Trial Outcomes & Findings for 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 (NCT NCT02773368)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

420 participants

Primary outcome timeframe

Week 0, Week 26

Results posted on

2020-08-11

Participant Flow

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).

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.

Participant milestones

Participant milestones
Measure	IDegLira 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.	IGlar 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 Study STARTED	210	210
Overall Study Exposed	209	210
Overall Study COMPLETED	200	206
Overall Study NOT COMPLETED	10	4

Reasons for withdrawal

Reasons for withdrawal
Measure	IDegLira 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.	IGlar 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 Study Lost to Follow-up	4	1
Overall Study Withdrawal by Subject	5	1
Overall Study Unclassified	1	1
Overall Study Missing	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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 n=420 Participants Total of all reporting groups
Age, Continuous	56.1 years STANDARD_DEVIATION 10.4 • n=5 Participants	57.2 years STANDARD_DEVIATION 10.2 • n=7 Participants	56.7 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	89 Participants n=5 Participants	84 Participants n=7 Participants	173 Participants n=5 Participants
Sex: Female, Male Male	121 Participants n=5 Participants	126 Participants n=7 Participants	247 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	31 Participants n=5 Participants	37 Participants n=7 Participants	68 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	179 Participants n=5 Participants	173 Participants n=7 Participants	352 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	31 Participants n=5 Participants	35 Participants n=7 Participants	66 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	175 Participants n=5 Participants	171 Participants n=7 Participants	346 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 0, Week 26

Population: 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.

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.

Outcome measures

Outcome measures
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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.
Change in HbA1c (Glycosylated Haemoglobin) HbA1c (%) at baseline	8.20 Percentage of glycosylated haemoglobin Standard Deviation 0.93	8.36 Percentage of glycosylated haemoglobin Standard Deviation 1.08
Change in HbA1c (Glycosylated Haemoglobin) HbA1c (%) change from baseline to week 26	-1.94 Percentage of glycosylated haemoglobin Standard Deviation 0.95	-1.68 Percentage of glycosylated haemoglobin Standard Deviation 1.05

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: 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.

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.

Outcome measures

Outcome measures
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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.
Change in Body Weight Body weight (kg) at baseline	89.3 kg Standard Deviation 17.6	87.2 kg Standard Deviation 17.2
Change in Body Weight Body weight (kg) change from baseline to week 26	-0.0 kg Standard Deviation 3.8	2.0 kg Standard Deviation 3.9

SECONDARY outcome

Timeframe: Week 0-26

Population: 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".

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.

Outcome measures

Outcome measures
Measure	IDegLira n=209 Participants 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.	IGlar n=210 Participants 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.
Number of Treatment-emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes	38 Number of episodes	95 Number of episodes

SECONDARY outcome

Timeframe: After 26 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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.
Insulin Dose, Total Daily Dose (U)	36.2 Units (U) Standard Deviation 13.4	53.5 Units (U) Standard Deviation 26.1

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: 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.

Change from baseline (week 0) in FPG was evaluated after 26 weeks of randomised treatment.

Outcome measures

Outcome measures
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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.
Change in Fasting Plasma Glucose (FPG) FPG (mmol/L) at baseline	9.51 mmol/ L Standard Deviation 2.69	9.57 mmol/ L Standard Deviation 2.40
Change in Fasting Plasma Glucose (FPG) FPG (mmol/L) change from baseline to week 26	-3.72 mmol/ L Standard Deviation 2.89	-3.50 mmol/ L Standard Deviation 2.43

SECONDARY outcome

Timeframe: Week 0-26

Population: 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".

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.

Outcome measures

Outcome measures
Measure	IDegLira n=209 Participants 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.	IGlar n=210 Participants 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.
Number of Treatment-emergent Adverse Events	450 Number of events	386 Number of events

SECONDARY outcome

Timeframe: After 26 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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.
Responder (Yes/No) for HbA1c Below 7.0% Yes	167 Participants	144 Participants
Responder (Yes/No) for HbA1c Below 7.0% No	30 Participants	58 Participants

SECONDARY outcome

Timeframe: After 26 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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.
Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain No	106 Participants	164 Participants
Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain Yes	91 Participants	38 Participants

SECONDARY outcome

Timeframe: After 26 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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.
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 Yes	156 Participants	114 Participants
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 No	41 Participants	88 Participants

SECONDARY outcome

Timeframe: After 26 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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.
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 Yes	83 Participants	34 Participants
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 No	114 Participants	168 Participants

SECONDARY outcome

Timeframe: After 26 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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.
Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Yes	147 Participants	100 Participants
Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% No	50 Participants	102 Participants

SECONDARY outcome

Timeframe: After 26 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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.
Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Weight Gain Yes	84 Participants	26 Participants
Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Weight Gain No	113 Participants	176 Participants

SECONDARY outcome

Timeframe: After 26 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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.
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 No	60 Particpants	123 Particpants
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 Yes	137 Particpants	79 Particpants

SECONDARY outcome

Timeframe: After 26 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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.
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 Yes	77 Partcipants	24 Partcipants
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 No	120 Partcipants	178 Partcipants

SECONDARY outcome

Timeframe: After 26 weeks

Population: 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.

Mean change from baseline in waist circumference after 26 weeks of randomised treatment.

Outcome measures

Outcome measures
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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.
Change From Baseline After 26 Weeks in Waist Circumference Waist circum. (cm) at baseline	105.9 cm Standard Deviation 12.7	104.7 cm Standard Deviation 11.3
Change From Baseline After 26 Weeks in Waist Circumference Waist circum. (cm) change from baseline to week 26	-0.6 cm Standard Deviation 4.6	0.7 cm Standard Deviation 3.9

SECONDARY outcome

Timeframe: After 26 weeks

Population: 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.

The values of total cholesterol from fasting lipid profile after 26 weeks of randomised treatment.

Outcome measures

Outcome measures
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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.
Change From Baseline in Fasting Lipid Profile: Cholesterol Total cholesterol (mmol/L) at baseline	4.42 mmol/L Interval 2.02 to 10.62	4.45 mmol/L Interval 2.12 to 11.37
Change From Baseline in Fasting Lipid Profile: Cholesterol Total cholesterol (mmol/L) at week 26	4.27 mmol/L Interval 2.12 to 9.87	4.27 mmol/L Interval 1.84 to 9.4

SECONDARY outcome

Timeframe: After 26 weeks

Population: 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.

The values of LDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.

Outcome measures

Outcome measures
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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.
Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein Cholesterol (LDL Cholesterol) LDL cholesterol (mmol/L) at baseline	2.28 mmol/L Interval 0.26 to 7.1	2.28 mmol/L Interval 0.1 to 6.73
Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein Cholesterol (LDL Cholesterol) LDL cholesterol (mmol/L) at week 26	2.20 mmol/L Interval 0.57 to 6.42	2.31 mmol/L Interval 0.62 to 5.34

SECONDARY outcome

Timeframe: After 26 weeks

Population: 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.

The values of HDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.

Outcome measures

Outcome measures
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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.
Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein Cholesterol (HDL Cholesterol) HDL cholesterol (mmol/L) at baseline	1.14 mmol/L Interval 0.57 to 2.69	1.14 mmol/L Interval 0.31 to 2.59
Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein Cholesterol (HDL Cholesterol) HDL cholesterol (mmol/L) at week 26	1.17 mmol/L Interval 0.57 to 2.72	1.17 mmol/L Interval 0.36 to 2.49

SECONDARY outcome

Timeframe: After 26 weeks

Population: 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.

The values of VLDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.

Outcome measures

Outcome measures
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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.
Change From Baseline in Fasting Lipid Profile: Very-low-density Lipoprotein Cholesterol (VLDL Cholesterol) VLDL cholesterol (mmol/L) at baseline	0.75 mmol/L Interval 0.18 to 8.6	0.80 mmol/L Interval 0.21 to 8.13
Change From Baseline in Fasting Lipid Profile: Very-low-density Lipoprotein Cholesterol (VLDL Cholesterol) VLDL cholesterol (mmol/L) at week 26	0.70 mmol/L Interval 0.21 to 5.75	0.67 mmol/L Interval 0.21 to 3.32

SECONDARY outcome

Timeframe: After 26 weeks

Population: 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.

The values of triglycerides from fasting lipid profile after 26 weeks of randomised treatment.

Outcome measures

Outcome measures
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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.
Change From Baseline in Fasting Lipid Profile: Triglycerides Triglycerides (mmol/L) at baseline	1.67 mmol/L Interval 0.38 to 23.6	1.73 mmol/L Interval 0.43 to 27.8
Change From Baseline in Fasting Lipid Profile: Triglycerides Triglycerides (mmol/L) at week 26	1.55 mmol/L Interval 0.46 to 17.03	1.47 mmol/L Interval 0.47 to 8.81

SECONDARY outcome

Timeframe: After 26 weeks

Population: 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.

The values of free fatty acids from fasting lipid profile after 26 weeks of randomised treatment.

Outcome measures

Outcome measures
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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.
Change From Baseline in Fasting Lipid Profile: Free Fatty Acids Free fatty acids (mmol/L) at baseline	0.58 mmol/L Interval 0.08 to 1.44	0.61 mmol/L Interval 0.06 to 1.73
Change From Baseline in Fasting Lipid Profile: Free Fatty Acids Free fatty acids (mmol/L) at week 26	0.38 mmol/L Interval 0.1 to 0.92	0.42 mmol/L Interval 0.02 to 1.3

SECONDARY outcome

Timeframe: After 26 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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.
Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile Before breakfast - Baseline	9.01 mmol/L Standard Deviation 2.18	9.00 mmol/L Standard Deviation 1.91
Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile Ninety (90) minutes after breakfast - Baseline	11.79 mmol/L Standard Deviation 3.09	11.77 mmol/L Standard Deviation 2.99
Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile Before lunch - Baseline	8.93 mmol/L Standard Deviation 2.80	9.20 mmol/L Standard Deviation 2.95
Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile Ninety (90) minutes after lunch - Baseline	11.24 mmol/L Standard Deviation 3.26	11.22 mmol/L Standard Deviation 3.06
Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile Before dinner - Baseline	9.33 mmol/L Standard Deviation 2.70	9.36 mmol/L Standard Deviation 2.89
Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile Ninety (90) minutes after dinner - Baseline	11.40 mmol/L Standard Deviation 3.04	11.40 mmol/L Standard Deviation 2.99
Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile At bedtime - Baseline	10.38 mmol/L Standard Deviation 3.16	10.71 mmol/L Standard Deviation 3.13
Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile At 4.00 AM - Baseline	8.80 mmol/L Standard Deviation 2.41	9.00 mmol/L Standard Deviation 2.50
Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile Before breakfast the following day - Baseline	8.60 mmol/L Standard Deviation 2.02	8.81 mmol/L Standard Deviation 1.92
Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile Before breakfast - Week 26	5.40 mmol/L Standard Deviation 1.24	5.39 mmol/L Standard Deviation 1.21
Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile Ninety (90) minutes after breakfast - Week 26	7.20 mmol/L Standard Deviation 1.86	8.35 mmol/L Standard Deviation 2.40
Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile Before lunch - Week 26	5.83 mmol/L Standard Deviation 1.36	6.35 mmol/L Standard Deviation 1.88
Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile Ninety (90) minutes after lunch - Week 26	7.25 mmol/L Standard Deviation 1.73	8.49 mmol/L Standard Deviation 2.28
Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile Before dinner - Week 26:	6.43 mmol/L Standard Deviation 1.61	6.77 mmol/L Standard Deviation 2.03
Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile Ninety (90) minutes after dinner - Week 26	7.85 mmol/L Standard Deviation 1.95	8.70 mmol/L Standard Deviation 2.19
Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile At bedtime - Week 26	7.05 mmol/L Standard Deviation 1.91	7.79 mmol/L Standard Deviation 2.20
Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile At 4.00 AM - Week 26	5.58 mmol/L Standard Deviation 1.17	5.72 mmol/L Standard Deviation 1.51
Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile Before breakfast the following day - Week 26	5.23 mmol/L Standard Deviation 1.09	5.36 mmol/L Standard Deviation 1.38

SECONDARY outcome

Timeframe: After 26 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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.
Change From Baseline in Self-measured Plasma Glucose (SMPG) 9-point Profile: Mean of the 9-point Profile Mean 9-point SMPG (mmol/L) at baseline	9.98 mmol/L Standard Deviation 2.17	10.06 mmol/L Standard Deviation 2.04
Change From Baseline in Self-measured Plasma Glucose (SMPG) 9-point Profile: Mean of the 9-point Profile Mean 9-point SMPG change from baseline to week 26	-3.47 mmol/L Standard Deviation 2.01	-2.98 mmol/L Standard Deviation 1.91

SECONDARY outcome

Timeframe: After 26 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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.
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 Baseline	2.38 mmol/L Standard Deviation 1.73	2.28 mmol/L Standard Deviation 1.88
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 Change from baseline to week 26	-0.86 mmol/L Standard Deviation 1.95	-0.09 mmol/L Standard Deviation 1.96

SECONDARY outcome

Timeframe: After 26 weeks

Population: 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.

Change from baseline (week 0) in systolic blood pressure (BP) was evaluated after 26 weeks of randomised treatment.

Outcome measures

Outcome measures
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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.
Change From Baseline in Systolic Blood Pressure Systolic BP (mmHg) at baseline	130.5 mmHg Standard Deviation 14.3	128.9 mmHg Standard Deviation 13.1
Change From Baseline in Systolic Blood Pressure Systolic BP (mmHg) change from baseline to week 26	-3.0 mmHg Standard Deviation 12.7	0.6 mmHg Standard Deviation 12.0

SECONDARY outcome

Timeframe: After 26 weeks

Population: 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.

Change from baseline (week 0) in diastolic blood pressure was evaluated after 26 weeks of randomised treatment.

Outcome measures

Outcome measures
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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.
Change From Baseline in Diastolic Blood Pressure Diastolic (mmHg) at baseline	79.4 mmHg Standard Deviation 8.0	78.9 mmHg Standard Deviation 8.9
Change From Baseline in Diastolic Blood Pressure Diastolic (mmHg) change from baseline to week 26	-1.2 mmHg Standard Deviation 8.4	-1.1 mmHg Standard Deviation 8.3

SECONDARY outcome

Timeframe: Week 0-26

Population: 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 of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes (00:01-05:59 - inclusive) during 26 weeks of randomised treatment.

Outcome measures

Outcome measures
Measure	IDegLira n=209 Participants 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.	IGlar n=210 Participants 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.
Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks	6 Number of episodes	13 Number of episodes

SECONDARY outcome

Timeframe: Week 0-26

Population: 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".

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.

Outcome measures

Outcome measures
Measure	IDegLira n=209 Participants 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.	IGlar n=210 Participants 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.
Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks Severe - ADA	1 Number of episodes	0 Number of episodes
Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks Documented symptomatic - ADA	239 Number of episodes	419 Number of episodes
Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks Asymptomatic - ADA	850 Number of episodes	902 Number of episodes
Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks Probably symptomatic - ADA	23 Number of episodes	5 Number of episodes
Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks Pseudo - ADA	10 Number of episodes	14 Number of episodes
Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks Unclassifiable hypoglycaemia - ADA	2 Number of episodes	0 Number of episodes

SECONDARY outcome

Timeframe: After 26 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	IDegLira n=209 Participants 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.	IGlar n=210 Participants 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.
Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG) Screening, Normal	142 Number of subjects	141 Number of subjects
Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG) Screening, Abnormal NCS	66 Number of subjects	69 Number of subjects
Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG) Screening, Abnormal CS	1 Number of subjects	0 Number of subjects
Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG) Screening, Missing	0 Number of subjects	0 Number of subjects
Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG) Week 26, Normal	134 Number of subjects	136 Number of subjects
Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG) Week 26, Abnormal NCS	58 Number of subjects	64 Number of subjects
Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG) Week 26, Abnormal CS	2 Number of subjects	0 Number of subjects
Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG) Week 26, Missing	0 Number of subjects	0 Number of subjects

SECONDARY outcome

Timeframe: After 26 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	IDegLira n=209 Participants 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.	IGlar n=210 Participants 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.
Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography Screening, Left eye (Normal)	134 Number of subjects	131 Number of subjects
Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography Screening, Left eye (Abnormal -NCS)	68 Number of subjects	74 Number of subjects
Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography Screening, Left eye (Abnormal-CS)	7 Number of subjects	4 Number of subjects
Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography Screening, Left eye (Missing)	0 Number of subjects	0 Number of subjects
Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography Week 26, Left eye (Normal)	123 Number of subjects	125 Number of subjects
Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography Week 26, Left eye (Abnormal -NCS)	66 Number of subjects	68 Number of subjects
Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography Week 26, Left eye (Abnormal-CS)	2 Number of subjects	4 Number of subjects
Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography Week 26, Left eye (Missing)	0 Number of subjects	0 Number of subjects
Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography Screening, Right eye (Normal)	133 Number of subjects	133 Number of subjects
Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography Screening, Right eye (Abnormal-NCS)	69 Number of subjects	72 Number of subjects
Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography Screening, Right eye (Abnormal- CS)	7 Number of subjects	4 Number of subjects
Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography Screening, Right eye (Missing)	0 Number of subjects	0 Number of subjects
Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography Week 26, Right eye (Normal)	120 Number of subjects	127 Number of subjects
Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography Week 26, Right eye (Abnormal-NCS)	69 Number of subjects	66 Number of subjects
Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography Week 26, Right eye (Abnormal- CS)	2 Number of subjects	4 Number of subjects
Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography Week 26, Right eye (Missing)	0 Number of subjects	0 Number of subjects

SECONDARY outcome

Timeframe: After 26 weeks

Population: 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.

Change from baseline (week 0) in pulse rate was evaluated after 26 weeks of randomised treatment.

Outcome measures

Outcome measures
Measure	IDegLira n=209 Participants 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.	IGlar n=210 Participants 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.
Change From Baseline in Clinical Evaluation After 26 Weeks: Pulse Rate Pulse (beats/min) at baseline	76.1 Beats/minute Standard Deviation 9.1	75.0 Beats/minute Standard Deviation 9.5
Change From Baseline in Clinical Evaluation After 26 Weeks: Pulse Rate Pulse (beats/min) change from baseline to week 26	2.0 Beats/minute Standard Deviation 8.4	-0.4 Beats/minute Standard Deviation 8.2

SECONDARY outcome

Timeframe: After 26 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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.
Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2) Overall physical - Baseline	51.3 Scores on a scale Interval 22.0 to 61.6	51.5 Scores on a scale Interval 21.9 to 62.4
Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2) Overall physical - Week 26	53.2 Scores on a scale Interval 22.9 to 64.0	54.6 Scores on a scale Interval 25.0 to 65.6
Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2) Overall mental - Baseline	53.3 Scores on a scale Interval 15.6 to 67.9	53.3 Scores on a scale Interval 19.7 to 68.8
Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2) Overall mental - Week 26	54.4 Scores on a scale Interval 14.8 to 68.3	54.4 Scores on a scale Interval 31.0 to 67.3

SECONDARY outcome

Timeframe: After 26 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	IDegLira n=210 Participants 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.	IGlar n=210 Participants 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.
Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Treatment Related Impact Measure for Diabetes (TRIM-D) TRIM-D scores at baseline	75.9 Scores on a scale Interval 44.6 to 100.0	75.9 Scores on a scale Interval 38.4 to 100.0
Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Treatment Related Impact Measure for Diabetes (TRIM-D) TRIM-D scores at week 26	84.4 Scores on a scale Interval 37.5 to 100.0	83.9 Scores on a scale Interval 44.6 to 100.0

Adverse Events

IDegLira

Serious events: 6 serious events

Other events: 49 other events

Deaths: 0 deaths

IGlar

Serious events: 7 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IDegLira n=209 participants at risk 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.	IGlar n=210 participants at risk 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.
Gastrointestinal disorders Abdominal pain	0.00% 0/209 • 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). 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".	0.48% 1/210 • Number of events 1 • 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). 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".
Renal and urinary disorders Acute kidney injury	0.00% 0/209 • 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). 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".	0.48% 1/210 • Number of events 1 • 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). 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".
Investigations Blood potassium increased	0.48% 1/209 • Number of events 1 • 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). 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".	0.00% 0/210 • 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). 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".
Cardiac disorders Cardiac failure chronic	0.00% 0/209 • 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). 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".	0.48% 1/210 • Number of events 1 • 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). 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".
Investigations Cardiovascular evaluation	0.48% 1/209 • Number of events 1 • 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). 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".	0.00% 0/210 • 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). 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".
Renal and urinary disorders Chronic kidney disease	0.00% 0/209 • 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). 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".	0.48% 1/210 • Number of events 1 • 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). 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".
Cardiac disorders Coronary artery disease	0.00% 0/209 • 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). 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".	0.48% 1/210 • Number of events 1 • 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). 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".
Product Issues Device failure	0.48% 1/209 • Number of events 2 • 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). 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".	0.00% 0/210 • 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). 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".
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.00% 0/209 • 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). 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".	0.48% 1/210 • Number of events 1 • 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). 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".
Nervous system disorders Haemorrhagic stroke	0.48% 1/209 • Number of events 1 • 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). 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".	0.00% 0/210 • 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). 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".
Infections and infestations Infected skin ulcer	0.00% 0/209 • 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). 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".	0.48% 1/210 • Number of events 1 • 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). 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".
Cardiac disorders Myocardial infarction	0.48% 1/209 • Number of events 1 • 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). 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".	0.00% 0/210 • 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). 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".
Infections and infestations Pneumonia	0.96% 2/209 • Number of events 2 • 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). 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".	0.48% 1/210 • Number of events 1 • 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). 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".
Infections and infestations Urinary tract infection	0.00% 0/209 • 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). 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".	0.48% 1/210 • Number of events 1 • 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). 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".

Other adverse events

Other adverse events
Measure	IDegLira n=209 participants at risk 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.	IGlar n=210 participants at risk 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.
Musculoskeletal and connective tissue disorders Back pain	5.3% 11/209 • Number of events 12 • 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). 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".	4.3% 9/210 • Number of events 15 • 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). 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".
Nervous system disorders Headache	8.6% 18/209 • Number of events 35 • 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). 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".	9.0% 19/210 • Number of events 27 • 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). 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".
Investigations Lipase increased	5.7% 12/209 • Number of events 15 • 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). 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".	1.4% 3/210 • Number of events 3 • 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). 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".
Gastrointestinal disorders Nausea	5.7% 12/209 • Number of events 22 • 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). 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".	0.48% 1/210 • Number of events 2 • 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). 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".
Infections and infestations Viral upper respiratory tract infection	7.7% 16/209 • Number of events 22 • 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). 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".	10.5% 22/210 • Number of events 24 • 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). 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".

Additional Information

Clinical Reporting Anchor and Disclosure (1452)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

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Results disclosure agreements

Principal investigator is a sponsor employee 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".
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