Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Asia. The aim of this trial is to confirm the efficacy of insulin degludec/liraglutide in controlling glycaemia in Chinese subjects with type 2 diabetes mellitus inadequately controlled on oral antidiabetic agents
Interventions
DRUGInsulin degludec/liraglutide
Subcutaneously (s.c., under the skin)administration once daily in combination with metformin. For 26 weeks.
DRUGInsulin degludec
Subcutaneously (s.c., under the skin)administration once daily in combination with metformin. For 26 weeks.
DRUGLiraglutide
Subcutaneously (s.c., under the skin)administration once daily in combination with metformin. For 26 weeks.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 * Type 2 diabetes mellitus (clinically diagnosed) * Male or female, age at least 18 years at the time of signing informed consent * HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis, with the aim of a median of8.3%. When approximately 50% of the randomised subjects have an HbA1c above 8.3%, the remaining subjects randomised must have an HbA1c below or equal to 8.3%; or when approximately 50% of the randomised subjects have an HbA1c below or equal to 8.3%, the remaining subjects randomised must have an HbA1c above 8.3% * Current treatment for at least 90 calendar days prior to screening with metformin plus/minus one other OAD: α-glucosidase inhibitors, sulphonylureas, glinides or thiazolidinediones. For above or equal to 60 calendar days prior to screening subjects should be on a stable dose of: * Metformin (above or equal to 1500 mg or max tolerated dose) or * Metformin (above or equal to 1500 mg or max tolerated dose) and sulphonylureas (above or equal to half of the max approved dose according to local label) or * Metformin (above or equal to 1500 mg or max tolerated dose) and glinides (above or equal to half of the max approved dose according to local label) or * Metformin (above or equal to 1500 mg or max tolerated dose) and α-glucosidase inhibitors (above or equal to half of the max approved dose according to local label) or * Metformin (above or equal to 1500 mg or max tolerated dose) and thiazolidinediones (above or equal to half of the max approved dose according to local label)
Exclusion criteria
* Treatment with insulin (except for short-term treatment at the discretion of the investigator) * Treatment with glucagon-like-peptide-1 receptor agonists or dipeptidyl-peptidase-4 inhibitors within 90 days prior to screening * Impaired liver function, defined as alanine aminotransferase above or equal to 2.5 times upper normal range * Impaired renal function defined as serum-creatinine above or equal to 133 μmol/L for males and above or equal to 125 μmol/L for females, or as defined according to local contraindications for metformin * Screening calcitonin above or equal to 50 ng/L * Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2) * Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months prior to screening and/or planned coronary, carotid or peripheral artery revascularisation procedures * Severe uncontrolled treated or untreated hypertension (systolic blood pressure above or equal to 180 mmHg or diastolic blood pressure above or equal to 100 mmHg * Proliferative retinopathy or maculopathy (macular oedema), requiring acute treatment * History of pancreatitis (acute or chronic)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | Week 0, week 26 | Change in HbA1c from baseline (week 0) after 26 weeks of treatment is presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline | Week 0, week 26 | Change in fasting VLDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline |
| Change in Fasting Triglycerides - Ratio to Baseline. | Week 0, week 26 | Change in fasting triglycerides (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline. |
| Change in Body Weight | Week 0, week 26 | Change in body weight from baseline (week 0) after 26 weeks of treatment is presented. |
| Number of Treatment Emergent Severe or BG Confirmed Hypoglycaemic Episodes | Weeks 0-26 | Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or blood glucose (BG) confirmed by a plasma glucose (PG) value \< 3.1 millimoles per liter (mmol/L) with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. The number of episodes are represented as rates. The observed rates of treatment-emergent severe or BG confirmed hypoglycaemic episodes per patient years of exposure (PYE) (number of episodes divided by PYE multiplied by 100) during 26 weeks of treatment are presented. |
| Insulin Dose | Week 26 | The actual daily total insulin dose after 26 weeks of treatment is presented. This outcome measure is only applicable for Insulin degludec/liraglutide and Insulin degludec treatment arms. |
| Participants Who Achieved HbA1c < 7.0%, American Diabetes Association (ADA) Target (Yes/no) | Week 26 | Number of participants who achieved ADA HbA1c target (HbA1c \< 7.0%) (yes/no) after 26 weeks of treatment are presented. |
| Participants Who Achieved HbA1c ≤ 6.5%, International Diabetes Federation (IDF) Target (Yes/no) | Week 26 | Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) after 26 weeks of treatment are presented. |
| Participants Who Achieved HbA1c <7.0% and Change in Body Weight From Baseline Below or Equal to Zero | Week 26 | Number of participants who achieved ADA HbA1c target (HbA1c \< 7.0%) (yes/no) and change from baseline in body weight below or equal to zero after 26 weeks are presented. Missing values are imputed by LOCF. |
| Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero | Week 26 | Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) and change from baseline in body weight below or equal to zero after 26 weeks are presented. Missing values are imputed by LOCF. |
| Participants Who Achieved HbA1c < 7.0% Without Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes | Week 26 | Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \<3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Number of participants who achieved ADA HbA1c target (HbA1c \<7.0%) (yes/no) after 26 weeks of treatment and without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment are presented. Missing values are imputed by LOCF. |
| Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Hypoglycaemic Episodes | Week 26 | Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) after 26 weeks of treatment and without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment are presented. Missing values are imputed by LOCF. |
| Participants Who Achieved HbA1c < 7.0% Without Severe or BG Confirmed Episodes, and Change From Baseline in Body Weight Below or Equal to Zero. | Week 26 | Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Number of participants who achieved ADA HbA1c target (HbA1c \< 7.0%) (yes/no) after 26 weeks of treatment without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment and with change from baseline in body weight below or equal to zero are presented. Missing values are imputed by LOCF. |
| Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Episodes and Change From Baseline in Body Weight Below or Equal to Zero. | Week 26 | Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) after 26 weeks of treatment without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment and with change from baseline in body weight below or equal to zero are presented. Missing values are imputed by LOCF. |
| Change in Fasting Plasma Glucose (FPG) | Week 0, week 26 | Change from baseline (week 0) in FPG after 26 weeks of treatment is presented. |
| Change in Waist Circumferance | Week 0, week 26 | Change from baseline (week 0) in waist circumferance after 26 weeks of treatment is presented. |
| 9-point SMPG Profile | Week 26 | Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). 9-point SMPG values at 26 weeks of treatment are presented. |
| Change in Mean of 9-point SMPG Profile | Week 0, week 26 | Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). The mean of profile is defined as the area under the profile divided by measurement time and is calculated using the trapezoidal method. Change in mean of the 9-point SMPG profile from baseline (week 0) to week 26 is presented. |
| Change in Fasting Free Fatty Acid - Ratio to Baseline | Week 0, week 26 | Change in fasting free fatty acid (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline. |
| Number of Treatment-emergent Adverse Events (TEAE) | Weeks 0-26 | A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. The observed rates of adverse events (AEs) per patient years of exposure (PYE) (number of AEs divided by PYE multiplied by 100) after 26 weeks are presented. |
| Change in Mean Post-prandial Plasma Glucose (PG) Increments | Week 0, week 26 | Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). Post-prandial SMPG increments from before meal to 90 minutes after for breakfast, lunch and dinner were calculated. The mean increment over all meals was derived as the mean of all available meal increments. Change from baseline (week 0) in post-prandial SMPG increments for all meals after 26 weeks of treatment is presented. |
| Change in Fasting C-peptide - Ratio to Baseline | Week 0, week 26 | Change in fasting C-peptide (measured in nanomoles per liter \[nmol/L\]) from baseline (week 0) to week 26 is presented as ratio to baseline. |
| Change in Fasting Human Insulin - Ratio to Baseline | Week 0, week 26 | Change in fasting human insulin (measured in picomoles per liter \[pmol/L\]) from baseline (week 0) to week 26 is presented as ratio to baseline. |
| Change in Fasting Glucagon - Ratio to Baseline | Week 0, week 26 | Change in fasting glucagon (measured in picograms per milliliter \[pg/mL\]) from baseline (week 0) to week 26 is presented as ratio to baseline. |
| Change in HOMA-B (Beta Cell Function)- Ratio to Baseline | Week 0, week 26 | Change in HOMA-B (measured in %) from baseline (week 0) to week 26 is presented as ratio to baseline. |
| Change in Fasting Total Cholesterol - Ratio to Baseline | Week 0, week 26 | Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline. |
| Change in Fasting High Density Lipoprotein (HDL) Cholesterol- Ratio to Baseline | Week 0, week 26 | Change in fasting HDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline |
| Number of Treatment Emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes. | Weeks 0-26 | Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as nocturnal if the time of the onset was between 00:01 and 05.59 both inclusive. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented. |
| Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes. | Weeks 0-26 | Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented. |
| Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | Weeks 0-26 | Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as nocturnal if the time of the onset was between 00:01 and 05.59 both inclusive. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented. |
| Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition | Weeks 0-26 | A hypoglycaemic episode was 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 7 days after the last day on trial product. The number of episodes are represented as rates. The observed rates of episodes (according to the ADA definition) per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented. |
| Change in Physical Examination | Week -2, week 26 | Physical examination parameters are categorised as cardiovascular system; central and peripheral nervous system; gastrointestinal system including mouth; general appearance; head, ears, eyes, nose, throat, neck; lymph node palpation; musculoskeletal system; respiratory system; skin and thyroid gland. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at screening (week -2) and week 26 per each category is presented. |
| Eye Examination | Week -2, Week 26 | Dilated fundoscopy or fundus photography was performed by the investigator at screening (week -2) and week 26. The results of the examination were interpreted for each eye (left and right) and are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at screening (week -2) and week 26 is presented. |
| Change in Electrocardiogram (ECG) | Week -2, week 26 | Electrocardiogram was assessed by the investigator as normal, abnormal NCS and abnormal CS. Number of participants at screening (week -2) and at week 26 is presented. |
| Change in Pulse | Week 0, week 26 | Change in pulse from baseline (week 0) after 26 weeks of treatment is presented |
| Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Week 0, week 26 | Change in blood pressure (systolic and diastolic blood pressure) from baseline (week 0) after 26 weeks of treatment is presented |
| Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum | Week 0, week 26 | Change in alkaline phosphatase, ALT, AST, creatine kinase, amylase, lipase, creatine kinase serum from baseline (week 0) after 26 weeks of treatment is presented. |
| Change in Biochemistry Parameters (Albumin Serum, Total Protein) | Week 0, week 26 | Change in total protein, albumin serum from baseline (week 0) after 26 weeks of treatment is presented. |
| Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum | Week 0, week 26 | Change in calcium serum (total), calcium corrected serum, potassium serum, sodium serum, urea serum from baseline (week 0) after 26 weeks of treatment is presented. |
| Change in Biochemistry Parameters: Total Bilirubin Serum, Creatinine Serum | Week 0, week 26 | Change in total bilirubin serum, creatinine serum from baseline (week 0) after 26 weeks of treatment is presented. |
| Change in Haematological Parameter: Erythrocytes Blood | Week 0, week 26 | Change in erythrocyte blood from baseline (week 0) after 26 weeks of treatment is presented. |
| Change in Haematological Parameter: Haematocrits | Week 0, week 26 | Change in haematocrits from baseline (week 0) after 26 weeks of treatment is presented. |
| Change in Haemotological Parameter- Eosinophils | Week 0, week 26 | Change in eosinophils from baseline after 26 weeks of treatment is presented. |
| Change in Haematological Parameter - Neutrophils | Week 0, week 26 | Change in neutrophils from baseline (week 0) after 26 weeks of treatment is presented. |
| Change in Haematological Parameter: Basophils | Week 0, week 26 | Change in basophils from baseline (week 0) after 26 weeks of treatment is presented. |
| Change in Haemotological Parameter- Monocytes | Week 0, week 26 | Change in monocytes from baseline (week 0) after 26 weeks of treatment is presented |
| Change in Haematological Parameter - Lymphocytes | Week 0, week 26 | Change in lymphocytes from baseline (week 0) after 26 weeks of treatment is presented |
| Change in Haematology: Haemoglobin Blood | Week 0, week 26 | Change in haemoglobin from baseline (week 0) after 26 weeks of treatment is presented. |
| Change in Haematologcal Parameter: Leukocytes | Week 0, week 26 | Change in leukocytes from baseline (week 0) after 26 weeks of treatment |
| Change in Haematological Parameter: Thrombocytes | Week 0, week 26 | Change in thrombocytes from baseline (week 0) after 26 weeks of treatment |
| Change in Calcitonin | Week 0, week 26 | Calcitonin levels were measured and were categorised as low, normal or high in relation to reference range (8.31- 14.3 picogram/milliliter \[pg/mL\]). Number of participants in each category at baseline (week 0) and week 26 are presented. |
| Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0, week 26 | The urinalysis assessment was the measurements of protein, glucose, erythrocytes and ketones in urine at baseline (week 0) and week 26 and categorised as negative, trace and positive. Number of participants in each category at week 0 and week 26 is presented. |
| Occurence of Anti-insulin Degludec Specific Antibodies | Week 27 | This outcome measure is only applicable for the insulin degludec/liraglutide arm and insulin degludec arm. Serum samples were analysed for the presence of anti-insulin degludec specific antibodies. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T). |
| Occurence of Antibodies Cross-reacting to Human Insulin | Week 27 | This outcome measure is only applicable for the insulin degludec/liraglutide arm and insulin degludec arm. Serum samples were analysed for the presence of cross-reacting antibodies to human insulin. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T). |
| Change in Fasting Low Density Lipoprotein (LDL) Cholesterol- Ratio to Baseline | Week 0, week 26 | Change in fasting LDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline. |
| Occurence of Anti-liraglutide Antibodies | Week 27 | This outcome measure is applicable for the Insulin degludec/liraglutide arm and the liraglutide arm. Serum samples were analysed for the presence of anti-liraglutide antibodies. Number of participants who were assessed for anti-liraglutide antibodies at week 27 are presented. |
| Occurence of Antibodies Cross-reacting to Native Glucagon-like Peptide (GLP-1) | Week 27 | This outcome measure is applicable to the Insulin degludec/liraglutide arm and the liraglutide arm. Serum samples were analysed for the presence of cross-reacting antibodies to native GLP-1. Number of participants who measured with anti-liraglutide antibodies cross reacting native GLP-1 at week 27 are presented. |
| Occurence of Neutralising Liraglutide Antibodies | Week 27 | This outcome measure is only applicable for the Insulin degludec/liraglutide arm and liraglutide arm. Neutralising antibodies were assessed when the corresponding anti-Liraglutide antibody were positive at week 27. Number of participants who measured with neutralising liraglutide antibodies at week 27 are presented. |
| Occurence of Neutralising Antibodies Cross-reacting to Native GLP-1 | Week 27 | This outcome measure is only applicable for the Insulin degludec/liraglutide arm and liraglutide arm. Cross reacting antibodies were assessed when anti-liraglutide antibody was positive. Number of participants who measured with neutralising liraglutide antibodies cross-reacting to native GLP-1 at week 27 are presented. |
| Serum Concentrations of Insulin Degludec | Week 0, week 26 | This outcome measure is applicable for Insulin degludec and Insulin degludec/liraglutide arms. Serum samples from the Insulin degludec/liraglutide and Insulin degludec arms were assayed using population PK analysis. The maximum serum concentrations (Cmax) are summarised for the two arms. |
| Plasma Concentration of Liraglutide | Week 0, week 26 | This outcome measure is for Insulin degludec/liraglutide and liraglutide arms. Serum samples from the Insulin degludec/liraglutide and liraglutide arms were assayed using population PK analysis. The Cmax are summarised for the two arms. |
| Occurence of Total Insulin Antibodies | Week 27 | This outcome measure is only applicable for the Insulin degludec/liraglutide arm and Insulin degludec arm. Serum samples were analysed for the presence of antobodies to human insulin. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T). |
Countries
China
Participant flow
Recruitment details
The trial was conducted at 38 sites in China mainland.
Pre-assignment details
Participants were randomised in a 2:1:1 manner to receive insulin degludec/liraglutide, insulin degludec or liraglutide in combination with metformin.
Participants by arm
| Arm | Count |
|---|---|
| Insulin Degludec/Liraglutide Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide. | 361 |
| Insulin Degludec Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec. | 179 |
| Liraglutide Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment. | 180 |
| Total | 720 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 1 | 15 |
| Overall Study | Lack of Efficacy | 0 | 0 | 4 |
| Overall Study | Non-compliance towards treatment | 2 | 0 | 0 |
| Overall Study | Pregnancy | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 3 | 2 | 1 |
| Overall Study | Severe hypoglycaemic episode | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 10 | 8 | 8 |
Baseline characteristics
| Characteristic | Insulin Degludec/Liraglutide | Insulin Degludec | Liraglutide | Total |
|---|---|---|---|---|
| Age, Continuous | 54.5 years STANDARD_DEVIATION 10.3 | 55.7 years STANDARD_DEVIATION 10.2 | 54.1 years STANDARD_DEVIATION 10.2 | 54.7 years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 361 Participants | 179 Participants | 180 Participants | 720 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Glycosylated haemoglobin (HbA1c) | 8.20 Percentage points of HbA1c STANDARD_DEVIATION 0.83 | 8.31 Percentage points of HbA1c STANDARD_DEVIATION 0.84 | 8.21 Percentage points of HbA1c STANDARD_DEVIATION 0.77 | 8.23 Percentage points of HbA1c STANDARD_DEVIATION 0.82 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 361 Participants | 179 Participants | 180 Participants | 720 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 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 |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Female | 142 Participants | 79 Participants | 72 Participants | 293 Participants |
| Sex/Gender, Customized Male | 219 Participants | 100 Participants | 108 Participants | 427 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 358 | 0 / 175 | 0 / 180 |
| other Total, other adverse events | 161 / 358 | 55 / 175 | 98 / 180 |
| serious Total, serious adverse events | 14 / 358 | 7 / 175 | 14 / 180 |
Outcome results
Primary
Change in HbA1c
Change in HbA1c from baseline (week 0) after 26 weeks of treatment is presented.
Time frame: Week 0, week 26
Population: FAS included all randomised participants. Overall number of participants analysed = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in HbA1c | -1.71 Percentage points of HbA1c | Standard Deviation 0.88 |
| Insulin Degludec | Change in HbA1c | -1.20 Percentage points of HbA1c | Standard Deviation 0.99 |
| Liraglutide | Change in HbA1c | -1.16 Percentage points of HbA1c | Standard Deviation 0.89 |
Comparison: The change from baseline in HbA1c after 26 weeks of treatment was analysed using an analysis of covariance (ANCOVA) model with treatment and previous oral anti-diabetic (OAD) treatment as fixed factors and baseline HbA1c as covariate. Missing values were imputed by last observation carried forward (LOCF).p-value: <0.000195% CI: [-0.73, -0.46]ANCOVA
Comparison: The change from baseline in HbA1c after 26 weeks of treatment was analysed using an ANCOVA model with treatment and previous OAD treatment as fixed factors and baseline HbA1c as covariate. Missing values were imputed by LOCF.p-value: <0.000195% CI: [-0.76, -0.49]ANCOVA
Secondary
9-point SMPG Profile
Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). 9-point SMPG values at 26 weeks of treatment are presented.
Time frame: Week 26
Population: FAS included all randomised participants. Number analysed= number of participants with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | 9-point SMPG Profile | 90 minutes after the start of the lunch | 8.87 mmol/L | Standard Deviation 2.15 |
| Insulin Degludec/Liraglutide | 9-point SMPG Profile | Before breakfast the following day | 5.35 mmol/L | Standard Deviation 0.96 |
| Insulin Degludec/Liraglutide | 9-point SMPG Profile | 90 minutes after start of the dinner | 9.33 mmol/L | Standard Deviation 2.4 |
| Insulin Degludec/Liraglutide | 9-point SMPG Profile | Before dinner | 6.52 mmol/L | Standard Deviation 1.77 |
| Insulin Degludec/Liraglutide | 9-point SMPG Profile | Before breakfast | 5.41 mmol/L | Standard Deviation 1.07 |
| Insulin Degludec/Liraglutide | 9-point SMPG Profile | At 4:00 am | 5.60 mmol/L | Standard Deviation 1.26 |
| Insulin Degludec/Liraglutide | 9-point SMPG Profile | Before lunch | 6.31 mmol/L | Standard Deviation 1.8 |
| Insulin Degludec/Liraglutide | 9-point SMPG Profile | 90 minutes after the start of breakfast | 8.97 mmol/L | Standard Deviation 2.48 |
| Insulin Degludec/Liraglutide | 9-point SMPG Profile | At bedtime | 7.99 mmol/L | Standard Deviation 2.28 |
| Insulin Degludec | 9-point SMPG Profile | Before dinner | 7.39 mmol/L | Standard Deviation 2.23 |
| Insulin Degludec | 9-point SMPG Profile | Before breakfast | 5.66 mmol/L | Standard Deviation 1.2 |
| Insulin Degludec | 9-point SMPG Profile | 90 minutes after the start of breakfast | 9.85 mmol/L | Standard Deviation 2.73 |
| Insulin Degludec | 9-point SMPG Profile | Before lunch | 7.10 mmol/L | Standard Deviation 2.35 |
| Insulin Degludec | 9-point SMPG Profile | 90 minutes after the start of the lunch | 10.18 mmol/L | Standard Deviation 2.81 |
| Insulin Degludec | 9-point SMPG Profile | 90 minutes after start of the dinner | 10.27 mmol/L | Standard Deviation 2.68 |
| Insulin Degludec | 9-point SMPG Profile | At bedtime | 8.86 mmol/L | Standard Deviation 2.38 |
| Insulin Degludec | 9-point SMPG Profile | At 4:00 am | 6.12 mmol/L | Standard Deviation 1.75 |
| Insulin Degludec | 9-point SMPG Profile | Before breakfast the following day | 5.47 mmol/L | Standard Deviation 1.07 |
| Liraglutide | 9-point SMPG Profile | Before lunch | 7.48 mmol/L | Standard Deviation 2.14 |
| Liraglutide | 9-point SMPG Profile | Before breakfast | 6.89 mmol/L | Standard Deviation 1.37 |
| Liraglutide | 9-point SMPG Profile | At bedtime | 8.49 mmol/L | Standard Deviation 2.26 |
| Liraglutide | 9-point SMPG Profile | 90 minutes after the start of breakfast | 10.04 mmol/L | Standard Deviation 2.81 |
| Liraglutide | 9-point SMPG Profile | Before breakfast the following day | 6.81 mmol/L | Standard Deviation 1.47 |
| Liraglutide | 9-point SMPG Profile | Before dinner | 7.50 mmol/L | Standard Deviation 2.11 |
| Liraglutide | 9-point SMPG Profile | 90 minutes after the start of the lunch | 9.54 mmol/L | Standard Deviation 2.43 |
| Liraglutide | 9-point SMPG Profile | At 4:00 am | 6.86 mmol/L | Standard Deviation 1.6 |
| Liraglutide | 9-point SMPG Profile | 90 minutes after start of the dinner | 9.45 mmol/L | Standard Deviation 2.13 |
Secondary
Change in Biochemistry Parameters (Albumin Serum, Total Protein)
Change in total protein, albumin serum from baseline (week 0) after 26 weeks of treatment is presented.
Time frame: Week 0, week 26
Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameters (Albumin Serum, Total Protein) | Albumin serum | -0.05 grams per decileter (g/dL) | Standard Deviation 0.28 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameters (Albumin Serum, Total Protein) | Total protein | -0.08 grams per decileter (g/dL) | Standard Deviation 0.42 |
| Insulin Degludec | Change in Biochemistry Parameters (Albumin Serum, Total Protein) | Albumin serum | -0.09 grams per decileter (g/dL) | Standard Deviation 0.26 |
| Insulin Degludec | Change in Biochemistry Parameters (Albumin Serum, Total Protein) | Total protein | -0.08 grams per decileter (g/dL) | Standard Deviation 0.39 |
| Liraglutide | Change in Biochemistry Parameters (Albumin Serum, Total Protein) | Albumin serum | 0.04 grams per decileter (g/dL) | Standard Deviation 0.26 |
| Liraglutide | Change in Biochemistry Parameters (Albumin Serum, Total Protein) | Total protein | -0.01 grams per decileter (g/dL) | Standard Deviation 0.39 |
Secondary
Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum
Change in alkaline phosphatase, ALT, AST, creatine kinase, amylase, lipase, creatine kinase serum from baseline (week 0) after 26 weeks of treatment is presented.
Time frame: Week 0, week 26
Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum | Alkaline phosphatase | -2.0 Units per liter (U/L) | Standard Deviation 14.85 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum | ALT | -4.63 Units per liter (U/L) | Standard Deviation 13.06 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum | AST | -1.31 Units per liter (U/L) | Standard Deviation 7.94 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum | Creatine kinase | 10.67 Units per liter (U/L) | Standard Deviation 100.87 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum | Amylase | 9.84 Units per liter (U/L) | Standard Deviation 36.73 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum | Lipase | 16.13 Units per liter (U/L) | Standard Deviation 101.19 |
| Insulin Degludec | Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum | Lipase | -1.87 Units per liter (U/L) | Standard Deviation 15.64 |
| Insulin Degludec | Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum | Alkaline phosphatase | -2.29 Units per liter (U/L) | Standard Deviation 11.49 |
| Insulin Degludec | Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum | Creatine kinase | 15.37 Units per liter (U/L) | Standard Deviation 52.99 |
| Insulin Degludec | Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum | Amylase | 5.09 Units per liter (U/L) | Standard Deviation 14.68 |
| Insulin Degludec | Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum | ALT | -6.17 Units per liter (U/L) | Standard Deviation 13.54 |
| Insulin Degludec | Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum | AST | -2.65 Units per liter (U/L) | Standard Deviation 8.4 |
| Liraglutide | Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum | ALT | -2.81 Units per liter (U/L) | Standard Deviation 16.97 |
| Liraglutide | Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum | AST | -0.99 Units per liter (U/L) | Standard Deviation 9.64 |
| Liraglutide | Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum | Lipase | 14.11 Units per liter (U/L) | Standard Deviation 19.76 |
| Liraglutide | Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum | Creatine kinase | 0.52 Units per liter (U/L) | Standard Deviation 56.2 |
| Liraglutide | Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum | Alkaline phosphatase | -0.48 Units per liter (U/L) | Standard Deviation 14.11 |
| Liraglutide | Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum | Amylase | 5.68 Units per liter (U/L) | Standard Deviation 13.7 |
Secondary
Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum
Change in calcium serum (total), calcium corrected serum, potassium serum, sodium serum, urea serum from baseline (week 0) after 26 weeks of treatment is presented.
Time frame: Week 0, week 26
Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum | Urea serum | 0.05 mmol/L | Standard Deviation 0.57 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum | Sodium serum | 1.21 mmol/L | Standard Deviation 2.09 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum | Calcium serum (total) | -0.01 mmol/L | Standard Deviation 0.1 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum | Calcium corrected serum | -0.00 mmol/L | Standard Deviation 0.08 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum | Potassium serum | -0.04 mmol/L | Standard Deviation 0.34 |
| Insulin Degludec | Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum | Sodium serum | 0.98 mmol/L | Standard Deviation 2.37 |
| Insulin Degludec | Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum | Calcium serum (total) | -0.02 mmol/L | Standard Deviation 0.1 |
| Insulin Degludec | Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum | Calcium corrected serum | -0.00 mmol/L | Standard Deviation 0.08 |
| Insulin Degludec | Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum | Urea serum | 0.03 mmol/L | Standard Deviation 0.53 |
| Insulin Degludec | Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum | Potassium serum | -0.09 mmol/L | Standard Deviation 0.39 |
| Liraglutide | Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum | Potassium serum | -0.04 mmol/L | Standard Deviation 0.34 |
| Liraglutide | Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum | Urea serum | 0.16 mmol/L | Standard Deviation 0.67 |
| Liraglutide | Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum | Calcium serum (total) | -0.00 mmol/L | Standard Deviation 0.09 |
| Liraglutide | Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum | Sodium serum | 0.32 mmol/L | Standard Deviation 2.12 |
| Liraglutide | Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum | Calcium corrected serum | -0.01 mmol/L | Standard Deviation 0.07 |
Secondary
Change in Biochemistry Parameters: Total Bilirubin Serum, Creatinine Serum
Change in total bilirubin serum, creatinine serum from baseline (week 0) after 26 weeks of treatment is presented.
Time frame: Week 0, week 26
Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameters: Total Bilirubin Serum, Creatinine Serum | Total bilirubin | -0.78 micromoles per liter (umol/L) | Standard Deviation 3.35 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameters: Total Bilirubin Serum, Creatinine Serum | creatinine serum | 1.02 micromoles per liter (umol/L) | Standard Deviation 8.41 |
| Insulin Degludec | Change in Biochemistry Parameters: Total Bilirubin Serum, Creatinine Serum | Total bilirubin | -0.55 micromoles per liter (umol/L) | Standard Deviation 4.52 |
| Insulin Degludec | Change in Biochemistry Parameters: Total Bilirubin Serum, Creatinine Serum | creatinine serum | 1.36 micromoles per liter (umol/L) | Standard Deviation 7.92 |
| Liraglutide | Change in Biochemistry Parameters: Total Bilirubin Serum, Creatinine Serum | Total bilirubin | -1.16 micromoles per liter (umol/L) | Standard Deviation 3.92 |
| Liraglutide | Change in Biochemistry Parameters: Total Bilirubin Serum, Creatinine Serum | creatinine serum | -0.60 micromoles per liter (umol/L) | Standard Deviation 7.89 |
Secondary
Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
Change in blood pressure (systolic and diastolic blood pressure) from baseline (week 0) after 26 weeks of treatment is presented
Time frame: Week 0, week 26
Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Systolic blood pressure | -3.5 Millimeters of mercury (mmHg) | Standard Deviation 12.7 |
| Insulin Degludec/Liraglutide | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Distolic blood pressure | -0.4 Millimeters of mercury (mmHg) | Standard Deviation 8.3 |
| Insulin Degludec | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Systolic blood pressure | -1.2 Millimeters of mercury (mmHg) | Standard Deviation 11.7 |
| Insulin Degludec | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Distolic blood pressure | -0.7 Millimeters of mercury (mmHg) | Standard Deviation 8.1 |
| Liraglutide | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Systolic blood pressure | -3.3 Millimeters of mercury (mmHg) | Standard Deviation 13.8 |
| Liraglutide | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Distolic blood pressure | 0.0 Millimeters of mercury (mmHg) | Standard Deviation 8.4 |
Secondary
Change in Body Weight
Change in body weight from baseline (week 0) after 26 weeks of treatment is presented.
Time frame: Week 0, week 26
Population: FAS included all randomised participants. Overall number of participants analysed = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Body Weight | 0.2 Kilogram (Kg) | Standard Deviation 2.7 |
| Insulin Degludec | Change in Body Weight | 1.3 Kilogram (Kg) | Standard Deviation 2.7 |
| Liraglutide | Change in Body Weight | -2.5 Kilogram (Kg) | Standard Deviation 2.7 |
Secondary
Change in Calcitonin
Calcitonin levels were measured and were categorised as low, normal or high in relation to reference range (8.31- 14.3 picogram/milliliter \[pg/mL\]). Number of participants in each category at baseline (week 0) and week 26 are presented.
Time frame: Week 0, week 26
Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Number analysed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Calcitonin | Week 0 | Low | 0 Participants |
| Insulin Degludec/Liraglutide | Change in Calcitonin | Week 0 | Normal | 351 Participants |
| Insulin Degludec/Liraglutide | Change in Calcitonin | Week 0 | High | 7 Participants |
| Insulin Degludec/Liraglutide | Change in Calcitonin | Week 26 | Low | 0 Participants |
| Insulin Degludec/Liraglutide | Change in Calcitonin | Week 26 | Normal | 334 Participants |
| Insulin Degludec/Liraglutide | Change in Calcitonin | Week 26 | High | 6 Participants |
| Insulin Degludec | Change in Calcitonin | Week 26 | High | 2 Participants |
| Insulin Degludec | Change in Calcitonin | Week 0 | Low | 0 Participants |
| Insulin Degludec | Change in Calcitonin | Week 26 | Low | 0 Participants |
| Insulin Degludec | Change in Calcitonin | Week 26 | Normal | 165 Participants |
| Insulin Degludec | Change in Calcitonin | Week 0 | Normal | 172 Participants |
| Insulin Degludec | Change in Calcitonin | Week 0 | High | 3 Participants |
| Liraglutide | Change in Calcitonin | Week 0 | Normal | 178 Participants |
| Liraglutide | Change in Calcitonin | Week 0 | High | 2 Participants |
| Liraglutide | Change in Calcitonin | Week 26 | High | 3 Participants |
| Liraglutide | Change in Calcitonin | Week 26 | Low | 0 Participants |
| Liraglutide | Change in Calcitonin | Week 0 | Low | 0 Participants |
| Liraglutide | Change in Calcitonin | Week 26 | Normal | 147 Participants |
Secondary
Change in Electrocardiogram (ECG)
Electrocardiogram was assessed by the investigator as normal, abnormal NCS and abnormal CS. Number of participants at screening (week -2) and at week 26 is presented.
Time frame: Week -2, week 26
Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Number of participants analyzed = participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Electrocardiogram (ECG) | Week -2 | Normal | 223 Participants |
| Insulin Degludec/Liraglutide | Change in Electrocardiogram (ECG) | Week -2 | Abnormal, NCS | 94 Participants |
| Insulin Degludec/Liraglutide | Change in Electrocardiogram (ECG) | Week -2 | Abnormal CS | 41 Participants |
| Insulin Degludec/Liraglutide | Change in Electrocardiogram (ECG) | Week 26 | Normal | 227 Participants |
| Insulin Degludec/Liraglutide | Change in Electrocardiogram (ECG) | Week 26 | Abnormal, NCS | 76 Participants |
| Insulin Degludec/Liraglutide | Change in Electrocardiogram (ECG) | Week 26 | Abnormal CS | 38 Participants |
| Insulin Degludec | Change in Electrocardiogram (ECG) | Week 26 | Abnormal CS | 12 Participants |
| Insulin Degludec | Change in Electrocardiogram (ECG) | Week -2 | Normal | 109 Participants |
| Insulin Degludec | Change in Electrocardiogram (ECG) | Week 26 | Normal | 108 Participants |
| Insulin Degludec | Change in Electrocardiogram (ECG) | Week 26 | Abnormal, NCS | 47 Participants |
| Insulin Degludec | Change in Electrocardiogram (ECG) | Week -2 | Abnormal, NCS | 46 Participants |
| Insulin Degludec | Change in Electrocardiogram (ECG) | Week -2 | Abnormal CS | 20 Participants |
| Liraglutide | Change in Electrocardiogram (ECG) | Week -2 | Abnormal, NCS | 52 Participants |
| Liraglutide | Change in Electrocardiogram (ECG) | Week -2 | Abnormal CS | 20 Participants |
| Liraglutide | Change in Electrocardiogram (ECG) | Week 26 | Abnormal CS | 24 Participants |
| Liraglutide | Change in Electrocardiogram (ECG) | Week 26 | Normal | 87 Participants |
| Liraglutide | Change in Electrocardiogram (ECG) | Week -2 | Normal | 108 Participants |
| Liraglutide | Change in Electrocardiogram (ECG) | Week 26 | Abnormal, NCS | 40 Participants |
Secondary
Change in Fasting C-peptide - Ratio to Baseline
Change in fasting C-peptide (measured in nanomoles per liter \[nmol/L\]) from baseline (week 0) to week 26 is presented as ratio to baseline.
Time frame: Week 0, week 26
Population: FAS included all randomised participants. Overall, number of participants analysed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting C-peptide - Ratio to Baseline | 0.54 Ratio of fasting C-peptide | Geometric Coefficient of Variation 52.8 |
| Insulin Degludec | Change in Fasting C-peptide - Ratio to Baseline | 0.38 Ratio of fasting C-peptide | Geometric Coefficient of Variation 68.5 |
| Liraglutide | Change in Fasting C-peptide - Ratio to Baseline | 0.98 Ratio of fasting C-peptide | Geometric Coefficient of Variation 37.6 |
Secondary
Change in Fasting Free Fatty Acid - Ratio to Baseline
Change in fasting free fatty acid (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.
Time frame: Week 0, week 26
Population: FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting Free Fatty Acid - Ratio to Baseline | 0.55 Ratio of fasting free fatty acid | Geometric Coefficient of Variation 69.9 |
| Insulin Degludec | Change in Fasting Free Fatty Acid - Ratio to Baseline | 0.48 Ratio of fasting free fatty acid | Geometric Coefficient of Variation 76.5 |
| Liraglutide | Change in Fasting Free Fatty Acid - Ratio to Baseline | 0.80 Ratio of fasting free fatty acid | Geometric Coefficient of Variation 69.3 |
Secondary
Change in Fasting Glucagon - Ratio to Baseline
Change in fasting glucagon (measured in picograms per milliliter \[pg/mL\]) from baseline (week 0) to week 26 is presented as ratio to baseline.
Time frame: Week 0, week 26
Population: FAS included all randomised participants. Overall number of particiapants analysed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting Glucagon - Ratio to Baseline | 0.90 Ratio of fasting glucagon | Geometric Coefficient of Variation 76.6 |
| Insulin Degludec | Change in Fasting Glucagon - Ratio to Baseline | 0.95 Ratio of fasting glucagon | Geometric Coefficient of Variation 56.4 |
| Liraglutide | Change in Fasting Glucagon - Ratio to Baseline | 0.98 Ratio of fasting glucagon | Geometric Coefficient of Variation 75.9 |
Secondary
Change in Fasting High Density Lipoprotein (HDL) Cholesterol- Ratio to Baseline
Change in fasting HDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline
Time frame: Week 0, week 26
Population: FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting High Density Lipoprotein (HDL) Cholesterol- Ratio to Baseline | 1.01 Ratio of fasting HDL cholesterol | Geometric Coefficient of Variation 14.7 |
| Insulin Degludec | Change in Fasting High Density Lipoprotein (HDL) Cholesterol- Ratio to Baseline | 1.02 Ratio of fasting HDL cholesterol | Geometric Coefficient of Variation 15.7 |
| Liraglutide | Change in Fasting High Density Lipoprotein (HDL) Cholesterol- Ratio to Baseline | 1.03 Ratio of fasting HDL cholesterol | Geometric Coefficient of Variation 14.8 |
Secondary
Change in Fasting Human Insulin - Ratio to Baseline
Change in fasting human insulin (measured in picomoles per liter \[pmol/L\]) from baseline (week 0) to week 26 is presented as ratio to baseline.
Time frame: Week 0, week 26
Population: FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting Human Insulin - Ratio to Baseline | 0.53 Ratio of fasting human insulin | Geometric Coefficient of Variation 71.7 |
| Insulin Degludec | Change in Fasting Human Insulin - Ratio to Baseline | 0.38 Ratio of fasting human insulin | Geometric Coefficient of Variation 77.6 |
| Liraglutide | Change in Fasting Human Insulin - Ratio to Baseline | 1.04 Ratio of fasting human insulin | Geometric Coefficient of Variation 53.3 |
Secondary
Change in Fasting Low Density Lipoprotein (LDL) Cholesterol- Ratio to Baseline
Change in fasting LDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.
Time frame: Week 0, week 26
Population: FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting Low Density Lipoprotein (LDL) Cholesterol- Ratio to Baseline | 0.92 Ratio of fasting LDL cholesterol | Geometric Coefficient of Variation 34.2 |
| Insulin Degludec | Change in Fasting Low Density Lipoprotein (LDL) Cholesterol- Ratio to Baseline | 1.01 Ratio of fasting LDL cholesterol | Geometric Coefficient of Variation 36.2 |
| Liraglutide | Change in Fasting Low Density Lipoprotein (LDL) Cholesterol- Ratio to Baseline | 0.96 Ratio of fasting LDL cholesterol | Geometric Coefficient of Variation 34.4 |
Secondary
Change in Fasting Plasma Glucose (FPG)
Change from baseline (week 0) in FPG after 26 weeks of treatment is presented.
Time frame: Week 0, week 26
Population: FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting Plasma Glucose (FPG) | -3.64 mmol/L | Standard Deviation 2.27 |
| Insulin Degludec | Change in Fasting Plasma Glucose (FPG) | -3.45 mmol/L | Standard Deviation 2.34 |
| Liraglutide | Change in Fasting Plasma Glucose (FPG) | -1.86 mmol/L | Standard Deviation 2.11 |
Secondary
Change in Fasting Total Cholesterol - Ratio to Baseline
Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.
Time frame: Week 0, week 26
Population: FAS included all randomised participants. Overall number of participants analysed = number of participants with available data
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting Total Cholesterol - Ratio to Baseline | 0.94 Ratio of fasting total cholesterol | Geometric Coefficient of Variation 19.1 |
| Insulin Degludec | Change in Fasting Total Cholesterol - Ratio to Baseline | 0.99 Ratio of fasting total cholesterol | Geometric Coefficient of Variation 16.8 |
| Liraglutide | Change in Fasting Total Cholesterol - Ratio to Baseline | 0.97 Ratio of fasting total cholesterol | Geometric Coefficient of Variation 17.7 |
Secondary
Change in Fasting Triglycerides - Ratio to Baseline.
Change in fasting triglycerides (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.
Time frame: Week 0, week 26
Population: FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting Triglycerides - Ratio to Baseline. | 0.88 Ratio of fasting triglycerides | Geometric Coefficient of Variation 54.4 |
| Insulin Degludec | Change in Fasting Triglycerides - Ratio to Baseline. | 0.82 Ratio of fasting triglycerides | Geometric Coefficient of Variation 50.5 |
| Liraglutide | Change in Fasting Triglycerides - Ratio to Baseline. | 0.90 Ratio of fasting triglycerides | Geometric Coefficient of Variation 45.2 |
Secondary
Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline
Change in fasting VLDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline
Time frame: Week 0, week 26
Population: FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline | 0.90 Ratio of fasting VLDL cholesterol | Geometric Coefficient of Variation 49.9 |
| Insulin Degludec | Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline | 0.84 Ratio of fasting VLDL cholesterol | Geometric Coefficient of Variation 47.2 |
| Liraglutide | Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline | 0.92 Ratio of fasting VLDL cholesterol | Geometric Coefficient of Variation 38.6 |
Secondary
Change in Haematologcal Parameter: Leukocytes
Change in leukocytes from baseline (week 0) after 26 weeks of treatment
Time frame: Week 0, week 26
Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Haematologcal Parameter: Leukocytes | 0.25 10^9 cells per liter (10^9/L) | Standard Deviation 1.18 |
| Insulin Degludec | Change in Haematologcal Parameter: Leukocytes | 0.23 10^9 cells per liter (10^9/L) | Standard Deviation 1.41 |
| Liraglutide | Change in Haematologcal Parameter: Leukocytes | -0.01 10^9 cells per liter (10^9/L) | Standard Deviation 1.14 |
Secondary
Change in Haematological Parameter: Basophils
Change in basophils from baseline (week 0) after 26 weeks of treatment is presented.
Time frame: Week 0, week 26
Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Haematological Parameter: Basophils | -0.02 % of basophils | Standard Deviation 0.29 |
| Insulin Degludec | Change in Haematological Parameter: Basophils | -0.01 % of basophils | Standard Deviation 0.28 |
| Liraglutide | Change in Haematological Parameter: Basophils | -0.03 % of basophils | Standard Deviation 0.26 |
Secondary
Change in Haematological Parameter: Erythrocytes Blood
Change in erythrocyte blood from baseline (week 0) after 26 weeks of treatment is presented.
Time frame: Week 0, week 26
Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Haematological Parameter: Erythrocytes Blood | -0.05 10^12 cells per liter (10^12/L) | Standard Deviation 0.27 |
| Insulin Degludec | Change in Haematological Parameter: Erythrocytes Blood | -0.00 10^12 cells per liter (10^12/L) | Standard Deviation 0.27 |
| Liraglutide | Change in Haematological Parameter: Erythrocytes Blood | -0.05 10^12 cells per liter (10^12/L) | Standard Deviation 0.25 |
Secondary
Change in Haematological Parameter: Haematocrits
Change in haematocrits from baseline (week 0) after 26 weeks of treatment is presented.
Time frame: Week 0, week 26
Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Haematological Parameter: Haematocrits | -0.56 Percentage points (%) of red blood cells | Standard Deviation 2.65 |
| Insulin Degludec | Change in Haematological Parameter: Haematocrits | -0.49 Percentage points (%) of red blood cells | Standard Deviation 2.69 |
| Liraglutide | Change in Haematological Parameter: Haematocrits | -0.42 Percentage points (%) of red blood cells | Standard Deviation 2.57 |
Secondary
Change in Haematological Parameter - Lymphocytes
Change in lymphocytes from baseline (week 0) after 26 weeks of treatment is presented
Time frame: Week 0, week 26
Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Haematological Parameter - Lymphocytes | -0.46 % of lymphocytes | Standard Deviation 6.04 |
| Insulin Degludec | Change in Haematological Parameter - Lymphocytes | -0.38 % of lymphocytes | Standard Deviation 7.12 |
| Liraglutide | Change in Haematological Parameter - Lymphocytes | 0.40 % of lymphocytes | Standard Deviation 6.11 |
Secondary
Change in Haematological Parameter - Neutrophils
Change in neutrophils from baseline (week 0) after 26 weeks of treatment is presented.
Time frame: Week 0, week 26
Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Haematological Parameter - Neutrophils | 0.57 % of neutrophils | Standard Deviation 6.46 |
| Insulin Degludec | Change in Haematological Parameter - Neutrophils | 0.18 % of neutrophils | Standard Deviation 7.7 |
| Liraglutide | Change in Haematological Parameter - Neutrophils | -0.53 % of neutrophils | Standard Deviation 7.05 |
Secondary
Change in Haematological Parameter: Thrombocytes
Change in thrombocytes from baseline (week 0) after 26 weeks of treatment
Time frame: Week 0, week 26
Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Haematological Parameter: Thrombocytes | 8.19 10^9 cells per liter (10^9/L) | Standard Deviation 28.02 |
| Insulin Degludec | Change in Haematological Parameter: Thrombocytes | 8.32 10^9 cells per liter (10^9/L) | Standard Deviation 34.48 |
| Liraglutide | Change in Haematological Parameter: Thrombocytes | 4.32 10^9 cells per liter (10^9/L) | Standard Deviation 33.39 |
Secondary
Change in Haematology: Haemoglobin Blood
Change in haemoglobin from baseline (week 0) after 26 weeks of treatment is presented.
Time frame: Week 0, week 26
Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Haematology: Haemoglobin Blood | -0.10 mmol/L | Standard Deviation 0.53 |
| Insulin Degludec | Change in Haematology: Haemoglobin Blood | -0.06 mmol/L | Standard Deviation 0.48 |
| Liraglutide | Change in Haematology: Haemoglobin Blood | -0.05 mmol/L | Standard Deviation 0.47 |
Secondary
Change in Haemotological Parameter- Eosinophils
Change in eosinophils from baseline after 26 weeks of treatment is presented.
Time frame: Week 0, week 26
Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Haemotological Parameter- Eosinophils | -0.06 % of eosinophils | Standard Deviation 1.9 |
| Insulin Degludec | Change in Haemotological Parameter- Eosinophils | 0.19 % of eosinophils | Standard Deviation 1.73 |
| Liraglutide | Change in Haemotological Parameter- Eosinophils | 0.11 % of eosinophils | Standard Deviation 1.94 |
Secondary
Change in Haemotological Parameter- Monocytes
Change in monocytes from baseline (week 0) after 26 weeks of treatment is presented
Time frame: Week 0, week 26
Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Haemotological Parameter- Monocytes | -0.03 % of monocytes | Standard Deviation 1.92 |
| Insulin Degludec | Change in Haemotological Parameter- Monocytes | 0.01 % of monocytes | Standard Deviation 1.85 |
| Liraglutide | Change in Haemotological Parameter- Monocytes | 0.05 % of monocytes | Standard Deviation 2.13 |
Secondary
Change in HOMA-B (Beta Cell Function)- Ratio to Baseline
Change in HOMA-B (measured in %) from baseline (week 0) to week 26 is presented as ratio to baseline.
Time frame: Week 0, week 26
Population: FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in HOMA-B (Beta Cell Function)- Ratio to Baseline | 1.38 Ratio of HOMA-B (beta cell function) | Geometric Coefficient of Variation 77.3 |
| Insulin Degludec | Change in HOMA-B (Beta Cell Function)- Ratio to Baseline | 0.94 Ratio of HOMA-B (beta cell function) | Geometric Coefficient of Variation 77.4 |
| Liraglutide | Change in HOMA-B (Beta Cell Function)- Ratio to Baseline | 1.53 Ratio of HOMA-B (beta cell function) | Geometric Coefficient of Variation 63.8 |
Secondary
Change in Mean of 9-point SMPG Profile
Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). The mean of profile is defined as the area under the profile divided by measurement time and is calculated using the trapezoidal method. Change in mean of the 9-point SMPG profile from baseline (week 0) to week 26 is presented.
Time frame: Week 0, week 26
Population: FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Mean of 9-point SMPG Profile | -3.17 mmol/L | Standard Deviation 2.16 |
| Insulin Degludec | Change in Mean of 9-point SMPG Profile | -2.47 mmol/L | Standard Deviation 2.14 |
| Liraglutide | Change in Mean of 9-point SMPG Profile | -2.13 mmol/L | Standard Deviation 2.02 |
Secondary
Change in Mean Post-prandial Plasma Glucose (PG) Increments
Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). Post-prandial SMPG increments from before meal to 90 minutes after for breakfast, lunch and dinner were calculated. The mean increment over all meals was derived as the mean of all available meal increments. Change from baseline (week 0) in post-prandial SMPG increments for all meals after 26 weeks of treatment is presented.
Time frame: Week 0, week 26
Population: FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Mean Post-prandial Plasma Glucose (PG) Increments | -0.20 mmol/L | Standard Deviation 2.4 |
| Insulin Degludec | Change in Mean Post-prandial Plasma Glucose (PG) Increments | 0.09 mmol/L | Standard Deviation 2.4 |
| Liraglutide | Change in Mean Post-prandial Plasma Glucose (PG) Increments | -0.54 mmol/L | Standard Deviation 2.57 |
Secondary
Change in Physical Examination
Physical examination parameters are categorised as cardiovascular system; central and peripheral nervous system; gastrointestinal system including mouth; general appearance; head, ears, eyes, nose, throat, neck; lymph node palpation; musculoskeletal system; respiratory system; skin and thyroid gland. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at screening (week -2) and week 26 per each category is presented.
Time frame: Week -2, week 26
Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analyzed=participants with available data
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: General appearance | Abnormal CS | 4 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Central and peripheral nervous system | Abnormal, NCS | 1 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Musculoskeletal system | Abnormal CS | 7 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: General appearance | Normal | 336 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Thyroid gland | Abnormal CS | 4 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Musculoskeletal system | Normal | 332 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: General appearance | Abnormal, NCS | 2 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Cardiovascular system | Abnormal CS | 2 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Musculoskeletal system | Abnormal CS | 3 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: General appearance | Abnormal CS | 3 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Central and peripheral nervous system | Abnormal CS | 2 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Musculoskeletal system | Abnormal, NCS | 2 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Head, ears, eyes, nose, throat, neck | Normal | 348 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Thyroid gland | Normal | 334 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Musculoskeletal system | Normal | 353 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Head, ears, eyes, nose, throat, neck | Abnormal, NCS | 6 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Skin | Abnormal, NCS | 36 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Lymph node palpation | Abnormal CS | 1 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Head, ears, eyes, nose, throat, neck | Abnormal CS | 4 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Central and peripheral nervous system | Normal | 338 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Cardiovascular system | Normal | 336 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Lymph node palpation | Abnormal, NCS | 0 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Head, ears, eyes, nose, throat, neck | Normal | 332 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Lymph node palpation | Normal | 340 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Head, ears, eyes, nose, throat, neck | Abnormal, NCS | 6 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Skin | Normal | 297 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Lymph node palpation | Abnormal CS | 1 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Head, ears, eyes, nose, throat, neck | Abnormal CS | 3 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Central and peripheral nervous system | Abnormal, NCS | 1 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Lymph node palpation | Abnormal, NCS | 0 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Lymph node palpation | Normal | 357 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Cardiovascular system | Abnormal, NCS | 2 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | week -2: Skin | Abnormal CS | 9 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Central and peripheral nervous system | Abnormal CS | 2 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Thyroid gland | Abnormal, NCS | 5 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | week -2: Skin | Abnormal, NCS | 37 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Gastrointestinal system including mouth | Normal | 355 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Cardiovascular system | Abnormal, NCS | 3 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | week -2: Skin | Normal | 312 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Gastrointestinal system including mouth | Abnormal, NCS | 3 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Cardiovascular system | Normal | 353 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Respiratory system | Abnormal CS | 0 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Gastrointestinal system including mouth | Abnormal CS | 0 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Thyroid gland | Normal | 348 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Respiratory system | Abnormal, NCS | 0 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Gastrointestinal system including mouth | Normal | 339 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Thyroid gland | Abnormal, NCS | 3 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Respiratory system | Normal | 341 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Gastrointestinal system including mouth | Abnormal, NCS | 2 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Thyroid gland | Abnormal CS | 5 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week-2: Respiratory system | Abnormal CS | 0 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Gastrointestinal system including mouth | Abnormal CS | 0 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Central and peripheral nervous system | Normal | 355 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week-2: Respiratory system | Abnormal, NCS | 0 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: General appearance | Normal | 351 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Cardiovascular system | Abnormal CS | 3 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week-2: Respiratory system | Normal | 358 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: General appearance | Abnormal, NCS | 3 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Skin | Abnormal CS | 8 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Musculoskeletal system | Abnormal, NCS | 2 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Skin | Abnormal, NCS | 19 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Cardiovascular system | Normal | 173 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Cardiovascular system | Abnormal, NCS | 2 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Cardiovascular system | Abnormal CS | 0 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Cardiovascular system | Normal | 166 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Cardiovascular system | Abnormal, NCS | 1 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Cardiovascular system | Abnormal CS | 0 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Central and peripheral nervous system | Normal | 172 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Central and peripheral nervous system | Abnormal, NCS | 0 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Central and peripheral nervous system | Abnormal CS | 3 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Central and peripheral nervous system | Normal | 164 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Central and peripheral nervous system | Abnormal, NCS | 0 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Central and peripheral nervous system | Abnormal CS | 3 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Gastrointestinal system including mouth | Normal | 174 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Gastrointestinal system including mouth | Abnormal, NCS | 1 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Gastrointestinal system including mouth | Abnormal CS | 0 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Gastrointestinal system including mouth | Normal | 166 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Gastrointestinal system including mouth | Abnormal, NCS | 1 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Gastrointestinal system including mouth | Abnormal CS | 0 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: General appearance | Normal | 169 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: General appearance | Abnormal, NCS | 2 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: General appearance | Abnormal CS | 4 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: General appearance | Normal | 161 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: General appearance | Abnormal, NCS | 2 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: General appearance | Abnormal CS | 4 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Head, ears, eyes, nose, throat, neck | Normal | 170 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Head, ears, eyes, nose, throat, neck | Abnormal, NCS | 4 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Head, ears, eyes, nose, throat, neck | Normal | 164 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Head, ears, eyes, nose, throat, neck | Abnormal CS | 1 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Head, ears, eyes, nose, throat, neck | Abnormal, NCS | 3 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Head, ears, eyes, nose, throat, neck | Abnormal CS | 0 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Lymph node palpation | Normal | 174 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Lymph node palpation | Abnormal, NCS | 0 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Lymph node palpation | Abnormal CS | 1 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Lymph node palpation | Normal | 166 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Lymph node palpation | Abnormal, NCS | 0 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Lymph node palpation | Abnormal CS | 1 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Musculoskeletal system | Normal | 172 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Musculoskeletal system | Abnormal, NCS | 2 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Musculoskeletal system | Abnormal CS | 1 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Musculoskeletal system | Normal | 165 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Musculoskeletal system | Abnormal, NCS | 1 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Musculoskeletal system | Abnormal CS | 1 Participants |
| Insulin Degludec | Change in Physical Examination | Week-2: Respiratory system | Normal | 175 Participants |
| Insulin Degludec | Change in Physical Examination | Week-2: Respiratory system | Abnormal, NCS | 0 Participants |
| Insulin Degludec | Change in Physical Examination | Week-2: Respiratory system | Abnormal CS | 0 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Respiratory system | Normal | 167 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Respiratory system | Abnormal, NCS | 0 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Respiratory system | Abnormal CS | 0 Participants |
| Insulin Degludec | Change in Physical Examination | week -2: Skin | Normal | 152 Participants |
| Insulin Degludec | Change in Physical Examination | week -2: Skin | Abnormal, NCS | 20 Participants |
| Insulin Degludec | Change in Physical Examination | week -2: Skin | Abnormal CS | 3 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Skin | Normal | 146 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Skin | Abnormal CS | 2 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Thyroid gland | Normal | 171 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Thyroid gland | Abnormal, NCS | 1 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Thyroid gland | Abnormal CS | 3 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Thyroid gland | Normal | 163 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Thyroid gland | Abnormal, NCS | 2 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Thyroid gland | Abnormal CS | 2 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Cardiovascular system | Abnormal CS | 0 Participants |
| Liraglutide | Change in Physical Examination | Week -2: General appearance | Abnormal, NCS | 1 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Thyroid gland | Normal | 151 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Musculoskeletal system | Abnormal, NCS | 0 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Skin | Abnormal CS | 2 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Musculoskeletal system | Abnormal CS | 2 Participants |
| Liraglutide | Change in Physical Examination | Week -2: General appearance | Normal | 177 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Cardiovascular system | Abnormal, NCS | 0 Participants |
| Liraglutide | Change in Physical Examination | Week-2: Respiratory system | Normal | 180 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Gastrointestinal system including mouth | Abnormal CS | 0 Participants |
| Liraglutide | Change in Physical Examination | Week -2: Cardiovascular system | Abnormal, NCS | 0 Participants |
| Liraglutide | Change in Physical Examination | Week-2: Respiratory system | Abnormal, NCS | 0 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Gastrointestinal system including mouth | Abnormal, NCS | 1 Participants |
| Liraglutide | Change in Physical Examination | Week -2: Thyroid gland | Normal | 179 Participants |
| Liraglutide | Change in Physical Examination | Week-2: Respiratory system | Abnormal CS | 0 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Gastrointestinal system including mouth | Normal | 150 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Cardiovascular system | Normal | 151 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Respiratory system | Normal | 151 Participants |
| Liraglutide | Change in Physical Examination | Week -2: Gastrointestinal system including mouth | Abnormal CS | 0 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Thyroid gland | Abnormal CS | 0 Participants |
| Liraglutide | Change in Physical Examination | week -2: Skin | Normal | 156 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Respiratory system | Abnormal, NCS | 0 Participants |
| Liraglutide | Change in Physical Examination | Week -2: Gastrointestinal system including mouth | Abnormal, NCS | 1 Participants |
| Liraglutide | Change in Physical Examination | Week -2: Thyroid gland | Abnormal, NCS | 1 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Respiratory system | Abnormal CS | 0 Participants |
| Liraglutide | Change in Physical Examination | Week -2: Gastrointestinal system including mouth | Normal | 179 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Thyroid gland | Abnormal, NCS | 0 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Central and peripheral nervous system | Abnormal CS | 1 Participants |
| Liraglutide | Change in Physical Examination | Week -2: Thyroid gland | Abnormal CS | 0 Participants |
| Liraglutide | Change in Physical Examination | week -2: Skin | Abnormal, NCS | 20 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Central and peripheral nervous system | Abnormal, NCS | 0 Participants |
| Liraglutide | Change in Physical Examination | Week -2: Cardiovascular system | Abnormal CS | 0 Participants |
| Liraglutide | Change in Physical Examination | Week -2: Lymph node palpation | Normal | 180 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Head, ears, eyes, nose, throat, neck | Abnormal CS | 0 Participants |
| Liraglutide | Change in Physical Examination | week -2: Skin | Abnormal CS | 4 Participants |
| Liraglutide | Change in Physical Examination | Week -2: Lymph node palpation | Abnormal, NCS | 0 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Head, ears, eyes, nose, throat, neck | Abnormal, NCS | 1 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Central and peripheral nervous system | Normal | 150 Participants |
| Liraglutide | Change in Physical Examination | Week -2: Lymph node palpation | Abnormal CS | 0 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Head, ears, eyes, nose, throat, neck | Normal | 150 Participants |
| Liraglutide | Change in Physical Examination | Week -2: Cardiovascular system | Normal | 180 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Lymph node palpation | Normal | 151 Participants |
| Liraglutide | Change in Physical Examination | Week -2: Head, ears, eyes, nose, throat, neck | Abnormal CS | 2 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Skin | Normal | 134 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Lymph node palpation | Abnormal, NCS | 0 Participants |
| Liraglutide | Change in Physical Examination | Week -2: Head, ears, eyes, nose, throat, neck | Abnormal, NCS | 3 Participants |
| Liraglutide | Change in Physical Examination | Week -2: Central and peripheral nervous system | Abnormal CS | 1 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Lymph node palpation | Abnormal CS | 0 Participants |
| Liraglutide | Change in Physical Examination | Week -2: Head, ears, eyes, nose, throat, neck | Normal | 175 Participants |
| Liraglutide | Change in Physical Examination | Week -2: Central and peripheral nervous system | Abnormal, NCS | 0 Participants |
| Liraglutide | Change in Physical Examination | Week -2: Musculoskeletal system | Normal | 177 Participants |
| Liraglutide | Change in Physical Examination | Week 26: General appearance | Abnormal CS | 1 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Skin | Abnormal, NCS | 15 Participants |
| Liraglutide | Change in Physical Examination | Week -2: Musculoskeletal system | Abnormal, NCS | 0 Participants |
| Liraglutide | Change in Physical Examination | Week 26: General appearance | Abnormal, NCS | 0 Participants |
| Liraglutide | Change in Physical Examination | Week 26: Musculoskeletal system | Normal | 149 Participants |
| Liraglutide | Change in Physical Examination | Week -2: Central and peripheral nervous system | Normal | 179 Participants |
| Liraglutide | Change in Physical Examination | Week -2: Musculoskeletal system | Abnormal CS | 3 Participants |
| Liraglutide | Change in Physical Examination | Week 26: General appearance | Normal | 150 Participants |
| Liraglutide | Change in Physical Examination | Week -2: General appearance | Abnormal CS | 2 Participants |
Secondary
Change in Pulse
Change in pulse from baseline (week 0) after 26 weeks of treatment is presented
Time frame: Week 0, week 26
Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Pulse | 4.6 Beats per minuts (beats/min) | Standard Deviation 8.6 |
| Insulin Degludec | Change in Pulse | -0.1 Beats per minuts (beats/min) | Standard Deviation 8.6 |
| Liraglutide | Change in Pulse | 4.9 Beats per minuts (beats/min) | Standard Deviation 9.7 |
Secondary
Change in Waist Circumferance
Change from baseline (week 0) in waist circumferance after 26 weeks of treatment is presented.
Time frame: Week 0, week 26
Population: FAS included all randomised participants. Overall number of participants analysed = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Waist Circumferance | -0.3 Centimeters (cm) | Standard Deviation 3.4 |
| Insulin Degludec | Change in Waist Circumferance | 1.2 Centimeters (cm) | Standard Deviation 4.2 |
| Liraglutide | Change in Waist Circumferance | -2.6 Centimeters (cm) | Standard Deviation 3.8 |
Secondary
Eye Examination
Dilated fundoscopy or fundus photography was performed by the investigator at screening (week -2) and week 26. The results of the examination were interpreted for each eye (left and right) and are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at screening (week -2) and week 26 is presented.
Time frame: Week -2, Week 26
Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Eye Examination | Week -2: Left eye | Normal | 222 Participants |
| Insulin Degludec/Liraglutide | Eye Examination | Week -2: Left eye | Abnormal, NCS | 45 Participants |
| Insulin Degludec/Liraglutide | Eye Examination | Week -2: Left eye | Abnormal, CS | 91 Participants |
| Insulin Degludec/Liraglutide | Eye Examination | Week 26: Left eye | Normal | 217 Participants |
| Insulin Degludec/Liraglutide | Eye Examination | Week 26: Left eye | Abnormal, NCS | 39 Participants |
| Insulin Degludec/Liraglutide | Eye Examination | Week 26: Left eye | Abnormal, CS | 85 Participants |
| Insulin Degludec/Liraglutide | Eye Examination | Week -2: Right eye | Normal | 230 Participants |
| Insulin Degludec/Liraglutide | Eye Examination | Week -2: Right eye | Abnormal, NCS | 42 Participants |
| Insulin Degludec/Liraglutide | Eye Examination | Week -2: Right eye | Abnormal, CS | 86 Participants |
| Insulin Degludec/Liraglutide | Eye Examination | Week 26: Right eye | Normal | 217 Participants |
| Insulin Degludec/Liraglutide | Eye Examination | Week 26: Right eye | Abnormal, NCS | 40 Participants |
| Insulin Degludec/Liraglutide | Eye Examination | Week 26: Right eye | Abnormal, CS | 84 Participants |
| Insulin Degludec | Eye Examination | Week -2: Right eye | Abnormal, NCS | 16 Participants |
| Insulin Degludec | Eye Examination | Week -2: Left eye | Normal | 109 Participants |
| Insulin Degludec | Eye Examination | Week 26: Left eye | Abnormal, NCS | 20 Participants |
| Insulin Degludec | Eye Examination | Week 26: Right eye | Normal | 103 Participants |
| Insulin Degludec | Eye Examination | Week -2: Left eye | Abnormal, NCS | 14 Participants |
| Insulin Degludec | Eye Examination | Week -2: Right eye | Normal | 112 Participants |
| Insulin Degludec | Eye Examination | Week 26: Right eye | Abnormal, CS | 41 Participants |
| Insulin Degludec | Eye Examination | Week -2: Left eye | Abnormal, CS | 52 Participants |
| Insulin Degludec | Eye Examination | Week 26: Right eye | Abnormal, NCS | 23 Participants |
| Insulin Degludec | Eye Examination | Week -2: Right eye | Abnormal, CS | 47 Participants |
| Insulin Degludec | Eye Examination | Week 26: Left eye | Normal | 99 Participants |
| Insulin Degludec | Eye Examination | Week 26: Left eye | Abnormal, CS | 48 Participants |
| Liraglutide | Eye Examination | Week 26: Left eye | Normal | 100 Participants |
| Liraglutide | Eye Examination | Week 26: Left eye | Abnormal, NCS | 13 Participants |
| Liraglutide | Eye Examination | Week 26: Left eye | Abnormal, CS | 38 Participants |
| Liraglutide | Eye Examination | Week 26: Right eye | Abnormal, CS | 40 Participants |
| Liraglutide | Eye Examination | Week -2: Right eye | Normal | 111 Participants |
| Liraglutide | Eye Examination | Week 26: Right eye | Normal | 96 Participants |
| Liraglutide | Eye Examination | Week -2: Left eye | Normal | 110 Participants |
| Liraglutide | Eye Examination | Week -2: Right eye | Abnormal, NCS | 22 Participants |
| Liraglutide | Eye Examination | Week -2: Left eye | Abnormal, NCS | 20 Participants |
| Liraglutide | Eye Examination | Week 26: Right eye | Abnormal, NCS | 15 Participants |
| Liraglutide | Eye Examination | Week -2: Left eye | Abnormal, CS | 50 Participants |
| Liraglutide | Eye Examination | Week -2: Right eye | Abnormal, CS | 47 Participants |
Secondary
Insulin Dose
The actual daily total insulin dose after 26 weeks of treatment is presented. This outcome measure is only applicable for Insulin degludec/liraglutide and Insulin degludec treatment arms.
Time frame: Week 26
Population: SAS included all participants receiving at least one dose of the insulin degludec/liraglutide or insulin degludec. Overall number of participants analysed = participants with available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Insulin Dose | 24.8 Units of insulin (U) | Standard Deviation 11.9 |
| Insulin Degludec | Insulin Dose | 30.1 Units of insulin (U) | Standard Deviation 14.4 |
Secondary
Number of Treatment-emergent Adverse Events (TEAE)
A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. The observed rates of adverse events (AEs) per patient years of exposure (PYE) (number of AEs divided by PYE multiplied by 100) after 26 weeks are presented.
Time frame: Weeks 0-26
Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Number of participants analysed = number of participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Degludec/Liraglutide | Number of Treatment-emergent Adverse Events (TEAE) | 410.82 (Number of AEs/PYE)*100 |
| Insulin Degludec | Number of Treatment-emergent Adverse Events (TEAE) | 306.19 (Number of AEs/PYE)*100 |
| Liraglutide | Number of Treatment-emergent Adverse Events (TEAE) | 541.00 (Number of AEs/PYE)*100 |
Secondary
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition
A hypoglycaemic episode was 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 7 days after the last day on trial product. The number of episodes are represented as rates. The observed rates of episodes (according to the ADA definition) per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented.
Time frame: Weeks 0-26
Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Degludec/Liraglutide | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition | 668.55 (Number of episodes/PYE)*100 |
| Insulin Degludec | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition | 746.20 (Number of episodes/PYE)*100 |
| Liraglutide | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition | 37.19 (Number of episodes/PYE)*100 |
Secondary
Number of Treatment Emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes.
Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as nocturnal if the time of the onset was between 00:01 and 05.59 both inclusive. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented.
Time frame: Weeks 0-26
Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Degludec/Liraglutide | Number of Treatment Emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes. | 4.45 (Number of episodes/PYE)*100 |
| Insulin Degludec | Number of Treatment Emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes. | 4.54 (Number of episodes/PYE)*100 |
Secondary
Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as nocturnal if the time of the onset was between 00:01 and 05.59 both inclusive. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented.
Time frame: Weeks 0-26
Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Degludec/Liraglutide | Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | 2.78 (Number of episodes/PYE)*100 |
| Insulin Degludec | Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | 3.40 (Number of episodes/PYE)*100 |
Secondary
Number of Treatment Emergent Severe or BG Confirmed Hypoglycaemic Episodes
Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or blood glucose (BG) confirmed by a plasma glucose (PG) value \< 3.1 millimoles per liter (mmol/L) with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. The number of episodes are represented as rates. The observed rates of treatment-emergent severe or BG confirmed hypoglycaemic episodes per patient years of exposure (PYE) (number of episodes divided by PYE multiplied by 100) during 26 weeks of treatment are presented.
Time frame: Weeks 0-26
Population: Safety analysis set (SAS) included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Degludec/Liraglutide | Number of Treatment Emergent Severe or BG Confirmed Hypoglycaemic Episodes | 23.94 (Number of episodes/PYE)*100 |
| Insulin Degludec | Number of Treatment Emergent Severe or BG Confirmed Hypoglycaemic Episodes | 17.01 (Number of episodes/PYE)*100 |
| Liraglutide | Number of Treatment Emergent Severe or BG Confirmed Hypoglycaemic Episodes | 3.60 (Number of episodes/PYE)*100 |
Secondary
Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes.
Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented.
Time frame: Weeks 0-26
Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Degludec/Liraglutide | Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes. | 15.03 (Number of episodes/PYE)*100 |
| Insulin Degludec | Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes. | 9.07 (Number of episodes/PYE)*100 |
| Liraglutide | Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes. | 1.20 (Number of episodes/PYE)*100 |
Secondary
Occurence of Antibodies Cross-reacting to Human Insulin
This outcome measure is only applicable for the insulin degludec/liraglutide arm and insulin degludec arm. Serum samples were analysed for the presence of cross-reacting antibodies to human insulin. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T).
Time frame: Week 27
Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide or insulin degludec. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Occurence of Antibodies Cross-reacting to Human Insulin | 6.61 %B/T | Standard Deviation 15 |
| Insulin Degludec | Occurence of Antibodies Cross-reacting to Human Insulin | 2.99 %B/T | Standard Deviation 10.89 |
Secondary
Occurence of Antibodies Cross-reacting to Native Glucagon-like Peptide (GLP-1)
This outcome measure is applicable to the Insulin degludec/liraglutide arm and the liraglutide arm. Serum samples were analysed for the presence of cross-reacting antibodies to native GLP-1. Number of participants who measured with anti-liraglutide antibodies cross reacting native GLP-1 at week 27 are presented.
Time frame: Week 27
Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide or insulin degludec. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Insulin Degludec/Liraglutide | Occurence of Antibodies Cross-reacting to Native Glucagon-like Peptide (GLP-1) | 6 Participants |
| Insulin Degludec | Occurence of Antibodies Cross-reacting to Native Glucagon-like Peptide (GLP-1) | 3 Participants |
Secondary
Occurence of Anti-insulin Degludec Specific Antibodies
This outcome measure is only applicable for the insulin degludec/liraglutide arm and insulin degludec arm. Serum samples were analysed for the presence of anti-insulin degludec specific antibodies. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T).
Time frame: Week 27
Population: SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Occurence of Anti-insulin Degludec Specific Antibodies | 0.22 %B/T | Standard Deviation 1.02 |
| Insulin Degludec | Occurence of Anti-insulin Degludec Specific Antibodies | 0.12 %B/T | Standard Deviation 0.79 |
Secondary
Occurence of Anti-liraglutide Antibodies
This outcome measure is applicable for the Insulin degludec/liraglutide arm and the liraglutide arm. Serum samples were analysed for the presence of anti-liraglutide antibodies. Number of participants who were assessed for anti-liraglutide antibodies at week 27 are presented.
Time frame: Week 27
Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide or insulin degludec. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Occurence of Anti-liraglutide Antibodies | Yes | 45 Participants |
| Insulin Degludec/Liraglutide | Occurence of Anti-liraglutide Antibodies | No | 287 Participants |
| Insulin Degludec | Occurence of Anti-liraglutide Antibodies | No | 120 Participants |
| Insulin Degludec | Occurence of Anti-liraglutide Antibodies | Yes | 40 Participants |
Secondary
Occurence of Neutralising Antibodies Cross-reacting to Native GLP-1
This outcome measure is only applicable for the Insulin degludec/liraglutide arm and liraglutide arm. Cross reacting antibodies were assessed when anti-liraglutide antibody was positive. Number of participants who measured with neutralising liraglutide antibodies cross-reacting to native GLP-1 at week 27 are presented.
Time frame: Week 27
Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Insulin Degludec/Liraglutide | Occurence of Neutralising Antibodies Cross-reacting to Native GLP-1 | 0 Participants |
| Insulin Degludec | Occurence of Neutralising Antibodies Cross-reacting to Native GLP-1 | 0 Participants |
Secondary
Occurence of Neutralising Liraglutide Antibodies
This outcome measure is only applicable for the Insulin degludec/liraglutide arm and liraglutide arm. Neutralising antibodies were assessed when the corresponding anti-Liraglutide antibody were positive at week 27. Number of participants who measured with neutralising liraglutide antibodies at week 27 are presented.
Time frame: Week 27
Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Insulin Degludec/Liraglutide | Occurence of Neutralising Liraglutide Antibodies | 9 Participants |
| Insulin Degludec | Occurence of Neutralising Liraglutide Antibodies | 8 Participants |
Secondary
Occurence of Total Insulin Antibodies
This outcome measure is only applicable for the Insulin degludec/liraglutide arm and Insulin degludec arm. Serum samples were analysed for the presence of antobodies to human insulin. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T).
Time frame: Week 27
Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide or insulin degludec. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Occurence of Total Insulin Antibodies | 6.83 %B/T | Standard Deviation 15.78 |
| Insulin Degludec | Occurence of Total Insulin Antibodies | 3.11 %B/T | Standard Deviation 11.42 |
Secondary
Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero
Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) and change from baseline in body weight below or equal to zero after 26 weeks are presented. Missing values are imputed by LOCF.
Time frame: Week 26
Population: FAS included all randomised participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero | Yes | 111 Participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero | No | 250 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero | Yes | 21 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero | No | 158 Participants |
| Liraglutide | Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero | Yes | 37 Participants |
| Liraglutide | Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero | No | 143 Participants |
Secondary
Participants Who Achieved HbA1c ≤ 6.5%, International Diabetes Federation (IDF) Target (Yes/no)
Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) after 26 weeks of treatment are presented.
Time frame: Week 26
Population: FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c ≤ 6.5%, International Diabetes Federation (IDF) Target (Yes/no) | Yes | 201 Participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c ≤ 6.5%, International Diabetes Federation (IDF) Target (Yes/no) | No | 140 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c ≤ 6.5%, International Diabetes Federation (IDF) Target (Yes/no) | Yes | 48 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c ≤ 6.5%, International Diabetes Federation (IDF) Target (Yes/no) | No | 119 Participants |
| Liraglutide | Participants Who Achieved HbA1c ≤ 6.5%, International Diabetes Federation (IDF) Target (Yes/no) | Yes | 41 Participants |
| Liraglutide | Participants Who Achieved HbA1c ≤ 6.5%, International Diabetes Federation (IDF) Target (Yes/no) | No | 110 Participants |
Secondary
Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Episodes and Change From Baseline in Body Weight Below or Equal to Zero.
Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) after 26 weeks of treatment without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment and with change from baseline in body weight below or equal to zero are presented. Missing values are imputed by LOCF.
Time frame: Week 26
Population: FAS included all randomised participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Episodes and Change From Baseline in Body Weight Below or Equal to Zero. | Yes | 103 Participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Episodes and Change From Baseline in Body Weight Below or Equal to Zero. | No | 258 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Episodes and Change From Baseline in Body Weight Below or Equal to Zero. | Yes | 21 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Episodes and Change From Baseline in Body Weight Below or Equal to Zero. | No | 158 Participants |
| Liraglutide | Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Episodes and Change From Baseline in Body Weight Below or Equal to Zero. | Yes | 36 Participants |
| Liraglutide | Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Episodes and Change From Baseline in Body Weight Below or Equal to Zero. | No | 144 Participants |
Secondary
Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Hypoglycaemic Episodes
Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) after 26 weeks of treatment and without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment are presented. Missing values are imputed by LOCF.
Time frame: Week 26
Population: FAS included all randomised participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Hypoglycaemic Episodes | Yes | 195 Participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Hypoglycaemic Episodes | No | 166 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Hypoglycaemic Episodes | Yes | 46 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Hypoglycaemic Episodes | No | 133 Participants |
| Liraglutide | Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Hypoglycaemic Episodes | Yes | 43 Participants |
| Liraglutide | Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Hypoglycaemic Episodes | No | 137 Participants |
Secondary
Participants Who Achieved HbA1c < 7.0%, American Diabetes Association (ADA) Target (Yes/no)
Number of participants who achieved ADA HbA1c target (HbA1c \< 7.0%) (yes/no) after 26 weeks of treatment are presented.
Time frame: Week 26
Population: FAS included all randomised participants. Overall number of participants analysied = number of participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c < 7.0%, American Diabetes Association (ADA) Target (Yes/no) | Yes | 272 Participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c < 7.0%, American Diabetes Association (ADA) Target (Yes/no) | No | 69 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c < 7.0%, American Diabetes Association (ADA) Target (Yes/no) | Yes | 83 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c < 7.0%, American Diabetes Association (ADA) Target (Yes/no) | No | 84 Participants |
| Liraglutide | Participants Who Achieved HbA1c < 7.0%, American Diabetes Association (ADA) Target (Yes/no) | Yes | 80 Participants |
| Liraglutide | Participants Who Achieved HbA1c < 7.0%, American Diabetes Association (ADA) Target (Yes/no) | No | 71 Participants |
Secondary
Participants Who Achieved HbA1c <7.0% and Change in Body Weight From Baseline Below or Equal to Zero
Number of participants who achieved ADA HbA1c target (HbA1c \< 7.0%) (yes/no) and change from baseline in body weight below or equal to zero after 26 weeks are presented. Missing values are imputed by LOCF.
Time frame: Week 26
Population: FAS included all randomised participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c <7.0% and Change in Body Weight From Baseline Below or Equal to Zero | Yes | 147 Participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c <7.0% and Change in Body Weight From Baseline Below or Equal to Zero | No | 214 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c <7.0% and Change in Body Weight From Baseline Below or Equal to Zero | No | 145 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c <7.0% and Change in Body Weight From Baseline Below or Equal to Zero | Yes | 34 Participants |
| Liraglutide | Participants Who Achieved HbA1c <7.0% and Change in Body Weight From Baseline Below or Equal to Zero | Yes | 74 Participants |
| Liraglutide | Participants Who Achieved HbA1c <7.0% and Change in Body Weight From Baseline Below or Equal to Zero | No | 106 Participants |
Secondary
Participants Who Achieved HbA1c < 7.0% Without Severe or BG Confirmed Episodes, and Change From Baseline in Body Weight Below or Equal to Zero.
Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Number of participants who achieved ADA HbA1c target (HbA1c \< 7.0%) (yes/no) after 26 weeks of treatment without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment and with change from baseline in body weight below or equal to zero are presented. Missing values are imputed by LOCF.
Time frame: Week 26
Population: FAS included all randomised participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c < 7.0% Without Severe or BG Confirmed Episodes, and Change From Baseline in Body Weight Below or Equal to Zero. | Yes | 136 Participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c < 7.0% Without Severe or BG Confirmed Episodes, and Change From Baseline in Body Weight Below or Equal to Zero. | No | 225 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c < 7.0% Without Severe or BG Confirmed Episodes, and Change From Baseline in Body Weight Below or Equal to Zero. | Yes | 33 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c < 7.0% Without Severe or BG Confirmed Episodes, and Change From Baseline in Body Weight Below or Equal to Zero. | No | 146 Participants |
| Liraglutide | Participants Who Achieved HbA1c < 7.0% Without Severe or BG Confirmed Episodes, and Change From Baseline in Body Weight Below or Equal to Zero. | Yes | 72 Participants |
| Liraglutide | Participants Who Achieved HbA1c < 7.0% Without Severe or BG Confirmed Episodes, and Change From Baseline in Body Weight Below or Equal to Zero. | No | 108 Participants |
Secondary
Participants Who Achieved HbA1c < 7.0% Without Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes
Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \<3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Number of participants who achieved ADA HbA1c target (HbA1c \<7.0%) (yes/no) after 26 weeks of treatment and without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment are presented. Missing values are imputed by LOCF.
Time frame: Week 26
Population: FAS included all randomised participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c < 7.0% Without Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes | Yes | 265 Participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c < 7.0% Without Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes | No | 96 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c < 7.0% Without Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes | Yes | 80 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c < 7.0% Without Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes | No | 99 Participants |
| Liraglutide | Participants Who Achieved HbA1c < 7.0% Without Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes | Yes | 84 Participants |
| Liraglutide | Participants Who Achieved HbA1c < 7.0% Without Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes | No | 96 Participants |
Secondary
Plasma Concentration of Liraglutide
This outcome measure is for Insulin degludec/liraglutide and liraglutide arms. Serum samples from the Insulin degludec/liraglutide and liraglutide arms were assayed using population PK analysis. The Cmax are summarised for the two arms.
Time frame: Week 0, week 26
Population: FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Plasma Concentration of Liraglutide | 9963 pmol/L | Geometric Coefficient of Variation 50.4 |
| Insulin Degludec | Plasma Concentration of Liraglutide | 21602 pmol/L | Geometric Coefficient of Variation 37 |
Secondary
Serum Concentrations of Insulin Degludec
This outcome measure is applicable for Insulin degludec and Insulin degludec/liraglutide arms. Serum samples from the Insulin degludec/liraglutide and Insulin degludec arms were assayed using population PK analysis. The maximum serum concentrations (Cmax) are summarised for the two arms.
Time frame: Week 0, week 26
Population: FAS included all randomised participants. Overall the number of participants analysed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Serum Concentrations of Insulin Degludec | 3583 pmol/L | Geometric Coefficient of Variation 55.9 |
| Insulin Degludec | Serum Concentrations of Insulin Degludec | 4133 pmol/L | Geometric Coefficient of Variation 52.8 |
Secondary
Urinalysis (Protein, Glucose, Erythrocytes and Ketones)
The urinalysis assessment was the measurements of protein, glucose, erythrocytes and ketones in urine at baseline (week 0) and week 26 and categorised as negative, trace and positive. Number of participants in each category at week 0 and week 26 is presented.
Time frame: Week 0, week 26
Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Number of participants analysed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Glucose | Negative | 253 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Erythrocytes | Trace | 36 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Erythrocytes | Positive | 22 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Erythrocytes | Negative | 297 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Erythrocytes | Trace | 28 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Erythrocytes | Positive | 14 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Erythrocytes | Negative | 299 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Glucose | Trace | 35 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Glucose | Positive | 69 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Glucose | Negative | 322 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Glucose | Trace | 11 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Glucose | Positive | 6 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Ketones | Negative | 325 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Ketones | Trace | 25 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Ketones | Positive | 7 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Ketones | Negative | 334 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Ketones | Trace | 4 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Ketones | Positive | 1 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Protein | Negative | 216 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Protein | Trace | 86 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Protein | Positive | 55 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Protein | Negative | 254 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Protein | Trace | 58 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Protein | Positive | 27 Participants |
| Insulin Degludec | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Protein | Negative | 120 Participants |
| Insulin Degludec | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Erythrocytes | Negative | 153 Participants |
| Insulin Degludec | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Ketones | Negative | 152 Participants |
| Insulin Degludec | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Ketones | Trace | 3 Participants |
| Insulin Degludec | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Erythrocytes | Trace | 16 Participants |
| Insulin Degludec | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Glucose | Trace | 3 Participants |
| Insulin Degludec | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Protein | Positive | 31 Participants |
| Insulin Degludec | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Erythrocytes | Positive | 6 Participants |
| Insulin Degludec | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Ketones | Trace | 20 Participants |
| Insulin Degludec | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Protein | Trace | 26 Participants |
| Insulin Degludec | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Erythrocytes | Negative | 146 Participants |
| Insulin Degludec | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Glucose | Negative | 157 Participants |
| Insulin Degludec | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Ketones | Positive | 1 Participants |
| Insulin Degludec | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Erythrocytes | Trace | 16 Participants |
| Insulin Degludec | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Ketones | Positive | 3 Participants |
| Insulin Degludec | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Glucose | Positive | 7 Participants |
| Insulin Degludec | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Erythrocytes | Positive | 5 Participants |
| Insulin Degludec | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Glucose | Positive | 37 Participants |
| Insulin Degludec | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Protein | Positive | 21 Participants |
| Insulin Degludec | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Glucose | Negative | 119 Participants |
| Insulin Degludec | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Ketones | Negative | 163 Participants |
| Insulin Degludec | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Protein | Negative | 104 Participants |
| Insulin Degludec | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Glucose | Trace | 19 Participants |
| Insulin Degludec | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Protein | Trace | 40 Participants |
| Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Glucose | Trace | 18 Participants |
| Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Glucose | Positive | 39 Participants |
| Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Glucose | Negative | 131 Participants |
| Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Glucose | Trace | 5 Participants |
| Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Protein | Trace | 37 Participants |
| Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Glucose | Positive | 15 Participants |
| Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Protein | Trace | 28 Participants |
| Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Ketones | Negative | 167 Participants |
| Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Ketones | Trace | 11 Participants |
| Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Protein | Positive | 27 Participants |
| Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Ketones | Positive | 2 Participants |
| Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Protein | Positive | 18 Participants |
| Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Ketones | Negative | 141 Participants |
| Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Erythrocytes | Negative | 156 Participants |
| Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Erythrocytes | Trace | 16 Participants |
| Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Ketones | Trace | 10 Participants |
| Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Erythrocytes | Positive | 8 Participants |
| Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Protein | Negative | 105 Participants |
| Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Erythrocytes | Negative | 136 Participants |
| Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Erythrocytes | Trace | 11 Participants |
| Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Ketones | Positive | 0 Participants |
| Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 26: Erythrocytes | Positive | 4 Participants |
| Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Glucose | Negative | 123 Participants |
| Liraglutide | Urinalysis (Protein, Glucose, Erythrocytes and Ketones) | Week 0: Protein | Negative | 116 Participants |