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A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus (DUALTM IX)

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ClinicalTrials.gov Identifier: NCT02773368
Recruitment Status : Completed
First Posted : May 16, 2016
Results First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetes
Diabetes Mellitus, Type 2
Interventions Drug: insulin degludec/liraglutide
Drug: insulin glargine
Enrollment 420
Recruitment Details The trial was conducted at 74 sites in 11 countries as follows: Argentina (3), Canada (5), Finland (6), Hungary (5), India (8), Russian Federation (7), Slovakia (5), Slovenia (4), Spain (6), Switzerland (5) and United States (20).
Pre-assignment Details Subjects with type 2 diabetes mellitus on oral anti-diabetic drug (OAD) therapy with stable daily dose of sodium glucose co-transporter 2 inhibitors (SGLT2i) either as monotherapy or in combination with metformin ± dipeptidyl peptidase-4 inhibitors (DPP4i) ± pioglitazone according to locally approved label for at least 90 days prior to screening.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern. Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Period Title: Overall Study
Started 210 210
Exposed 209 210
Completed 200 206
Not Completed 10 4
Reason Not Completed
Lost to Follow-up             4             1
Withdrawal by Subject             5             1
Unclassified             1             1
Missing             0             1
Arm/Group Title IDegLira IGlar Total
Hide Arm/Group Description Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern. Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern. Total of all reporting groups
Overall Number of Baseline Participants 210 210 420
Hide Baseline Analysis Population Description
The full analysis set (FAS) included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 210 participants 210 participants 420 participants
56.1  (10.4) 57.2  (10.2) 56.7  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants 210 participants 420 participants
Female
89
  42.4%
84
  40.0%
173
  41.2%
Male
121
  57.6%
126
  60.0%
247
  58.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants 210 participants 420 participants
Hispanic or Latino
31
  14.8%
37
  17.6%
68
  16.2%
Not Hispanic or Latino
179
  85.2%
173
  82.4%
352
  83.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants 210 participants 420 participants
American Indian or Alaska Native
0
   0.0%
1
   0.5%
1
   0.2%
Asian
31
  14.8%
35
  16.7%
66
  15.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   1.4%
2
   1.0%
5
   1.2%
White
175
  83.3%
171
  81.4%
346
  82.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   0.5%
1
   0.5%
2
   0.5%
1.Primary Outcome
Title Change in HbA1c (Glycosylated Haemoglobin)
Hide Description The mean change from baseline (week 0) in HbA1c values evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline and week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 210 210
Mean (Standard Deviation)
Unit of Measure: Percentage of glycosylated haemoglobin
HbA1c (%) at baseline Number Analyzed 210 participants 210 participants
8.20  (0.93) 8.36  (1.08)
HbA1c (%) change from baseline to week 26 Number Analyzed 197 participants 202 participants
-1.94  (0.95) -1.68  (1.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IDegLira, IGlar
Comments Analysis was based on ANCOVA model with treatment, pre-trial OAD, region as factors and baseline HbA1c as covariate. Data obtained after premature treatment discontinuation are included in the analysis. Missing data was imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation. The non-inferiority margin of 0.3 % was added to the end-of-treatment value for prematurely discontinued and withdrawn from trial IDegLira subjects.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority of IDegLira was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (IDegLira minus IGlar) was strictly below 0.3%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Contrast
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-0.48 to -0.20
Estimation Comments IDegLira minus IGlar
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IDegLira, IGlar
Comments This endpoint was analysed using an ANCOVA model with treatment, pre-trial OAD and region as factors and corresponding baseline value as covariate. Data obtained after premature treatment discontinuation were included in the analysis. Missing data were imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation.
Type of Statistical Test Superiority
Comments Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c; and superiority of IDegLira was confirmed for weight change and the number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes) and if the upper limit of the two-sided 95% CI for the mean treatment difference (IDegLira minus IGlar) in change from baseline in HbA1c was strictly below 0%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Contrast
Estimated Value -0.36
Confidence Interval (2-Sided) 95%
-0.50 to -0.21
Estimation Comments IDegLira minus IGlar
2.Secondary Outcome
Title Change in Body Weight
Hide Description The mean change from baseline (week 0) in body weight evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline and week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 210 210
Mean (Standard Deviation)
Unit of Measure: kg
Body weight (kg) at baseline Number Analyzed 210 participants 210 participants
89.3  (17.6) 87.2  (17.2)
Body weight (kg) change from baseline to week 26 Number Analyzed 199 participants 204 participants
-0.0  (3.8) 2.0  (3.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IDegLira, IGlar
Comments This endpoint was analysed using an ANCOVA model with treatment, pre-trial OAD and region as factors and corresponding baseline weight as covariate. Data obtained after premature treatment discontinuation were included in the analysis. Missing data were imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation.
Type of Statistical Test Superiority
Comments Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c) and if the upper limit of the two-sided 95% CI for the mean treatment difference (IDegLira minus IGlar) in change from baseline in body weight was strictly below 0 kg.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Contrast
Estimated Value -1.92
Confidence Interval (2-Sided) 95%
-2.64 to -1.19
Estimation Comments IDegLira minus IGlar
3.Secondary Outcome
Title Number of Treatment-emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes
Hide Description Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe (subjects who were not able to self-treat) and/or BG confirmed by a plasma glucose values <3.1 mmol/L (56 mg/dL) with accompanied symptoms consistent with hypoglycaemia.
Time Frame Week 0-26
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation “as treated”.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 209 210
Measure Type: Number
Unit of Measure: Number of episodes
38 95
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IDegLira, IGlar
Comments This endpoint was analysed using a negative binomial regression model with a log link and the logarithm of the exposure time as offset. The model included treatment and pre-trial OAD as fixed factors. Missing data were imputed using multiple imputations (conditioning on expected event rate before premature treatment discontinuation or withdrawal from trial as if treated with IGlar).
Type of Statistical Test Superiority
Comments Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c and superiority of IDegLira was confirmed for change from baseline in body weight) and if the upper limit of the two-sided 95% CI for the rate ratio (IDegLira over IGlar) of rate of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes was strictly below 1.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Negative binomial regression model
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Ratio
Estimated Value 0.42
Confidence Interval (2-Sided) 95%
0.23 to 0.75
Estimation Comments IDegLira over IGlar
4.Secondary Outcome
Title Insulin Dose, Total Daily Dose (U)
Hide Description Actual daily total insulin dose (Units) was evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time Frame After 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 210 210
Mean (Standard Deviation)
Unit of Measure: Units (U)
36.2  (13.4) 53.5  (26.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IDegLira, IGlar
Comments The endpoint was analysed using an ANCOVA model with treatment, pre-trial OAD and region as factors and corresponding baseline HbA1c as covariate. Missing data were imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation.
Type of Statistical Test Superiority
Comments Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c; and superiority of IDegLira was confirmed for weight change, number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and change in HbA1c) and if the upper limit of the two-sided 95% CI for the mean treatment difference (IDegLira minus IGlar) in insulin dose after 26 weeks was strictly below 0 U.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Contrast
Estimated Value -15.37
Confidence Interval (2-Sided) 95%
-19.60 to -11.13
Estimation Comments IDegLira minus IGlar
5.Secondary Outcome
Title Change in Fasting Plasma Glucose (FPG)
Hide Description Change from baseline (week 0) in FPG was evaluated after 26 weeks of randomised treatment.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 210 210
Mean (Standard Deviation)
Unit of Measure: mmol/ L
FPG (mmol/L) at baseline Number Analyzed 206 participants 206 participants
9.51  (2.69) 9.57  (2.40)
FPG (mmol/L) change from baseline to week 26 Number Analyzed 189 participants 195 participants
-3.72  (2.89) -3.50  (2.43)
6.Secondary Outcome
Title Number of Treatment-emergent Adverse Events
Hide Description Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 26. TEAE was defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.
Time Frame Week 0-26
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation “as treated”.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 209 210
Measure Type: Number
Unit of Measure: Number of events
450 386
7.Secondary Outcome
Title Responder (Yes/No) for HbA1c Below 7.0%
Hide Description The proportion of subjects achieving pre-defined HbA1c targets <7.0% after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time Frame After 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 210 210
Measure Type: Number
Unit of Measure: Participants
Yes Number Analyzed 197 participants 202 participants
167 144
No Number Analyzed 197 participants 202 participants
30 58
8.Secondary Outcome
Title Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain
Hide Description The proportion of subjects achieving pre-defined HbA1c targets <7.0% without weight gain after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time Frame After 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 210 210
Measure Type: Number
Unit of Measure: Participants
Yes Number Analyzed 197 participants 202 participants
91 38
No Number Analyzed 197 participants 202 participants
106 164
9.Secondary Outcome
Title Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
Hide Description The proportion of subjects achieving pre-defined HbA1c targets <7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time Frame After 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 210 210
Measure Type: Number
Unit of Measure: Participants
Yes Number Analyzed 197 participants 202 participants
156 114
No Number Analyzed 197 participants 202 participants
41 88
10.Secondary Outcome
Title Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain
Hide Description The proportion of subjects achieving pre-defined HbA1c targets <7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment and without weight gain. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time Frame After 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 210 210
Measure Type: Number
Unit of Measure: Participants
Yes Number Analyzed 197 participants 202 participants
83 34
No Number Analyzed 197 participants 202 participants
114 168
11.Secondary Outcome
Title Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5%
Hide Description The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5% after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time Frame After 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 210 210
Measure Type: Number
Unit of Measure: Participants
Yes Number Analyzed 197 participants 202 participants
147 100
No Number Analyzed 197 participants 202 participants
50 102
12.Secondary Outcome
Title Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Weight Gain
Hide Description The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5% without weight gain after 26 weeks of randomised treatment. The results are based on retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time Frame After 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 210 210
Measure Type: Number
Unit of Measure: Participants
Yes Number Analyzed 197 participants 202 participants
84 26
No Number Analyzed 197 participants 202 participants
113 176
13.Secondary Outcome
Title Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
Hide Description The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5%without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time Frame After 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 210 210
Measure Type: Number
Unit of Measure: Particpants
Yes Number Analyzed 197 participants 202 participants
137 79
No Number Analyzed 197 participants 202 participants
60 123
14.Secondary Outcome
Title Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain
Hide Description The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5%without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment and without weight gain. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time Frame After 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 210 210
Measure Type: Number
Unit of Measure: Partcipants
Yes Number Analyzed 197 participants 202 participants
77 24
No Number Analyzed 197 participants 202 participants
120 178
15.Secondary Outcome
Title Change From Baseline After 26 Weeks in Waist Circumference
Hide Description Mean change from baseline in waist circumference after 26 weeks of randomised treatment.
Time Frame After 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 210 210
Mean (Standard Deviation)
Unit of Measure: cm
Waist circum. (cm) at baseline Number Analyzed 210 participants 210 participants
105.9  (12.7) 104.7  (11.3)
Waist circum. (cm) change from baseline to week 26 Number Analyzed 194 participants 200 participants
-0.6  (4.6) 0.7  (3.9)
16.Secondary Outcome
Title Change From Baseline in Fasting Lipid Profile: Cholesterol
Hide Description The values of total cholesterol from fasting lipid profile after 26 weeks of randomised treatment.
Time Frame After 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 210 210
Median (Full Range)
Unit of Measure: mmol/L
Total cholesterol (mmol/L) at baseline Number Analyzed 206 participants 205 participants
4.42
(2.02 to 10.62)
4.45
(2.12 to 11.37)
Total cholesterol (mmol/L) at week 26 Number Analyzed 191 participants 199 participants
4.27
(2.12 to 9.87)
4.27
(1.84 to 9.40)
17.Secondary Outcome
Title Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein Cholesterol (LDL Cholesterol)
Hide Description The values of LDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.
Time Frame After 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 210 210
Median (Full Range)
Unit of Measure: mmol/L
LDL cholesterol (mmol/L) at baseline Number Analyzed 205 participants 205 participants
2.28
(0.26 to 7.10)
2.28
(0.10 to 6.73)
LDL cholesterol (mmol/L) at week 26 Number Analyzed 191 participants 199 participants
2.20
(0.57 to 6.42)
2.31
(0.62 to 5.34)
18.Secondary Outcome
Title Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein Cholesterol (HDL Cholesterol)
Hide Description The values of HDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.
Time Frame After 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 210 210
Median (Full Range)
Unit of Measure: mmol/L
HDL cholesterol (mmol/L) at baseline Number Analyzed 206 participants 205 participants
1.14
(0.57 to 2.69)
1.14
(0.31 to 2.59)
HDL cholesterol (mmol/L) at week 26 Number Analyzed 191 participants 199 participants
1.17
(0.57 to 2.72)
1.17
(0.36 to 2.49)
19.Secondary Outcome
Title Change From Baseline in Fasting Lipid Profile: Very-low-density Lipoprotein Cholesterol (VLDL Cholesterol)
Hide Description The values of VLDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.
Time Frame After 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 210 210
Median (Full Range)
Unit of Measure: mmol/L
VLDL cholesterol (mmol/L) at baseline Number Analyzed 205 participants 205 participants
0.75
(0.18 to 8.60)
0.80
(0.21 to 8.13)
VLDL cholesterol (mmol/L) at week 26 Number Analyzed 191 participants 199 participants
0.70
(0.21 to 5.75)
0.67
(0.21 to 3.32)
20.Secondary Outcome
Title Change From Baseline in Fasting Lipid Profile: Triglycerides
Hide Description The values of triglycerides from fasting lipid profile after 26 weeks of randomised treatment.
Time Frame After 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 210 210
Median (Full Range)
Unit of Measure: mmol/L
Triglycerides (mmol/L) at baseline Number Analyzed 206 participants 205 participants
1.67
(0.38 to 23.60)
1.73
(0.43 to 27.80)
Triglycerides (mmol/L) at week 26 Number Analyzed 191 participants 199 participants
1.55
(0.46 to 17.03)
1.47
(0.47 to 8.81)
21.Secondary Outcome
Title Change From Baseline in Fasting Lipid Profile: Free Fatty Acids
Hide Description The values of free fatty acids from fasting lipid profile after 26 weeks of randomised treatment.
Time Frame After 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 210 210
Median (Full Range)
Unit of Measure: mmol/L
Free fatty acids (mmol/L) at baseline Number Analyzed 204 participants 207 participants
0.58
(0.08 to 1.44)
0.61
(0.06 to 1.73)
Free fatty acids (mmol/L) at week 26 Number Analyzed 189 participants 199 participants
0.38
(0.10 to 0.92)
0.42
(0.02 to 1.30)
22.Secondary Outcome
Title Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile
Hide Description Change in 9-point SMPG profile was evaluated after 26 weeks of randomised treatment. SMPG measurements at baseline and week 26 are presented here at the following mentioned time points:1) Before breakfast, 2) 90 mins after the start of Breakfast, 3) Before lunch, 4) 90 mins after the start of lunch, 5) Before dinner, 6) 90 mins after the start of dinner, 7) At bedtime, 8) At 4 AM, 9) Before breakfast the following day.
Time Frame After 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline and week 26 for mentioned time points.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 210 210
Mean (Standard Deviation)
Unit of Measure: mmol/L
Before breakfast - Baseline Number Analyzed 210 participants 207 participants
9.01  (2.18) 9.00  (1.91)
Ninety (90) minutes after breakfast - Baseline Number Analyzed 209 participants 207 participants
11.79  (3.09) 11.77  (2.99)
Before lunch - Baseline Number Analyzed 208 participants 207 participants
8.93  (2.80) 9.20  (2.95)
Ninety (90) minutes after lunch - Baseline Number Analyzed 210 participants 207 participants
11.24  (3.26) 11.22  (3.06)
Before dinner - Baseline Number Analyzed 210 participants 206 participants
9.33  (2.70) 9.36  (2.89)
Ninety (90) minutes after dinner - Baseline Number Analyzed 205 participants 206 participants
11.40  (3.04) 11.40  (2.99)
At bedtime - Baseline Number Analyzed 202 participants 202 participants
10.38  (3.16) 10.71  (3.13)
At 4.00 AM - Baseline Number Analyzed 198 participants 201 participants
8.80  (2.41) 9.00  (2.50)
Before breakfast the following day - Baseline Number Analyzed 204 participants 207 participants
8.60  (2.02) 8.81  (1.92)
Before breakfast - Week 26 Number Analyzed 184 participants 188 participants
5.40  (1.24) 5.39  (1.21)
Ninety (90) minutes after breakfast - Week 26 Number Analyzed 182 participants 187 participants
7.20  (1.86) 8.35  (2.40)
Before lunch - Week 26 Number Analyzed 182 participants 187 participants
5.83  (1.36) 6.35  (1.88)
Ninety (90) minutes after lunch - Week 26 Number Analyzed 179 participants 187 participants
7.25  (1.73) 8.49  (2.28)
Before dinner - Week 26: Number Analyzed 181 participants 186 participants
6.43  (1.61) 6.77  (2.03)
Ninety (90) minutes after dinner - Week 26 Number Analyzed 180 participants 186 participants
7.85  (1.95) 8.70  (2.19)
At bedtime - Week 26 Number Analyzed 173 participants 183 participants
7.05  (1.91) 7.79  (2.20)
At 4.00 AM - Week 26 Number Analyzed 175 participants 178 participants
5.58  (1.17) 5.72  (1.51)
Before breakfast the following day - Week 26 Number Analyzed 180 participants 188 participants
5.23  (1.09) 5.36  (1.38)
23.Secondary Outcome
Title Change From Baseline in Self-measured Plasma Glucose (SMPG) 9-point Profile: Mean of the 9-point Profile
Hide Description Change in mean of the 9-point profile SMPG was evaluated after 26 weeks of randomised treatment. 9-point profile SMPG was measured at the following mentioned time points:1) Before breakfast, 2) 90 mins after the start of Breakfast, 3) Before lunch, 4) 90 mins after the start of lunch, 5) Before dinner, 6) 90 mins after the start of dinner, 7) At bedtime, 8) At 4 AM, 9) Before breakfast the following day.
Time Frame After 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 210 210
Mean (Standard Deviation)
Unit of Measure: mmol/L
Mean 9-point SMPG (mmol/L) at baseline Number Analyzed 204 participants 207 participants
9.98  (2.17) 10.06  (2.04)
Mean 9-point SMPG change from baseline to week 26 Number Analyzed 176 participants 185 participants
-3.47  (2.01) -2.98  (1.91)
24.Secondary Outcome
Title Change From Baseline in SMPG 9-point Profile: Prandial Plasma Glucose Increments (From Before Meal to 90 Min After Breakfast, Lunch and Dinner). The Mean Increment Over All Meals Will be Derived as the Mean of All Available Meal Increments
Hide Description Mean prandial plasma glucose increments for each meal (from before meal to 90 min after breakfast, lunch and dinner) was evaluated after 26 weeks of randomised treatment. The mean increment over all meals was derived as the mean of all available meal increments are presented here.
Time Frame After 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 210 210
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 210 participants 207 participants
2.38  (1.73) 2.28  (1.88)
Change from baseline to week 26 Number Analyzed 182 participants 185 participants
-0.86  (1.95) -0.09  (1.96)
25.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure
Hide Description Change from baseline (week 0) in systolic blood pressure (BP) was evaluated after 26 weeks of randomised treatment.
Time Frame After 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 210 210
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic BP (mmHg) at baseline Number Analyzed 210 participants 210 participants
130.5  (14.3) 128.9  (13.1)
Systolic BP (mmHg) change from baseline to week 26 Number Analyzed 194 participants 200 participants
-3.0  (12.7) 0.6  (12.0)
26.Secondary Outcome
Title Change From Baseline in Diastolic Blood Pressure
Hide Description Change from baseline (week 0) in diastolic blood pressure was evaluated after 26 weeks of randomised treatment.
Time Frame After 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 210 210
Mean (Standard Deviation)
Unit of Measure: mmHg
Diastolic (mmHg) at baseline Number Analyzed 210 participants 210 participants
79.4  (8.0) 78.9  (8.9)
Diastolic (mmHg) change from baseline to week 26 Number Analyzed 194 participants 200 participants
-1.2  (8.4) -1.1  (8.3)
27.Secondary Outcome
Title Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks
Hide Description Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes (00:01-05:59 – inclusive) during 26 weeks of randomised treatment.
Time Frame Week 0-26
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who received at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation “as treated”.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 209 210
Measure Type: Number
Unit of Measure: Number of episodes
6 13
28.Secondary Outcome
Title Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks
Hide Description American Diabetes Association (ADA) classification of hypoglycaemic episodes: 1)Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo: PG >3.9 mmol/L with symptoms. 6) Unclassifiable.
Time Frame Week 0-26
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who received at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation “as treated”.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 209 210
Measure Type: Number
Unit of Measure: Number of episodes
Severe - ADA 1 0
Documented symptomatic - ADA 239 419
Asymptomatic - ADA 850 902
Probably symptomatic - ADA 23 5
Pseudo - ADA 10 14
Unclassifiable hypoglycaemia - ADA 2 0
29.Secondary Outcome
Title Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG)
Hide Description Reported results are ECG findings at screening and week 26 of randomised treatment. Since the values measured at the baseline (week 0) were not collected, the screening data (week -2, which is <= 2 weeks before baseline) is presented here. The findings are categorised as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). 4) Missing.
Time Frame After 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation “as treated”. Number analysed = Number of subjects contributed to the analysis at screening and week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 209 210
Measure Type: Number
Unit of Measure: Number of subjects
Screening, Normal Number Analyzed 209 participants 210 participants
142 141
Screening, Abnormal NCS Number Analyzed 209 participants 210 participants
66 69
Screening, Abnormal CS Number Analyzed 209 participants 210 participants
1 0
Screening, Missing Number Analyzed 209 participants 210 participants
0 0
Week 26, Normal Number Analyzed 194 participants 200 participants
134 136
Week 26, Abnormal NCS Number Analyzed 194 participants 200 participants
58 64
Week 26, Abnormal CS Number Analyzed 194 participants 200 participants
2 0
Week 26, Missing Number Analyzed 194 participants 200 participants
0 0
30.Secondary Outcome
Title Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography
Hide Description Reported results are fundus photography/fundoscopy (for both left and right eye) findings at screening and week 26 of randomised treatment. Since the values measured at the baseline (week 0) were not collected, the screening data (week -2, which is <= 2 weeks before baseline) is presented here. The findings are categorised as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). 4) Missing.
Time Frame After 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who received at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation “as treated”. Number analysed = Number of subjects contributed to the analysis at screening and week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 209 210
Measure Type: Number
Unit of Measure: Number of subjects
Screening, Left eye (Normal) Number Analyzed 209 participants 209 participants
134 131
Screening, Left eye (Abnormal -NCS) Number Analyzed 209 participants 209 participants
68 74
Screening, Left eye (Abnormal-CS) Number Analyzed 209 participants 209 participants
7 4
Screening, Left eye (Missing) Number Analyzed 209 participants 209 participants
0 0
Week 26, Left eye (Normal) Number Analyzed 191 participants 197 participants
123 125
Week 26, Left eye (Abnormal -NCS) Number Analyzed 191 participants 197 participants
66 68
Week 26, Left eye (Abnormal-CS) Number Analyzed 191 participants 197 participants
2 4
Week 26, Left eye (Missing) Number Analyzed 191 participants 197 participants
0 0
Screening, Right eye (Normal) Number Analyzed 209 participants 209 participants
133 133
Screening, Right eye (Abnormal-NCS) Number Analyzed 209 participants 209 participants
69 72
Screening, Right eye (Abnormal- CS) Number Analyzed 209 participants 209 participants
7 4
Screening, Right eye (Missing) Number Analyzed 209 participants 209 participants
0 0
Week 26, Right eye (Normal) Number Analyzed 191 participants 197 participants
120 127
Week 26, Right eye (Abnormal-NCS) Number Analyzed 191 participants 197 participants
69 66
Week 26, Right eye (Abnormal- CS) Number Analyzed 191 participants 197 participants
2 4
Week 26, Right eye (Missing) Number Analyzed 191 participants 197 participants
0 0
31.Secondary Outcome
Title Change From Baseline in Clinical Evaluation After 26 Weeks: Pulse Rate
Hide Description Change from baseline (week 0) in pulse rate was evaluated after 26 weeks of randomised treatment.
Time Frame After 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who received at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation “as treated”. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 209 210
Mean (Standard Deviation)
Unit of Measure: Beats/minute
Pulse (beats/min) at baseline Number Analyzed 209 participants 210 participants
76.1  (9.1) 75.0  (9.5)
Pulse (beats/min) change from baseline to week 26 Number Analyzed 194 participants 200 participants
2.0  (8.4) -0.4  (8.2)
32.Secondary Outcome
Title Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2)
Hide Description The Short Form (SF)-36v2™ patient reported outcomes (PRO) questionnaire was used to assess the subject’s overall health related quality of life (HRQoL). PRO questionnaire (SF-36v2™) measured the HRQoL which contains 36 items covering 8 domains of physical and mental health status. The raw scale scores from the SF-36 were transformed to a 0-100 scale scores (where higher scores indicated a better health status) which is further converted to norm-based scores using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 2009 reference population . The total/overall (SF-36v2™) scores for physical and mental health from baseline to week 26 are presented here.
Time Frame After 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline and week 26 for overall physical and mental scores.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 210 210
Median (Full Range)
Unit of Measure: Scores on a scale
Overall physical - Baseline Number Analyzed 208 participants 209 participants
51.3
(22.0 to 61.6)
51.5
(21.9 to 62.4)
Overall physical - Week 26 Number Analyzed 194 participants 200 participants
53.2
(22.9 to 64.0)
54.6
(25.0 to 65.6)
Overall mental - Baseline Number Analyzed 208 participants 210 participants
53.3
(15.6 to 67.9)
53.3
(19.7 to 68.8)
Overall mental - Week 26 Number Analyzed 194 participants 200 participants
54.4
(14.8 to 68.3)
54.4
(31.0 to 67.3)
33.Secondary Outcome
Title Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Treatment Related Impact Measure for Diabetes (TRIM-D)
Hide Description The patient reported outcomes are calculated based on TRIM-D questionnaire. The TRIM-D questionnaire consists of 5 sub-domains (treatment burden, daily life, diabetes management, compliance and psychological health), where each question is scored to a 1–5-point scale with a higher score indicating a better health state (less negative impact). Mean TRIM-D domain scores and the total scores are later transformed to a 0–100 scale for analysis. Summary scores from baseline and week 26 for total/overall scores are presented here.
Time Frame After 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline and week 26.
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description:
Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
Overall Number of Participants Analyzed 210 210
Median (Full Range)
Unit of Measure: Scores on a scale
TRIM-D scores at baseline Number Analyzed 208 participants 210 participants
75.9
(44.6 to 100.0)
75.9
(38.4 to 100.0)
TRIM-D scores at week 26 Number Analyzed 194 participants 199 participants
84.4
(37.5 to 100.0)
83.9
(44.6 to 100.0)
Time Frame Adverse events (AEs) were collected from first day (week 0) of exposure to randomised treatment of 26 weeks + 30 days follow-up visits after the last dose on trial product. All reported AEs are treatment emergent (i.e., TEAE).
Adverse Event Reporting Description Results are based on the safety analysis set, which included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation “as treated”.
 
Arm/Group Title IDegLira IGlar
Hide Arm/Group Description Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern. Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L [72 - 90 mg/dL]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.
All-Cause Mortality
IDegLira IGlar
Affected / at Risk (%) Affected / at Risk (%)
Total   0/209 (0.00%)      0/210 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
IDegLira IGlar
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/209 (2.87%)      7/210 (3.33%)    
Cardiac disorders     
Cardiac failure chronic  1  0/209 (0.00%)  0 1/210 (0.48%)  1
Coronary artery disease  1  0/209 (0.00%)  0 1/210 (0.48%)  1
Myocardial infarction  1  1/209 (0.48%)  1 0/210 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  0/209 (0.00%)  0 1/210 (0.48%)  1
Infections and infestations     
Infected skin ulcer  1  0/209 (0.00%)  0 1/210 (0.48%)  1
Pneumonia  1  2/209 (0.96%)  2 1/210 (0.48%)  1
Urinary tract infection  1  0/209 (0.00%)  0 1/210 (0.48%)  1
Investigations     
Blood potassium increased  1  1/209 (0.48%)  1 0/210 (0.00%)  0
Cardiovascular evaluation  1  1/209 (0.48%)  1 0/210 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Gastrointestinal stromal tumour  1  0/209 (0.00%)  0 1/210 (0.48%)  1
Nervous system disorders     
Haemorrhagic stroke  1  1/209 (0.48%)  1 0/210 (0.00%)  0
Product Issues     
Device failure  1  1/209 (0.48%)  2 0/210 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  0/209 (0.00%)  0 1/210 (0.48%)  1
Chronic kidney disease  1  0/209 (0.00%)  0 1/210 (0.48%)  1
1
Term from vocabulary, MedDRA 20
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IDegLira IGlar
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   49/209 (23.44%)      45/210 (21.43%)    
Gastrointestinal disorders     
Nausea  1  12/209 (5.74%)  22 1/210 (0.48%)  2
Infections and infestations     
Viral upper respiratory tract infection  1  16/209 (7.66%)  22 22/210 (10.48%)  24
Investigations     
Lipase increased  1  12/209 (5.74%)  15 3/210 (1.43%)  3
Musculoskeletal and connective tissue disorders     
Back pain  1  11/209 (5.26%)  12 9/210 (4.29%)  15
Nervous system disorders     
Headache  1  18/209 (8.61%)  35 19/210 (9.05%)  27
1
Term from vocabulary, MedDRA 20
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
At the end of the trial, one or more scientific publications may be prepared collaboratively by the Investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property".
Results Point of Contact
Name/Title: Clinical Reporting Anchor and Disclosure (1452)
Organization: Novo Nordisk A/S
Phone: (+1) 866-867-7178
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02773368     History of Changes
Other Study ID Numbers: NN9068-4229
2015-001596-48 ( EudraCT Number )
U1111-1168-9343 ( Other Identifier: WHO )
REec-2016-2248 ( Other Identifier: REec )
First Submitted: May 13, 2016
First Posted: May 16, 2016
Results First Submitted: September 24, 2018
Results First Posted: October 23, 2018
Last Update Posted: October 23, 2018