Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Africa, Asia, Europe, North America and South America. The purpose is to compare long-term glycaemic control of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) in insulin naïve subjects with type 2 diabetes mellitus inadequately controlled with oral anti diabetics.
Interventions
DRUGinsulin degludec/liraglutide
Injected subcutaneously (under the skin) once daily for 104 weeks. Dose individually adjusted.
DRUGinsulin glargine
Injected subcutaneously (under the skin) once daily for 104 weeks. Dose individually adjusted.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, age greater than or equal to 18 years at the time of signing informed consent * Subjects diagnosed with type 2 diabetes mellitus * HbA1c 7.0-11.0% (both inclusive) (53-97 mmol/mol) by central laboratory analysis * Body mass index greater than or equal to 20 kg/m\^2 * Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes * Stable daily dose(s) including any of the following antidiabetic drug(s)/regimens within 90 days prior to the day of screening: a) Biguanides (metformin greater than or equal to 1500 mg or maximum tolerated dose documented in the subject medical record), b) Other OAD(s) allowed: sulphonylurea, glinides, pioglitazone, and DPP4-inhibitors (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subjects medical record)
Exclusion criteria
* Screening calcitonin greater than or equal to 50 ng/L * Renal impairment estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73 m2 as per CKD-EPI value to be defined as listed in the classification CKD-EPI using IDMS for serum creatinine measurement on the day of screening * Impaired liver function, defined as ALAT or ASAT greater than or equal to 2.5 times upper limit of normal * Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma * History of pancreatitis (acute or chronic) * Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening * Anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification | Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2 | Inadequate glycaemic control and need for treatment intensification was defined as a glycosylated haemoglobin (HbA1c) of 7.0% or greater at 2 consecutive visits from week 26, including week 26 if HbA1c was greater than or equal to 7% at week 12. Time from randomisation to inadequate glycaemic control and need for treatment intensification was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable baseline HbA1c group was a dichotomised baseline HbA1c variable with 2 categories: HbA1c \< 8.5% or HbA1c ≥ 8.5% and the variable previous OAD treatment was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | Week 0, week 26 | Change in HbA1c from baseline (week 0) to week 26 is presented. |
| Change in Body Weight | Week 0, week 26, week 104 | Change in body weight from baseline (week 0) to week 26 and week 104 is presented. |
| Insulin Dose | Week 26, week 104 | Insulin dose after 26 and 104 weeks of treatment is presented. |
| Participants Who Achieved (Yes/no): HbA1c <7.0% | Week 26, week 104 | Percentage of participants who achieved (yes/no) HbA1c \<7.0% at week 26 and week 104 is presented. |
| Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain | Week 26, week 104 | Percentage of participants who achieved (yes/no) HbA1c \<7.0% without weight gain at week 26 and week 104 is presented. |
| Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | Week 26, week 104 | Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) 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. Percentage of participants who achieved (yes/no) HbA1c \<7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes at week 26 and week 104 is presented. |
| Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain | Week 26, week 104 | Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) 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. Percentage of participants who achieved (yes/no) HbA1c \<7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and without weight gain at week 26 and week 104 is presented. |
| Participants Who Achieved (Yes/no): HbA1c ≤6.5% | Week 26, week 104 | Percentage of participants who achieved (yes/no) HbA1c ≤6.5% at week 26 and week 104 is presented. |
| Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain | Week 26, week 104 | Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without weight gain at week 26 and week 104 is presented. |
| Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | Week 26, week 104 | Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) 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. Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes at week 26 and week 104 is presented. |
| Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain | Week 26, week 104 | Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) 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. Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and without weight gain at week 26 and week 104 is presented. |
| Change in FPG | Week 0, week 26, week 104 | Change in fasting plasma glucose (FPG) from baseline (week 0) to week 26 and week 104 is presented. |
| SMPG-9-point Profile (Individual Points in the Profile) | Week 26, week 104 | 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. Self-measured plasma glucose (SMPG)-9-point profile (individual points in the profile) at week 26 and week 104 is presented. |
| Change in SMPG-mean 9-point Profile | Week 0, week 26, week 104 | 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 9-point profile from baseline (week 0) to week 26 and week 104 is presented. |
| Change in SMPG-mean Postprandial Increment Over All Meals | Week 0, week 26, week 104 | 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 and week 104 is presented. |
| Change in Blood Pressure (Systolic and Diastolic) | Week 0, week 26, week 104 | Change in blood pressure (systolic and diastolic) from baseline (week 0) to week 26 and week 104 is presented. |
| Change in Fasting C-peptide | Week 0, week 26, week 104 | Change in fasting C-peptide (measured in nanomoles per liter \[nmol/L\]) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. |
| Change in Fasting Human Insulin | Week 0, week 26, week 104 | Change in fasting human insulin (measured in picomoles per liter \[pmol/L\]) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. |
| Change in Fasting Total Cholesterol | Week 0, week 26, week 104 | Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. |
| Change in Fasting LDL-cholesterol | Week 0, week 26, week 104 | Change in fasting low density lipoprotein (LDL)-cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. |
| Change in Fasting HDL-cholesterol | Week 0, week 26, week 104 | Change in fasting high density lipoprotein (HDL)- cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. |
| Change in Fasting VLDL-cholesterol | Week 0, week 26, week 104 | Change in fasting very low density lipoprotein (VLDL)-cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. |
| Change in Fasting Triglycerides | Week 0, week 26, week 104 | Change in fasting triglycerides (measured as mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. |
| Change in Fasting Free Fatty Acids | Week 0, week 26, week 104 | Change in fasting free fatty acids (measured as mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. |
| Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment | Weeks 0-26 | Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) 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 during 26 weeks of treatment is presented. |
| Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment | Weeks 0-104 | Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) 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 during 104 weeks of treatment is presented. |
| Number of Treatment Emergent Hypoglycaemic Episodes During 26 Weeks of Treatment | Weeks 0-26 | Hypoglycaemic episodes (SMPG value ≤3.9 mmol/L (70 mg/dL)) were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as 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 during 26 weeks of treatment is presented. |
| Number of Treatment Emergent Hypoglycaemic Episodes During 104 Weeks of Treatment | Weeks 0-104 | Hypoglycaemic episodes (SMPG value ≤3.9 mmol/L (70 mg/dL)) were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as 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 during 104 weeks of treatment is presented. |
| Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment | Weeks 0-26 | Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 both inclusive. 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 nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes during 26 weeks of treatment is presented. |
| Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment | Weeks 0-104 | Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 both inclusive. 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 nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes during 104 weeks of treatment is presented. |
| Number of TEAEs During 26 Weeks of Treatment | Weeks 0-26 | An adverse event is any untoward medical occurrence in a participant administered a product, and which does not necessarily have a causal relationship with this treatment. A treatment emergent adverse event (TEAE) was defined as an adverse event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product. If the event had onset date before the first day of exposure on trial product and increased in severity during the treatment period and until 7 days after the last drug date, then this event was also considered as a TEAE. Number of TEAEs during 26 weeks of treatment is presented. |
| Number of TEAEs During 104 Weeks of Treatment | Week 0 to week 104 | An adverse event is any untoward medical occurrence in a participant administered a product, and which does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product. If the event had onset date before the first day of exposure on trial product and increased in severity during the treatment period and until 7 days after the last drug date, then this event was also considered as a TEAE. Number of TEAEs during 104 weeks of treatment is presented. |
| Eye Examination Category | Baseline (within 12 weeks prior to week 0), week 104 | Fundus photography or a dilated fundoscopy was performed at baseline (within 12 weeks prior to week 0) and week 104. The investigator interpreted each eye's (left and right) results and categorised them as: normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). Number of participants in each category at baseline and week 104 were presented. |
| ECG Evaluation | Baseline (within 2 weeks prior to week 0), week 104 | The electrocardiogram (ECG) was assessed at baseline (within 2 weeks prior to week 0) and week 104. The investigator interpreted the results and categorised them as: normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 104 are presented. |
| Change in Urine Albumin/Creatinine Ratio | Week 0, week 104 | Change in urine albumin/creatinine ratio from baseline (week 0) to week 104 is presented. |
| Change in Pulse Rate | Week 0, week 26, week 104 | Change in pulse rate from baseline (week 0) to week 26 and week 104 is presented. |
| Change in Biochemistry Parameter- Creatinine, Total Bilirubin | Week 0, week 26, week 104 | Change in biochemistry parameter- creatinine, total bilirubin from baseline (week 0) to week 26 and week 104 is presented. |
| Change in Biochemistry Parameter- Albumin | Week 0, week 26, week 104 | Change in biochemistry parameter- albumin from baseline (week 0) to week 26 and week 104 is presented. |
| Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase | Week 0, week 26, week 104 | Change in biochemistry parameters- alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lipase and amylase from baseline (week 0) to week 26 and week 104 is presented. |
| Change in Biochemistry Parameter- Sodium, Potassium and Calcium | Week 0, week 26, week 104 | Change in sodium, potassium and calcium from baseline (week 0) to week 26 and week 104 is presented. |
| Change in Haematological Parameter- Haemoglobin | Week 0, week 26, week 104 | Change in haemoglobin from baseline (week 0) to week 26 and week 104 is presented. |
| Change in Haematological Parameter- Haematocrit | Week 0, week 26, week 104 | Change in haematocrit from baseline (week 0) to week 26 and week 104 is presented. |
| Change in Haematological Parameter- Erythrocytes | Week 0, week 26, week 104 | Change in erythrocytes from baseline (week 0) to week 26 and week 104 is presented. |
| Change in Haematological Parameter- Thrombocytes and Leukocytes | Week 0, week 26, week 104 | Change in thrombocytes and leukocytes from baseline (week 0) to week 26 and week 104 is presented. |
| Change in Haematological Parameter- Eosinophils | Week 0, week 26, week 104 | Change in eosinophils from baseline (week 0) to week 26 and week 104 is presented. |
| Change in Haematological Parameter- Neutrophils | Week 0, week 26, week 104 | Change in neutrophils from baseline (week 0) to week 26 and week 104 is presented. |
| Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits | Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2 | Time to HbA1c \> 6.5% at 2 consecutive visits is defined as time from randomization to HbA1c \> 6.5% at 2 consecutive planned scheduled visits from week 26 (including week 26 if HbA1c was \> 6.5% at week 12). Time from randomisation to HbA1c \>6.5% at 2 consecutive visits was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable baseline HbA1c group was a dichotomised baseline HbA1c variable with 2 categories: HbA1c \< 8.5% or HbA1c ≥ 8.5% and the variable previous OAD treatment was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function. |
| Change in Haematological Parameter- Monocytes | Week 0, week 26, week 104 | Change in monocytes from baseline (week 0) to week 26 and week 104 is presented. |
| Change in Haematological Parameter- Lymphocytes | Week 0, week 26, week 104 | Change in lymphocytes from baseline (week 0) to week 26 and week 104 is presented. |
| Change in Calcitonin | Week 0, week 26, week 104 | The number of participants who reported low, normal and high levels of calcitonin in relation to reference ranges at baseline (week 0), week 26 and week 104 are presented. |
| Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 0, week 26, week 104 | SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in the sub-domain scores and component summary (PCS and MCS) scores are presented. A positive change score indicates an improvement since baseline. |
| Change in TRIM-D | Week 0, week 26, week 104 | Treatment related impact measures-diabetes (TRIM-D) was developed according to the FDA guidance from 2009 on development of new PRO measures. The questionnaire consists of 5 sub-domains, which are scored according to a 1-5 point scale with a higher score indicating a better health state (less negative impact). Sub-domain scores are calculated by summing across items in the same sub-domain, and the total score is calculated by summing scores from all the sub-domains. The highest possible summed score within a sub-domain ranges from 20 (compliance sub-domain) to 40 (psychological health sub-domain) points and the highest possible total score is 140 points. Change in TRIM-D total score from baseline (week 0) to week 26 and week 104 is presented. A positive change score indicates an improvement since baseline. |
| Change in Haematological Parameter- Basophils | Week 0, week 26, week 104 | Change in basophils from baseline (week 0) to week 26 and week 104 is presented. |
Countries
Argentina, Brazil, Czechia, Hungary, India, Israel, Italy, Mexico, Norway, Poland, Russia, Slovakia, South Africa, Turkey (Türkiye), United Kingdom, United States
Participant flow
Recruitment details
The trial was conducted at 130 sites in Argentina (4),Czech Republic (4), Hungary (5), India (11), Israel (8), Italy (7), Mexico (4), Norway (7), Poland (3), Russian Federation (8), Slovakia (5), South Africa (10), Turkey (8), United Kingdom (9) and United States (37).
Pre-assignment details
Participants were randomised in a 1:1 manner to receive either IDegLira or IGlar as an adjunct to oral anti-diabetic drugs (OADs). OADs allowed were: biguanides, sulphonylurea (SU), glinides, pioglitazone, and dipeptidyl peptidase-4 inhibitors (DPP4-inhibitors), though glinides and DPP4-inhibitors were not allowed as monotherapy or in combination.
Participants by arm
| Arm | Count |
|---|---|
| Insulin Degludec/Liraglutide Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | 506 |
| Insulin Glargine Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. | 506 |
| Total | 1,012 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 6 |
| Overall Study | Lost to Follow-up | 7 | 4 |
| Overall Study | Other | 3 | 0 |
| Overall Study | Withdrawal by Subject | 10 | 15 |
Baseline characteristics
| Characteristic | Insulin Degludec/Liraglutide | Insulin Glargine | Total |
|---|---|---|---|
| Age, Continuous | 56.8 Years STANDARD_DEVIATION 10 | 56.4 Years STANDARD_DEVIATION 10.1 | 56.6 Years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 115 Participants | 126 Participants | 241 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 391 Participants | 380 Participants | 771 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 54 Participants | 61 Participants | 115 Participants |
| Race/Ethnicity, Customized Black or African American | 25 Participants | 28 Participants | 53 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 424 Participants | 414 Participants | 838 Participants |
| Sex: Female, Male Female | 226 Participants | 231 Participants | 457 Participants |
| Sex: Female, Male Male | 280 Participants | 275 Participants | 555 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 506 | 5 / 504 |
| other Total, other adverse events | 206 / 506 | 156 / 504 |
| serious Total, serious adverse events | 60 / 506 | 43 / 504 |
Outcome results
Primary
Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification
Inadequate glycaemic control and need for treatment intensification was defined as a glycosylated haemoglobin (HbA1c) of 7.0% or greater at 2 consecutive visits from week 26, including week 26 if HbA1c was greater than or equal to 7% at week 12. Time from randomisation to inadequate glycaemic control and need for treatment intensification was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable baseline HbA1c group was a dichotomised baseline HbA1c variable with 2 categories: HbA1c \< 8.5% or HbA1c ≥ 8.5% and the variable previous OAD treatment was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function.
Time frame: Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2
Population: FAS included all randomised participants. Number analyzed=participants in the specified category.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification | Baseline HbA1c <8.5% + Non-SU users | NA Weeks |
| Insulin Degludec/Liraglutide | Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification | Baseline HbA1c <8.5% + SU users | 106.7 Weeks |
| Insulin Degludec/Liraglutide | Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification | Baseline HbA1c >=8.5% + Non-SU users | NA Weeks |
| Insulin Degludec/Liraglutide | Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification | Baseline HbA1c >=8.5% + SU users | 104.0 Weeks |
| Insulin Glargine | Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification | Baseline HbA1c >=8.5% + SU users | 26.6 Weeks |
| Insulin Glargine | Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification | Baseline HbA1c <8.5% + Non-SU users | 104.3 Weeks |
| Insulin Glargine | Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification | Baseline HbA1c >=8.5% + Non-SU users | 64.6 Weeks |
| Insulin Glargine | Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification | Baseline HbA1c <8.5% + SU users | 90.3 Weeks |
Comparison: Test for no treatment difference was based on using a stratified log-rank test where treatment, baseline HbA1c group and pre-trial OAD treatment group were included as strata in the model.p-value: <0.0001Stratified log-rank test
Secondary
Change in Biochemistry Parameter- Albumin
Change in biochemistry parameter- albumin from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameter- Albumin | Week 26 | -0.03 Grams per deciliter (g/dL) | Standard Deviation 0.24 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameter- Albumin | Week 104 | 0.01 Grams per deciliter (g/dL) | Standard Deviation 0.24 |
| Insulin Glargine | Change in Biochemistry Parameter- Albumin | Week 26 | -0.03 Grams per deciliter (g/dL) | Standard Deviation 0.21 |
| Insulin Glargine | Change in Biochemistry Parameter- Albumin | Week 104 | 0.03 Grams per deciliter (g/dL) | Standard Deviation 0.27 |
Secondary
Change in Biochemistry Parameter- Creatinine, Total Bilirubin
Change in biochemistry parameter- creatinine, total bilirubin from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameter- Creatinine, Total Bilirubin | Week 26: creatinine | -0.50 Micromoles per liter (umol/L) | Standard Deviation 10.08 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameter- Creatinine, Total Bilirubin | Week 104: creatinine | 0.75 Micromoles per liter (umol/L) | Standard Deviation 10.85 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameter- Creatinine, Total Bilirubin | Week 26: total bilirubin | -0.30 Micromoles per liter (umol/L) | Standard Deviation 3.35 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameter- Creatinine, Total Bilirubin | Week 104: total bilirubin | -0.33 Micromoles per liter (umol/L) | Standard Deviation 3.42 |
| Insulin Glargine | Change in Biochemistry Parameter- Creatinine, Total Bilirubin | Week 104: total bilirubin | -0.59 Micromoles per liter (umol/L) | Standard Deviation 3.01 |
| Insulin Glargine | Change in Biochemistry Parameter- Creatinine, Total Bilirubin | Week 26: creatinine | 0.25 Micromoles per liter (umol/L) | Standard Deviation 8.78 |
| Insulin Glargine | Change in Biochemistry Parameter- Creatinine, Total Bilirubin | Week 26: total bilirubin | -0.32 Micromoles per liter (umol/L) | Standard Deviation 2.8 |
| Insulin Glargine | Change in Biochemistry Parameter- Creatinine, Total Bilirubin | Week 104: creatinine | 2.20 Micromoles per liter (umol/L) | Standard Deviation 11.86 |
Secondary
Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase
Change in biochemistry parameters- alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lipase and amylase from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase | Week 26: ALP | -4.16 Units per liter (U/L) | Standard Deviation 14.16 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase | Week 104: ALP | -1.35 Units per liter (U/L) | Standard Deviation 15.71 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase | Week 26: ALT | -5.45 Units per liter (U/L) | Standard Deviation 18.5 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase | Week 104: ALT | -5.39 Units per liter (U/L) | Standard Deviation 14.16 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase | Week 26: AST | -1.62 Units per liter (U/L) | Standard Deviation 9.78 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase | Week 104: AST | -1.84 Units per liter (U/L) | Standard Deviation 9.86 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase | Week 26: lipase | 9.26 Units per liter (U/L) | Standard Deviation 42.92 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase | Week 104: lipase | 5.41 Units per liter (U/L) | Standard Deviation 48.35 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase | Week 26: amylase | 9.72 Units per liter (U/L) | Standard Deviation 23.28 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase | Week 104: amylase | 7.23 Units per liter (U/L) | Standard Deviation 25.42 |
| Insulin Glargine | Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase | Week 104: lipase | -13.33 Units per liter (U/L) | Standard Deviation 42.27 |
| Insulin Glargine | Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase | Week 26: ALP | -4.33 Units per liter (U/L) | Standard Deviation 12.84 |
| Insulin Glargine | Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase | Week 104: AST | -0.67 Units per liter (U/L) | Standard Deviation 10.78 |
| Insulin Glargine | Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase | Week 104: ALP | -1.34 Units per liter (U/L) | Standard Deviation 14.22 |
| Insulin Glargine | Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase | Week 104: amylase | -0.13 Units per liter (U/L) | Standard Deviation 25.94 |
| Insulin Glargine | Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase | Week 26: ALT | -3.33 Units per liter (U/L) | Standard Deviation 13.24 |
| Insulin Glargine | Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase | Week 26: lipase | -7.97 Units per liter (U/L) | Standard Deviation 34.28 |
| Insulin Glargine | Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase | Week 104: ALT | -3.45 Units per liter (U/L) | Standard Deviation 14.46 |
| Insulin Glargine | Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase | Week 26: amylase | 2.79 Units per liter (U/L) | Standard Deviation 20.92 |
| Insulin Glargine | Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase | Week 26: AST | -0.39 Units per liter (U/L) | Standard Deviation 9.51 |
Secondary
Change in Biochemistry Parameter- Sodium, Potassium and Calcium
Change in sodium, potassium and calcium from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameter- Sodium, Potassium and Calcium | Week 26: sodium | 0.89 mmol/L | Standard Deviation 2.74 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameter- Sodium, Potassium and Calcium | Week 104: sodium | 1.22 mmol/L | Standard Deviation 2.54 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameter- Sodium, Potassium and Calcium | Week 26: potassium | -0.05 mmol/L | Standard Deviation 0.4 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameter- Sodium, Potassium and Calcium | Week 104: potassium | -0.06 mmol/L | Standard Deviation 0.42 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameter- Sodium, Potassium and Calcium | Week 26: calcium | -0.01 mmol/L | Standard Deviation 0.11 |
| Insulin Degludec/Liraglutide | Change in Biochemistry Parameter- Sodium, Potassium and Calcium | Week 104: calcium | -0.07 mmol/L | Standard Deviation 0.1 |
| Insulin Glargine | Change in Biochemistry Parameter- Sodium, Potassium and Calcium | Week 26: calcium | -0.00 mmol/L | Standard Deviation 0.11 |
| Insulin Glargine | Change in Biochemistry Parameter- Sodium, Potassium and Calcium | Week 26: sodium | 1.03 mmol/L | Standard Deviation 2.61 |
| Insulin Glargine | Change in Biochemistry Parameter- Sodium, Potassium and Calcium | Week 104: potassium | -0.07 mmol/L | Standard Deviation 0.43 |
| Insulin Glargine | Change in Biochemistry Parameter- Sodium, Potassium and Calcium | Week 104: sodium | 1.47 mmol/L | Standard Deviation 2.39 |
| Insulin Glargine | Change in Biochemistry Parameter- Sodium, Potassium and Calcium | Week 104: calcium | -0.06 mmol/L | Standard Deviation 0.11 |
| Insulin Glargine | Change in Biochemistry Parameter- Sodium, Potassium and Calcium | Week 26: potassium | -0.08 mmol/L | Standard Deviation 0.42 |
Secondary
Change in Blood Pressure (Systolic and Diastolic)
Change in blood pressure (systolic and diastolic) from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Blood Pressure (Systolic and Diastolic) | Week 26: Systolic blood pressure | -1.2 Millimeters of mercury (mmHg) | Standard Deviation 14 |
| Insulin Degludec/Liraglutide | Change in Blood Pressure (Systolic and Diastolic) | Week 26: Diastolic blood pressure | 0.1 Millimeters of mercury (mmHg) | Standard Deviation 8.8 |
| Insulin Degludec/Liraglutide | Change in Blood Pressure (Systolic and Diastolic) | Week 104: Systolic blood pressure | 0.5 Millimeters of mercury (mmHg) | Standard Deviation 14.3 |
| Insulin Degludec/Liraglutide | Change in Blood Pressure (Systolic and Diastolic) | Week 104: Diastolic blood pressure | -0.1 Millimeters of mercury (mmHg) | Standard Deviation 8.8 |
| Insulin Glargine | Change in Blood Pressure (Systolic and Diastolic) | Week 104: Diastolic blood pressure | -0.2 Millimeters of mercury (mmHg) | Standard Deviation 8.6 |
| Insulin Glargine | Change in Blood Pressure (Systolic and Diastolic) | Week 26: Systolic blood pressure | 0.5 Millimeters of mercury (mmHg) | Standard Deviation 13.1 |
| Insulin Glargine | Change in Blood Pressure (Systolic and Diastolic) | Week 104: Systolic blood pressure | 0.9 Millimeters of mercury (mmHg) | Standard Deviation 13.6 |
| Insulin Glargine | Change in Blood Pressure (Systolic and Diastolic) | Week 26: Diastolic blood pressure | -0.3 Millimeters of mercury (mmHg) | Standard Deviation 8.4 |
Secondary
Change in Body Weight
Change in body weight from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Body Weight | Week 26 | 0.5 Kilogram (kg) | Standard Deviation 3.3 |
| Insulin Degludec/Liraglutide | Change in Body Weight | Week 104 | 1.2 Kilogram (kg) | Standard Deviation 4.9 |
| Insulin Glargine | Change in Body Weight | Week 26 | 2.2 Kilogram (kg) | Standard Deviation 3.6 |
| Insulin Glargine | Change in Body Weight | Week 104 | 3.0 Kilogram (kg) | Standard Deviation 4.9 |
Secondary
Change in Calcitonin
The number of participants who reported low, normal and high levels of calcitonin in relation to reference ranges at baseline (week 0), week 26 and week 104 are presented.
Time frame: Week 0, week 26, week 104
Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Calcitonin | Week 104: Normal | 301 Participants |
| Insulin Degludec/Liraglutide | Change in Calcitonin | Week 0: Low | 0 Participants |
| Insulin Degludec/Liraglutide | Change in Calcitonin | Week 0: Normal | 481 Participants |
| Insulin Degludec/Liraglutide | Change in Calcitonin | Week 0: High | 25 Participants |
| Insulin Degludec/Liraglutide | Change in Calcitonin | Week 26: Low | 0 Participants |
| Insulin Degludec/Liraglutide | Change in Calcitonin | Week 26: Normal | 437 Participants |
| Insulin Degludec/Liraglutide | Change in Calcitonin | Week 26: High | 40 Participants |
| Insulin Degludec/Liraglutide | Change in Calcitonin | Week 104: Low | 0 Participants |
| Insulin Degludec/Liraglutide | Change in Calcitonin | Week 104: High | 31 Participants |
| Insulin Glargine | Change in Calcitonin | Week 104: Low | 0 Participants |
| Insulin Glargine | Change in Calcitonin | Week 26: Normal | 431 Participants |
| Insulin Glargine | Change in Calcitonin | Week 0: Low | 0 Participants |
| Insulin Glargine | Change in Calcitonin | Week 104: Normal | 169 Participants |
| Insulin Glargine | Change in Calcitonin | Week 0: Normal | 472 Participants |
| Insulin Glargine | Change in Calcitonin | Week 26: High | 30 Participants |
| Insulin Glargine | Change in Calcitonin | Week 0: High | 32 Participants |
| Insulin Glargine | Change in Calcitonin | Week 104: High | 17 Participants |
| Insulin Glargine | Change in Calcitonin | Week 26: Low | 0 Participants |
Secondary
Change in Fasting C-peptide
Change in fasting C-peptide (measured in nanomoles per liter \[nmol/L\]) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.
Time frame: Week 0, week 26, week 104
Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting C-peptide | Week 26 | 0.63 Ratio of C-peptide | Geometric Coefficient of Variation 60.79 |
| Insulin Degludec/Liraglutide | Change in Fasting C-peptide | Week 104 | 0.58 Ratio of C-peptide | Geometric Coefficient of Variation 64.21 |
| Insulin Glargine | Change in Fasting C-peptide | Week 26 | 0.57 Ratio of C-peptide | Geometric Coefficient of Variation 62.44 |
| Insulin Glargine | Change in Fasting C-peptide | Week 104 | 0.54 Ratio of C-peptide | Geometric Coefficient of Variation 70.45 |
Secondary
Change in Fasting Free Fatty Acids
Change in fasting free fatty acids (measured as mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.
Time frame: Week 0, week 26, week 104
Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting Free Fatty Acids | Week 26 | 0.68 Ratio of free fatty acids | Geometric Coefficient of Variation 59.69 |
| Insulin Degludec/Liraglutide | Change in Fasting Free Fatty Acids | Week 104 | 0.70 Ratio of free fatty acids | Geometric Coefficient of Variation 57.71 |
| Insulin Glargine | Change in Fasting Free Fatty Acids | Week 26 | 0.75 Ratio of free fatty acids | Geometric Coefficient of Variation 60.25 |
| Insulin Glargine | Change in Fasting Free Fatty Acids | Week 104 | 0.78 Ratio of free fatty acids | Geometric Coefficient of Variation 59.48 |
Secondary
Change in Fasting HDL-cholesterol
Change in fasting high density lipoprotein (HDL)- cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.
Time frame: Week 0, week 26, week 104
Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting HDL-cholesterol | Week 26 | 1.03 Ratio of HDL-cholesterol | Geometric Coefficient of Variation 16.61 |
| Insulin Degludec/Liraglutide | Change in Fasting HDL-cholesterol | Week 104 | 1.02 Ratio of HDL-cholesterol | Geometric Coefficient of Variation 16.93 |
| Insulin Glargine | Change in Fasting HDL-cholesterol | Week 26 | 1.02 Ratio of HDL-cholesterol | Geometric Coefficient of Variation 15.57 |
| Insulin Glargine | Change in Fasting HDL-cholesterol | Week 104 | 1.03 Ratio of HDL-cholesterol | Geometric Coefficient of Variation 17.36 |
Secondary
Change in Fasting Human Insulin
Change in fasting human insulin (measured in picomoles per liter \[pmol/L\]) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.
Time frame: Week 0, week 26, week 104
Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting Human Insulin | Week 26 | 0.67 Ratio of insulin | Geometric Coefficient of Variation 90.68 |
| Insulin Degludec/Liraglutide | Change in Fasting Human Insulin | Week 104 | 0.60 Ratio of insulin | Geometric Coefficient of Variation 91.84 |
| Insulin Glargine | Change in Fasting Human Insulin | Week 26 | 0.68 Ratio of insulin | Geometric Coefficient of Variation 89.19 |
| Insulin Glargine | Change in Fasting Human Insulin | Week 104 | 0.62 Ratio of insulin | Geometric Coefficient of Variation 92.55 |
Secondary
Change in Fasting LDL-cholesterol
Change in fasting low density lipoprotein (LDL)-cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.
Time frame: Week 0, week 26, week 104
Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting LDL-cholesterol | Week 26 | 1.05 Ratio of LDL-cholesterol | Geometric Coefficient of Variation 35.97 |
| Insulin Degludec/Liraglutide | Change in Fasting LDL-cholesterol | Week 104 | 0.96 Ratio of LDL-cholesterol | Geometric Coefficient of Variation 38.83 |
| Insulin Glargine | Change in Fasting LDL-cholesterol | Week 26 | 1.02 Ratio of LDL-cholesterol | Geometric Coefficient of Variation 30.1 |
| Insulin Glargine | Change in Fasting LDL-cholesterol | Week 104 | 0.98 Ratio of LDL-cholesterol | Geometric Coefficient of Variation 34.4 |
Secondary
Change in Fasting Total Cholesterol
Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.
Time frame: Week 0, week 26, week 104
Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting Total Cholesterol | Week 26 | 0.99 Ratio of total cholesterol | Geometric Coefficient of Variation 17.38 |
| Insulin Degludec/Liraglutide | Change in Fasting Total Cholesterol | Week 104 | 0.97 Ratio of total cholesterol | Geometric Coefficient of Variation 19.11 |
| Insulin Glargine | Change in Fasting Total Cholesterol | Week 26 | 0.99 Ratio of total cholesterol | Geometric Coefficient of Variation 17.68 |
| Insulin Glargine | Change in Fasting Total Cholesterol | Week 104 | 0.97 Ratio of total cholesterol | Geometric Coefficient of Variation 20.4 |
Secondary
Change in Fasting Triglycerides
Change in fasting triglycerides (measured as mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.
Time frame: Week 0, week 26, week 104
Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting Triglycerides | Week 26 | 0.84 Ratio of triglycerides | Geometric Coefficient of Variation 43.82 |
| Insulin Degludec/Liraglutide | Change in Fasting Triglycerides | Week 104 | 0.89 Ratio of triglycerides | Geometric Coefficient of Variation 42.2 |
| Insulin Glargine | Change in Fasting Triglycerides | Week 26 | 0.85 Ratio of triglycerides | Geometric Coefficient of Variation 45.75 |
| Insulin Glargine | Change in Fasting Triglycerides | Week 104 | 0.89 Ratio of triglycerides | Geometric Coefficient of Variation 40.08 |
Secondary
Change in Fasting VLDL-cholesterol
Change in fasting very low density lipoprotein (VLDL)-cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.
Time frame: Week 0, week 26, week 104
Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Fasting VLDL-cholesterol | Week 26 | 0.85 Ratio of VLDL-cholesterol | Geometric Coefficient of Variation 40.78 |
| Insulin Degludec/Liraglutide | Change in Fasting VLDL-cholesterol | Week 104 | 0.90 Ratio of VLDL-cholesterol | Geometric Coefficient of Variation 40.9 |
| Insulin Glargine | Change in Fasting VLDL-cholesterol | Week 26 | 0.85 Ratio of VLDL-cholesterol | Geometric Coefficient of Variation 42.01 |
| Insulin Glargine | Change in Fasting VLDL-cholesterol | Week 104 | 0.88 Ratio of VLDL-cholesterol | Geometric Coefficient of Variation 35.98 |
Secondary
Change in FPG
Change in fasting plasma glucose (FPG) from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in FPG | Week 26 | -3.97 mmol/L | Standard Deviation 3.06 |
| Insulin Degludec/Liraglutide | Change in FPG | Week 104 | -3.93 mmol/L | Standard Deviation 2.96 |
| Insulin Glargine | Change in FPG | Week 26 | -3.79 mmol/L | Standard Deviation 3.18 |
| Insulin Glargine | Change in FPG | Week 104 | -3.73 mmol/L | Standard Deviation 2.75 |
Secondary
Change in Haematological Parameter- Basophils
Change in basophils from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Haematological Parameter- Basophils | Week 26 | 0.00 Percentage of basophils | Standard Deviation 0.28 |
| Insulin Degludec/Liraglutide | Change in Haematological Parameter- Basophils | Week 104 | 0.20 Percentage of basophils | Standard Deviation 0.38 |
| Insulin Glargine | Change in Haematological Parameter- Basophils | Week 104 | 0.16 Percentage of basophils | Standard Deviation 0.35 |
| Insulin Glargine | Change in Haematological Parameter- Basophils | Week 26 | -0.00 Percentage of basophils | Standard Deviation 0.29 |
Secondary
Change in Haematological Parameter- Eosinophils
Change in eosinophils from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Haematological Parameter- Eosinophils | Week 26 | 0.10 Percentage of eosinophils | Standard Deviation 1.88 |
| Insulin Degludec/Liraglutide | Change in Haematological Parameter- Eosinophils | Week 104 | 0.32 Percentage of eosinophils | Standard Deviation 2.08 |
| Insulin Glargine | Change in Haematological Parameter- Eosinophils | Week 26 | 0.06 Percentage of eosinophils | Standard Deviation 2.09 |
| Insulin Glargine | Change in Haematological Parameter- Eosinophils | Week 104 | 0.43 Percentage of eosinophils | Standard Deviation 1.56 |
Secondary
Change in Haematological Parameter- Erythrocytes
Change in erythrocytes from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Haematological Parameter- Erythrocytes | Week 26 | -0.02 10^12 cells/L | Standard Deviation 0.28 |
| Insulin Degludec/Liraglutide | Change in Haematological Parameter- Erythrocytes | Week 104 | -0.12 10^12 cells/L | Standard Deviation 0.3 |
| Insulin Glargine | Change in Haematological Parameter- Erythrocytes | Week 26 | -0.03 10^12 cells/L | Standard Deviation 0.27 |
| Insulin Glargine | Change in Haematological Parameter- Erythrocytes | Week 104 | -0.11 10^12 cells/L | Standard Deviation 0.32 |
Secondary
Change in Haematological Parameter- Haematocrit
Change in haematocrit from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Haematological Parameter- Haematocrit | Week 26 | -0.33 Percentage of red blood cells | Standard Deviation 2.45 |
| Insulin Degludec/Liraglutide | Change in Haematological Parameter- Haematocrit | Week 104 | -0.71 Percentage of red blood cells | Standard Deviation 2.83 |
| Insulin Glargine | Change in Haematological Parameter- Haematocrit | Week 26 | -0.36 Percentage of red blood cells | Standard Deviation 2.43 |
| Insulin Glargine | Change in Haematological Parameter- Haematocrit | Week 104 | -0.95 Percentage of red blood cells | Standard Deviation 3.02 |
Secondary
Change in Haematological Parameter- Haemoglobin
Change in haemoglobin from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Haematological Parameter- Haemoglobin | Week 26 | 0.08 g/dL | Standard Deviation 0.72 |
| Insulin Degludec/Liraglutide | Change in Haematological Parameter- Haemoglobin | Week 104 | -0.00 g/dL | Standard Deviation 0.89 |
| Insulin Glargine | Change in Haematological Parameter- Haemoglobin | Week 26 | 0.08 g/dL | Standard Deviation 0.74 |
| Insulin Glargine | Change in Haematological Parameter- Haemoglobin | Week 104 | -0.03 g/dL | Standard Deviation 0.92 |
Secondary
Change in Haematological Parameter- Lymphocytes
Change in lymphocytes from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Haematological Parameter- Lymphocytes | Week 26 | -1.87 Percentage of lymphocytes | Standard Deviation 6.29 |
| Insulin Degludec/Liraglutide | Change in Haematological Parameter- Lymphocytes | Week 104 | -2.25 Percentage of lymphocytes | Standard Deviation 6.76 |
| Insulin Glargine | Change in Haematological Parameter- Lymphocytes | Week 26 | -0.84 Percentage of lymphocytes | Standard Deviation 6.73 |
| Insulin Glargine | Change in Haematological Parameter- Lymphocytes | Week 104 | -2.38 Percentage of lymphocytes | Standard Deviation 7.29 |
Secondary
Change in Haematological Parameter- Monocytes
Change in monocytes from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Haematological Parameter- Monocytes | Week 26 | -0.10 Percentage of monocytes | Standard Deviation 2.04 |
| Insulin Degludec/Liraglutide | Change in Haematological Parameter- Monocytes | Week 104 | 0.49 Percentage of monocytes | Standard Deviation 2.02 |
| Insulin Glargine | Change in Haematological Parameter- Monocytes | Week 26 | 0.01 Percentage of monocytes | Standard Deviation 1.91 |
| Insulin Glargine | Change in Haematological Parameter- Monocytes | Week 104 | 0.59 Percentage of monocytes | Standard Deviation 1.88 |
Secondary
Change in Haematological Parameter- Neutrophils
Change in neutrophils from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Haematological Parameter- Neutrophils | Week 26 | 1.86 Percentage of neutrophils | Standard Deviation 7.2 |
| Insulin Degludec/Liraglutide | Change in Haematological Parameter- Neutrophils | Week 104 | 1.25 Percentage of neutrophils | Standard Deviation 7.94 |
| Insulin Glargine | Change in Haematological Parameter- Neutrophils | Week 26 | 0.78 Percentage of neutrophils | Standard Deviation 7.68 |
| Insulin Glargine | Change in Haematological Parameter- Neutrophils | Week 104 | 1.21 Percentage of neutrophils | Standard Deviation 8.02 |
Secondary
Change in Haematological Parameter- Thrombocytes and Leukocytes
Change in thrombocytes and leukocytes from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Haematological Parameter- Thrombocytes and Leukocytes | Week 26: Thrombocytes | 8.77 10^9 cells/L | Standard Deviation 35.82 |
| Insulin Degludec/Liraglutide | Change in Haematological Parameter- Thrombocytes and Leukocytes | Week 104: Thrombocytes | 16.87 10^9 cells/L | Standard Deviation 39.27 |
| Insulin Degludec/Liraglutide | Change in Haematological Parameter- Thrombocytes and Leukocytes | Week 26: Leukocytes | 0.49 10^9 cells/L | Standard Deviation 1.45 |
| Insulin Degludec/Liraglutide | Change in Haematological Parameter- Thrombocytes and Leukocytes | Week 104: Leukocytes | 0.07 10^9 cells/L | Standard Deviation 1.5 |
| Insulin Glargine | Change in Haematological Parameter- Thrombocytes and Leukocytes | Week 104: Leukocytes | 0.32 10^9 cells/L | Standard Deviation 1.55 |
| Insulin Glargine | Change in Haematological Parameter- Thrombocytes and Leukocytes | Week 26: Thrombocytes | 7.05 10^9 cells/L | Standard Deviation 41.71 |
| Insulin Glargine | Change in Haematological Parameter- Thrombocytes and Leukocytes | Week 26: Leukocytes | 0.39 10^9 cells/L | Standard Deviation 1.43 |
| Insulin Glargine | Change in Haematological Parameter- Thrombocytes and Leukocytes | Week 104: Thrombocytes | 18.73 10^9 cells/L | Standard Deviation 53.76 |
Secondary
Change in HbA1c
Change in HbA1c from baseline (week 0) to week 26 is presented.
Time frame: Week 0, week 26
Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in HbA1c | -1.99 Percentage of HbA1c | Standard Deviation 1.14 |
| Insulin Glargine | Change in HbA1c | -1.69 Percentage of HbA1c | Standard Deviation 1.1 |
Secondary
Change in Pulse Rate
Change in pulse rate from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Pulse Rate | Week 26 | 2.0 Beats per minute | Standard Deviation 8.8 |
| Insulin Degludec/Liraglutide | Change in Pulse Rate | Week 104 | 1.7 Beats per minute | Standard Deviation 9.3 |
| Insulin Glargine | Change in Pulse Rate | Week 26 | -0.4 Beats per minute | Standard Deviation 8.7 |
| Insulin Glargine | Change in Pulse Rate | Week 104 | -0.5 Beats per minute | Standard Deviation 9.7 |
Secondary
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)
SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in the sub-domain scores and component summary (PCS and MCS) scores are presented. A positive change score indicates an improvement since baseline.
Time frame: Week 0, week 26, week 104
Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 26: Physical functioning | 1.2 Score on a scale | Standard Deviation 6.8 |
| Insulin Degludec/Liraglutide | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 104: Physical functioning | 0.7 Score on a scale | Standard Deviation 7.5 |
| Insulin Degludec/Liraglutide | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 26: Role-physical | 1.4 Score on a scale | Standard Deviation 7.7 |
| Insulin Degludec/Liraglutide | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 104: Role-physical | 1.4 Score on a scale | Standard Deviation 8.7 |
| Insulin Degludec/Liraglutide | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 26: Bodily pain | 1.5 Score on a scale | Standard Deviation 9.7 |
| Insulin Degludec/Liraglutide | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 104: Bodily pain | 1.6 Score on a scale | Standard Deviation 11.2 |
| Insulin Degludec/Liraglutide | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 26: General health | 2.5 Score on a scale | Standard Deviation 8.2 |
| Insulin Degludec/Liraglutide | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 104: General health | 2.3 Score on a scale | Standard Deviation 8.7 |
| Insulin Degludec/Liraglutide | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 26: Vitality | 1.4 Score on a scale | Standard Deviation 8.1 |
| Insulin Degludec/Liraglutide | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 104: Vitality | 1.5 Score on a scale | Standard Deviation 8.4 |
| Insulin Degludec/Liraglutide | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 26: Social functioning | 1.8 Score on a scale | Standard Deviation 8.1 |
| Insulin Degludec/Liraglutide | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 104: Social functioning | 0.9 Score on a scale | Standard Deviation 8.9 |
| Insulin Degludec/Liraglutide | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 26: Role-emotional | 0.6 Score on a scale | Standard Deviation 8.9 |
| Insulin Degludec/Liraglutide | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 104: Role-emotional | 1.6 Score on a scale | Standard Deviation 10.1 |
| Insulin Degludec/Liraglutide | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 26: Mental health | 1.7 Score on a scale | Standard Deviation 8.7 |
| Insulin Degludec/Liraglutide | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 104: Mental health | 2.5 Score on a scale | Standard Deviation 9.4 |
| Insulin Degludec/Liraglutide | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 26: PCS | 1.6 Score on a scale | Standard Deviation 6.3 |
| Insulin Degludec/Liraglutide | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 104: PCS | 1.0 Score on a scale | Standard Deviation 7.2 |
| Insulin Degludec/Liraglutide | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 26: MCS | 1.3 Score on a scale | Standard Deviation 8.2 |
| Insulin Degludec/Liraglutide | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 104: MCS | 2.0 Score on a scale | Standard Deviation 9 |
| Insulin Glargine | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 104: PCS | 0.8 Score on a scale | Standard Deviation 6 |
| Insulin Glargine | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 26: Physical functioning | 1.1 Score on a scale | Standard Deviation 7 |
| Insulin Glargine | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 26: Social functioning | 0.9 Score on a scale | Standard Deviation 8.8 |
| Insulin Glargine | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 104: Physical functioning | 0.6 Score on a scale | Standard Deviation 7.9 |
| Insulin Glargine | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 104: Mental health | 0.3 Score on a scale | Standard Deviation 8.9 |
| Insulin Glargine | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 26: Role-physical | 0.5 Score on a scale | Standard Deviation 7.4 |
| Insulin Glargine | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 104: Social functioning | 1.1 Score on a scale | Standard Deviation 7.6 |
| Insulin Glargine | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 104: Role-physical | 0.7 Score on a scale | Standard Deviation 7.5 |
| Insulin Glargine | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 104: MCS | 1.0 Score on a scale | Standard Deviation 7.8 |
| Insulin Glargine | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 26: Bodily pain | 0.4 Score on a scale | Standard Deviation 10 |
| Insulin Glargine | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 26: Role-emotional | 0.7 Score on a scale | Standard Deviation 8.8 |
| Insulin Glargine | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 104: Bodily pain | 0.1 Score on a scale | Standard Deviation 8.5 |
| Insulin Glargine | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 26: PCS | 0.9 Score on a scale | Standard Deviation 6.3 |
| Insulin Glargine | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 26: General health | 2.1 Score on a scale | Standard Deviation 7.6 |
| Insulin Glargine | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 104: Role-emotional | 1.2 Score on a scale | Standard Deviation 8.2 |
| Insulin Glargine | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 104: General health | 2.1 Score on a scale | Standard Deviation 8.3 |
| Insulin Glargine | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 26: MCS | 1.2 Score on a scale | Standard Deviation 8 |
| Insulin Glargine | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 26: Vitality | 1.4 Score on a scale | Standard Deviation 8 |
| Insulin Glargine | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 26: Mental health | 1.3 Score on a scale | Standard Deviation 8.4 |
| Insulin Glargine | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | Week 104: Vitality | 1.5 Score on a scale | Standard Deviation 8 |
Secondary
Change in SMPG-mean 9-point 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. Change in SMPG-mean 9-point profile from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in SMPG-mean 9-point Profile | Week 26 | -3.34 mmol/L | Standard Deviation 2.46 |
| Insulin Degludec/Liraglutide | Change in SMPG-mean 9-point Profile | Week 104 | -3.27 mmol/L | Standard Deviation 2.36 |
| Insulin Glargine | Change in SMPG-mean 9-point Profile | Week 26 | -3.32 mmol/L | Standard Deviation 2.62 |
| Insulin Glargine | Change in SMPG-mean 9-point Profile | Week 104 | -2.76 mmol/L | Standard Deviation 2.41 |
Secondary
Change in SMPG-mean Postprandial Increment Over All Meals
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 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in SMPG-mean Postprandial Increment Over All Meals | Week 26 | -0.28 mmol/L | Standard Deviation 2.13 |
| Insulin Degludec/Liraglutide | Change in SMPG-mean Postprandial Increment Over All Meals | Week 104 | -0.47 mmol/L | Standard Deviation 1.99 |
| Insulin Glargine | Change in SMPG-mean Postprandial Increment Over All Meals | Week 26 | 0.20 mmol/L | Standard Deviation 2.17 |
| Insulin Glargine | Change in SMPG-mean Postprandial Increment Over All Meals | Week 104 | 0.12 mmol/L | Standard Deviation 2.17 |
Secondary
Change in TRIM-D
Treatment related impact measures-diabetes (TRIM-D) was developed according to the FDA guidance from 2009 on development of new PRO measures. The questionnaire consists of 5 sub-domains, which are scored according to a 1-5 point scale with a higher score indicating a better health state (less negative impact). Sub-domain scores are calculated by summing across items in the same sub-domain, and the total score is calculated by summing scores from all the sub-domains. The highest possible summed score within a sub-domain ranges from 20 (compliance sub-domain) to 40 (psychological health sub-domain) points and the highest possible total score is 140 points. Change in TRIM-D total score from baseline (week 0) to week 26 and week 104 is presented. A positive change score indicates an improvement since baseline.
Time frame: Week 0, week 26, week 104
Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in TRIM-D | Week 26 | 9.6 Score on a scale | Standard Deviation 12.4 |
| Insulin Degludec/Liraglutide | Change in TRIM-D | Week 104 | 11.4 Score on a scale | Standard Deviation 13.7 |
| Insulin Glargine | Change in TRIM-D | Week 26 | 7.3 Score on a scale | Standard Deviation 13.1 |
| Insulin Glargine | Change in TRIM-D | Week 104 | 9.5 Score on a scale | Standard Deviation 12.8 |
Secondary
Change in Urine Albumin/Creatinine Ratio
Change in urine albumin/creatinine ratio from baseline (week 0) to week 104 is presented.
Time frame: Week 0, week 104
Population: SAS included all participants receiving at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Change in Urine Albumin/Creatinine Ratio | -1.09 Milligrams per millimole (mg/mmol) | Standard Deviation 7.43 |
| Insulin Glargine | Change in Urine Albumin/Creatinine Ratio | -0.74 Milligrams per millimole (mg/mmol) | Standard Deviation 15.58 |
Secondary
ECG Evaluation
The electrocardiogram (ECG) was assessed at baseline (within 2 weeks prior to week 0) and week 104. The investigator interpreted the results and categorised them as: normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 104 are presented.
Time frame: Baseline (within 2 weeks prior to week 0), week 104
Population: SAS included all participants receiving at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | ECG Evaluation | Normal (Baseline) | 335 Participants |
| Insulin Degludec/Liraglutide | ECG Evaluation | Abnormal NCS (Baseline) | 162 Participants |
| Insulin Degludec/Liraglutide | ECG Evaluation | Abnormal CS (Baseline) | 9 Participants |
| Insulin Degludec/Liraglutide | ECG Evaluation | Normal (week 104) | 227 Participants |
| Insulin Degludec/Liraglutide | ECG Evaluation | Abnormal NCS (week 104) | 97 Participants |
| Insulin Degludec/Liraglutide | ECG Evaluation | Abnormal CS (week 104) | 7 Participants |
| Insulin Glargine | ECG Evaluation | Abnormal NCS (week 104) | 65 Participants |
| Insulin Glargine | ECG Evaluation | Normal (Baseline) | 335 Participants |
| Insulin Glargine | ECG Evaluation | Normal (week 104) | 122 Participants |
| Insulin Glargine | ECG Evaluation | Abnormal NCS (Baseline) | 165 Participants |
| Insulin Glargine | ECG Evaluation | Abnormal CS (week 104) | 2 Participants |
| Insulin Glargine | ECG Evaluation | Abnormal CS (Baseline) | 4 Participants |
Secondary
Eye Examination Category
Fundus photography or a dilated fundoscopy was performed at baseline (within 12 weeks prior to week 0) and week 104. The investigator interpreted each eye's (left and right) results and categorised them as: normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). Number of participants in each category at baseline and week 104 were presented.
Time frame: Baseline (within 12 weeks prior to week 0), week 104
Population: SAS included all participants receiving at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Eye Examination Category | Left eye: Normal (baseline) | 345 Participants |
| Insulin Degludec/Liraglutide | Eye Examination Category | Left eye: Abnormal NCS (baseline) | 151 Participants |
| Insulin Degludec/Liraglutide | Eye Examination Category | Left eye: Abnormal CS (baseline) | 10 Participants |
| Insulin Degludec/Liraglutide | Eye Examination Category | Left eye: Normal (week 104) | 204 Participants |
| Insulin Degludec/Liraglutide | Eye Examination Category | Left eye: Abnormal NCS (week 104) | 97 Participants |
| Insulin Degludec/Liraglutide | Eye Examination Category | Left eye: Abnormal CS (week 104) | 17 Participants |
| Insulin Degludec/Liraglutide | Eye Examination Category | Right eye: Normal (baseline) | 344 Participants |
| Insulin Degludec/Liraglutide | Eye Examination Category | Right eye: Abnormal NCS (baseline) | 151 Participants |
| Insulin Degludec/Liraglutide | Eye Examination Category | Right eye: Abnormal CS (baseline) | 11 Participants |
| Insulin Degludec/Liraglutide | Eye Examination Category | Right eye: Normal (week 104) | 200 Participants |
| Insulin Degludec/Liraglutide | Eye Examination Category | Right eye: Abnormal NCS (week 104) | 99 Participants |
| Insulin Degludec/Liraglutide | Eye Examination Category | Right eye: Abnormal CS (week 104) | 19 Participants |
| Insulin Glargine | Eye Examination Category | Right eye: Abnormal NCS (week 104) | 48 Participants |
| Insulin Glargine | Eye Examination Category | Left eye: Normal (baseline) | 341 Participants |
| Insulin Glargine | Eye Examination Category | Right eye: Normal (baseline) | 355 Participants |
| Insulin Glargine | Eye Examination Category | Left eye: Abnormal NCS (baseline) | 155 Participants |
| Insulin Glargine | Eye Examination Category | Right eye: Normal (week 104) | 132 Participants |
| Insulin Glargine | Eye Examination Category | Left eye: Abnormal CS (baseline) | 8 Participants |
| Insulin Glargine | Eye Examination Category | Right eye: Abnormal NCS (baseline) | 143 Participants |
| Insulin Glargine | Eye Examination Category | Left eye: Normal (week 104) | 129 Participants |
| Insulin Glargine | Eye Examination Category | Right eye: Abnormal CS (week 104) | 5 Participants |
| Insulin Glargine | Eye Examination Category | Left eye: Abnormal NCS (week 104) | 50 Participants |
| Insulin Glargine | Eye Examination Category | Right eye: Abnormal CS (baseline) | 6 Participants |
| Insulin Glargine | Eye Examination Category | Left eye: Abnormal CS (week 104) | 6 Participants |
Secondary
Insulin Dose
Insulin dose after 26 and 104 weeks of treatment is presented.
Time frame: Week 26, week 104
Population: Safety analysis set (SAS) included all participants receiving at least 1 dose of the investigational product (IDegLira) or comparator (IGlar). 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | Insulin Dose | Week 104 | 36.1 Units | Standard Deviation 12.9 |
| Insulin Degludec/Liraglutide | Insulin Dose | Week 26 | 34.6 Units | Standard Deviation 13.4 |
| Insulin Glargine | Insulin Dose | Week 104 | 50.6 Units | Standard Deviation 31.5 |
| Insulin Glargine | Insulin Dose | Week 26 | 48.6 Units | Standard Deviation 28.2 |
Secondary
Number of TEAEs During 104 Weeks of Treatment
An adverse event is any untoward medical occurrence in a participant administered a product, and which does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product. If the event had onset date before the first day of exposure on trial product and increased in severity during the treatment period and until 7 days after the last drug date, then this event was also considered as a TEAE. Number of TEAEs during 104 weeks of treatment is presented.
Time frame: Week 0 to week 104
Population: SAS included all participants receiving at least 1 dose of the investigational product or comparator.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Degludec/Liraglutide | Number of TEAEs During 104 Weeks of Treatment | 1788 Adverse events |
| Insulin Glargine | Number of TEAEs During 104 Weeks of Treatment | 1368 Adverse events |
Secondary
Number of TEAEs During 26 Weeks of Treatment
An adverse event is any untoward medical occurrence in a participant administered a product, and which does not necessarily have a causal relationship with this treatment. A treatment emergent adverse event (TEAE) was defined as an adverse event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product. If the event had onset date before the first day of exposure on trial product and increased in severity during the treatment period and until 7 days after the last drug date, then this event was also considered as a TEAE. Number of TEAEs during 26 weeks of treatment is presented.
Time frame: Weeks 0-26
Population: SAS included all participants receiving at least 1 dose of the investigational product or comparator.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Degludec/Liraglutide | Number of TEAEs During 26 Weeks of Treatment | 718 Adverse events |
| Insulin Glargine | Number of TEAEs During 26 Weeks of Treatment | 624 Adverse events |
Secondary
Number of Treatment Emergent Hypoglycaemic Episodes During 104 Weeks of Treatment
Hypoglycaemic episodes (SMPG value ≤3.9 mmol/L (70 mg/dL)) were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as 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 during 104 weeks of treatment is presented.
Time frame: Weeks 0-104
Population: SAS included all participants receiving at least 1 dose of the investigational product or comparator.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Degludec/Liraglutide | Number of Treatment Emergent Hypoglycaemic Episodes During 104 Weeks of Treatment | 8934 Episodes |
| Insulin Glargine | Number of Treatment Emergent Hypoglycaemic Episodes During 104 Weeks of Treatment | 10658 Episodes |
Secondary
Number of Treatment Emergent Hypoglycaemic Episodes During 26 Weeks of Treatment
Hypoglycaemic episodes (SMPG value ≤3.9 mmol/L (70 mg/dL)) were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as 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 during 26 weeks of treatment is presented.
Time frame: Weeks 0-26
Population: SAS included all participants receiving at least 1 dose of the investigational product or comparator.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Degludec/Liraglutide | Number of Treatment Emergent Hypoglycaemic Episodes During 26 Weeks of Treatment | 3190 Episodes |
| Insulin Glargine | Number of Treatment Emergent Hypoglycaemic Episodes During 26 Weeks of Treatment | 3806 Episodes |
Secondary
Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment
Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 both inclusive. 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 nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes during 104 weeks of treatment is presented.
Time frame: Weeks 0-104
Population: SAS included all participants receiving at least 1 dose of the investigational product or comparator.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Degludec/Liraglutide | Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment | 61 Episodes |
| Insulin Glargine | Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment | 164 Episodes |
Secondary
Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment
Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 both inclusive. 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 nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes during 26 weeks of treatment is presented.
Time frame: Weeks 0-26
Population: SAS included all participants receiving at least 1 dose of the investigational product or comparator.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Degludec/Liraglutide | Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment | 27 Episodes |
| Insulin Glargine | Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment | 60 Episodes |
Secondary
Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment
Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) 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 during 104 weeks of treatment is presented.
Time frame: Weeks 0-104
Population: SAS included all participants receiving at least 1 dose of the investigational product or comparator.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Degludec/Liraglutide | Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment | 319 Episodes |
| Insulin Glargine | Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment | 642 Episodes |
Secondary
Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment
Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) 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 during 26 weeks of treatment is presented.
Time frame: Weeks 0-26
Population: SAS included all participants receiving at least 1 dose of the investigational product or comparator.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Degludec/Liraglutide | Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment | 143 Episodes |
| Insulin Glargine | Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment | 261 Episodes |
Secondary
Participants Who Achieved (Yes/no): HbA1c ≤6.5%
Percentage of participants who achieved (yes/no) HbA1c ≤6.5% at week 26 and week 104 is presented.
Time frame: Week 26, week 104
Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c ≤6.5% | Week 26: Yes | 63.6 Percentage of participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c ≤6.5% | Week 104: Yes | 43.3 Percentage of participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c ≤6.5% | Week 26: No | 36.4 Percentage of participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c ≤6.5% | Week 104: No | 56.7 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c ≤6.5% | Week 26: No | 64.6 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c ≤6.5% | Week 26: Yes | 35.4 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c ≤6.5% | Week 104: No | 78.3 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c ≤6.5% | Week 104: Yes | 21.7 Percentage of participants |
Secondary
Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) 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. Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes at week 26 and week 104 is presented.
Time frame: Week 26, week 104
Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | Week 26: Yes | 57.9 Percentage of participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | Week 26: No | 42.1 Percentage of participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | Week 104: Yes | 40.1 Percentage of participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | Week 104: No | 59.9 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | Week 104: No | 80.8 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | Week 26: Yes | 27.9 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | Week 104: Yes | 19.2 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | Week 26: No | 72.1 Percentage of participants |
Secondary
Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain
Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) 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. Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and without weight gain at week 26 and week 104 is presented.
Time frame: Week 26, week 104
Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain | Week 26: Yes | 30.2 Percentage of participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain | Week 26: No | 69.8 Percentage of participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain | Week 104: Yes | 16.6 Percentage of participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain | Week 104: No | 83.4 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain | Week 104: No | 94.5 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain | Week 26: Yes | 8.7 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain | Week 104: Yes | 5.5 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain | Week 26: No | 91.3 Percentage of participants |
Secondary
Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain
Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without weight gain at week 26 and week 104 is presented.
Time frame: Week 26, week 104
Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain | Week 26: Yes | 33.2 Percentage of participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain | Week 26: No | 66.8 Percentage of participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain | Week 104: Yes | 17.6 Percentage of participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain | Week 104: No | 82.4 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain | Week 104: No | 94.3 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain | Week 26: Yes | 9.9 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain | Week 104: Yes | 5.7 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain | Week 26: No | 90.1 Percentage of participants |
Secondary
Participants Who Achieved (Yes/no): HbA1c <7.0%
Percentage of participants who achieved (yes/no) HbA1c \<7.0% at week 26 and week 104 is presented.
Time frame: Week 26, week 104
Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c <7.0% | Week 26: Yes | 78.7 Percentage of participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c <7.0% | Week 26: No | 21.3 Percentage of participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c <7.0% | Week 104: Yes | 55.5 Percentage of participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c <7.0% | Week 104: No | 44.5 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c <7.0% | Week 104: No | 71.5 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c <7.0% | Week 26: Yes | 55.7 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c <7.0% | Week 104: Yes | 28.5 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c <7.0% | Week 26: No | 44.3 Percentage of participants |
Secondary
Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain
Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) 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. Percentage of participants who achieved (yes/no) HbA1c \<7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and without weight gain at week 26 and week 104 is presented.
Time frame: Week 26, week 104
Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain | Week 26: Yes | 35.2 Percentage of participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain | Week 26: No | 64.8 Percentage of participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain | Week 104: Yes | 20.0 Percentage of participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain | Week 104: No | 80.0 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain | Week 104: No | 93.9 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain | Week 26: Yes | 13.6 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain | Week 104: Yes | 6.1 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain | Week 26: No | 86.4 Percentage of participants |
Secondary
Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) 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. Percentage of participants who achieved (yes/no) HbA1c \<7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes at week 26 and week 104 is presented.
Time frame: Week 26, week 104
Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | Week 26: Yes | 71.3 Percentage of participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | Week 26: No | 28.7 Percentage of participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | Week 104: Yes | 51.8 Percentage of participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | Week 104: No | 48.2 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | Week 104: No | 74.5 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | Week 26: Yes | 44.9 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | Week 104: Yes | 25.5 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | Week 26: No | 55.1 Percentage of participants |
Secondary
Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain
Percentage of participants who achieved (yes/no) HbA1c \<7.0% without weight gain at week 26 and week 104 is presented.
Time frame: Week 26, week 104
Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain | Week 26: Yes | 38.5 Percentage of participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain | Week 26: No | 61.5 Percentage of participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain | Week 104: Yes | 20.9 Percentage of participants |
| Insulin Degludec/Liraglutide | Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain | Week 104: No | 79.1 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain | Week 104: No | 93.7 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain | Week 26: Yes | 15.4 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain | Week 104: Yes | 6.3 Percentage of participants |
| Insulin Glargine | Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain | Week 26: No | 84.6 Percentage of 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. Self-measured plasma glucose (SMPG)-9-point profile (individual points in the profile) at week 26 and week 104 is presented.
Time frame: Week 26, week 104
Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | Week 26: Bedtime | 7.48 mmol/L | Standard Deviation 2.42 |
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | Week 26: Before breakfast | 5.59 mmol/L | Standard Deviation 1.57 |
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | Week 26: 90 minutes after breakfast | 8.34 mmol/L | Standard Deviation 2.62 |
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | Week 26: Before lunch | 6.03 mmol/L | Standard Deviation 2 |
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | Week 26: 90 minutes after lunch | 8.02 mmol/L | Standard Deviation 2.32 |
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | Week 26: Before dinner | 6.67 mmol/L | Standard Deviation 2.26 |
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | Week 26: 90 minutes after dinner | 8.31 mmol/L | Standard Deviation 2.47 |
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | Week 26: At 4:00 a.m. | 5.72 mmol/L | Standard Deviation 1.55 |
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | Week 26: Before breakfast the following day | 5.53 mmol/L | Standard Deviation 1.37 |
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | Week 104: Before breakfast | 5.58 mmol/L | Standard Deviation 1.38 |
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | Week 104: 90 minutes after breakfast | 7.99 mmol/L | Standard Deviation 2.5 |
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | Week 104: Before lunch | 6.06 mmol/L | Standard Deviation 1.91 |
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | Week 104: 90 minutes after lunch | 7.80 mmol/L | Standard Deviation 2.16 |
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | Week 104: Before dinner | 6.58 mmol/L | Standard Deviation 1.97 |
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | Week 104: 90 minutes after dinner | 8.20 mmol/L | Standard Deviation 2.2 |
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | Week 104: Bedtime | 7.47 mmol/L | Standard Deviation 2.17 |
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | Week 104: At 4:00 a.m. | 5.67 mmol/L | Standard Deviation 1.35 |
| Insulin Degludec/Liraglutide | SMPG-9-point Profile (Individual Points in the Profile) | Week 104: Before breakfast the following day | 5.44 mmol/L | Standard Deviation 1.23 |
| Insulin Glargine | SMPG-9-point Profile (Individual Points in the Profile) | Week 104: Before dinner | 7.02 mmol/L | Standard Deviation 2.45 |
| Insulin Glargine | SMPG-9-point Profile (Individual Points in the Profile) | Week 104: Before breakfast | 5.57 mmol/L | Standard Deviation 1.27 |
| Insulin Glargine | SMPG-9-point Profile (Individual Points in the Profile) | Week 26: Before breakfast | 5.58 mmol/L | Standard Deviation 1.58 |
| Insulin Glargine | SMPG-9-point Profile (Individual Points in the Profile) | Week 104: Before breakfast the following day | 5.47 mmol/L | Standard Deviation 1.35 |
| Insulin Glargine | SMPG-9-point Profile (Individual Points in the Profile) | Week 26: 90 minutes after breakfast | 8.76 mmol/L | Standard Deviation 2.68 |
| Insulin Glargine | SMPG-9-point Profile (Individual Points in the Profile) | Week 104: 90 minutes after breakfast | 8.64 mmol/L | Standard Deviation 2.59 |
| Insulin Glargine | SMPG-9-point Profile (Individual Points in the Profile) | Week 26: Before lunch | 6.43 mmol/L | Standard Deviation 2.24 |
| Insulin Glargine | SMPG-9-point Profile (Individual Points in the Profile) | Week 104: 90 minutes after dinner | 9.10 mmol/L | Standard Deviation 2.61 |
| Insulin Glargine | SMPG-9-point Profile (Individual Points in the Profile) | Week 26: 90 minutes after lunch | 8.79 mmol/L | Standard Deviation 2.64 |
| Insulin Glargine | SMPG-9-point Profile (Individual Points in the Profile) | Week 104: Before lunch | 6.37 mmol/L | Standard Deviation 2.02 |
| Insulin Glargine | SMPG-9-point Profile (Individual Points in the Profile) | Week 26: Before dinner | 6.91 mmol/L | Standard Deviation 2.35 |
| Insulin Glargine | SMPG-9-point Profile (Individual Points in the Profile) | Week 104: At 4:00 a.m. | 5.96 mmol/L | Standard Deviation 1.73 |
| Insulin Glargine | SMPG-9-point Profile (Individual Points in the Profile) | Week 26: 90 minutes after dinner | 9.10 mmol/L | Standard Deviation 2.7 |
| Insulin Glargine | SMPG-9-point Profile (Individual Points in the Profile) | Week 26: Bedtime | 8.13 mmol/L | Standard Deviation 2.68 |
| Insulin Glargine | SMPG-9-point Profile (Individual Points in the Profile) | Week 104: 90 minutes after lunch | 8.87 mmol/L | Standard Deviation 2.45 |
| Insulin Glargine | SMPG-9-point Profile (Individual Points in the Profile) | Week 26: At 4:00 a.m. | 5.91 mmol/L | Standard Deviation 1.99 |
| Insulin Glargine | SMPG-9-point Profile (Individual Points in the Profile) | Week 104: Bedtime | 7.90 mmol/L | Standard Deviation 2.41 |
| Insulin Glargine | SMPG-9-point Profile (Individual Points in the Profile) | Week 26: Before breakfast the following day | 5.56 mmol/L | Standard Deviation 1.56 |
Secondary
Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits
Time to HbA1c \> 6.5% at 2 consecutive visits is defined as time from randomization to HbA1c \> 6.5% at 2 consecutive planned scheduled visits from week 26 (including week 26 if HbA1c was \> 6.5% at week 12). Time from randomisation to HbA1c \>6.5% at 2 consecutive visits was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable baseline HbA1c group was a dichotomised baseline HbA1c variable with 2 categories: HbA1c \< 8.5% or HbA1c ≥ 8.5% and the variable previous OAD treatment was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function.
Time frame: Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2
Population: FAS included all randomised participants. Number analyzed=participants with event.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Insulin Degludec/Liraglutide | Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits | Baseline HbA1c <8.5% + Non-SU users | NA Weeks |
| Insulin Degludec/Liraglutide | Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits | Baseline HbA1c <8.5% + SU users | 90.1 Weeks |
| Insulin Degludec/Liraglutide | Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits | Baseline HbA1c >=8.5% + Non-SU users | 64.1 Weeks |
| Insulin Degludec/Liraglutide | Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits | Baseline HbA1c >=8.5% + SU users | 52.1 Weeks |
| Insulin Glargine | Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits | Baseline HbA1c >=8.5% + SU users | 26.1 Weeks |
| Insulin Glargine | Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits | Baseline HbA1c <8.5% + Non-SU users | 64.1 Weeks |
| Insulin Glargine | Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits | Baseline HbA1c >=8.5% + Non-SU users | 26.6 Weeks |
| Insulin Glargine | Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits | Baseline HbA1c <8.5% + SU users | 26.6 Weeks |
Comparison: Test for no treatment difference was based on using a stratified log-rank test where treatment, baseline HbA1c group and pre-trial OAD treatment group were included as strata in the model.p-value: <0.0001Stratified log-rank test