Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Asia. The aim of this trial is to confirm the superiority of insulin degludec/liraglutide versus insulin degludec in controlling glycaemia in Chinese subjects with type 2 diabetes mellitus after 26 weeks of treatment
Interventions
DRUGInsulin degludec/liraglutide
Administered subcutaneously (s.c., under the skin) once daily in combination with metformin for the treatment duration of 26 weeks.
DRUGInsulin degludec
Administered subcutaneously (s.c., under the skin) once daily in combination with metformin for the treatment duration of 26 weeks.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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 procedures to determine suitability for the trial - Male or female, age at least 18 years at the time of signing inform consent - Type 2 diabetes mellitus (clinically diagnosed) - HbA1c (glycosylated haemoglobin) above or equal to 7.5% by central laboratory analysis, with the aim of a median of 8.5%. When approximately 50% of the randomised subjects have an HbA1c above 8.5%, the remaining subjects randomised must have an HbA1c below or equal to 8.5% or when approximately 50% of the subjects randomised have an HbA1c below or equal to 8.5%, the remaining subjects randomised must have an HbA1c above 8.5% - Current treatment for at least 90 calendar days prior to screening with basal insulin plus metformin plus/minus α-glucosidase inhibitors, sulphonylureas, glinides or thiazolidinediones. Subjects should be on a stable dose for at least 60 calendar days prior to screening of: Basal insulin 20-50 units (U)/day (both inclusive) ( Individual fluctuations of plus/minus 5U during the 60 day period prior to the day of screening are acceptable.) on the day of screening in combination with: - 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 glinide (at least 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 (AGI) (at least half of the max approved dose according to local label) or - Metformin (above or equal to 1500 mg or max tolerated dose) and thiazolidinediones (at least half of the max approved dose according to local label) - Body mass index (BMI) above or equal to 24 kg/m\^2
Exclusion criteria
Current use of any antidiabetic drug (except for basal insulin, metformin, α-glucosidase inhibitors, sulphonylureas, glinides or thiazolidinediones) or anticipated change in concomitant medication, that in the investigator´s opinion could interfere with glucose level (e.g. systemic corticosteroids) - Treatment with glucagon like peptide -1 receptor agonists, or dipeptidyl-peptidase-4 inhibitors or insulin (except for basal insulin) within 90 days prior to Visit 1 - 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 mm Hg or diastolic blood pressure above or equal to 100 mm Hg) - 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 glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 26 is presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes | Up to 26 weeks | 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 BG confirmed by a plasma glucose 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. Number of treatment-emergent severe or BG confirmed hypoglycaemic episodes during 26 weeks of treatment is presented. |
| Change in Fasting Plasma Glucose (FPG) | Week 0, week 26 | Change in FPG from baseline (week 0) to week 26 is presented. |
| Change in Waist Circumference | Week 0, week 26 | Change in waist circumference from baseline (week 0) to week 26 is presented. |
| Change in Mean of the 9-point Self-measured Plasma Glucose (SMPG) Profile | Week 0, week 26 | Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and 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 SMPG-mean Post Prandial Increments | Week 0, week 26 | Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Change in SMPG-mean postprandial increment over all meals from baseline (week 0) to week 26 is presented. |
| Insulin Dose | Week 26 | The mean of actual daily total insulin dose after 26 weeks of treatment is presented. |
| SMPG-9-point Profile (Individual Points in the Profile) | Week 26 | Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. SMPG-9-point profile (individual points in the profile) at week 26 is presented. |
| 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. |
| 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. |
| 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 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 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 Fasting Free Fatty Acids- Ratio to Baseline | Week 0, week 26 | Change in fasting free fatty acids (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline. |
| 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 Insulin- Ratio to Baseline | Week 0, week 26 | Change in fasting 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 from baseline (week 0) to week 26 is presented as ratio to baseline. |
| Participants Who Achieved HbA1c < 7.0%, ADA Target (Yes/no) | Week 26 | Participants who achieved HbA1c \< 7.0%, ADA target (yes/no) is presented. |
| Participants Who Achieved HbA1c ≤ 6.5%, American Association of Clinical Endocrinologists (AACE) Target (Yes/no) | Week 26 | Participants who achieved HbA1c ≤ 6.5%, AACE target (yes/no) is presented. |
| Participants Who Achieved HbA1c < 7.0% and Change From Baseline in Body Weight Below or Equal to Zero | Week 26 | Participants who achieved HbA1c \< 7.0% and change from baseline in body weight below or equal to zero is presented. |
| Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero | Week 26 | Participants who achieved HbA1c ≤ 6.5% and change from baseline in body weight below or equal to zero is presented. |
| Participants Who Achieved HbA1c < 7.0% Without Treatment-emergent 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 plasma glucose 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. Participants who achieved HbA1c \< 7.0% at week 26 without treatment-emergent severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment is presented. |
| Participants Who Achieved HbA1c ≤ 6.5% Without Treatment-emergent 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 plasma glucose 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. Participants who achieved HbA1c ≤ 6.5% at week 26 without treatment-emergent severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment is presented. |
| Participants Who Achieved HbA1c < 7.0% and Change From Baseline in Body Weight Below or Equal to Zero and Without Treatment-emergent 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 plasma glucose 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. Participants who achieved HbA1c \< 7.0% and change from baseline in body weight below or equal to zero and without treatment-emergent severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment is presented. |
| Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero and Without Treatment-emergent 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 plasma glucose 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. Participants who achieved HbA1c ≤ 6.5% and change from baseline in body weight below or equal to zero and without treatment-emergent severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment is presented. |
| Number of Treatment-emergent Adverse Events (TEAEs) | Weeks 0-27 | A TEAE was defined as an adverse event with onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE. |
| Number of Treatment-emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes | Weeks 0-27 | 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 plasma glucose 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. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 a.m. both inclusive. Number of treatment-emergent nocturnal severe or BG confirmed hypoglycaemic episodes is presented. |
| Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | Weeks 0-27 | 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 plasma glucose 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. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes is presented. |
| Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | Weeks 0-27 | 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 plasma glucose 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. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 a.m. both inclusive. Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes is presented. |
| Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition | Weeks 0-27 | 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 treatment-emergent hypoglycaemic episodes according to ADA definition is 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 week -2 and week 26 is presented. |
| Eye Examination | Week -2, week 26 | Dilated fundoscopy or fundus photography was performed by the investigator at week -2 and week 26. The results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at week -2 and week 26 were presented. |
| Change in Electrocardiogram (ECG) | Week -2, week 26 | The ECG was assessed by the investigator at baseline (week -2) and week 26 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 26 were presented. |
| Change in Pulse | Week 0, week 26 | Change in pulse from baseline (week 0) to week 26 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) to week 26 is presented. |
| Change in Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) | Week 0, week 26 | Change in amylase, lipase, creatinine kinase, ALT, AST, ALP from baseline (week 0) to week 26 is presented. |
| Change in Biochemical Parameter-calcium (Total), Albumin Corrected Calcium, Potassium, Sodium, Urea | Week 0, week 26 | Change in calcium (total), albumin corrected calcium, potassium, sodium, urea from baseline (week 0) to week 26 is presented. |
| Change in Albumin | Week 0, week 26 | Change in albumin from baseline (week 0) to week 26 is presented. |
| Change in Total Bilirubin | Week 0, week 26 | Change in total bilirubin from baseline (week 0) to week 26 is presented. |
| Change in Creatinine | Week 0, week 26 | Change in creatinine from baseline (week 0) to week 26 is presented. |
| Change in Total Protein | Week 0, week 26 | Change in total protein from baseline (week 0) to week 26 is presented. |
| Change in Haematological Parameter- Haematocrit | Week 0, week 26 | Change in haematocrit from baseline (week 0) to week 26 is presented. |
| Change in Haematological Parameter- Haemoglobin | Week 0, week 26 | Change in haemoglobin from baseline (week 0) to week 26 is presented. |
| Change in Haematological Parameter- Leukocytes and Thrombocytes | Week 0, week 26 | Change in leukocytes and thrombocytes from baseline (week 0) to week 26 is presented. |
| Change in Haematological Parameter- Erythrocytes | Week 0, week 26 | Change in erythrocytes from baseline (week 0) to week 26 is presented. |
| Change in Haematological Parameter- Basophils | Week 0, week 26 | Change in basophils from baseline (week 0) to week 26 is presented. |
| Change in Haematological Parameter- Eosinophils | Week 0, week 26 | Change in eosinophils from baseline (week 0) to week 26 is presented. |
| Change in Haematological Parameter- Lymphocytes | Week 0, week 26 | Change in lymphocytes from baseline (week 0) to week 26 is presented. |
| Change in Haematological Parameter- Monocytes | Week 0, week 26 | Change in monocytes from baseline (week 0) to week 26 is presented. |
| Change in Haematological Parameter- Neutrophils | Week 0, week 26 | Change in neutrophils from baseline (week 0) to week 26 is presented. |
| Change in Calcitonin | Week 0, week 26 | Calcitonin levels were measured and were categorised as low, normal or high. Number of participants in each category at week 0 and week 26 were presented. |
| Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0, week 26 | The urinalysis was the measurements of protein, glucose, erythrocytes and ketones at week 0 and week 26 and categorised as negative, trace, 1+, 2+ and 3+. Number of participants in each category at week 0 and week 26 are presented. |
| Change in Body Weight | Week 0, week 26 | Change in body weight from baseline (week 0) to week 26 is presented. |
| Antibodies Cross-reacting to Human Insulin | Week 27 | Serum samples were analysed for the presence of antibodies cross-reacting to human insulin. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/T). |
| Total Insulin Antibodies | Week 27 | Serum samples were analysed for the presence of total insulin antibodies. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/T). |
| Occurrence of Anti-liraglutide Antibodies (Yes/no) | Week 27 | This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. Number of participants who measured with anti-liraglutide antibodies at week 27 are presented. |
| Occurrence of Anti-liraglutide Antibodies Cross Reacting Native Glucagon-like Peptide-1 (GLP-1) | Week 27 | This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. Number of participants who measured with anti-liraglutide antibodies cross reacting native GLP-1 at week 27 are presented. |
| Occurrence of Neutralising Liraglutide Antibodies | Week 27 | This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. Number of participants who measured with neutralising liraglutide antibodies at week 27 are presented. |
| Occurrence of Neutralising Liraglutide Antibodies Cross Reacting Native GLP-1 | Week 27 | This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. Number of participants who measured with neutralising liraglutide antibodies cross reacting native GLP-1 at week 27 are presented. |
| Anti-insulin Degludec Specific Antibodies | Week 27 | Serum samples were analysed for the presence of anti-insulin degludec specific antibodies. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/T). |
Countries
China, Hong Kong
Participant flow
Recruitment details
The trial was conducted at 40 sites in China.
Pre-assignment details
Participants were randomised in a 2:1 manner to receive either IDegLira or IDeg in combination with metformin.
Participants by arm
| Arm | Count |
|---|---|
| Insulin Degludec/Liraglutide Participants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide. | 302 |
| Insulin Degludec Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg. | 151 |
| Total | 453 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Other | 2 | 3 |
| Overall Study | Protocol Violation | 5 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 5 |
Baseline characteristics
| Characteristic | Insulin Degludec/Liraglutide | Insulin Degludec | Total |
|---|---|---|---|
| Age, Continuous | 54.5 Years STANDARD_DEVIATION 9.8 | 55.3 Years STANDARD_DEVIATION 10 | 54.7 Years STANDARD_DEVIATION 9.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 302 Participants | 151 Participants | 453 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Glycosylated haemoglobin (HbA1c) | 8.93 Percentage of HbA1c STANDARD_DEVIATION 1.2 | 8.96 Percentage of HbA1c STANDARD_DEVIATION 1.17 | 8.94 Percentage of HbA1c STANDARD_DEVIATION 1.19 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 302 Participants | 151 Participants | 453 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 119 Participants | 60 Participants | 179 Participants |
| Sex: Female, Male Male | 183 Participants | 91 Participants | 274 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 301 | 0 / 151 |
| other Total, other adverse events | 113 / 301 | 43 / 151 |
| serious Total, serious adverse events | 13 / 301 | 7 / 151 |
Outcome results
Primary
Change in HbA1c
Change in glycosylated haemoglobin (HbA1c) 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 = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in HbA1c | -1.93 Percentage point of HbA1c | Standard Deviation 1.14 |
| Insulin Degludec | Change in HbA1c | -1.06 Percentage point of HbA1c | Standard Deviation 1.19 |
Comparison: The response and change from baseline in response after 26 weeks are analysed using an analysis of covariance (ANCOVA) model with treatment and previous anti-diabetic treatment as fixed factors and corresponding baseline value as covariate.p-value: <0.000195% CI: [-1.09, -0.75]ANCOVA
Secondary
Antibodies Cross-reacting to Human Insulin
Serum samples were analysed for the presence of antibodies cross-reacting to human insulin. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/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 | Antibodies Cross-reacting to Human Insulin | 9.07 %B/T | Standard Deviation 16.61 |
| Insulin Degludec | Antibodies Cross-reacting to Human Insulin | 8.64 %B/T | Standard Deviation 16.84 |
Secondary
Anti-insulin Degludec Specific Antibodies
Serum samples were analysed for the presence of anti-insulin degludec specific antibodies. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/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 | Anti-insulin Degludec Specific Antibodies | 0.25 %B/T | Standard Deviation 1.25 |
| Insulin Degludec | Anti-insulin Degludec Specific Antibodies | 0.13 %B/T | Standard Deviation 0.57 |
Secondary
Change in Albumin
Change in albumin from baseline (week 0) to week 26 is presented.
Time frame: Week 0, week 26
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 | Change in Albumin | 0.05 Grams per deciliter (g/dL) | Standard Deviation 0.29 |
| Insulin Degludec | Change in Albumin | 0.02 Grams per deciliter (g/dL) | Standard Deviation 0.25 |
Secondary
Change in Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
Change in amylase, lipase, creatinine kinase, ALT, AST, ALP from baseline (week 0) to week 26 is presented.
Time frame: Week 0, week 26
Population: SAS included all participants who received at least one dose of IDegLira or IDeg. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) | Amylase | 10.45 Units per liter (U/L) | Standard Deviation 23.14 |
| Insulin Degludec/Liraglutide | Change in Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) | Lipase | 16.97 Units per liter (U/L) | Standard Deviation 35.24 |
| Insulin Degludec/Liraglutide | Change in Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) | Creatinine kinase | 3.32 Units per liter (U/L) | Standard Deviation 65.17 |
| Insulin Degludec/Liraglutide | Change in Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) | ALT | -3.02 Units per liter (U/L) | Standard Deviation 12.03 |
| Insulin Degludec/Liraglutide | Change in Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) | AST | -1.42 Units per liter (U/L) | Standard Deviation 7.46 |
| Insulin Degludec/Liraglutide | Change in Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) | ALP | -1.62 Units per liter (U/L) | Standard Deviation 13.3 |
| Insulin Degludec | Change in Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) | AST | -2.06 Units per liter (U/L) | Standard Deviation 7.92 |
| Insulin Degludec | Change in Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) | Amylase | 2.69 Units per liter (U/L) | Standard Deviation 11.72 |
| Insulin Degludec | Change in Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) | ALT | -4.06 Units per liter (U/L) | Standard Deviation 11.97 |
| Insulin Degludec | Change in Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) | Lipase | -0.35 Units per liter (U/L) | Standard Deviation 13.81 |
| Insulin Degludec | Change in Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) | ALP | -1.70 Units per liter (U/L) | Standard Deviation 11.39 |
| Insulin Degludec | Change in Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) | Creatinine kinase | 6.99 Units per liter (U/L) | Standard Deviation 84.31 |
Secondary
Change in Biochemical Parameter-calcium (Total), Albumin Corrected Calcium, Potassium, Sodium, Urea
Change in calcium (total), albumin corrected calcium, potassium, sodium, urea from baseline (week 0) to week 26 is presented.
Time frame: Week 0, week 26
Population: SAS included all participants who received at least one dose of IDegLira or IDeg. Number analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Biochemical Parameter-calcium (Total), Albumin Corrected Calcium, Potassium, Sodium, Urea | Albumin corrected calcium | -0.00 mmol/L | Standard Deviation 0.08 |
| Insulin Degludec/Liraglutide | Change in Biochemical Parameter-calcium (Total), Albumin Corrected Calcium, Potassium, Sodium, Urea | Sodium | 1.03 mmol/L | Standard Deviation 2.47 |
| Insulin Degludec/Liraglutide | Change in Biochemical Parameter-calcium (Total), Albumin Corrected Calcium, Potassium, Sodium, Urea | Potassium | -0.03 mmol/L | Standard Deviation 0.34 |
| Insulin Degludec/Liraglutide | Change in Biochemical Parameter-calcium (Total), Albumin Corrected Calcium, Potassium, Sodium, Urea | Urea | -0.09 mmol/L | Standard Deviation 1.32 |
| Insulin Degludec/Liraglutide | Change in Biochemical Parameter-calcium (Total), Albumin Corrected Calcium, Potassium, Sodium, Urea | Calcium (total) | 0.01 mmol/L | Standard Deviation 0.1 |
| Insulin Degludec | Change in Biochemical Parameter-calcium (Total), Albumin Corrected Calcium, Potassium, Sodium, Urea | Urea | 0.17 mmol/L | Standard Deviation 1.29 |
| Insulin Degludec | Change in Biochemical Parameter-calcium (Total), Albumin Corrected Calcium, Potassium, Sodium, Urea | Calcium (total) | -0.01 mmol/L | Standard Deviation 0.09 |
| Insulin Degludec | Change in Biochemical Parameter-calcium (Total), Albumin Corrected Calcium, Potassium, Sodium, Urea | Albumin corrected calcium | -0.01 mmol/L | Standard Deviation 0.08 |
| Insulin Degludec | Change in Biochemical Parameter-calcium (Total), Albumin Corrected Calcium, Potassium, Sodium, Urea | Potassium | -0.11 mmol/L | Standard Deviation 0.35 |
| Insulin Degludec | Change in Biochemical Parameter-calcium (Total), Albumin Corrected Calcium, Potassium, Sodium, Urea | Sodium | 1.40 mmol/L | Standard Deviation 2.43 |
Secondary
Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
Change in blood pressure (systolic and diastolic blood pressure) from baseline (week 0) to week 26 is presented.
Time frame: Week 0, week 26
Population: SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analysed = 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 13.6 |
| Insulin Degludec/Liraglutide | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure | 0.1 Millimeters of mercury (mmHg) | Standard Deviation 7.8 |
| Insulin Degludec | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Systolic blood pressure | -0.5 Millimeters of mercury (mmHg) | Standard Deviation 12.5 |
| Insulin Degludec | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure | -0.4 Millimeters of mercury (mmHg) | Standard Deviation 8.1 |
Secondary
Change in Body Weight
Change in body weight 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 = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Body Weight | -0.7 Kilogram (kg) | Standard Deviation 3 |
| Insulin Degludec | Change in Body Weight | 0.5 Kilogram (kg) | Standard Deviation 2.7 |
Secondary
Change in Calcitonin
Calcitonin levels were measured and were categorised as low, normal or high. Number of participants in each category at week 0 and week 26 were presented.
Time frame: Week 0, week 26
Population: SAS included all participants who received at least one dose of IDegLira or IDeg. Number analyzed = participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Calcitonin | Week 0 | Normal | 293 Participants |
| Insulin Degludec/Liraglutide | Change in Calcitonin | Week 26 | Low | 0 Participants |
| Insulin Degludec/Liraglutide | Change in Calcitonin | Week 0 | Low | 0 Participants |
| Insulin Degludec/Liraglutide | Change in Calcitonin | Week 26 | Normal | 279 Participants |
| Insulin Degludec/Liraglutide | Change in Calcitonin | Week 26 | High | 10 Participants |
| Insulin Degludec/Liraglutide | Change in Calcitonin | Week 0 | High | 8 Participants |
| Insulin Degludec | Change in Calcitonin | Week 26 | High | 3 Participants |
| Insulin Degludec | Change in Calcitonin | Week 0 | Low | 0 Participants |
| Insulin Degludec | Change in Calcitonin | Week 0 | Normal | 149 Participants |
| Insulin Degludec | Change in Calcitonin | Week 0 | High | 2 Participants |
| Insulin Degludec | Change in Calcitonin | Week 26 | Low | 0 Participants |
| Insulin Degludec | Change in Calcitonin | Week 26 | Normal | 136 Participants |
Secondary
Change in Creatinine
Change in creatinine from baseline (week 0) to week 26 is presented.
Time frame: Week 0, week 26
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 | Change in Creatinine | 0.44 umol/L | Standard Deviation 7.93 |
| Insulin Degludec | Change in Creatinine | -0.32 umol/L | Standard Deviation 7.52 |
Secondary
Change in Electrocardiogram (ECG)
The ECG was assessed by the investigator at baseline (week -2) and week 26 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 26 were presented.
Time frame: Week -2, week 26
Population: SAS included all participants who received at least one dose of IDegLira or IDeg. Number analyzed=participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Electrocardiogram (ECG) | Week -2 | Normal | 175 Participants |
| Insulin Degludec/Liraglutide | Change in Electrocardiogram (ECG) | Week -2 | Abnormal NCS | 76 Participants |
| Insulin Degludec/Liraglutide | Change in Electrocardiogram (ECG) | Week -2 | Abnormal CS | 50 Participants |
| Insulin Degludec/Liraglutide | Change in Electrocardiogram (ECG) | Week 26 | Normal | 175 Participants |
| Insulin Degludec/Liraglutide | Change in Electrocardiogram (ECG) | Week 26 | Abnormal NCS | 73 Participants |
| Insulin Degludec/Liraglutide | Change in Electrocardiogram (ECG) | Week 26 | Abnormal CS | 39 Participants |
| Insulin Degludec | Change in Electrocardiogram (ECG) | Week 26 | Abnormal NCS | 32 Participants |
| Insulin Degludec | Change in Electrocardiogram (ECG) | Week -2 | Normal | 90 Participants |
| Insulin Degludec | Change in Electrocardiogram (ECG) | Week 26 | Normal | 91 Participants |
| Insulin Degludec | Change in Electrocardiogram (ECG) | Week -2 | Abnormal NCS | 41 Participants |
| Insulin Degludec | Change in Electrocardiogram (ECG) | Week 26 | Abnormal CS | 16 Participants |
| Insulin Degludec | Change in Electrocardiogram (ECG) | Week -2 | Abnormal CS | 20 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 = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting C-peptide- Ratio to Baseline | 0.64 Ratio of C-peptide | Geometric Coefficient of Variation 71.2 |
| Insulin Degludec | Change in Fasting C-peptide- Ratio to Baseline | 0.52 Ratio of C-peptide | Geometric Coefficient of Variation 71.8 |
Secondary
Change in Fasting Free Fatty Acids- Ratio to Baseline
Change in fasting free fatty acids (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 = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting Free Fatty Acids- Ratio to Baseline | 0.65 Ratio of free fatty acids | Geometric Coefficient of Variation 76.4 |
| Insulin Degludec | Change in Fasting Free Fatty Acids- Ratio to Baseline | 0.64 Ratio of free fatty acids | Geometric Coefficient of Variation 61.9 |
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 participants analysed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting Glucagon- Ratio to Baseline | 1.01 Ratio of glucagon | Geometric Coefficient of Variation 95.8 |
| Insulin Degludec | Change in Fasting Glucagon- Ratio to Baseline | 1.09 Ratio of glucagon | Geometric Coefficient of Variation 81.7 |
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 = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting High-density Lipoprotein (HDL) Cholesterol- Ratio to Baseline | 1.00 Ratio of HDL cholesterol | Geometric Coefficient of Variation 17.5 |
| Insulin Degludec | Change in Fasting High-density Lipoprotein (HDL) Cholesterol- Ratio to Baseline | 1.03 Ratio of HDL cholesterol | Geometric Coefficient of Variation 15.9 |
Secondary
Change in Fasting Insulin- Ratio to Baseline
Change in fasting 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 = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting Insulin- Ratio to Baseline | 0.63 Ratio of insulin | Geometric Coefficient of Variation 118.3 |
| Insulin Degludec | Change in Fasting Insulin- Ratio to Baseline | 0.50 Ratio of insulin | Geometric Coefficient of Variation 106.4 |
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 = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting Low-density Lipoprotein (LDL) Cholesterol- Ratio to Baseline | 0.89 Ratio of LDL cholesterol | Geometric Coefficient of Variation 32.5 |
| Insulin Degludec | Change in Fasting Low-density Lipoprotein (LDL) Cholesterol- Ratio to Baseline | 0.95 Ratio of LDL cholesterol | Geometric Coefficient of Variation 37.7 |
Secondary
Change in Fasting Plasma Glucose (FPG)
Change in FPG 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 = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting Plasma Glucose (FPG) | -3.57 mmol/L | Standard Deviation 3 |
| Insulin Degludec | Change in Fasting Plasma Glucose (FPG) | -2.82 mmol/L | Standard Deviation 3.15 |
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 = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting Total Cholesterol- Ratio to Baseline | 0.92 Ratio of total cholesterol | Geometric Coefficient of Variation 19.1 |
| Insulin Degludec | Change in Fasting Total Cholesterol- Ratio to Baseline | 0.97 Ratio of total cholesterol | Geometric Coefficient of Variation 20 |
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 = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting Triglycerides- Ratio to Baseline | 0.91 Ratio of triglycerides | Geometric Coefficient of Variation 63.7 |
| Insulin Degludec | Change in Fasting Triglycerides- Ratio to Baseline | 0.92 Ratio of triglycerides | Geometric Coefficient of Variation 55.8 |
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 = 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 | 0.92 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 55.2 |
| Insulin Degludec | Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline | 0.93 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 49.1 |
Secondary
Change in Haematological Parameter- Basophils
Change in basophils from baseline (week 0) to week 26 is presented.
Time frame: Week 0, week 26
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 | Change in Haematological Parameter- Basophils | 0.00 Percentage of basophils | Standard Deviation 0.34 |
| Insulin Degludec | Change in Haematological Parameter- Basophils | 0.01 Percentage of basophils | Standard Deviation 0.27 |
Secondary
Change in Haematological Parameter- Eosinophils
Change in eosinophils from baseline (week 0) to week 26 is presented.
Time frame: Week 0, week 26
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 | Change in Haematological Parameter- Eosinophils | -0.15 Percentage of eosinophils | Standard Deviation 1.84 |
| Insulin Degludec | Change in Haematological Parameter- Eosinophils | -0.25 Percentage of eosinophils | Standard Deviation 1.72 |
Secondary
Change in Haematological Parameter- Erythrocytes
Change in erythrocytes from baseline (week 0) to week 26 is presented.
Time frame: Week 0, week 26
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 | Change in Haematological Parameter- Erythrocytes | -0.06 10^12 cells per liter (10^12/L) | Standard Deviation 0.26 |
| Insulin Degludec | Change in Haematological Parameter- Erythrocytes | -0.05 10^12 cells per liter (10^12/L) | Standard Deviation 0.24 |
Secondary
Change in Haematological Parameter- Haematocrit
Change in haematocrit from baseline (week 0) to week 26 is presented.
Time frame: Week 0, week 26
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 | Change in Haematological Parameter- Haematocrit | -0.07 Percentage of red blood cells | Standard Deviation 2.56 |
| Insulin Degludec | Change in Haematological Parameter- Haematocrit | -0.12 Percentage of red blood cells | Standard Deviation 2.14 |
Secondary
Change in Haematological Parameter- Haemoglobin
Change in haemoglobin from baseline (week 0) to week 26 is presented.
Time frame: Week 0, week 26
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 | Change in Haematological Parameter- Haemoglobin | -0.08 mmol/L | Standard Deviation 0.52 |
| Insulin Degludec | Change in Haematological Parameter- Haemoglobin | -0.09 mmol/L | Standard Deviation 0.41 |
Secondary
Change in Haematological Parameter- Leukocytes and Thrombocytes
Change in leukocytes and thrombocytes from baseline (week 0) to week 26 is presented.
Time frame: Week 0, week 26
Population: SAS included all participants who received at least one dose of IDegLira or IDeg. Number of participants analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Haematological Parameter- Leukocytes and Thrombocytes | Leukocytes | 0.32 10^9 cells per liter (10^9/L) | Standard Deviation 1.39 |
| Insulin Degludec/Liraglutide | Change in Haematological Parameter- Leukocytes and Thrombocytes | Thrombocytes | 14.13 10^9 cells per liter (10^9/L) | Standard Deviation 34.34 |
| Insulin Degludec | Change in Haematological Parameter- Leukocytes and Thrombocytes | Leukocytes | 0.31 10^9 cells per liter (10^9/L) | Standard Deviation 1.18 |
| Insulin Degludec | Change in Haematological Parameter- Leukocytes and Thrombocytes | Thrombocytes | 12.19 10^9 cells per liter (10^9/L) | Standard Deviation 34.01 |
Secondary
Change in Haematological Parameter- Lymphocytes
Change in lymphocytes from baseline (week 0) to week 26 is presented.
Time frame: Week 0, week 26
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 | Change in Haematological Parameter- Lymphocytes | -1.00 Percentage of lymphocytes | Standard Deviation 6.95 |
| Insulin Degludec | Change in Haematological Parameter- Lymphocytes | -0.82 Percentage of lymphocytes | Standard Deviation 6.41 |
Secondary
Change in Haematological Parameter- Monocytes
Change in monocytes from baseline (week 0) to week 26 is presented.
Time frame: Week 0, week 26
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 | Change in Haematological Parameter- Monocytes | -0.19 Percentage of monocytes | Standard Deviation 2.02 |
| Insulin Degludec | Change in Haematological Parameter- Monocytes | -0.06 Percentage of monocytes | Standard Deviation 2.19 |
Secondary
Change in Haematological Parameter- Neutrophils
Change in neutrophils from baseline (week 0) to week 26 is presented.
Time frame: Week 0, week 26
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 | Change in Haematological Parameter- Neutrophils | 1.34 Percentage of neutrophils | Standard Deviation 7.85 |
| Insulin Degludec | Change in Haematological Parameter- Neutrophils | 0.99 Percentage of neutrophils | Standard Deviation 7.41 |
Secondary
Change in HOMA-B (Beta-cell Function)- Ratio to Baseline
Change in HOMA-B 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 = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in HOMA-B (Beta-cell Function)- Ratio to Baseline | 1.47 Ratio of beta-cell function | Geometric Coefficient of Variation 115 |
| Insulin Degludec | Change in HOMA-B (Beta-cell Function)- Ratio to Baseline | 0.99 Ratio of beta-cell function | Geometric Coefficient of Variation 113.4 |
Secondary
Change in Mean of the 9-point Self-measured Plasma Glucose (SMPG) Profile
Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and 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 = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Mean of the 9-point Self-measured Plasma Glucose (SMPG) Profile | -3.35 mmol/L | Standard Deviation 2.63 |
| Insulin Degludec | Change in Mean of the 9-point Self-measured Plasma Glucose (SMPG) Profile | -2.31 mmol/L | Standard Deviation 2.61 |
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 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 IDegLira or IDeg. Number analyzed=participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week-2: Central and peripheral nervous system | Normal | 299 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Lymph node palpation | Normal | 301 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Gastrointestinal system | Abnormal CS | 0 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 26: General appearance | Abnormal NCS | 9 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Lymph node palpation | Abnormal CS | 0 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Gastrointestinal system | Normal | 285 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Lymph node palpation | Normal | 288 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week-2: Central and peripheral nervous system | Abnormal NCS | 2 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: Gastrointestinal system | Abnormal NCS | 2 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Lymph node palpation | Abnormal CS | 0 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Cardiovascular system | Normal | 286 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Musculoskeletal system | Normal | 296 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Gastrointestinal system | Abnormal CS | 1 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: Central and peripheral nervous system | Abnormal CS | 0 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Musculoskeletal system | Abnormal CS | 3 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: General appearance | Normal | 283 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Musculoskeletal system | Normal | 280 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: General appearance | Abnormal NCS | 11 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Musculoskeletal system | Abnormal NCS | 3 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week-2: Cardiovascular system | Abnormal NCS | 1 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Musculoskeletal system | Abnormal CS | 5 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: General appearance | Abnormal CS | 7 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Respiratory system | Normal | 301 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Central and peripheral nervous system | Normal | 287 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Respiratory system | Abnormal NCS | 0 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: General appearance | Normal | 273 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: Respiratory system | Normal | 288 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Cardiovascular system | Abnormal NCS | 1 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: Central and peripheral nervous system | Abnormal NCS | 1 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Respiratory system | Abnormal CS | 0 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: General appearance | Abnormal CS | 6 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Skin | Normal | 270 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week-2: Cardiovascular system | Normal | 299 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Skin | Abnormal NCS | 22 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Head, eyes, ENTand Neck | Normal | 295 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 | 0 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Skin | Normal | 259 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Head, eyes, ENTand Neck | Abnormal NCS | 2 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Skin | Abnormal NCS | 22 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Cardiovascular system | Abnormal CS | 1 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Skin | Abnormal CS | 7 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Head, eyes, ENTand Neck | Abnormal CS | 4 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Thyroid gland | Normal | 295 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Gastrointestinal system | Normal | 299 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Thyroid gland | Abnormal NCS | 4 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Head, eyes, ENTand Neck | Normal | 283 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Thyroid gland | Abnormal CS | 2 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week-2: Cardiovascular system | Abnormal CS | 1 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Thyroid gland | Normal | 284 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Head, eyes, ENTand Neck | Abnormal NCS | 2 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Thyroid gland | Abnormal NCS | 3 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week -2: Gastrointestinal system | Abnormal NCS | 2 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Thyroid gland | Abnormal CS | 1 Participants |
| Insulin Degludec/Liraglutide | Change in Physical Examination | Week 26: Head, eyes, ENTand Neck | Abnormal CS | 3 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Head, eyes, ENTand Neck | Abnormal CS | 1 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Respiratory system | Abnormal CS | 0 Participants |
| Insulin Degludec | Change in Physical Examination | Week-2: Cardiovascular system | Normal | 149 Participants |
| Insulin Degludec | Change in Physical Examination | Week-2: Cardiovascular system | Abnormal NCS | 0 Participants |
| Insulin Degludec | Change in Physical Examination | Week-2: Cardiovascular system | Abnormal CS | 2 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Cardiovascular system | Normal | 137 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Cardiovascular system | Abnormal NCS | 0 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Cardiovascular system | Abnormal CS | 2 Participants |
| Insulin Degludec | Change in Physical Examination | Week-2: Central and peripheral nervous system | Normal | 150 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 | 1 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Central and peripheral nervous system | Normal | 139 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 | 0 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Gastrointestinal system | Normal | 150 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Gastrointestinal system | Abnormal NCS | 1 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Gastrointestinal system | Abnormal CS | 0 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Gastrointestinal system | Normal | 139 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Gastrointestinal system | Abnormal NCS | 0 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Gastrointestinal system | Abnormal CS | 0 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 | 8 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: General appearance | Normal | 130 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 | 7 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Head, eyes, ENTand Neck | Normal | 147 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Head, eyes, ENTand Neck | Abnormal NCS | 2 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Head, eyes, ENTand Neck | Abnormal CS | 2 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Head, eyes, ENTand Neck | Normal | 137 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Head, eyes, ENTand Neck | Abnormal NCS | 1 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: General appearance | Normal | 141 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Lymph node palpation | Normal | 151 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 | 0 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Lymph node palpation | Normal | 139 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 | 0 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Musculoskeletal system | Normal | 145 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Musculoskeletal system | Abnormal NCS | 3 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Musculoskeletal system | Abnormal CS | 3 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Musculoskeletal system | Normal | 137 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 | 151 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Respiratory system | Abnormal NCS | 0 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Respiratory system | Normal | 139 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 | 132 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Skin | Abnormal NCS | 13 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Skin | Abnormal CS | 6 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Skin | Normal | 126 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Skin | Abnormal NCS | 9 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Skin | Abnormal CS | 4 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Thyroid gland | Normal | 147 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Thyroid gland | Abnormal NCS | 2 Participants |
| Insulin Degludec | Change in Physical Examination | Week -2: Thyroid gland | Abnormal CS | 2 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Thyroid gland | Normal | 134 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Thyroid gland | Abnormal NCS | 3 Participants |
| Insulin Degludec | Change in Physical Examination | Week 26: Thyroid gland | Abnormal CS | 2 Participants |
Secondary
Change in Pulse
Change in pulse from baseline (week 0) to week 26 is presented.
Time frame: Week 0, week 26
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 | Change in Pulse | 5.7 Beats per minute (beats/min) | Standard Deviation 9.6 |
| Insulin Degludec | Change in Pulse | 1.3 Beats per minute (beats/min) | Standard Deviation 8.7 |
Secondary
Change in SMPG-mean Post Prandial Increments
Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Change in SMPG-mean postprandial increment over all meals 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 = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in SMPG-mean Post Prandial Increments | 0.08 mmol/L | Standard Deviation 2.19 |
| Insulin Degludec | Change in SMPG-mean Post Prandial Increments | 0.28 mmol/L | Standard Deviation 2.71 |
Secondary
Change in Total Bilirubin
Change in total bilirubin from baseline (week 0) to week 26 is presented.
Time frame: Week 0, week 26
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 | Change in Total Bilirubin | -0.30 Micromoles per liter (umol/L) | Standard Deviation 3.89 |
| Insulin Degludec | Change in Total Bilirubin | -0.54 Micromoles per liter (umol/L) | Standard Deviation 3.66 |
Secondary
Change in Total Protein
Change in total protein from baseline (week 0) to week 26 is presented.
Time frame: Week 0, week 26
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 | Change in Total Protein | 0.08 g/dL | Standard Deviation 0.41 |
| Insulin Degludec | Change in Total Protein | 0.03 g/dL | Standard Deviation 0.39 |
Secondary
Change in Waist Circumference
Change in waist circumference 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 = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Waist Circumference | -0.4 Centimeter (cm) | Standard Deviation 4.3 |
| Insulin Degludec | Change in Waist Circumference | 0.7 Centimeter (cm) | Standard Deviation 3.3 |
Secondary
Eye Examination
Dilated fundoscopy or fundus photography was performed by the investigator at week -2 and week 26. The results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at week -2 and week 26 were presented.
Time frame: Week -2, week 26
Population: SAS included all participants who received at least one dose of IDegLira or IDeg. Number analyzed=participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Eye Examination | Week -2: Left eye | Normal | 167 Participants |
| Insulin Degludec/Liraglutide | Eye Examination | Week -2: Left eye | Abnormal NCS | 34 Participants |
| Insulin Degludec/Liraglutide | Eye Examination | Week -2: Left eye | Abnormal CS | 100 Participants |
| Insulin Degludec/Liraglutide | Eye Examination | Week 26: Left eye | Normal | 147 Participants |
| Insulin Degludec/Liraglutide | Eye Examination | Week 26: Left eye | Abnormal NCS | 35 Participants |
| Insulin Degludec/Liraglutide | Eye Examination | Week 26: Left eye | Abnormal CS | 105 Participants |
| Insulin Degludec/Liraglutide | Eye Examination | Week -2: Right eye | Normal | 162 Participants |
| Insulin Degludec/Liraglutide | Eye Examination | Week -2: Right eye | Abnormal NCS | 41 Participants |
| Insulin Degludec/Liraglutide | Eye Examination | Week -2: Right eye | Abnormal CS | 98 Participants |
| Insulin Degludec/Liraglutide | Eye Examination | Week 26: Right eye | Normal | 139 Participants |
| Insulin Degludec/Liraglutide | Eye Examination | Week 26: Right eye | Abnormal NCS | 37 Participants |
| Insulin Degludec/Liraglutide | Eye Examination | Week 26: Right eye | Abnormal CS | 111 Participants |
| Insulin Degludec | Eye Examination | Week 26: Right eye | Abnormal NCS | 12 Participants |
| Insulin Degludec | Eye Examination | Week -2: Left eye | Normal | 87 Participants |
| Insulin Degludec | Eye Examination | Week -2: Right eye | Normal | 85 Participants |
| Insulin Degludec | Eye Examination | Week -2: Left eye | Abnormal NCS | 15 Participants |
| Insulin Degludec | Eye Examination | Week 26: Right eye | Normal | 84 Participants |
| Insulin Degludec | Eye Examination | Week -2: Left eye | Abnormal CS | 49 Participants |
| Insulin Degludec | Eye Examination | Week -2: Right eye | Abnormal NCS | 18 Participants |
| Insulin Degludec | Eye Examination | Week 26: Left eye | Normal | 80 Participants |
| Insulin Degludec | Eye Examination | Week 26: Right eye | Abnormal CS | 42 Participants |
| Insulin Degludec | Eye Examination | Week 26: Left eye | Abnormal NCS | 14 Participants |
| Insulin Degludec | Eye Examination | Week -2: Right eye | Abnormal CS | 47 Participants |
| Insulin Degludec | Eye Examination | Week 26: Left eye | Abnormal CS | 45 Participants |
Secondary
Insulin Dose
The mean of actual daily total insulin dose after 26 weeks of treatment is presented.
Time frame: Week 26
Population: SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analysed = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Insulin Dose | 34.6 Units of insulin (U) | Standard Deviation 11.1 |
| Insulin Degludec | Insulin Dose | 37.9 Units of insulin (U) | Standard Deviation 10.8 |
Secondary
Number of Treatment-emergent Adverse Events (TEAEs)
A TEAE was defined as an adverse event with onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.
Time frame: Weeks 0-27
Population: SAS included all participants who received at least one dose of IDegLira or IDeg.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Degludec/Liraglutide | Number of Treatment-emergent Adverse Events (TEAEs) | 641 Adverse events |
| Insulin Degludec | Number of Treatment-emergent Adverse Events (TEAEs) | 230 Adverse events |
Secondary
Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition
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 treatment-emergent hypoglycaemic episodes according to ADA definition is presented.
Time frame: Weeks 0-27
Population: SAS included all participants who received at least one dose of IDegLira or IDeg.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Degludec/Liraglutide | Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition | 1099 Episodes |
| Insulin Degludec | Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition | 680 Episodes |
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 (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose 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. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 a.m. both inclusive. Number of treatment-emergent nocturnal severe or BG confirmed hypoglycaemic episodes is presented.
Time frame: Weeks 0-27
Population: SAS included all participants who received at least one dose of IDegLira or IDeg.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Degludec/Liraglutide | Number of Treatment-emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes | 9 Episodes |
| Insulin Degludec | Number of Treatment-emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes | 8 Episodes |
Secondary
Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic 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 plasma glucose 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. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 a.m. both inclusive. Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes is presented.
Time frame: Weeks 0-27
Population: SAS included all participants who received at least one dose of IDegLira or IDeg.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Degludec/Liraglutide | Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | 7 Episodes |
| Insulin Degludec | Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | 7 Episodes |
Secondary
Number of Treatment-emergent Severe or BG Confirmed Symptomatic 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 plasma glucose 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. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes is presented.
Time frame: Weeks 0-27
Population: SAS included all participants who received at least one dose of IDegLira or IDeg.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Degludec/Liraglutide | Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | 23 Episodes |
| Insulin Degludec | Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | 21 Episodes |
Secondary
Number of Treatment-emergent Severe or Blood Glucose (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 BG confirmed by a plasma glucose 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. Number of treatment-emergent severe or BG confirmed hypoglycaemic episodes during 26 weeks of treatment is presented.
Time frame: Up to 26 weeks
Population: Safety analysis set (SAS) included all participants who received at least one dose of IDegLira or IDeg.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Degludec/Liraglutide | Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes | 38 Episodes |
| Insulin Degludec | Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes | 36 Episodes |
Secondary
Occurrence of Anti-liraglutide Antibodies Cross Reacting Native Glucagon-like Peptide-1 (GLP-1)
This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. 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 IDegLira or IDeg. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Occurrence of Anti-liraglutide Antibodies Cross Reacting Native Glucagon-like Peptide-1 (GLP-1) | Yes | 6 Participants |
Secondary
Occurrence of Anti-liraglutide Antibodies (Yes/no)
This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. Number of participants who measured with anti-liraglutide antibodies at week 27 are presented.
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 | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Occurrence of Anti-liraglutide Antibodies (Yes/no) | Yes | 24 Participants |
| Insulin Degludec/Liraglutide | Occurrence of Anti-liraglutide Antibodies (Yes/no) | No | 264 Participants |
Secondary
Occurrence of Neutralising Liraglutide Antibodies
This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. 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 IDegLira or IDeg. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Occurrence of Neutralising Liraglutide Antibodies | Yes | 0 Participants |
Secondary
Occurrence of Neutralising Liraglutide Antibodies Cross Reacting Native GLP-1
This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. Number of participants who measured with neutralising 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 IDegLira or IDeg. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Occurrence of Neutralising Liraglutide Antibodies Cross Reacting Native GLP-1 | Yes | 0 Participants |
Secondary
Participants Who Achieved HbA1c ≤ 6.5%, American Association of Clinical Endocrinologists (AACE) Target (Yes/no)
Participants who achieved HbA1c ≤ 6.5%, AACE target (yes/no) is presented.
Time frame: Week 26
Population: FAS included all randomised participants. Overall number of participants analysed = participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c ≤ 6.5%, American Association of Clinical Endocrinologists (AACE) Target (Yes/no) | Yes | 96 Participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c ≤ 6.5%, American Association of Clinical Endocrinologists (AACE) Target (Yes/no) | No | 193 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c ≤ 6.5%, American Association of Clinical Endocrinologists (AACE) Target (Yes/no) | Yes | 10 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c ≤ 6.5%, American Association of Clinical Endocrinologists (AACE) Target (Yes/no) | No | 128 Participants |
Secondary
Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero
Participants who achieved HbA1c ≤ 6.5% and change from baseline in body weight below or equal to zero is presented.
Time frame: Week 26
Population: FAS included all randomised participants. Overall number of participants analysed = participants with available data.
| 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 | 59 Participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero | No | 243 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero | Yes | 3 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero | No | 148 Participants |
Secondary
Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero and Without Treatment-emergent 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 plasma glucose 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. Participants who achieved HbA1c ≤ 6.5% and change from baseline in body weight below or equal to zero and without treatment-emergent severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment is presented.
Time frame: Week 26
Population: FAS included all randomised participants. Overall number of participants analysed = participants with available data.
| 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 and Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes | Yes | 58 Participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero and Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes | No | 244 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero and Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes | Yes | 3 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero and Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes | No | 148 Participants |
Secondary
Participants Who Achieved HbA1c ≤ 6.5% Without Treatment-emergent 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 plasma glucose 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. Participants who achieved HbA1c ≤ 6.5% at week 26 without treatment-emergent severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment is presented.
Time frame: Week 26
Population: FAS included all randomised participants. Overall number of participants analysed = participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes | Yes | 93 Participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes | No | 209 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes | Yes | 9 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes | No | 142 Participants |
Secondary
Participants Who Achieved HbA1c < 7.0%, ADA Target (Yes/no)
Participants who achieved HbA1c \< 7.0%, ADA target (yes/no) is presented.
Time frame: Week 26
Population: FAS included all randomised participants. Overall number of participants analysed = participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c < 7.0%, ADA Target (Yes/no) | Yes | 151 Participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c < 7.0%, ADA Target (Yes/no) | No | 138 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c < 7.0%, ADA Target (Yes/no) | Yes | 23 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c < 7.0%, ADA Target (Yes/no) | No | 115 Participants |
Secondary
Participants Who Achieved HbA1c < 7.0% and Change From Baseline in Body Weight Below or Equal to Zero
Participants who achieved HbA1c \< 7.0% and change from baseline in body weight below or equal to zero is presented.
Time frame: Week 26
Population: FAS included all randomised participants. Overall number of participants analysed = participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c < 7.0% and Change From Baseline in Body Weight Below or Equal to Zero | Yes | 98 Participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c < 7.0% and Change From Baseline in Body Weight Below or Equal to Zero | No | 204 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c < 7.0% and Change From Baseline in Body Weight Below or Equal to Zero | Yes | 7 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c < 7.0% and Change From Baseline in Body Weight Below or Equal to Zero | No | 144 Participants |
Secondary
Participants Who Achieved HbA1c < 7.0% and Change From Baseline in Body Weight Below or Equal to Zero and Without Treatment-emergent 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 plasma glucose 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. Participants who achieved HbA1c \< 7.0% and change from baseline in body weight below or equal to zero and without treatment-emergent severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment is presented.
Time frame: Week 26
Population: FAS included all randomised participants. Overall number of participants analysed = participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c < 7.0% and Change From Baseline in Body Weight Below or Equal to Zero and Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes | Yes | 94 Participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c < 7.0% and Change From Baseline in Body Weight Below or Equal to Zero and Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes | No | 208 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c < 7.0% and Change From Baseline in Body Weight Below or Equal to Zero and Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes | Yes | 7 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c < 7.0% and Change From Baseline in Body Weight Below or Equal to Zero and Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes | No | 144 Participants |
Secondary
Participants Who Achieved HbA1c < 7.0% Without Treatment-emergent 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 plasma glucose 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. Participants who achieved HbA1c \< 7.0% at week 26 without treatment-emergent severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment is presented.
Time frame: Week 26
Population: FAS included all randomised participants. Overall number of participants analysed = participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes | Yes | 148 Participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes | No | 154 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes | Yes | 22 Participants |
| Insulin Degludec | Participants Who Achieved HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes | No | 129 Participants |
Secondary
SMPG-9-point Profile (Individual Points in the Profile)
Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. SMPG-9-point profile (individual points in the profile) at week 26 is presented.
Time frame: Week 26
Population: FAS included all randomised participants. Number analysed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | 90 minutes after start of breakfast | 9.51 mmol/L | Standard Deviation 2.66 |
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | 90 minutes after main evening meal | 9.87 mmol/L | Standard Deviation 2.53 |
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | 90 minutes after start of lunch | 9.68 mmol/L | Standard Deviation 2.52 |
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | At bedtime | 8.57 mmol/L | Standard Deviation 2.52 |
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | Before lunch | 6.93 mmol/L | Standard Deviation 2.1 |
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | At 4:00 a.m. | 5.97 mmol/L | Standard Deviation 1.49 |
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | Before main evening meal | 7.24 mmol/L | Standard Deviation 2.16 |
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | Before breakfast the following day | 5.48 mmol/L | Standard Deviation 1.14 |
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | Before breakfast | 5.48 mmol/L | Standard Deviation 1.06 |
| Insulin Degludec | SMPG-9-point Profile (Individual Points in the Profile) | Before breakfast the following day | 5.83 mmol/L | Standard Deviation 1.52 |
| Insulin Degludec | SMPG-9-point Profile (Individual Points in the Profile) | Before breakfast | 5.88 mmol/L | Standard Deviation 1.3 |
| Insulin Degludec | SMPG-9-point Profile (Individual Points in the Profile) | 90 minutes after start of breakfast | 10.50 mmol/L | Standard Deviation 2.45 |
| Insulin Degludec | SMPG-9-point Profile (Individual Points in the Profile) | Before lunch | 8.17 mmol/L | Standard Deviation 3.19 |
| Insulin Degludec | SMPG-9-point Profile (Individual Points in the Profile) | 90 minutes after start of lunch | 11.21 mmol/L | Standard Deviation 2.93 |
| Insulin Degludec | SMPG-9-point Profile (Individual Points in the Profile) | Before main evening meal | 7.87 mmol/L | Standard Deviation 2.65 |
| Insulin Degludec | SMPG-9-point Profile (Individual Points in the Profile) | 90 minutes after main evening meal | 10.86 mmol/L | Standard Deviation 2.46 |
| Insulin Degludec | SMPG-9-point Profile (Individual Points in the Profile) | At bedtime | 9.52 mmol/L | Standard Deviation 2.61 |
| Insulin Degludec | SMPG-9-point Profile (Individual Points in the Profile) | At 4:00 a.m. | 6.61 mmol/L | Standard Deviation 1.99 |
Secondary
Total Insulin Antibodies
Serum samples were analysed for the presence of total insulin antibodies. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/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 | Total Insulin Antibodies | 9.31 %B/T | Standard Deviation 17.33 |
| Insulin Degludec | Total Insulin Antibodies | 8.77 %B/T | Standard Deviation 17.19 |
Secondary
Urinalysis (Erythrocytes, Protein, Glucose and Ketones)
The urinalysis was the measurements of protein, glucose, erythrocytes and ketones at week 0 and week 26 and categorised as negative, trace, 1+, 2+ and 3+. Number of participants in each category at 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 IDegLira or IDeg. Number analyzed = participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Erythrocytes | 2+ | 2 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Ketones | Trace | 21 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Ketones | Trace | 14 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Erythrocytes | Negative | 258 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Erythrocytes | Trace | 33 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Erythrocytes | 1+ | 3 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Erythrocytes | 2+ | 2 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Erythrocytes | 3+ | 4 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Erythrocytes | Negative | 255 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Erythrocytes | Trace | 22 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Erythrocytes | 1+ | 6 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Erythrocytes | 3+ | 2 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Glucose | Negative | 171 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Glucose | Trace | 33 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Glucose | 1+ | 30 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Glucose | 2+ | 25 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Glucose | 3+ | 41 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Glucose | Negative | 256 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Glucose | Trace | 14 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Glucose | 1+ | 10 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Glucose | 2+ | 4 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Glucose | 3+ | 3 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Ketones | Negative | 274 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Ketones | 1+ | 5 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Ketones | 2+ | 0 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Ketones | 3+ | 0 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Ketones | Negative | 272 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Ketones | 1+ | 1 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Ketones | 2+ | 0 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Ketones | 3+ | 0 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Protein | Negative | 172 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Protein | Trace | 72 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Protein | 1+ | 36 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Protein | 2+ | 16 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Protein | 3+ | 4 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Protein | Negative | 198 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Protein | Trace | 47 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Protein | 1+ | 29 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Protein | 2+ | 11 Participants |
| Insulin Degludec/Liraglutide | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Protein | 3+ | 2 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Protein | 1+ | 18 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Glucose | 2+ | 2 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Ketones | Negative | 132 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Protein | Negative | 89 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Glucose | 3+ | 2 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Erythrocytes | Negative | 121 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Protein | Negative | 89 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Erythrocytes | Trace | 22 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Ketones | Trace | 10 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Erythrocytes | 1+ | 4 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Protein | Trace | 32 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Erythrocytes | 2+ | 3 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Ketones | 1+ | 4 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Erythrocytes | 3+ | 1 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Protein | 3+ | 1 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Erythrocytes | Negative | 120 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Ketones | 2+ | 0 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Erythrocytes | Trace | 11 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Protein | 1+ | 18 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Erythrocytes | 1+ | 1 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Ketones | Negative | 137 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Erythrocytes | 2+ | 4 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Ketones | 3+ | 0 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Erythrocytes | 3+ | 3 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Protein | Trace | 22 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Glucose | Negative | 92 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Ketones | Trace | 7 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Glucose | Trace | 13 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Protein | 2+ | 10 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Glucose | 1+ | 17 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Ketones | 1+ | 0 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Glucose | 2+ | 13 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Protein | 2+ | 9 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Glucose | 3+ | 16 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Ketones | 2+ | 0 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Glucose | Negative | 110 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 0: Protein | 3+ | 2 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Glucose | Trace | 16 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Ketones | 3+ | 0 Participants |
| Insulin Degludec | Urinalysis (Erythrocytes, Protein, Glucose and Ketones) | Week 26: Glucose | 1+ | 9 Participants |