Trial Outcomes & Findings for A Trial Comparing Insulin Degludec/Liraglutide, Insulin Degludec, and Liraglutide in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs) (NCT NCT03172494)

Results Overview

Change in HbA1c from baseline (week 0) after 26 weeks of treatment is presented.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

720 participants

Primary outcome timeframe

Week 0, week 26

Results posted on

2022-12-14

Participant Flow

The trial was conducted at 38 sites in China mainland.

Participants were randomised in a 2:1:1 manner to receive insulin degludec/liraglutide, insulin degludec or liraglutide in combination with metformin.

Participant milestones

Participant milestones
Measure	Insulin Degludec/Liraglutide Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 milligrams (mg) liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 millimoles/litre (mmol/L). The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg per day (mg/day) was continued for the remaining period of treatment."
Overall Study STARTED	361	179	180
Overall Study Full Analysis Set (FAS)	361	179	180
Overall Study Safety Analysis Set (SAS)	358	175	180
Overall Study Exposed	358	175	180
Overall Study COMPLETED	341	167	151
Overall Study NOT COMPLETED	20	12	29

Reasons for withdrawal

Reasons for withdrawal
Measure	Insulin Degludec/Liraglutide Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 milligrams (mg) liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 millimoles/litre (mmol/L). The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg per day (mg/day) was continued for the remaining period of treatment."
Overall Study Adverse Event	5	1	15
Overall Study Protocol Violation	3	2	1
Overall Study Lack of Efficacy	0	0	4
Overall Study Pregnancy	0	1	0
Overall Study Withdrawal by Subject	10	8	8
Overall Study Severe hypoglycaemic episode	0	0	1
Overall Study Non-compliance towards treatment	2	0	0

Baseline Characteristics

A Trial Comparing Insulin Degludec/Liraglutide, Insulin Degludec, and Liraglutide in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Insulin Degludec/Liraglutide n=361 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=179 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=180 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."	Total n=720 Participants Total of all reporting groups
Age, Continuous	54.5 years STANDARD_DEVIATION 10.3 • n=5 Participants	55.7 years STANDARD_DEVIATION 10.2 • n=7 Participants	54.1 years STANDARD_DEVIATION 10.2 • n=5 Participants	54.7 years STANDARD_DEVIATION 10.3 • n=4 Participants
Sex/Gender, Customized Female	142 Participants n=5 Participants	79 Participants n=7 Participants	72 Participants n=5 Participants	293 Participants n=4 Participants
Sex/Gender, Customized Male	219 Participants n=5 Participants	100 Participants n=7 Participants	108 Participants n=5 Participants	427 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	361 Participants n=5 Participants	179 Participants n=7 Participants	180 Participants n=5 Participants	720 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	361 Participants n=5 Participants	179 Participants n=7 Participants	180 Participants n=5 Participants	720 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Glycosylated haemoglobin (HbA1c)	8.20 Percentage points of HbA1c STANDARD_DEVIATION 0.83 • n=5 Participants	8.31 Percentage points of HbA1c STANDARD_DEVIATION 0.84 • n=7 Participants	8.21 Percentage points of HbA1c STANDARD_DEVIATION 0.77 • n=5 Participants	8.23 Percentage points of HbA1c STANDARD_DEVIATION 0.82 • n=4 Participants

PRIMARY outcome

Timeframe: Week 0, week 26

Population: FAS included all randomised participants. Overall number of participants analysed = participants with available data.

Change in HbA1c from baseline (week 0) after 26 weeks of treatment is presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=341 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=151 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in HbA1c	-1.71 Percentage points of HbA1c Standard Deviation 0.88	-1.20 Percentage points of HbA1c Standard Deviation 0.99	-1.16 Percentage points of HbA1c Standard Deviation 0.89

SECONDARY outcome

Timeframe: Week 0, week 26

Population: FAS included all randomised participants. Overall number of participants analysed = participants with available data.

Change in body weight from baseline (week 0) after 26 weeks of treatment is presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=341 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=151 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Body Weight	0.2 Kilogram (Kg) Standard Deviation 2.7	1.3 Kilogram (Kg) Standard Deviation 2.7	-2.5 Kilogram (Kg) Standard Deviation 2.7

SECONDARY outcome

Timeframe: Weeks 0-26

Population: Safety analysis set (SAS) included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.

Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or blood glucose (BG) confirmed by a plasma glucose (PG) value \< 3.1 millimoles per liter (mmol/L) with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. The number of episodes are represented as rates. The observed rates of treatment-emergent severe or BG confirmed hypoglycaemic episodes per patient years of exposure (PYE) (number of episodes divided by PYE multiplied by 100) during 26 weeks of treatment are presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=29 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=14 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=3 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Number of Treatment Emergent Severe or BG Confirmed Hypoglycaemic Episodes	23.94 (Number of episodes/PYE)*100	17.01 (Number of episodes/PYE)*100	3.60 (Number of episodes/PYE)*100

SECONDARY outcome

Timeframe: Week 26

Population: SAS included all participants receiving at least one dose of the insulin degludec/liraglutide or insulin degludec. Overall number of participants analysed = participants with available data

The actual daily total insulin dose after 26 weeks of treatment is presented. This outcome measure is only applicable for Insulin degludec/liraglutide and Insulin degludec treatment arms.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=340 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Insulin Dose	24.8 Units of insulin (U) Standard Deviation 11.9	30.1 Units of insulin (U) Standard Deviation 14.4	—

SECONDARY outcome

Timeframe: Week 26

Population: FAS included all randomised participants. Overall number of participants analysied = number of participants with available data.

Number of participants who achieved ADA HbA1c target (HbA1c \< 7.0%) (yes/no) after 26 weeks of treatment are presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=341 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=151 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Participants Who Achieved HbA1c < 7.0%, American Diabetes Association (ADA) Target (Yes/no) Yes	272 Participants	83 Participants	80 Participants
Participants Who Achieved HbA1c < 7.0%, American Diabetes Association (ADA) Target (Yes/no) No	69 Participants	84 Participants	71 Participants

SECONDARY outcome

Timeframe: Week 26

Population: FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.

Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) after 26 weeks of treatment are presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=341 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=151 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Participants Who Achieved HbA1c ≤ 6.5%, International Diabetes Federation (IDF) Target (Yes/no) Yes	201 Participants	48 Participants	41 Participants
Participants Who Achieved HbA1c ≤ 6.5%, International Diabetes Federation (IDF) Target (Yes/no) No	140 Participants	119 Participants	110 Participants

SECONDARY outcome

Timeframe: Week 26

Population: FAS included all randomised participants.

Number of participants who achieved ADA HbA1c target (HbA1c \< 7.0%) (yes/no) and change from baseline in body weight below or equal to zero after 26 weeks are presented. Missing values are imputed by LOCF.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=361 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=179 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=180 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Participants Who Achieved HbA1c <7.0% and Change in Body Weight From Baseline Below or Equal to Zero Yes	147 Participants	34 Participants	74 Participants
Participants Who Achieved HbA1c <7.0% and Change in Body Weight From Baseline Below or Equal to Zero No	214 Participants	145 Participants	106 Participants

SECONDARY outcome

Timeframe: Week 26

Population: FAS included all randomised participants.

Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) and change from baseline in body weight below or equal to zero after 26 weeks are presented. Missing values are imputed by LOCF.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=361 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=179 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=180 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero Yes	111 Participants	21 Participants	37 Participants
Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero No	250 Participants	158 Participants	143 Participants

SECONDARY outcome

Timeframe: Week 26

Population: FAS included all randomised participants.

Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \<3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of participants who achieved ADA HbA1c target (HbA1c \<7.0%) (yes/no) after 26 weeks of treatment and without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment are presented. Missing values are imputed by LOCF.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=361 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=179 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=180 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Participants Who Achieved HbA1c < 7.0% Without Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes Yes	265 Participants	80 Participants	84 Participants
Participants Who Achieved HbA1c < 7.0% Without Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes No	96 Participants	99 Participants	96 Participants

SECONDARY outcome

Timeframe: Week 26

Population: FAS included all randomised participants.

Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) after 26 weeks of treatment and without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment are presented. Missing values are imputed by LOCF.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=361 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=179 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=180 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Hypoglycaemic Episodes Yes	195 Participants	46 Participants	43 Participants
Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Hypoglycaemic Episodes No	166 Participants	133 Participants	137 Participants

SECONDARY outcome

Timeframe: Week 26

Population: FAS included all randomised participants.

Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of participants who achieved ADA HbA1c target (HbA1c \< 7.0%) (yes/no) after 26 weeks of treatment without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment and with change from baseline in body weight below or equal to zero are presented. Missing values are imputed by LOCF.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=361 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=179 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=180 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Participants Who Achieved HbA1c < 7.0% Without Severe or BG Confirmed Episodes, and Change From Baseline in Body Weight Below or Equal to Zero. Yes	136 Participants	33 Participants	72 Participants
Participants Who Achieved HbA1c < 7.0% Without Severe or BG Confirmed Episodes, and Change From Baseline in Body Weight Below or Equal to Zero. No	225 Participants	146 Participants	108 Participants

SECONDARY outcome

Timeframe: Week 26

Population: FAS included all randomised participants.

Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) after 26 weeks of treatment without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment and with change from baseline in body weight below or equal to zero are presented. Missing values are imputed by LOCF.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=361 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=179 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=180 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Episodes and Change From Baseline in Body Weight Below or Equal to Zero. Yes	103 Participants	21 Participants	36 Participants
Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Episodes and Change From Baseline in Body Weight Below or Equal to Zero. No	258 Participants	158 Participants	144 Participants

SECONDARY outcome

Timeframe: Week 0, week 26

Population: FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.

Change from baseline (week 0) in FPG after 26 weeks of treatment is presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=341 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=150 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Fasting Plasma Glucose (FPG)	-3.64 mmol/L Standard Deviation 2.27	-3.45 mmol/L Standard Deviation 2.34	-1.86 mmol/L Standard Deviation 2.11

SECONDARY outcome

Timeframe: Week 0, week 26

Population: FAS included all randomised participants. Overall number of participants analysed = participants with available data.

Change from baseline (week 0) in waist circumferance after 26 weeks of treatment is presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=341 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=166 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=151 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Waist Circumferance	-0.3 Centimeters (cm) Standard Deviation 3.4	1.2 Centimeters (cm) Standard Deviation 4.2	-2.6 Centimeters (cm) Standard Deviation 3.8

SECONDARY outcome

Timeframe: Week 26

Population: FAS included all randomised participants. Number analysed= number of participants with available data

Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). 9-point SMPG values at 26 weeks of treatment are presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=361 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=179 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=180 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
9-point SMPG Profile Before breakfast	5.41 mmol/L Standard Deviation 1.07	5.66 mmol/L Standard Deviation 1.20	6.89 mmol/L Standard Deviation 1.37
9-point SMPG Profile 90 minutes after the start of breakfast	8.97 mmol/L Standard Deviation 2.48	9.85 mmol/L Standard Deviation 2.73	10.04 mmol/L Standard Deviation 2.81
9-point SMPG Profile Before lunch	6.31 mmol/L Standard Deviation 1.80	7.10 mmol/L Standard Deviation 2.35	7.48 mmol/L Standard Deviation 2.14
9-point SMPG Profile 90 minutes after the start of the lunch	8.87 mmol/L Standard Deviation 2.15	10.18 mmol/L Standard Deviation 2.81	9.54 mmol/L Standard Deviation 2.43
9-point SMPG Profile Before dinner	6.52 mmol/L Standard Deviation 1.77	7.39 mmol/L Standard Deviation 2.23	7.50 mmol/L Standard Deviation 2.11
9-point SMPG Profile 90 minutes after start of the dinner	9.33 mmol/L Standard Deviation 2.40	10.27 mmol/L Standard Deviation 2.68	9.45 mmol/L Standard Deviation 2.13
9-point SMPG Profile At bedtime	7.99 mmol/L Standard Deviation 2.28	8.86 mmol/L Standard Deviation 2.38	8.49 mmol/L Standard Deviation 2.26
9-point SMPG Profile At 4:00 am	5.60 mmol/L Standard Deviation 1.26	6.12 mmol/L Standard Deviation 1.75	6.86 mmol/L Standard Deviation 1.60
9-point SMPG Profile Before breakfast the following day	5.35 mmol/L Standard Deviation 0.96	5.47 mmol/L Standard Deviation 1.07	6.81 mmol/L Standard Deviation 1.47

SECONDARY outcome

Timeframe: Week 0, week 26

Population: FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.

Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). The mean of profile is defined as the area under the profile divided by measurement time and is calculated using the trapezoidal method. Change in mean of the 9-point SMPG profile from baseline (week 0) to week 26 is presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=331 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=162 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=146 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Mean of 9-point SMPG Profile	-3.17 mmol/L Standard Deviation 2.16	-2.47 mmol/L Standard Deviation 2.14	-2.13 mmol/L Standard Deviation 2.02

SECONDARY outcome

Timeframe: Week 0, week 26

Population: FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.

Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). Post-prandial SMPG increments from before meal to 90 minutes after for breakfast, lunch and dinner were calculated. The mean increment over all meals was derived as the mean of all available meal increments. Change from baseline (week 0) in post-prandial SMPG increments for all meals after 26 weeks of treatment is presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=335 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=164 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=150 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Mean Post-prandial Plasma Glucose (PG) Increments	-0.20 mmol/L Standard Deviation 2.40	0.09 mmol/L Standard Deviation 2.40	-0.54 mmol/L Standard Deviation 2.57

SECONDARY outcome

Timeframe: Week 0, week 26

Population: FAS included all randomised participants. Overall, number of participants analysed = number of participants with available data.

Change in fasting C-peptide (measured in nanomoles per liter \[nmol/L\]) from baseline (week 0) to week 26 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=339 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=150 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Fasting C-peptide - Ratio to Baseline	0.54 Ratio of fasting C-peptide Geometric Coefficient of Variation 52.8	0.38 Ratio of fasting C-peptide Geometric Coefficient of Variation 68.5	0.98 Ratio of fasting C-peptide Geometric Coefficient of Variation 37.6

SECONDARY outcome

Timeframe: Week 0, week 26

Population: FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.

Change in fasting human insulin (measured in picomoles per liter \[pmol/L\]) from baseline (week 0) to week 26 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=328 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=162 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=142 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Fasting Human Insulin - Ratio to Baseline	0.53 Ratio of fasting human insulin Geometric Coefficient of Variation 71.7	0.38 Ratio of fasting human insulin Geometric Coefficient of Variation 77.6	1.04 Ratio of fasting human insulin Geometric Coefficient of Variation 53.3

SECONDARY outcome

Timeframe: Week 0, week 26

Population: FAS included all randomised participants. Overall number of particiapants analysed = number of participants with available data.

Change in fasting glucagon (measured in picograms per milliliter \[pg/mL\]) from baseline (week 0) to week 26 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=338 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=165 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=150 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Fasting Glucagon - Ratio to Baseline	0.90 Ratio of fasting glucagon Geometric Coefficient of Variation 76.6	0.95 Ratio of fasting glucagon Geometric Coefficient of Variation 56.4	0.98 Ratio of fasting glucagon Geometric Coefficient of Variation 75.9

SECONDARY outcome

Timeframe: Week 0, week 26

Population: FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.

Change in HOMA-B (measured in %) from baseline (week 0) to week 26 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=328 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=162 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=141 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in HOMA-B (Beta Cell Function)- Ratio to Baseline	1.38 Ratio of HOMA-B (beta cell function) Geometric Coefficient of Variation 77.3	0.94 Ratio of HOMA-B (beta cell function) Geometric Coefficient of Variation 77.4	1.53 Ratio of HOMA-B (beta cell function) Geometric Coefficient of Variation 63.8

SECONDARY outcome

Timeframe: Week 0, week 26

Population: FAS included all randomised participants. Overall number of participants analysed = number of participants with available data

Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=341 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=151 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Fasting Total Cholesterol - Ratio to Baseline	0.94 Ratio of fasting total cholesterol Geometric Coefficient of Variation 19.1	0.99 Ratio of fasting total cholesterol Geometric Coefficient of Variation 16.8	0.97 Ratio of fasting total cholesterol Geometric Coefficient of Variation 17.7

SECONDARY outcome

Timeframe: Week 0, week 26

Population: FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.

Change in fasting HDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=341 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=151 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Fasting High Density Lipoprotein (HDL) Cholesterol- Ratio to Baseline	1.01 Ratio of fasting HDL cholesterol Geometric Coefficient of Variation 14.7	1.02 Ratio of fasting HDL cholesterol Geometric Coefficient of Variation 15.7	1.03 Ratio of fasting HDL cholesterol Geometric Coefficient of Variation 14.8

SECONDARY outcome

Timeframe: Week 0, week 26

Population: FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.

Change in fasting LDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=340 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=151 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Fasting Low Density Lipoprotein (LDL) Cholesterol- Ratio to Baseline	0.92 Ratio of fasting LDL cholesterol Geometric Coefficient of Variation 34.2	1.01 Ratio of fasting LDL cholesterol Geometric Coefficient of Variation 36.2	0.96 Ratio of fasting LDL cholesterol Geometric Coefficient of Variation 34.4

SECONDARY outcome

Timeframe: Week 0, week 26

Population: FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.

Change in fasting VLDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=341 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=151 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline	0.90 Ratio of fasting VLDL cholesterol Geometric Coefficient of Variation 49.9	0.84 Ratio of fasting VLDL cholesterol Geometric Coefficient of Variation 47.2	0.92 Ratio of fasting VLDL cholesterol Geometric Coefficient of Variation 38.6

SECONDARY outcome

Timeframe: Week 0, week 26

Population: FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.

Change in fasting triglycerides (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=341 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=151 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Fasting Triglycerides - Ratio to Baseline.	0.88 Ratio of fasting triglycerides Geometric Coefficient of Variation 54.4	0.82 Ratio of fasting triglycerides Geometric Coefficient of Variation 50.5	0.90 Ratio of fasting triglycerides Geometric Coefficient of Variation 45.2

SECONDARY outcome

Timeframe: Week 0, week 26

Population: FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.

Change in fasting free fatty acid (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=340 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=150 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Fasting Free Fatty Acid - Ratio to Baseline	0.55 Ratio of fasting free fatty acid Geometric Coefficient of Variation 69.9	0.48 Ratio of fasting free fatty acid Geometric Coefficient of Variation 76.5	0.80 Ratio of fasting free fatty acid Geometric Coefficient of Variation 69.3

SECONDARY outcome

Timeframe: Weeks 0-26

Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Number of participants analysed = number of participants with available data.

A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. The observed rates of adverse events (AEs) per patient years of exposure (PYE) (number of AEs divided by PYE multiplied by 100) after 26 weeks are presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=267 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=117 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=143 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Number of Treatment-emergent Adverse Events (TEAE)	410.82 (Number of AEs/PYE)*100	306.19 (Number of AEs/PYE)*100	541.00 (Number of AEs/PYE)*100

SECONDARY outcome

Timeframe: Weeks 0-26

Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.

Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as nocturnal if the time of the onset was between 00:01 and 05.59 both inclusive. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=6 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=4 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Number of Treatment Emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes.	4.45 (Number of episodes/PYE)*100	4.54 (Number of episodes/PYE)*100	—

SECONDARY outcome

Timeframe: Weeks 0-26

Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.

Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=20 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=8 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=1 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes.	15.03 (Number of episodes/PYE)*100	9.07 (Number of episodes/PYE)*100	1.20 (Number of episodes/PYE)*100

SECONDARY outcome

Timeframe: Weeks 0-26

Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.

Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as nocturnal if the time of the onset was between 00:01 and 05.59 both inclusive. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=5 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=3 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes	2.78 (Number of episodes/PYE)*100	3.40 (Number of episodes/PYE)*100	—

SECONDARY outcome

Timeframe: Weeks 0-26

Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.

A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. The number of episodes are represented as rates. The observed rates of episodes (according to the ADA definition) per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=236 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=123 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=19 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition	668.55 (Number of episodes/PYE)*100	746.20 (Number of episodes/PYE)*100	37.19 (Number of episodes/PYE)*100

SECONDARY outcome

Timeframe: Week -2, week 26

Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analyzed=participants with available data

Physical examination parameters are categorised as cardiovascular system; central and peripheral nervous system; gastrointestinal system including mouth; general appearance; head, ears, eyes, nose, throat, neck; lymph node palpation; musculoskeletal system; respiratory system; skin and thyroid gland. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at screening (week -2) and week 26 per each category is presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=358 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=175 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=180 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Physical Examination Week -2: Cardiovascular system · Normal	353 Participants	173 Participants	180 Participants
Change in Physical Examination Week -2: Cardiovascular system · Abnormal, NCS	2 Participants	2 Participants	0 Participants
Change in Physical Examination Week -2: Cardiovascular system · Abnormal CS	3 Participants	0 Participants	0 Participants
Change in Physical Examination Week 26: Cardiovascular system · Normal	336 Participants	166 Participants	151 Participants
Change in Physical Examination Week 26: Cardiovascular system · Abnormal, NCS	3 Participants	1 Participants	0 Participants
Change in Physical Examination Week 26: Cardiovascular system · Abnormal CS	2 Participants	0 Participants	0 Participants
Change in Physical Examination Week -2: Central and peripheral nervous system · Normal	355 Participants	172 Participants	179 Participants
Change in Physical Examination Week -2: Central and peripheral nervous system · Abnormal, NCS	1 Participants	0 Participants	0 Participants
Change in Physical Examination Week -2: Central and peripheral nervous system · Abnormal CS	2 Participants	3 Participants	1 Participants
Change in Physical Examination Week 26: Central and peripheral nervous system · Normal	338 Participants	164 Participants	150 Participants
Change in Physical Examination Week 26: Central and peripheral nervous system · Abnormal, NCS	1 Participants	0 Participants	0 Participants
Change in Physical Examination Week 26: Central and peripheral nervous system · Abnormal CS	2 Participants	3 Participants	1 Participants
Change in Physical Examination Week -2: Gastrointestinal system including mouth · Normal	355 Participants	174 Participants	179 Participants
Change in Physical Examination Week -2: Gastrointestinal system including mouth · Abnormal, NCS	3 Participants	1 Participants	1 Participants
Change in Physical Examination Week -2: Gastrointestinal system including mouth · Abnormal CS	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 26: Gastrointestinal system including mouth · Normal	339 Participants	166 Participants	150 Participants
Change in Physical Examination Week 26: Gastrointestinal system including mouth · Abnormal, NCS	2 Participants	1 Participants	1 Participants
Change in Physical Examination Week 26: Gastrointestinal system including mouth · Abnormal CS	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week -2: General appearance · Normal	351 Participants	169 Participants	177 Participants
Change in Physical Examination Week -2: General appearance · Abnormal, NCS	3 Participants	2 Participants	1 Participants
Change in Physical Examination Week -2: General appearance · Abnormal CS	4 Participants	4 Participants	2 Participants
Change in Physical Examination Week 26: General appearance · Normal	336 Participants	161 Participants	150 Participants
Change in Physical Examination Week 26: General appearance · Abnormal, NCS	2 Participants	2 Participants	0 Participants
Change in Physical Examination Week 26: General appearance · Abnormal CS	3 Participants	4 Participants	1 Participants
Change in Physical Examination Week -2: Head, ears, eyes, nose, throat, neck · Normal	348 Participants	170 Participants	175 Participants
Change in Physical Examination Week -2: Head, ears, eyes, nose, throat, neck · Abnormal, NCS	6 Participants	4 Participants	3 Participants
Change in Physical Examination Week -2: Head, ears, eyes, nose, throat, neck · Abnormal CS	4 Participants	1 Participants	2 Participants
Change in Physical Examination Week 26: Head, ears, eyes, nose, throat, neck · Normal	332 Participants	164 Participants	150 Participants
Change in Physical Examination Week 26: Head, ears, eyes, nose, throat, neck · Abnormal, NCS	6 Participants	3 Participants	1 Participants
Change in Physical Examination Week 26: Head, ears, eyes, nose, throat, neck · Abnormal CS	3 Participants	0 Participants	0 Participants
Change in Physical Examination Week -2: Lymph node palpation · Normal	357 Participants	174 Participants	180 Participants
Change in Physical Examination Week -2: Lymph node palpation · Abnormal, NCS	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week -2: Lymph node palpation · Abnormal CS	1 Participants	1 Participants	0 Participants
Change in Physical Examination Week 26: Lymph node palpation · Normal	340 Participants	166 Participants	151 Participants
Change in Physical Examination Week 26: Lymph node palpation · Abnormal, NCS	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 26: Lymph node palpation · Abnormal CS	1 Participants	1 Participants	0 Participants
Change in Physical Examination Week -2: Musculoskeletal system · Normal	353 Participants	172 Participants	177 Participants
Change in Physical Examination Week -2: Musculoskeletal system · Abnormal, NCS	2 Participants	2 Participants	0 Participants
Change in Physical Examination Week -2: Musculoskeletal system · Abnormal CS	3 Participants	1 Participants	3 Participants
Change in Physical Examination Week 26: Musculoskeletal system · Normal	332 Participants	165 Participants	149 Participants
Change in Physical Examination Week 26: Musculoskeletal system · Abnormal, NCS	2 Participants	1 Participants	0 Participants
Change in Physical Examination Week 26: Musculoskeletal system · Abnormal CS	7 Participants	1 Participants	2 Participants
Change in Physical Examination Week-2: Respiratory system · Normal	358 Participants	175 Participants	180 Participants
Change in Physical Examination Week-2: Respiratory system · Abnormal, NCS	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week-2: Respiratory system · Abnormal CS	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 26: Respiratory system · Normal	341 Participants	167 Participants	151 Participants
Change in Physical Examination Week 26: Respiratory system · Abnormal, NCS	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 26: Respiratory system · Abnormal CS	0 Participants	0 Participants	0 Participants
Change in Physical Examination week -2: Skin · Normal	312 Participants	152 Participants	156 Participants
Change in Physical Examination week -2: Skin · Abnormal, NCS	37 Participants	20 Participants	20 Participants
Change in Physical Examination week -2: Skin · Abnormal CS	9 Participants	3 Participants	4 Participants
Change in Physical Examination Week 26: Skin · Normal	297 Participants	146 Participants	134 Participants
Change in Physical Examination Week 26: Skin · Abnormal, NCS	36 Participants	19 Participants	15 Participants
Change in Physical Examination Week 26: Skin · Abnormal CS	8 Participants	2 Participants	2 Participants
Change in Physical Examination Week -2: Thyroid gland · Normal	348 Participants	171 Participants	179 Participants
Change in Physical Examination Week -2: Thyroid gland · Abnormal, NCS	5 Participants	1 Participants	1 Participants
Change in Physical Examination Week -2: Thyroid gland · Abnormal CS	5 Participants	3 Participants	0 Participants
Change in Physical Examination Week 26: Thyroid gland · Normal	334 Participants	163 Participants	151 Participants
Change in Physical Examination Week 26: Thyroid gland · Abnormal, NCS	3 Participants	2 Participants	0 Participants
Change in Physical Examination Week 26: Thyroid gland · Abnormal CS	4 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Week -2, Week 26

Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analyzed = participants with available data.

Dilated fundoscopy or fundus photography was performed by the investigator at screening (week -2) and week 26. The results of the examination were interpreted for each eye (left and right) and are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at screening (week -2) and week 26 is presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=358 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=175 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=180 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Eye Examination Week -2: Left eye · Normal	222 Participants	109 Participants	110 Participants
Eye Examination Week 26: Right eye · Abnormal, NCS	40 Participants	23 Participants	15 Participants
Eye Examination Week 26: Right eye · Abnormal, CS	84 Participants	41 Participants	40 Participants
Eye Examination Week -2: Left eye · Abnormal, NCS	45 Participants	14 Participants	20 Participants
Eye Examination Week -2: Left eye · Abnormal, CS	91 Participants	52 Participants	50 Participants
Eye Examination Week 26: Left eye · Normal	217 Participants	99 Participants	100 Participants
Eye Examination Week 26: Left eye · Abnormal, NCS	39 Participants	20 Participants	13 Participants
Eye Examination Week 26: Left eye · Abnormal, CS	85 Participants	48 Participants	38 Participants
Eye Examination Week -2: Right eye · Normal	230 Participants	112 Participants	111 Participants
Eye Examination Week -2: Right eye · Abnormal, NCS	42 Participants	16 Participants	22 Participants
Eye Examination Week -2: Right eye · Abnormal, CS	86 Participants	47 Participants	47 Participants
Eye Examination Week 26: Right eye · Normal	217 Participants	103 Participants	96 Participants

SECONDARY outcome

Timeframe: Week -2, week 26

Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Number of participants analyzed = participants with available data.

Electrocardiogram was assessed by the investigator as normal, abnormal NCS and abnormal CS. Number of participants at screening (week -2) and at week 26 is presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=358 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=175 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=180 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Electrocardiogram (ECG) Week -2 · Normal	223 Participants	109 Participants	108 Participants
Change in Electrocardiogram (ECG) Week -2 · Abnormal, NCS	94 Participants	46 Participants	52 Participants
Change in Electrocardiogram (ECG) Week -2 · Abnormal CS	41 Participants	20 Participants	20 Participants
Change in Electrocardiogram (ECG) Week 26 · Normal	227 Participants	108 Participants	87 Participants
Change in Electrocardiogram (ECG) Week 26 · Abnormal, NCS	76 Participants	47 Participants	40 Participants
Change in Electrocardiogram (ECG) Week 26 · Abnormal CS	38 Participants	12 Participants	24 Participants

SECONDARY outcome

Timeframe: Week 0, week 26

Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.

Change in pulse from baseline (week 0) after 26 weeks of treatment is presented

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=341 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=151 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Pulse	4.6 Beats per minuts (beats/min) Standard Deviation 8.6	-0.1 Beats per minuts (beats/min) Standard Deviation 8.6	4.9 Beats per minuts (beats/min) Standard Deviation 9.7

SECONDARY outcome

Timeframe: Week 0, week 26

Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.

Change in blood pressure (systolic and diastolic blood pressure) from baseline (week 0) after 26 weeks of treatment is presented

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=341 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=151 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Blood Pressure (Systolic and Diastolic Blood Pressure) Systolic blood pressure	-3.5 Millimeters of mercury (mmHg) Standard Deviation 12.7	-1.2 Millimeters of mercury (mmHg) Standard Deviation 11.7	-3.3 Millimeters of mercury (mmHg) Standard Deviation 13.8
Change in Blood Pressure (Systolic and Diastolic Blood Pressure) Distolic blood pressure	-0.4 Millimeters of mercury (mmHg) Standard Deviation 8.3	-0.7 Millimeters of mercury (mmHg) Standard Deviation 8.1	0.0 Millimeters of mercury (mmHg) Standard Deviation 8.4

SECONDARY outcome

Timeframe: Week 0, week 26

Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.

Change in alkaline phosphatase, ALT, AST, creatine kinase, amylase, lipase, creatine kinase serum from baseline (week 0) after 26 weeks of treatment is presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=341 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=151 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum Alkaline phosphatase	-2.0 Units per liter (U/L) Standard Deviation 14.85	-2.29 Units per liter (U/L) Standard Deviation 11.49	-0.48 Units per liter (U/L) Standard Deviation 14.11
Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum ALT	-4.63 Units per liter (U/L) Standard Deviation 13.06	-6.17 Units per liter (U/L) Standard Deviation 13.54	-2.81 Units per liter (U/L) Standard Deviation 16.97
Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum AST	-1.31 Units per liter (U/L) Standard Deviation 7.94	-2.65 Units per liter (U/L) Standard Deviation 8.40	-0.99 Units per liter (U/L) Standard Deviation 9.64
Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum Creatine kinase	10.67 Units per liter (U/L) Standard Deviation 100.87	15.37 Units per liter (U/L) Standard Deviation 52.99	0.52 Units per liter (U/L) Standard Deviation 56.20
Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum Amylase	9.84 Units per liter (U/L) Standard Deviation 36.73	5.09 Units per liter (U/L) Standard Deviation 14.68	5.68 Units per liter (U/L) Standard Deviation 13.70
Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum Lipase	16.13 Units per liter (U/L) Standard Deviation 101.19	-1.87 Units per liter (U/L) Standard Deviation 15.64	14.11 Units per liter (U/L) Standard Deviation 19.76

SECONDARY outcome

Timeframe: Week 0, week 26

Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.

Change in total protein, albumin serum from baseline (week 0) after 26 weeks of treatment is presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=341 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=151 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Biochemistry Parameters (Albumin Serum, Total Protein) Albumin serum	-0.05 grams per decileter (g/dL) Standard Deviation 0.28	-0.09 grams per decileter (g/dL) Standard Deviation 0.26	0.04 grams per decileter (g/dL) Standard Deviation 0.26
Change in Biochemistry Parameters (Albumin Serum, Total Protein) Total protein	-0.08 grams per decileter (g/dL) Standard Deviation 0.42	-0.08 grams per decileter (g/dL) Standard Deviation 0.39	-0.01 grams per decileter (g/dL) Standard Deviation 0.39

SECONDARY outcome

Timeframe: Week 0, week 26

Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.

Change in calcium serum (total), calcium corrected serum, potassium serum, sodium serum, urea serum from baseline (week 0) after 26 weeks of treatment is presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=341 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=151 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum Calcium serum (total)	-0.01 mmol/L Standard Deviation 0.10	-0.02 mmol/L Standard Deviation 0.10	-0.00 mmol/L Standard Deviation 0.09
Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum Calcium corrected serum	-0.00 mmol/L Standard Deviation 0.08	-0.00 mmol/L Standard Deviation 0.08	-0.01 mmol/L Standard Deviation 0.07
Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum Sodium serum	1.21 mmol/L Standard Deviation 2.09	0.98 mmol/L Standard Deviation 2.37	0.32 mmol/L Standard Deviation 2.12
Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum Urea serum	0.05 mmol/L Standard Deviation 0.57	0.03 mmol/L Standard Deviation 0.53	0.16 mmol/L Standard Deviation 0.67
Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum Potassium serum	-0.04 mmol/L Standard Deviation 0.34	-0.09 mmol/L Standard Deviation 0.39	-0.04 mmol/L Standard Deviation 0.34

SECONDARY outcome

Timeframe: Week 0, week 26

Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.

Change in total bilirubin serum, creatinine serum from baseline (week 0) after 26 weeks of treatment is presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=341 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=151 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Biochemistry Parameters: Total Bilirubin Serum, Creatinine Serum Total bilirubin	-0.78 micromoles per liter (umol/L) Standard Deviation 3.35	-0.55 micromoles per liter (umol/L) Standard Deviation 4.52	-1.16 micromoles per liter (umol/L) Standard Deviation 3.92
Change in Biochemistry Parameters: Total Bilirubin Serum, Creatinine Serum creatinine serum	1.02 micromoles per liter (umol/L) Standard Deviation 8.41	1.36 micromoles per liter (umol/L) Standard Deviation 7.92	-0.60 micromoles per liter (umol/L) Standard Deviation 7.89

SECONDARY outcome

Timeframe: Week 0, week 26

Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.

Change in erythrocyte blood from baseline (week 0) after 26 weeks of treatment is presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=341 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=150 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Haematological Parameter: Erythrocytes Blood	-0.05 10^12 cells per liter (10^12/L) Standard Deviation 0.27	-0.00 10^12 cells per liter (10^12/L) Standard Deviation 0.27	-0.05 10^12 cells per liter (10^12/L) Standard Deviation 0.25

SECONDARY outcome

Timeframe: Week 0, week 26

Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.

Change in haematocrits from baseline (week 0) after 26 weeks of treatment is presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=341 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=150 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Haematological Parameter: Haematocrits	-0.56 Percentage points (%) of red blood cells Standard Deviation 2.65	-0.49 Percentage points (%) of red blood cells Standard Deviation 2.69	-0.42 Percentage points (%) of red blood cells Standard Deviation 2.57

SECONDARY outcome

Timeframe: Week 0, week 26

Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data

Change in eosinophils from baseline after 26 weeks of treatment is presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=341 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=150 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Haemotological Parameter- Eosinophils	-0.06 % of eosinophils Standard Deviation 1.90	0.19 % of eosinophils Standard Deviation 1.73	0.11 % of eosinophils Standard Deviation 1.94

SECONDARY outcome

Timeframe: Week 0, week 26

Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data

Change in neutrophils from baseline (week 0) after 26 weeks of treatment is presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=341 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=150 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Haematological Parameter - Neutrophils	0.57 % of neutrophils Standard Deviation 6.46	0.18 % of neutrophils Standard Deviation 7.70	-0.53 % of neutrophils Standard Deviation 7.05

SECONDARY outcome

Timeframe: Week 0, week 26

Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.

Change in basophils from baseline (week 0) after 26 weeks of treatment is presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=341 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=150 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Haematological Parameter: Basophils	-0.02 % of basophils Standard Deviation 0.29	-0.01 % of basophils Standard Deviation 0.28	-0.03 % of basophils Standard Deviation 0.26

SECONDARY outcome

Timeframe: Week 0, week 26

Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.

Change in monocytes from baseline (week 0) after 26 weeks of treatment is presented

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=341 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=150 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Haemotological Parameter- Monocytes	-0.03 % of monocytes Standard Deviation 1.92	0.01 % of monocytes Standard Deviation 1.85	0.05 % of monocytes Standard Deviation 2.13

SECONDARY outcome

Timeframe: Week 0, week 26

Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.

Change in lymphocytes from baseline (week 0) after 26 weeks of treatment is presented

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=341 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=150 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Haematological Parameter - Lymphocytes	-0.46 % of lymphocytes Standard Deviation 6.04	-0.38 % of lymphocytes Standard Deviation 7.12	0.40 % of lymphocytes Standard Deviation 6.11

SECONDARY outcome

Timeframe: Week 0, week 26

Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.

Change in haemoglobin from baseline (week 0) after 26 weeks of treatment is presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=341 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=150 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Haematology: Haemoglobin Blood	-0.10 mmol/L Standard Deviation 0.53	-0.06 mmol/L Standard Deviation 0.48	-0.05 mmol/L Standard Deviation 0.47

SECONDARY outcome

Timeframe: Week 0, week 26

Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.

Change in leukocytes from baseline (week 0) after 26 weeks of treatment

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=341 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=150 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Haematologcal Parameter: Leukocytes	0.25 10^9 cells per liter (10^9/L) Standard Deviation 1.18	0.23 10^9 cells per liter (10^9/L) Standard Deviation 1.41	-0.01 10^9 cells per liter (10^9/L) Standard Deviation 1.14

SECONDARY outcome

Timeframe: Week 0, week 26

Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.

Change in thrombocytes from baseline (week 0) after 26 weeks of treatment

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=340 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=167 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=149 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Haematological Parameter: Thrombocytes	8.19 10^9 cells per liter (10^9/L) Standard Deviation 28.02	8.32 10^9 cells per liter (10^9/L) Standard Deviation 34.48	4.32 10^9 cells per liter (10^9/L) Standard Deviation 33.39

SECONDARY outcome

Timeframe: Week 0, week 26

Population: SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Number analysed = number of participants with available data.

Calcitonin levels were measured and were categorised as low, normal or high in relation to reference range (8.31- 14.3 picogram/milliliter \[pg/mL\]). Number of participants in each category at baseline (week 0) and week 26 are presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=358 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=175 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=180 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Change in Calcitonin Week 26 · Low	0 Participants	0 Participants	0 Participants
Change in Calcitonin Week 0 · Low	0 Participants	0 Participants	0 Participants
Change in Calcitonin Week 0 · Normal	351 Participants	172 Participants	178 Participants
Change in Calcitonin Week 0 · High	7 Participants	3 Participants	2 Participants
Change in Calcitonin Week 26 · Normal	334 Participants	165 Participants	147 Participants
Change in Calcitonin Week 26 · High	6 Participants	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Week 0, week 26

Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Number of participants analysed = number of participants with available data.

The urinalysis assessment was the measurements of protein, glucose, erythrocytes and ketones in urine at baseline (week 0) and week 26 and categorised as negative, trace and positive. Number of participants in each category at week 0 and week 26 is presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=357 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=175 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=180 Participants Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Urinalysis (Protein, Glucose, Erythrocytes and Ketones) Week 26: Protein · Trace	58 Participants	26 Participants	28 Participants
Urinalysis (Protein, Glucose, Erythrocytes and Ketones) Week 26: Protein · Positive	27 Participants	21 Participants	18 Participants
Urinalysis (Protein, Glucose, Erythrocytes and Ketones) Week 26: Glucose · Trace	11 Participants	3 Participants	5 Participants
Urinalysis (Protein, Glucose, Erythrocytes and Ketones) Week 26: Glucose · Positive	6 Participants	7 Participants	15 Participants
Urinalysis (Protein, Glucose, Erythrocytes and Ketones) Week 0: Ketones · Negative	325 Participants	152 Participants	167 Participants
Urinalysis (Protein, Glucose, Erythrocytes and Ketones) Week 0: Ketones · Trace	25 Participants	20 Participants	11 Participants
Urinalysis (Protein, Glucose, Erythrocytes and Ketones) Week 0: Ketones · Positive	7 Participants	3 Participants	2 Participants
Urinalysis (Protein, Glucose, Erythrocytes and Ketones) Week 26: Ketones · Negative	334 Participants	163 Participants	141 Participants
Urinalysis (Protein, Glucose, Erythrocytes and Ketones) Week 26: Ketones · Trace	4 Participants	3 Participants	10 Participants
Urinalysis (Protein, Glucose, Erythrocytes and Ketones) Week 26: Ketones · Positive	1 Participants	1 Participants	0 Participants
Urinalysis (Protein, Glucose, Erythrocytes and Ketones) Week 0: Protein · Negative	216 Participants	104 Participants	116 Participants
Urinalysis (Protein, Glucose, Erythrocytes and Ketones) Week 0: Protein · Trace	86 Participants	40 Participants	37 Participants
Urinalysis (Protein, Glucose, Erythrocytes and Ketones) Week 0: Protein · Positive	55 Participants	31 Participants	27 Participants
Urinalysis (Protein, Glucose, Erythrocytes and Ketones) Week 26: Protein · Negative	254 Participants	120 Participants	105 Participants
Urinalysis (Protein, Glucose, Erythrocytes and Ketones) Week 0: Erythrocytes · Negative	299 Participants	153 Participants	156 Participants
Urinalysis (Protein, Glucose, Erythrocytes and Ketones) Week 0: Erythrocytes · Trace	36 Participants	16 Participants	16 Participants
Urinalysis (Protein, Glucose, Erythrocytes and Ketones) Week 0: Erythrocytes · Positive	22 Participants	6 Participants	8 Participants
Urinalysis (Protein, Glucose, Erythrocytes and Ketones) Week 26: Erythrocytes · Negative	297 Participants	146 Participants	136 Participants
Urinalysis (Protein, Glucose, Erythrocytes and Ketones) Week 26: Erythrocytes · Trace	28 Participants	16 Participants	11 Participants
Urinalysis (Protein, Glucose, Erythrocytes and Ketones) Week 26: Erythrocytes · Positive	14 Participants	5 Participants	4 Participants
Urinalysis (Protein, Glucose, Erythrocytes and Ketones) Week 0: Glucose · Negative	253 Participants	119 Participants	123 Participants
Urinalysis (Protein, Glucose, Erythrocytes and Ketones) Week 0: Glucose · Trace	35 Participants	19 Participants	18 Participants
Urinalysis (Protein, Glucose, Erythrocytes and Ketones) Week 0: Glucose · Positive	69 Participants	37 Participants	39 Participants
Urinalysis (Protein, Glucose, Erythrocytes and Ketones) Week 26: Glucose · Negative	322 Participants	157 Participants	131 Participants

SECONDARY outcome

Timeframe: Week 27

Population: SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.

This outcome measure is only applicable for the insulin degludec/liraglutide arm and insulin degludec arm. Serum samples were analysed for the presence of anti-insulin degludec specific antibodies. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T).

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=332 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=166 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Occurence of Anti-insulin Degludec Specific Antibodies	0.22 %B/T Standard Deviation 1.02	0.12 %B/T Standard Deviation 0.79	—

SECONDARY outcome

Timeframe: Week 27

Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide or insulin degludec. Overall number of participants analyzed = participants with available data.

This outcome measure is only applicable for the insulin degludec/liraglutide arm and insulin degludec arm. Serum samples were analysed for the presence of cross-reacting antibodies to human insulin. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T).

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=332 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=166 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Occurence of Antibodies Cross-reacting to Human Insulin	6.61 %B/T Standard Deviation 15.00	2.99 %B/T Standard Deviation 10.89	—

SECONDARY outcome

Timeframe: Week 27

Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide or insulin degludec. Overall number of participants analyzed = participants with available data.

This outcome measure is only applicable for the Insulin degludec/liraglutide arm and Insulin degludec arm. Serum samples were analysed for the presence of antobodies to human insulin. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T).

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=332 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=166 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Occurence of Total Insulin Antibodies	6.83 %B/T Standard Deviation 15.78	3.11 %B/T Standard Deviation 11.42	—

SECONDARY outcome

Timeframe: Week 27

Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide or insulin degludec. Overall number of participants analyzed = participants with available data.

This outcome measure is applicable for the Insulin degludec/liraglutide arm and the liraglutide arm. Serum samples were analysed for the presence of anti-liraglutide antibodies. Number of participants who were assessed for anti-liraglutide antibodies at week 27 are presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=332 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=160 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Occurence of Anti-liraglutide Antibodies Yes	45 Participants	40 Participants	—
Occurence of Anti-liraglutide Antibodies No	287 Participants	120 Participants	—

SECONDARY outcome

Timeframe: Week 27

Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide or insulin degludec. Overall number of participants analyzed = participants with available data.

This outcome measure is applicable to the Insulin degludec/liraglutide arm and the liraglutide arm. Serum samples were analysed for the presence of cross-reacting antibodies to native GLP-1. Number of participants who measured with anti-liraglutide antibodies cross reacting native GLP-1 at week 27 are presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=332 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=160 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Occurence of Antibodies Cross-reacting to Native Glucagon-like Peptide (GLP-1)	6 Participants	3 Participants	—

SECONDARY outcome

Timeframe: Week 27

Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analyzed = participants with available data.

This outcome measure is only applicable for the Insulin degludec/liraglutide arm and liraglutide arm. Neutralising antibodies were assessed when the corresponding anti-Liraglutide antibody were positive at week 27. Number of participants who measured with neutralising liraglutide antibodies at week 27 are presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=332 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=160 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Occurence of Neutralising Liraglutide Antibodies	9 Participants	8 Participants	—

SECONDARY outcome

Timeframe: Week 27

Population: SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analyzed = participants with available data.

This outcome measure is only applicable for the Insulin degludec/liraglutide arm and liraglutide arm. Cross reacting antibodies were assessed when anti-liraglutide antibody was positive. Number of participants who measured with neutralising liraglutide antibodies cross-reacting to native GLP-1 at week 27 are presented.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=332 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=160 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Occurence of Neutralising Antibodies Cross-reacting to Native GLP-1	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Week 0, week 26

Population: FAS included all randomised participants. Overall the number of participants analysed = number of participants with available data.

This outcome measure is applicable for Insulin degludec and Insulin degludec/liraglutide arms. Serum samples from the Insulin degludec/liraglutide and Insulin degludec arms were assayed using population PK analysis. The maximum serum concentrations (Cmax) are summarised for the two arms.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=339 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=168 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Serum Concentrations of Insulin Degludec	3583 pmol/L Geometric Coefficient of Variation 55.9	4133 pmol/L Geometric Coefficient of Variation 52.8	—

SECONDARY outcome

Timeframe: Week 0, week 26

Population: FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.

This outcome measure is for Insulin degludec/liraglutide and liraglutide arms. Serum samples from the Insulin degludec/liraglutide and liraglutide arms were assayed using population PK analysis. The Cmax are summarised for the two arms.

Outcome measures

Outcome measures
Measure	Insulin Degludec/Liraglutide n=339 Participants Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=165 Participants Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Plasma Concentration of Liraglutide	9963 pmol/L Geometric Coefficient of Variation 50.4	21602 pmol/L Geometric Coefficient of Variation 37	—

Adverse Events

Insulin Degludec/Liraglutide

Serious events: 14 serious events

Other events: 161 other events

Deaths: 0 deaths

Insulin Degludec

Serious events: 7 serious events

Other events: 55 other events

Deaths: 0 deaths

Liraglutide

Serious events: 14 serious events

Other events: 98 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Insulin Degludec/Liraglutide n=358 participants at risk Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.	Insulin Degludec n=175 participants at risk Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.	Liraglutide n=180 participants at risk Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."
Gastrointestinal disorders Abdominal discomfort	0.28% 1/358 • Number of events 1 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide	0.00% 0/175 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide	5.0% 9/180 • Number of events 9 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide
Metabolism and nutrition disorders Decreased appetite	3.6% 13/358 • Number of events 13 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide	1.1% 2/175 • Number of events 2 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide	14.4% 26/180 • Number of events 27 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide
Eye disorders Diabetic retinopathy	7.8% 28/358 • Number of events 28 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide	3.4% 6/175 • Number of events 6 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide	5.6% 10/180 • Number of events 10 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide
Gastrointestinal disorders Diarrhoea	6.4% 23/358 • Number of events 31 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide	1.7% 3/175 • Number of events 3 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide	14.4% 26/180 • Number of events 41 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide
Gastrointestinal disorders Gastrointestinal disorder	0.28% 1/358 • Number of events 1 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide	0.00% 0/175 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide	5.6% 10/180 • Number of events 11 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide
Metabolism and nutrition disorders Hyperlipidaemia	4.5% 16/358 • Number of events 16 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide	3.4% 6/175 • Number of events 6 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide	5.6% 10/180 • Number of events 11 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide
Investigations Lipase increased	7.5% 27/358 • Number of events 30 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide	2.9% 5/175 • Number of events 6 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide	12.2% 22/180 • Number of events 22 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide
Infections and infestations Nasopharyngitis	4.5% 16/358 • Number of events 20 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide	5.1% 9/175 • Number of events 11 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide	2.8% 5/180 • Number of events 7 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide
Gastrointestinal disorders Nausea	3.9% 14/358 • Number of events 25 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide	0.57% 1/175 • Number of events 1 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide	11.7% 21/180 • Number of events 23 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide
Infections and infestations Upper respiratory tract infection	18.4% 66/358 • Number of events 83 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide	17.7% 31/175 • Number of events 34 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide	10.0% 18/180 • Number of events 20 • Weeks 0-30 A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide

Additional Information

Clinical Reporting Anchor and Disclosure (1452)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: [email protected]

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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