Relative to Baseline | 0.644 Ratio of Cmax | Geometric Coefficient of Variation 89.4 |
Secondary
Cmax of C-peptide at Week 80 Relative to Baseline
Maximum observed concentration (Cmax) of a MMTT stimulated C-peptide at week 80 is presented as ratio to baseline. Cmax of C-peptide was measured as nanomoles per liter (nmol/L).
Time frame: 0-4 hours post-dose on week 0 and week 80
Population: The FAS included all randomised participants. Overall number of participants analysed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Cmax of C-peptide at Week 80 Relative to Baseline | 0.580 Ratio of Cmax | Geometric Coefficient of Variation 74.8 |
| NNC0114-0006 (Experimental) | Cmax of C-peptide at Week 80 Relative to Baseline | 0.592 Ratio of Cmax | Geometric Coefficient of Variation 76.8 |
| Liraglutide (Experimental) | Cmax of C-peptide at Week 80 Relative to Baseline | 0.389 Ratio of Cmax | Geometric Coefficient of Variation 109 |
| Placebo (Placebo) | Cmax of C-peptide at Week 80 Relative to Baseline | 0.568 Ratio of Cmax | Geometric Coefficient of Variation 97.7 |
Secondary
Cmax of Glucose at Week 54 Relative to Baseline
Maximum observed concentration (Cmax) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. Cmax of C-peptide was measured as 'mmol/L'.
Time frame: 0-4 hours post-dose on week 0 and week 54
Population: The FAS included all randomised participants. Overall number of participants analysed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Cmax of Glucose at Week 54 Relative to Baseline | 0.937 Ratio of Cmax | Geometric Coefficient of Variation 27.8 |
| NNC0114-0006 (Experimental) | Cmax of Glucose at Week 54 Relative to Baseline | 1.068 Ratio of Cmax | Geometric Coefficient of Variation 25.4 |
| Liraglutide (Experimental) | Cmax of Glucose at Week 54 Relative to Baseline | 1.004 Ratio of Cmax | Geometric Coefficient of Variation 29.1 |
| Placebo (Placebo) | Cmax of Glucose at Week 54 Relative to Baseline | 1.057 Ratio of Cmax | Geometric Coefficient of Variation 30.9 |
Secondary
Cmax of Glucose at Week 80 Relative to Baseline
Maximum observed concentration (Cmax) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. Cmax of C-peptide was measured as 'mmol/L'.
Time frame: 0-4 hours post-dose on week 0 and week 80
Population: The FAS included all randomised participants. Overall number of participants analysed = participants with available data
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Cmax of Glucose at Week 80 Relative to Baseline | 1.114 Ratio of Cmax | Geometric Coefficient of Variation 25.6 |
| NNC0114-0006 (Experimental) | Cmax of Glucose at Week 80 Relative to Baseline | 1.074 Ratio of Cmax | Geometric Coefficient of Variation 28.7 |
| Liraglutide (Experimental) | Cmax of Glucose at Week 80 Relative to Baseline | 1.104 Ratio of Cmax | Geometric Coefficient of Variation 31 |
| Placebo (Placebo) | Cmax of Glucose at Week 80 Relative to Baseline | 1.155 Ratio of Cmax | Geometric Coefficient of Variation 21.5 |
Secondary
Diabetes Retinopathy
Number of participants evaluated for diabetic retinopathy at baseline (Day -28 to -14), week 54 and week 80 are presented as 'yes', 'no' or 'unknown'.
Time frame: Baseline, week 54 and week 80
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Diabetes Retinopathy | Baseline (Day:-28 to -14) | Yes | 4 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Diabetes Retinopathy | Week 54 | Unknown | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Diabetes Retinopathy | Baseline (Day:-28 to -14) | Unknown | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Diabetes Retinopathy | Week 54 | Yes | 3 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Diabetes Retinopathy | Week 80 | No | 65 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Diabetes Retinopathy | Week 80 | Yes | 3 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Diabetes Retinopathy | Week 80 | Unknown | 1 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Diabetes Retinopathy | Week 54 | No | 65 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Diabetes Retinopathy | Baseline (Day:-28 to -14) | No | 73 Participants |
| NNC0114-0006 (Experimental) | Diabetes Retinopathy | Week 54 | Unknown | 0 Participants |
| NNC0114-0006 (Experimental) | Diabetes Retinopathy | Baseline (Day:-28 to -14) | Yes | 2 Participants |
| NNC0114-0006 (Experimental) | Diabetes Retinopathy | Baseline (Day:-28 to -14) | No | 75 Participants |
| NNC0114-0006 (Experimental) | Diabetes Retinopathy | Week 54 | Yes | 2 Participants |
| NNC0114-0006 (Experimental) | Diabetes Retinopathy | Week 54 | No | 63 Participants |
| NNC0114-0006 (Experimental) | Diabetes Retinopathy | Week 80 | No | 62 Participants |
| NNC0114-0006 (Experimental) | Diabetes Retinopathy | Week 80 | Yes | 2 Participants |
| NNC0114-0006 (Experimental) | Diabetes Retinopathy | Week 80 | Unknown | 1 Participants |
| NNC0114-0006 (Experimental) | Diabetes Retinopathy | Baseline (Day:-28 to -14) | Unknown | 0 Participants |
| Liraglutide (Experimental) | Diabetes Retinopathy | Week 80 | No | 67 Participants |
| Liraglutide (Experimental) | Diabetes Retinopathy | Baseline (Day:-28 to -14) | No | 75 Participants |
| Liraglutide (Experimental) | Diabetes Retinopathy | Baseline (Day:-28 to -14) | Unknown | 0 Participants |
| Liraglutide (Experimental) | Diabetes Retinopathy | Week 54 | No | 68 Participants |
| Liraglutide (Experimental) | Diabetes Retinopathy | Week 80 | Yes | 1 Participants |
| Liraglutide (Experimental) | Diabetes Retinopathy | Week 80 | Unknown | 1 Participants |
| Liraglutide (Experimental) | Diabetes Retinopathy | Baseline (Day:-28 to -14) | Yes | 1 Participants |
| Liraglutide (Experimental) | Diabetes Retinopathy | Week 54 | Yes | 1 Participants |
| Liraglutide (Experimental) | Diabetes Retinopathy | Week 54 | Unknown | 0 Participants |
| Placebo (Placebo) | Diabetes Retinopathy | Week 54 | Yes | 0 Participants |
| Placebo (Placebo) | Diabetes Retinopathy | Baseline (Day:-28 to -14) | No | 76 Participants |
| Placebo (Placebo) | Diabetes Retinopathy | Week 80 | Unknown | 1 Participants |
| Placebo (Placebo) | Diabetes Retinopathy | Baseline (Day:-28 to -14) | Yes | 1 Participants |
| Placebo (Placebo) | Diabetes Retinopathy | Week 54 | Unknown | 0 Participants |
| Placebo (Placebo) | Diabetes Retinopathy | Week 80 | No | 63 Participants |
| Placebo (Placebo) | Diabetes Retinopathy | Week 80 | Yes | 0 Participants |
| Placebo (Placebo) | Diabetes Retinopathy | Baseline (Day:-28 to -14) | Unknown | 0 Participants |
| Placebo (Placebo) | Diabetes Retinopathy | Week 54 | No | 68 Participants |
Secondary
Estimated Glomerular Filtration Rate (eGFR)- Ratio to Baseline
The eGFR was measured using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Change in eGFR (measured in milliliters per minute per 1.73 square meters) from baseline (week 0) at week 54 and week 80 is presented as ratio to baseline.
Time frame: (Week 0, week 54) and (week 0, week 80)
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Estimated Glomerular Filtration Rate (eGFR)- Ratio to Baseline | Change from week 0 to week 54 | 0.98 Ratio of eGFR | Geometric Coefficient of Variation 10.3 |
| NNC0114-0006 + Liraglutide (Experimental) | Estimated Glomerular Filtration Rate (eGFR)- Ratio to Baseline | Change from week 0 to week 80 | 0.97 Ratio of eGFR | Geometric Coefficient of Variation 9.3 |
| NNC0114-0006 (Experimental) | Estimated Glomerular Filtration Rate (eGFR)- Ratio to Baseline | Change from week 0 to week 80 | 0.94 Ratio of eGFR | Geometric Coefficient of Variation 11.4 |
| NNC0114-0006 (Experimental) | Estimated Glomerular Filtration Rate (eGFR)- Ratio to Baseline | Change from week 0 to week 54 | 0.95 Ratio of eGFR | Geometric Coefficient of Variation 8.2 |
| Liraglutide (Experimental) | Estimated Glomerular Filtration Rate (eGFR)- Ratio to Baseline | Change from week 0 to week 54 | 0.97 Ratio of eGFR | Geometric Coefficient of Variation 10.2 |
| Liraglutide (Experimental) | Estimated Glomerular Filtration Rate (eGFR)- Ratio to Baseline | Change from week 0 to week 80 | 0.96 Ratio of eGFR | Geometric Coefficient of Variation 11.5 |
| Placebo (Placebo) | Estimated Glomerular Filtration Rate (eGFR)- Ratio to Baseline | Change from week 0 to week 54 | 1.00 Ratio of eGFR | Geometric Coefficient of Variation 8.8 |
| Placebo (Placebo) | Estimated Glomerular Filtration Rate (eGFR)- Ratio to Baseline | Change from week 0 to week 80 | 0.99 Ratio of eGFR | Geometric Coefficient of Variation 10.9 |
Secondary
Liraglutide Concentration at Steady State (C Liraglutide)
C liraglutide was defined as the liraglutide concentration at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and Liraglutide treatment arms.
Time frame: Week 54 (post-dose)
Population: The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Liraglutide Concentration at Steady State (C Liraglutide) | 16287 picomole per liter (pmol/L) | Geometric Coefficient of Variation 41.7 |
| NNC0114-0006 (Experimental) | Liraglutide Concentration at Steady State (C Liraglutide) | 15920 picomole per liter (pmol/L) | Geometric Coefficient of Variation 66 |
Secondary
Mean Residence Time of NNC0114-0006 (MRT, NNC0114-0006)
This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms. Mean residence time of NNC0114-0006 is presented.
Time frame: Pre-dose and 1 hour post-dose during week 48 to week 80
Population: The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Mean Residence Time of NNC0114-0006 (MRT, NNC0114-0006) | 27.7 Days | Geometric Coefficient of Variation 24.5 |
| NNC0114-0006 (Experimental) | Mean Residence Time of NNC0114-0006 (MRT, NNC0114-0006) | 27.2 Days | Geometric Coefficient of Variation 22.6 |
Secondary
Number of Participants Experiencing Treatment Emergent Injection/Infusion Site Reactions Caused by NNC0114-0006/Liraglutide/Placebo Injection/Infusion
Injection/infusion site reactions episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of participants experiencing treatment emergent episodes of injection/infusion site reactions episodes from first dose of trial product to week 54 (treatment period) is presented.
Time frame: Week 0-54
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Number of Participants Experiencing Treatment Emergent Injection/Infusion Site Reactions Caused by NNC0114-0006/Liraglutide/Placebo Injection/Infusion | 2 Participants |
| NNC0114-0006 (Experimental) | Number of Participants Experiencing Treatment Emergent Injection/Infusion Site Reactions Caused by NNC0114-0006/Liraglutide/Placebo Injection/Infusion | 0 Participants |
| Liraglutide (Experimental) | Number of Participants Experiencing Treatment Emergent Injection/Infusion Site Reactions Caused by NNC0114-0006/Liraglutide/Placebo Injection/Infusion | 0 Participants |
| Placebo (Placebo) | Number of Participants Experiencing Treatment Emergent Injection/Infusion Site Reactions Caused by NNC0114-0006/Liraglutide/Placebo Injection/Infusion | 1 Participants |
Secondary
Number of Treatment Emergent Adverse Events
An adverse event was any untoward medical occurrence in a participants administered a product, and which did not necessarily have a causal relationship with this treatment. An adverse event was defined as treatment emergent if the onset of the adverse event occurs on or after the first day of trial product administration. Number of treatment emergent adverse events from first dose of trial product to week 54 and week 80 are presented. Results are based on the on-treatment and on-observation period. On-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit.
Time frame: Week 0-54; Week 54-80
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Number of Treatment Emergent Adverse Events | Week 0-54 | 434 Adverse events |
| NNC0114-0006 + Liraglutide (Experimental) | Number of Treatment Emergent Adverse Events | Week 54-80 | 70 Adverse events |
| NNC0114-0006 (Experimental) | Number of Treatment Emergent Adverse Events | Week 54-80 | 73 Adverse events |
| NNC0114-0006 (Experimental) | Number of Treatment Emergent Adverse Events | Week 0-54 | 327 Adverse events |
| Liraglutide (Experimental) | Number of Treatment Emergent Adverse Events | Week 0-54 | 410 Adverse events |
| Liraglutide (Experimental) | Number of Treatment Emergent Adverse Events | Week 54-80 | 78 Adverse events |
| Placebo (Placebo) | Number of Treatment Emergent Adverse Events | Week 0-54 | 364 Adverse events |
| Placebo (Placebo) | Number of Treatment Emergent Adverse Events | Week 54-80 | 87 Adverse events |
Secondary
Number of Treatment Emergent Episodes of Diabetic Ketoacidosis
Diabetic ketoacidosis episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of treatment emergent episodes of hyperglycaemic episodes from first dose of trial product to week 54 and from week 54 to week 80 are presented. Results are based on the on-treatment and on-observation period. On-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit.
Time frame: Weeks 0-54; Weeks 54-80
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Number of Treatment Emergent Episodes of Diabetic Ketoacidosis | Week 0-54 | 0 Episodes |
| NNC0114-0006 + Liraglutide (Experimental) | Number of Treatment Emergent Episodes of Diabetic Ketoacidosis | Week 54-80 | 0 Episodes |
| NNC0114-0006 (Experimental) | Number of Treatment Emergent Episodes of Diabetic Ketoacidosis | Week 54-80 | 0 Episodes |
| NNC0114-0006 (Experimental) | Number of Treatment Emergent Episodes of Diabetic Ketoacidosis | Week 0-54 | 0 Episodes |
| Liraglutide (Experimental) | Number of Treatment Emergent Episodes of Diabetic Ketoacidosis | Week 0-54 | 0 Episodes |
| Liraglutide (Experimental) | Number of Treatment Emergent Episodes of Diabetic Ketoacidosis | Week 54-80 | 1 Episodes |
| Placebo (Placebo) | Number of Treatment Emergent Episodes of Diabetic Ketoacidosis | Week 0-54 | 0 Episodes |
| Placebo (Placebo) | Number of Treatment Emergent Episodes of Diabetic Ketoacidosis | Week 54-80 | 1 Episodes |
Secondary
Number of Treatment Emergent Hyperglycaemic Episodes
Hyperglycaemic episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of treatment emergent episodes of hyperglycaemic episodes from first dose of trial product to week 54 and from week 54 to week 80 are presented. Results are based on the on-treatment and on-observation period. On-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit.
Time frame: Week 0-54; Week 54-80
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Number of Treatment Emergent Hyperglycaemic Episodes | Week 0-54 | 302 Episodes |
| NNC0114-0006 + Liraglutide (Experimental) | Number of Treatment Emergent Hyperglycaemic Episodes | Week 54-80 | 306 Episodes |
| NNC0114-0006 (Experimental) | Number of Treatment Emergent Hyperglycaemic Episodes | Week 54-80 | 74 Episodes |
| NNC0114-0006 (Experimental) | Number of Treatment Emergent Hyperglycaemic Episodes | Week 0-54 | 256 Episodes |
| Liraglutide (Experimental) | Number of Treatment Emergent Hyperglycaemic Episodes | Week 54-80 | 352 Episodes |
| Liraglutide (Experimental) | Number of Treatment Emergent Hyperglycaemic Episodes | Week 0-54 | 217 Episodes |
| Placebo (Placebo) | Number of Treatment Emergent Hyperglycaemic Episodes | Week 0-54 | 291 Episodes |
| Placebo (Placebo) | Number of Treatment Emergent Hyperglycaemic Episodes | Week 54-80 | 112 Episodes |
Secondary
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions
Hypoglycaemia episodes were recorded as per Novo Nordisk definition: Symptomatic BG-confirmed: An episode that is blood glucose (BG) confirmed by plasma glucose (PG) value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Asymptomatic BG-confirmed: An episode that is BG-confirmed by PG value \<3.1 mmol/L without symptoms consistent with hypoglycaemia. Severe or BG-confirmed symptomatic: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. BG-confirmed: An episode that is BG-confirmed by a PG value \<3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Severe or BG-confirmed: An episode that is severe according to the International Society for Pediatric and Adolescent Diabetes (ISPAD) classification or BG-confirmed by a PG value \<3.1 mmol/L with or without symptoms consistent with hypoglycaemia.
Time frame: Weeks 0-54; Weeks 54-80
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions | Symptomatic BG confirmed (Week 0-54) | 576 Episodes |
| NNC0114-0006 + Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions | Symptomatic BG confirmed (Week 54-80) | 368 Episodes |
| NNC0114-0006 + Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions | Severe or BG confirmed (Week 0-54) | 396 Episodes |
| NNC0114-0006 + Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions | Severe or BG confirmed (Week 54-80) | 216 Episodes |
| NNC0114-0006 (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions | Symptomatic BG confirmed (Week 0-54) | 616 Episodes |
| NNC0114-0006 (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions | Severe or BG confirmed (Week 54-80) | 130 Episodes |
| NNC0114-0006 (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions | Severe or BG confirmed (Week 0-54) | 394 Episodes |
| NNC0114-0006 (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions | Symptomatic BG confirmed (Week 54-80) | 207 Episodes |
| Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions | Severe or BG confirmed (Week 54-80) | 244 Episodes |
| Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions | Severe or BG confirmed (Week 0-54) | 315 Episodes |
| Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions | Symptomatic BG confirmed (Week 54-80) | 332 Episodes |
| Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions | Symptomatic BG confirmed (Week 0-54) | 479 Episodes |
| Placebo (Placebo) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions | Symptomatic BG confirmed (Week 0-54) | 646 Episodes |
| Placebo (Placebo) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions | Severe or BG confirmed (Week 0-54) | 503 Episodes |
| Placebo (Placebo) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions | Severe or BG confirmed (Week 54-80) | 240 Episodes |
| Placebo (Placebo) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions | Symptomatic BG confirmed (Week 54-80) | 292 Episodes |
Secondary
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA)
Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 1 day after the date of last contact. Number of treatment-emergent hypoglycaemic episodes according to American Diabetes Association (ADA) classification from first dose of trial product to week 54 and from week 54 to week 80 are presented. Results presented hypoglycaemia episodes were recorded as per ADA definition: Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Pseudo-hypoglycaemia.
Time frame: Weeks 0-54; Weeks 54-80
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Severe hypoglycaemia (Week 0-54) | 1 Episodes |
| NNC0114-0006 + Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Documented symptomatic hypoglycaemia (Week 0-54) | 1305 Episodes |
| NNC0114-0006 + Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Documented symptomatic hypoglycaemia (Week 54-80) | 514 Episodes |
| NNC0114-0006 + Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Probable symptomatic hypoglycaemia (Week 0-54) | 9 Episodes |
| NNC0114-0006 + Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Pseudo-hypoglycaemia (Week 54-80) | 0 Episodes |
| NNC0114-0006 + Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Pseudo-hypoglycaemia (Week 0-54) | 1 Episodes |
| NNC0114-0006 + Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Probable symptomatic hypoglycaemia (Week 54-80) | 1 Episodes |
| NNC0114-0006 + Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Asymptomatic hypoglycaemia (Week 0-54) | 2038 Episodes |
| NNC0114-0006 + Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Asymptomatic hypoglycaemia (Week 54-80) | 609 Episodes |
| NNC0114-0006 + Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Severe hypoglycaemia (Week 54-80) | 3 Episodes |
| NNC0114-0006 (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Documented symptomatic hypoglycaemia (Week 54-80) | 362 Episodes |
| NNC0114-0006 (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Pseudo-hypoglycaemia (Week 54-80) | 0 Episodes |
| NNC0114-0006 (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Asymptomatic hypoglycaemia (Week 0-54) | 1956 Episodes |
| NNC0114-0006 (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Probable symptomatic hypoglycaemia (Week 54-80) | 0 Episodes |
| NNC0114-0006 (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Documented symptomatic hypoglycaemia (Week 0-54) | 1461 Episodes |
| NNC0114-0006 (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Severe hypoglycaemia (Week 0-54) | 2 Episodes |
| NNC0114-0006 (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Pseudo-hypoglycaemia (Week 0-54) | 1 Episodes |
| NNC0114-0006 (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Probable symptomatic hypoglycaemia (Week 0-54) | 0 Episodes |
| NNC0114-0006 (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Severe hypoglycaemia (Week 54-80) | 1 Episodes |
| NNC0114-0006 (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Asymptomatic hypoglycaemia (Week 54-80) | 522 Episodes |
| Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Probable symptomatic hypoglycaemia (Week 0-54) | 4 Episodes |
| Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Severe hypoglycaemia (Week 0-54) | 0 Episodes |
| Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Asymptomatic hypoglycaemia (Week 0-54) | 2092 Episodes |
| Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Pseudo-hypoglycaemia (Week 54-80) | 1 Episodes |
| Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Probable symptomatic hypoglycaemia (Week 54-80) | 0 Episodes |
| Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Documented symptomatic hypoglycaemia (Week 54-80) | 651 Episodes |
| Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Asymptomatic hypoglycaemia (Week 54-80) | 670 Episodes |
| Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Pseudo-hypoglycaemia (Week 0-54) | 14 Episodes |
| Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Documented symptomatic hypoglycaemia (Week 0-54) | 1114 Episodes |
| Liraglutide (Experimental) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Severe hypoglycaemia (Week 54-80) | 0 Episodes |
| Placebo (Placebo) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Probable symptomatic hypoglycaemia (Week 54-80) | 2 Episodes |
| Placebo (Placebo) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Severe hypoglycaemia (Week 54-80) | 1 Episodes |
| Placebo (Placebo) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Severe hypoglycaemia (Week 0-54) | 0 Episodes |
| Placebo (Placebo) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Asymptomatic hypoglycaemia (Week 0-54) | 1774 Episodes |
| Placebo (Placebo) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Documented symptomatic hypoglycaemia (Week 0-54) | 1625 Episodes |
| Placebo (Placebo) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Probable symptomatic hypoglycaemia (Week 0-54) | 10 Episodes |
| Placebo (Placebo) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Asymptomatic hypoglycaemia (Week 54-80) | 449 Episodes |
| Placebo (Placebo) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Documented symptomatic hypoglycaemia (Week 54-80) | 527 Episodes |
| Placebo (Placebo) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Pseudo-hypoglycaemia (Week 54-80) | 2 Episodes |
| Placebo (Placebo) | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) | Pseudo-hypoglycaemia (Week 0-54) | 2 Episodes |
Secondary
Number of Weeks Off Bolus Insulin
The number of weeks off bolus insulin after 54 weeks of treatment and week 80 are presented.
Time frame: (Week 0 to week 54) and (week 0 to week 80)
Population: The FAS included all randomised participants. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Number of Weeks Off Bolus Insulin | Week 0 to week 54 | 10 Weeks | Standard Deviation 18 |
| NNC0114-0006 + Liraglutide (Experimental) | Number of Weeks Off Bolus Insulin | Week 0 to week 80 | 14 Weeks | Standard Deviation 25 |
| NNC0114-0006 (Experimental) | Number of Weeks Off Bolus Insulin | Week 0 to week 80 | 9 Weeks | Standard Deviation 20 |
| NNC0114-0006 (Experimental) | Number of Weeks Off Bolus Insulin | Week 0 to week 54 | 5 Weeks | Standard Deviation 14 |
| Liraglutide (Experimental) | Number of Weeks Off Bolus Insulin | Week 0 to week 54 | 9 Weeks | Standard Deviation 18 |
| Liraglutide (Experimental) | Number of Weeks Off Bolus Insulin | Week 0 to week 80 | 12 Weeks | Standard Deviation 24 |
| Placebo (Placebo) | Number of Weeks Off Bolus Insulin | Week 0 to week 54 | 4 Weeks | Standard Deviation 11 |
| Placebo (Placebo) | Number of Weeks Off Bolus Insulin | Week 0 to week 80 | 6 Weeks | Standard Deviation 14 |
Secondary
Observed NNC0114-0006 Concentration 1 Hour After Dosing of NNC0114-0006 at Steady State (C1h, NNC0114-0006)
C1h, NNC0114-0006 was defined as concentration of NNC0114-0006 at 1 hour after dosing of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.
Time frame: Week 48 (1 hour post-dose)
Population: The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Observed NNC0114-0006 Concentration 1 Hour After Dosing of NNC0114-0006 at Steady State (C1h, NNC0114-0006) | 298.6 ug/mL | Geometric Coefficient of Variation 16.8 |
| NNC0114-0006 (Experimental) | Observed NNC0114-0006 Concentration 1 Hour After Dosing of NNC0114-0006 at Steady State (C1h, NNC0114-0006) | 282.6 ug/mL | Geometric Coefficient of Variation 56.4 |
Secondary
Observed NNC0114-0006 Concentration Prior to Dosing of NNC0114-0006 at Steady State (Ctrough, NNC0114-0006)
Ctrough of NNC0114-0006 was defined as concentration prior to dosing of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.
Time frame: Week 48 (predose)
Population: The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Observed NNC0114-0006 Concentration Prior to Dosing of NNC0114-0006 at Steady State (Ctrough, NNC0114-0006) | 34.7 microgram/milliliter (ug/mL) | Geometric Coefficient of Variation 42.3 |
| NNC0114-0006 (Experimental) | Observed NNC0114-0006 Concentration Prior to Dosing of NNC0114-0006 at Steady State (Ctrough, NNC0114-0006) | 36.7 microgram/milliliter (ug/mL) | Geometric Coefficient of Variation 36.8 |
Secondary
Occurrence of Anti-liraglutide Antibodies
This outcome measure is applicable for NNC0114-0006 + Liraglutide treatment arm and Liraglutide treatment arm. Participants was assessed for anti-liraglutide antibodies. Participant who reported anti-liraglutide antibodies were further analyzed for cross-reactivity. Number of participants who measured with anti-liraglutide antibodies at week 54 and week 80 are presented.
Time frame: Week 0, week 54 and week 80
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Occurrence of Anti-liraglutide Antibodies | Week 0: Cross-reactivity to native GLP-1 | Positive | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Occurrence of Anti-liraglutide Antibodies | Week 54: Anti-Liraglutide antibodies | Positive | 1 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Occurrence of Anti-liraglutide Antibodies | Week 54: Anti-Liraglutide antibodies | Negative | 67 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Occurrence of Anti-liraglutide Antibodies | Week 0: Anti-Liraglutide antibodies | Negative | 77 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Occurrence of Anti-liraglutide Antibodies | Week 54: Cross-reactivity to native GLP-1 | Negative | 1 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Occurrence of Anti-liraglutide Antibodies | Week 0: Anti-Liraglutide antibodies | Positive | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Occurrence of Anti-liraglutide Antibodies | Week 54: Cross-reactivity to native GLP-1 | Positive | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Occurrence of Anti-liraglutide Antibodies | Week 80: Anti-Liraglutide antibodies | Positive | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Occurrence of Anti-liraglutide Antibodies | Week 80: Anti-Liraglutide antibodies | Negative | 67 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Occurrence of Anti-liraglutide Antibodies | Week 0: Cross-reactivity to native GLP-1 | Negative | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Occurrence of Anti-liraglutide Antibodies | Week 80: Cross-reactivity to native GLP-1 | Positive | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Occurrence of Anti-liraglutide Antibodies | Week 80: Cross-reactivity to native GLP-1 | Negative | 0 Participants |
| NNC0114-0006 (Experimental) | Occurrence of Anti-liraglutide Antibodies | Week 80: Cross-reactivity to native GLP-1 | Positive | 0 Participants |
| NNC0114-0006 (Experimental) | Occurrence of Anti-liraglutide Antibodies | Week 54: Anti-Liraglutide antibodies | Positive | 2 Participants |
| NNC0114-0006 (Experimental) | Occurrence of Anti-liraglutide Antibodies | Week 80: Anti-Liraglutide antibodies | Negative | 66 Participants |
| NNC0114-0006 (Experimental) | Occurrence of Anti-liraglutide Antibodies | Week 80: Cross-reactivity to native GLP-1 | Negative | 0 Participants |
| NNC0114-0006 (Experimental) | Occurrence of Anti-liraglutide Antibodies | Week 0: Anti-Liraglutide antibodies | Positive | 0 Participants |
| NNC0114-0006 (Experimental) | Occurrence of Anti-liraglutide Antibodies | Week 0: Cross-reactivity to native GLP-1 | Negative | 0 Participants |
| NNC0114-0006 (Experimental) | Occurrence of Anti-liraglutide Antibodies | Week 0: Cross-reactivity to native GLP-1 | Positive | 0 Participants |
| NNC0114-0006 (Experimental) | Occurrence of Anti-liraglutide Antibodies | Week 54: Anti-Liraglutide antibodies | Negative | 65 Participants |
| NNC0114-0006 (Experimental) | Occurrence of Anti-liraglutide Antibodies | Week 54: Cross-reactivity to native GLP-1 | Negative | 1 Participants |
| NNC0114-0006 (Experimental) | Occurrence of Anti-liraglutide Antibodies | Week 54: Cross-reactivity to native GLP-1 | Positive | 1 Participants |
| NNC0114-0006 (Experimental) | Occurrence of Anti-liraglutide Antibodies | Week 80: Anti-Liraglutide antibodies | Positive | 2 Participants |
| NNC0114-0006 (Experimental) | Occurrence of Anti-liraglutide Antibodies | Week 0: Anti-Liraglutide antibodies | Negative | 75 Participants |
Secondary
Occurrence of Anti-NNC0114-0006 Antibodies
This outcome measure was applicable for NNC0114-0006 + Liraglutide treatment arm and NNC0114-0006 treatment arm. Participants was assessed for anti-NNC0114-0006 antibodies. Participant who reported anti-NNC0114-0006 antibodies were further analyzed for cross-reactivity. Number of participants who measured with anti-NNC0114-0006 antibodies at week 54 and week 80 are presented.
Time frame: Week 0, week 54 and week 80
Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Occurrence of Anti-NNC0114-0006 Antibodies | Week 0: Anti-NNC0114-0006 antibodies | Positive | 9 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Occurrence of Anti-NNC0114-0006 Antibodies | Week 54: Cross-reactivity | Negative | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Occurrence of Anti-NNC0114-0006 Antibodies | Week 0: Cross-reactivity | Positive | 5 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Occurrence of Anti-NNC0114-0006 Antibodies | Week 54: Cross-reactivity | Positive | 0 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Occurrence of Anti-NNC0114-0006 Antibodies | Week 0: Anti-NNC0114-0006 antibodies | Negative | 68 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Occurrence of Anti-NNC0114-0006 Antibodies | Week 80: Anti-NNC0114-0006 antibodies | Negative | 65 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Occurrence of Anti-NNC0114-0006 Antibodies | Week 54: Anti-NNC0114-0006 | Negative | 68 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Occurrence of Anti-NNC0114-0006 Antibodies | Week 80: Anti-NNC0114-0006 antibodies | Positive | 2 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Occurrence of Anti-NNC0114-0006 Antibodies | Week 0: Cross-reactivity | Negative | 4 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Occurrence of Anti-NNC0114-0006 Antibodies | Week 80: Cross-reactivity | Negative | 1 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Occurrence of Anti-NNC0114-0006 Antibodies | Week 80: Cross-reactivity | Positive | 1 Participants |
| NNC0114-0006 + Liraglutide (Experimental) | Occurrence of Anti-NNC0114-0006 Antibodies | Week 54: Anti-NNC0114-0006 | Positive | 0 Participants |
| NNC0114-0006 (Experimental) | Occurrence of Anti-NNC0114-0006 Antibodies | Week 80: Cross-reactivity | Positive | 2 Participants |
| NNC0114-0006 (Experimental) | Occurrence of Anti-NNC0114-0006 Antibodies | Week 0: Anti-NNC0114-0006 antibodies | Negative | 62 Participants |
| NNC0114-0006 (Experimental) | Occurrence of Anti-NNC0114-0006 Antibodies | Week 0: Anti-NNC0114-0006 antibodies | Positive | 14 Participants |
| NNC0114-0006 (Experimental) | Occurrence of Anti-NNC0114-0006 Antibodies | Week 0: Cross-reactivity | Negative | 7 Participants |
| NNC0114-0006 (Experimental) | Occurrence of Anti-NNC0114-0006 Antibodies | Week 0: Cross-reactivity | Positive | 7 Participants |
| NNC0114-0006 (Experimental) | Occurrence of Anti-NNC0114-0006 Antibodies | Week 54: Anti-NNC0114-0006 | Negative | 62 Participants |
| NNC0114-0006 (Experimental) | Occurrence of Anti-NNC0114-0006 Antibodies | Week 54: Anti-NNC0114-0006 | Positive | 3 Participants |
| NNC0114-0006 (Experimental) | Occurrence of Anti-NNC0114-0006 Antibodies | Week 54: Cross-reactivity | Negative | 3 Participants |
| NNC0114-0006 (Experimental) | Occurrence of Anti-NNC0114-0006 Antibodies | Week 54: Cross-reactivity | Positive | 0 Participants |
| NNC0114-0006 (Experimental) | Occurrence of Anti-NNC0114-0006 Antibodies | Week 80: Anti-NNC0114-0006 antibodies | Negative | 60 Participants |
| NNC0114-0006 (Experimental) | Occurrence of Anti-NNC0114-0006 Antibodies | Week 80: Anti-NNC0114-0006 antibodies | Positive | 4 Participants |
| NNC0114-0006 (Experimental) | Occurrence of Anti-NNC0114-0006 Antibodies | Week 80: Cross-reactivity | Negative | 2 Participants |
Secondary
Terminal Half-life (t½) After Last Dose of NNC0114-0006
Terminal half life was calculated as log(2)/λz. The terminal rate constant λz was determined through linear regression with the logarithm to concentration as the response variable and actual measurement time as the explanatory variable. Valid observations from the terminal part of the curve, which is approximately linear, were used for the determination. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.
Time frame: Pre-dose and 1 hour post-dose during week 48 to week 80
Population: The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | Terminal Half-life (t½) After Last Dose of NNC0114-0006 | 22.3 Days | Geometric Coefficient of Variation 17.9 |
| NNC0114-0006 (Experimental) | Terminal Half-life (t½) After Last Dose of NNC0114-0006 | 22.2 Days | Geometric Coefficient of Variation 16.5 |