Trial Outcomes & Findings for A Double-blinded Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec Both in Combination With Metformin in Japanese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal or Pre-mix/Combination Insulin Therapy and Oral Anti-diabetic Drugs (NCT NCT02911948)

NCT ID: NCT02911948

Last Updated: 2021-04-09

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 210 participants
• Primary outcome timeframe: week 0, week 26
• Results posted on: 2021-04-09

Participant Flow

The trial was conducted at 38 sites in Japan as follows: 38 sites screened and 37 sites randomised subjects.

Participant milestones

Measure	Insulin Degludec/Liraglutide Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Overall Study STARTED	105	105
Overall Study COMPLETED	105	98
Overall Study NOT COMPLETED	0	7

Reasons for withdrawal

Measure	Insulin Degludec/Liraglutide Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Overall Study Protocol Violation	0	1
Overall Study Withdrawal by Subject	0	2
Overall Study Lack of Efficacy	0	1
Overall Study Unclassified	0	3

Baseline Characteristics

A Double-blinded Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec Both in Combination With Metformin in Japanese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal or Pre-mix/Combination Insulin Therapy and Oral Anti-diabetic Drugs

Baseline characteristics by cohort

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Total n=210 Participants Total of all reporting groups
Age, Continuous	56.6 Years STANDARD_DEVIATION 10.4 • n=5 Participants	55.5 Years STANDARD_DEVIATION 10.0 • n=7 Participants	56.0 Years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	42 Participants n=7 Participants	77 Participants n=5 Participants
Sex: Female, Male Male	70 Participants n=5 Participants	63 Participants n=7 Participants	133 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	105 Participants n=5 Participants	105 Participants n=7 Participants	210 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	105 Participants n=5 Participants	105 Participants n=7 Participants	210 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Glycosylated Haemoglobin (HbA1c)	8.61 Percentage of HbA1c STANDARD_DEVIATION 0.88 • n=5 Participants	8.56 Percentage of HbA1c STANDARD_DEVIATION 0.80 • n=7 Participants	8.58 Percentage of HbA1c STANDARD_DEVIATION 0.84 • n=5 Participants

PRIMARY outcome

Timeframe: week 0, week 26

Population: Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.

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

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Change in Glycosylated Haemoglobin (HbA1c)	-1.95 Percentage of HbA1c Standard Deviation 1.01	-0.65 Percentage of HbA1c Standard Deviation 0.98

SECONDARY outcome

Timeframe: week 0, week 26

Population: Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.

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

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Change in Body Weight	-0.7 Kg Standard Deviation 3.5	0.7 Kg Standard Deviation 2.7

SECONDARY outcome

Timeframe: week 0, week 26

Population: Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.

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

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Change in Fasting Plasma Glucose (FPG)	-2.81 mmol/L Standard Deviation 3.17	-2.29 mmol/L Standard Deviation 2.68

SECONDARY outcome

Timeframe: During 26 weeks of treatment

Population: Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (210 subjects). Subjects in the safety set contributed to the evaluation "as treated".

Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.

Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.

Severe hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes	124 Number of episodes	109 Number of episodes

SECONDARY outcome

Timeframe: After 26 weeks

Population: Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.

Actual daily total insulin dose after 26 weeks.

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Daily Insulin Dose	37.6 Units Standard Deviation 11.4	41.2 Units Standard Deviation 11.5

SECONDARY outcome

Timeframe: After 26 weeks

Population: Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.

Number of subjects with HbA1c less than 7.0% after 26 weeks.

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Responder (Yes/no): HbA1c Less Than 7.0% Yes	75 Participants	23 Participants
Responder (Yes/no): HbA1c Less Than 7.0% No	30 Participants	82 Participants

SECONDARY outcome

Timeframe: After 26 weeks

Population: Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.

Number of subjects with HbA1c less than 7.0% and without weight gain after 26 weeks.

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Responder (Yes/no): HbA1c Less Than 7.0% and Without Weight Gain Yes	50 Participants	9 Participants
Responder (Yes/no): HbA1c Less Than 7.0% and Without Weight Gain No	55 Participants	96 Participants

SECONDARY outcome

Timeframe: After 26 weeks

Population: Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.

Number of subjects with HbA1c less than 7.0% after 26 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.

Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.

Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=101 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Responder (Yes/no): HbA1c Less Than 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment Yes	70 Participants	20 Participants
Responder (Yes/no): HbA1c Less Than 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment No	35 Participants	81 Participants

SECONDARY outcome

Timeframe: After 26 weeks

Population: Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.

Number of subjects with HbA1c less than 7.0% and no weight gain after 26 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.

Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.

Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=101 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Responder (Yes/no): HbA1c Less Than 7.0% and Without Weight Gain and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment Yes	49 Participants	7 Participants
Responder (Yes/no): HbA1c Less Than 7.0% and Without Weight Gain and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment No	56 Participants	94 Participants

SECONDARY outcome

Timeframe: After 26 weeks

Population: Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.

Number of subjects with HbA1c less than or equal to 6.5% after 26 weeks.

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Responder (Yes/no): HbA1c Less Than or Equal to 6.5% Yes	57 Participants	9 Participants
Responder (Yes/no): HbA1c Less Than or Equal to 6.5% No	48 Participants	96 Participants

SECONDARY outcome

Timeframe: After 26 weeks

Population: Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.

Number of subjects with HbA1c less than or equal to 6.5% and without weight gain

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Responder (Yes/no): HbA1c Less Than or Equal to 6.5% and Without Weight Gain Yes	38 Participants	4 Participants
Responder (Yes/no): HbA1c Less Than or Equal to 6.5% and Without Weight Gain No	67 Participants	101 Participants

SECONDARY outcome

Timeframe: After 26 weeks

Population: Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.

Number of subjects with HbA1c less than or equal to 6.5% after 26 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.

Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.

Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=101 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Responder (Yes/no): HbA1c Less Than or Equal to 6.5% Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment Yes	53 Participants	8 Participants
Responder (Yes/no): HbA1c Less Than or Equal to 6.5% Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment No	52 Participants	93 Participants

SECONDARY outcome

Timeframe: After 26 weeks

Population: Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.

Number of subjects with HbA1c less than or equal to 6.5% and no weight gain after 26 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.

Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.

Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=101 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Responder (Yes/no): HbA1c Less Than or Equal to 6.5% and Without Weight Gain and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment Yes	37 Participants	3 Participants
Responder (Yes/no): HbA1c Less Than or Equal to 6.5% and Without Weight Gain and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment No	68 Participants	98 Participants

SECONDARY outcome

Timeframe: week 0, week 26

Population: Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.

Change from baseline (week 0) in waist circumference after 26 weeks of treatment.

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Change in Waist Circumference	-0.6 cm Standard Deviation 3.8	0.1 cm Standard Deviation 3.8

SECONDARY outcome

Timeframe: week 0, week 26

Population: Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.

Change from baseline in blood pressure (systolic and diastolic) after 26 weeks of treatment.

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Change in Blood Pressure (Systolic and Diastolic) Systolic blood pressure	-0.6 mmHg Standard Deviation 14.7	0.9 mmHg Standard Deviation 13.6
Change in Blood Pressure (Systolic and Diastolic) Diastolic blood pressure	0.9 mmHg Standard Deviation 9.0	1.2 mmHg Standard Deviation 9.0

SECONDARY outcome

Timeframe: After 26 weeks

Population: Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.

Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day.

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Self-measured Blood Glucose (SMBG) 9-point Profile (Individual Points in the Profile) Before breakfast	6.59 mmol/L Standard Deviation 2.32	6.53 mmol/L Standard Deviation 2.19
Self-measured Blood Glucose (SMBG) 9-point Profile (Individual Points in the Profile) 90 minutes after start of breakfast	11.00 mmol/L Standard Deviation 3.67	12.02 mmol/L Standard Deviation 3.57
Self-measured Blood Glucose (SMBG) 9-point Profile (Individual Points in the Profile) Before lunch	7.22 mmol/L Standard Deviation 2.96	8.49 mmol/L Standard Deviation 3.75
Self-measured Blood Glucose (SMBG) 9-point Profile (Individual Points in the Profile) 90 minutes after start of lunch	10.59 mmol/L Standard Deviation 3.17	12.84 mmol/L Standard Deviation 3.65
Self-measured Blood Glucose (SMBG) 9-point Profile (Individual Points in the Profile) Before dinner	7.39 mmol/L Standard Deviation 2.56	8.60 mmol/L Standard Deviation 3.97
Self-measured Blood Glucose (SMBG) 9-point Profile (Individual Points in the Profile) 90 minutes after start of dinner	11.09 mmol/L Standard Deviation 3.24	13.27 mmol/L Standard Deviation 4.05
Self-measured Blood Glucose (SMBG) 9-point Profile (Individual Points in the Profile) At Bedtime	9.57 mmol/L Standard Deviation 3.54	11.98 mmol/L Standard Deviation 4.17
Self-measured Blood Glucose (SMBG) 9-point Profile (Individual Points in the Profile) At 4:00 a.m.	6.75 mmol/L Standard Deviation 1.98	7.72 mmol/L Standard Deviation 2.90
Self-measured Blood Glucose (SMBG) 9-point Profile (Individual Points in the Profile) Before breakfast the following day	6.14 mmol/L Standard Deviation 1.68	6.40 mmol/L Standard Deviation 2.06

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.

Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day. Mean of the 9-point profile was defined as the area under the profile (calculated using the trapezoidal method) divided by the measurement time.

Outcome measures

Measure	Insulin Degludec/Liraglutide n=104 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Change in SMBG 9-point Profile: Mean of the 9-point Profile	-2.90 mmol/L Standard Deviation 2.87	-1.11 mmol/L Standard Deviation 2.68

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.

Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day. The mean increment over all meals was derived as the mean of all available meal increments.

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Change in SMBG 9-point Profile: Mean of Postprandial Plasma Glucose Increments (From Before Meal to 90 Minutes After Breakfast, Lunch and Dinner)	-0.76 mmol/L Standard Deviation 3.00	0.70 mmol/L Standard Deviation 2.93

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method. Number analyzed = subjects with available data.

Lipid profile includes total cholesterol, low density lipoprotein cholesterol (LDL cholesterol), high density lipoprotein cholesterol (HDL cholesterol), very low density lipoprotein cholesterol (VLDL cholesterol), triglycerides and free fatty acids. Lipid profile parameters are represented as ratio to baseline values.

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Fasting Lipid Profile Total cholesterol	0.90 Ratio Geometric Coefficient of Variation 15.9	0.96 Ratio Geometric Coefficient of Variation 13.0
Fasting Lipid Profile HDL cholesterol	0.90 Ratio Geometric Coefficient of Variation 17.5	0.95 Ratio Geometric Coefficient of Variation 12.2
Fasting Lipid Profile LDL cholesterol	0.86 Ratio Geometric Coefficient of Variation 26.7	0.95 Ratio Geometric Coefficient of Variation 21.5
Fasting Lipid Profile VLDL cholesterol	1.02 Ratio Geometric Coefficient of Variation 50.5	0.97 Ratio Geometric Coefficient of Variation 38.2
Fasting Lipid Profile Triglycerides	1.02 Ratio Geometric Coefficient of Variation 58.5	0.97 Ratio Geometric Coefficient of Variation 39.3
Fasting Lipid Profile Free fatty acids	0.86 Ratio Geometric Coefficient of Variation 67.7	0.77 Ratio Geometric Coefficient of Variation 55.3

SECONDARY outcome

Timeframe: During 26 weeks of treatment

Population: Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (210 subjects). Subjects in the safety set contributed to the evaluation "as treated".

Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Number of Treatment Emergent Adverse Events (TEAE)	280 Number of events	210 Number of events

SECONDARY outcome

Timeframe: During 26 weeks of treatment

Population: Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (210 subjects). Subjects in the safety set contributed to the evaluation "as treated".

Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.

Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

Severe hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes	52 Number of episodes	43 Number of episodes

SECONDARY outcome

Timeframe: During 26 weeks of treatment

Population: Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (210 subjects). Subjects in the safety set contributed to the evaluation "as treated".

Results represent total number of treatment emergent hypoglycaemic episodes that fall under ADA's definition of hypoglycaemia. ADA's definition of hypoglycaemia includes following categories:

1. Severe hypoglycaemia

2. Documented symptomatic hypoglycaemia

3. Asymptomatic hypoglycaemia

4. Probable symptomatic hypoglycaemia

5. Pseudo-hypoglycaemia. Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA) Definition	780 Number of episodes	717 Number of episodes

SECONDARY outcome

Timeframe: During 26 weeks of treatment

Population: Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (210 subjects). Subjects in the safety set contributed to the evaluation "as treated".

Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. Nocturnal period: The period between 00:01 and 05:59 a.m. (both inclusive).

Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

Severe hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes	4 Number of episodes	8 Number of episodes

SECONDARY outcome

Timeframe: Screening (week -2 to week 0), week 26

Population: Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (210 subjects). Subjects in the safety set contributed to the evaluation "as treated". Missing data were imputed using last observation carried forward (LOCF) method.

The result of the fundus photography/dilated fundoscopy was interpreted by the investigator into following categories: Normal; Abnormal (Abn), Not Clinically significant (NCS); Abnormal, Clinically significant (CS). Reported results are number of subjects with 'normal'; 'Abn, NCS' and 'Abn, CS' fundoscopy/fundus photography results at screening (week -2 to week 0) and week 26.

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Change in Clinical Evaluation: Fundoscopy or Fundus Photography Left eye - at screening visit - normal	53 Participants	70 Participants
Change in Clinical Evaluation: Fundoscopy or Fundus Photography Left eye - at screening visit - Abn, NCS	6 Participants	5 Participants
Change in Clinical Evaluation: Fundoscopy or Fundus Photography Left eye - at screening visit - Abn, CS	46 Participants	30 Participants
Change in Clinical Evaluation: Fundoscopy or Fundus Photography Left eye - week 26 - normal	54 Participants	64 Participants
Change in Clinical Evaluation: Fundoscopy or Fundus Photography Left eye - week 26 - Abn, NCS	7 Participants	7 Participants
Change in Clinical Evaluation: Fundoscopy or Fundus Photography Left eye - week 26 - Abn, CS	44 Participants	34 Participants
Change in Clinical Evaluation: Fundoscopy or Fundus Photography Right eye - at screening visit - normal	55 Participants	72 Participants
Change in Clinical Evaluation: Fundoscopy or Fundus Photography Right eye - at screening visit - Abn, NCS	7 Participants	6 Participants
Change in Clinical Evaluation: Fundoscopy or Fundus Photography Right eye - at screening visit - Abn, CS	43 Participants	27 Participants
Change in Clinical Evaluation: Fundoscopy or Fundus Photography Right eye - week 26 - normal	52 Participants	69 Participants
Change in Clinical Evaluation: Fundoscopy or Fundus Photography Right eye - week 26 - Abn, NCS	8 Participants	6 Participants
Change in Clinical Evaluation: Fundoscopy or Fundus Photography Right eye - week 26 - Abn, CS	45 Participants	30 Participants

SECONDARY outcome

Timeframe: Screening (week -2 to week 0), week 26

Population: Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (210 subjects). Subjects in the safety set contributed to the evaluation "as treated". Missing data were imputed using last observation carried forward (LOCF) method.

The result of the ECG was interpreted by the investigator into following categories: Normal; Abnormal (Abn), Not Clinically significant (NCS); Abnormal, Clinically significant (CS). Reported results are number of subjects with 'normal'; 'Abn, NCS' and 'Abn, CS' ECG results at screening (week -2 to week 0) and week 26.

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Change in Clinical Evaluation: Electrocardiogram (ECG) At screening visit - normal	80 Participants	82 Participants
Change in Clinical Evaluation: Electrocardiogram (ECG) At screening visit - Abn, NCS	20 Participants	18 Participants
Change in Clinical Evaluation: Electrocardiogram (ECG) At screening visit - Abn, CS	5 Participants	5 Participants
Change in Clinical Evaluation: Electrocardiogram (ECG) Week 26 -normal	82 Participants	82 Participants
Change in Clinical Evaluation: Electrocardiogram (ECG) Week 26 - Abn, NCS	17 Participants	20 Participants
Change in Clinical Evaluation: Electrocardiogram (ECG) Week 26 - Abn, CS	6 Participants	3 Participants

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (210 subjects). Missing data were imputed using last observation carried forward (LOCF) method.

Change in pulse after 26 weeks of treatment.

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Change in Pulse	6.1 beats per minute Standard Deviation 11.0	-0.2 beats per minute Standard Deviation 7.1

SECONDARY outcome

Timeframe: week 0, week 26

Population: Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.

For the DTR-QOL questionnaire, change from baseline in the 'Total score' and the following four 'Domain scores' were analysed:

1. Burden on social activities and daily activities

2. Anxiety and dissatisfaction with treatment

3. Hypoglycaemia

4. Satisfaction with treatment. The scoring range of 'Total score' was converted to 0-100 (best case response = 100; worst case response = 0).

The scoring range for each of four domains was converted to 0-100 (best case response = 100; worst case response = 0).

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Change From Baseline in Patient Reported Outcomes (PROs) of Treatment: Diabetes Therapy-Related Quality of Life (DTR-QOL)Questionnaire Total score	7.9 Score on a scale Standard Deviation 14.8	0.1 Score on a scale Standard Deviation 13.4
Change From Baseline in Patient Reported Outcomes (PROs) of Treatment: Diabetes Therapy-Related Quality of Life (DTR-QOL)Questionnaire Burden on social activities and daily activities	5.7 Score on a scale Standard Deviation 17.3	0.6 Score on a scale Standard Deviation 17.1
Change From Baseline in Patient Reported Outcomes (PROs) of Treatment: Diabetes Therapy-Related Quality of Life (DTR-QOL)Questionnaire Anxiety and dissatisfaction with treatment	12.9 Score on a scale Standard Deviation 20.8	0.4 Score on a scale Standard Deviation 17.2
Change From Baseline in Patient Reported Outcomes (PROs) of Treatment: Diabetes Therapy-Related Quality of Life (DTR-QOL)Questionnaire Hypoglycaemia	-2.6 Score on a scale Standard Deviation 25.5	-1.6 Score on a scale Standard Deviation 25.9
Change From Baseline in Patient Reported Outcomes (PROs) of Treatment: Diabetes Therapy-Related Quality of Life (DTR-QOL)Questionnaire Satisfaction with treatment	15.8 Score on a scale Standard Deviation 22.5	-0.4 Score on a scale Standard Deviation 24.7

SECONDARY outcome

Timeframe: week 0, week 26

Population: Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". Missing data were imputed using last observation carried forward (LOCF) method.

Overall health state was rated by patients using the EQ-5D-5L visual analogue scale (VAS) and the EQ-5D-5L index score. The EQ-5D-5L VAS is a vertical scale where patients can rank their health from 0 (worst health imaginable) to 100 (best health imaginable).

The EQ-5D-5L index score was calculated based on the 5 dimensions, i.e., mobility, self-care, usual activities (e.g., work, study), pain/discomfort and anxiety/depression with five response levels for each dimension, i.e., no problems, slight problems, moderate problems, severe problems and extreme problems. The scores from 5 dimensions are then converted to the EQ-5D-5L index score scale: 0 - 1 (full health/best-case response = 1; death/worst-case response = 0).

Outcome measures

Measure	Insulin Degludec/Liraglutide n=105 Participants Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 Participants Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Change From Baseline in Patient Reported Outcomes (PROs) of Treatment: EuroQol-5D (EQ-5D-5L) Questionnaire Change in VAS score	6.3 Score on a scale Standard Deviation 17.8	-1.0 Score on a scale Standard Deviation 15.5
Change From Baseline in Patient Reported Outcomes (PROs) of Treatment: EuroQol-5D (EQ-5D-5L) Questionnaire Index score	0.02 Score on a scale Standard Deviation 0.08	-0.01 Score on a scale Standard Deviation 0.11

Adverse Events

Insulin Degludec/Liraglutide

Serious events: 3 serious events

Other events: 54 other events

Deaths: 0 deaths

Insulin Degludec

Serious events: 4 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Measure	Insulin Degludec/Liraglutide n=105 participants at risk Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 participants at risk Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Cardiac disorders Acute myocardial infarction	0.95% 1/105 • Number of events 1 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.	0.00% 0/105 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.
Cardiac disorders Cardiac failure congestive	0.95% 1/105 • Number of events 1 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.	0.00% 0/105 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/105 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.	0.95% 1/105 • Number of events 1 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.
Infections and infestations Gastroenteritis	0.95% 1/105 • Number of events 1 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.	0.00% 0/105 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.
Injury, poisoning and procedural complications Hip fracture	0.95% 1/105 • Number of events 1 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.	0.00% 0/105 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.
Nervous system disorders Loss of consciousness	0.00% 0/105 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.	0.95% 1/105 • Number of events 2 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/105 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.	0.95% 1/105 • Number of events 1 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/105 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.	0.95% 1/105 • Number of events 1 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.
Eye disorders Retinal detachment	0.00% 0/105 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.	0.95% 1/105 • Number of events 1 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.

Other adverse events

Measure	Insulin Degludec/Liraglutide n=105 participants at risk Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), with the option of choosing up to 16 dose steps (16 units IDeg/0.6 mg liraglutide) at the investigator's discretion. IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDegLira was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.	Insulin Degludec n=105 participants at risk Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.
Gastrointestinal disorders Abdominal discomfort	7.6% 8/105 • Number of events 8 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.	4.8% 5/105 • Number of events 5 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.
Gastrointestinal disorders Constipation	8.6% 9/105 • Number of events 10 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.	3.8% 4/105 • Number of events 4 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.
Metabolism and nutrition disorders Decreased appetite	7.6% 8/105 • Number of events 8 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.	0.00% 0/105 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.
Eye disorders Diabetic retinopathy	16.2% 17/105 • Number of events 18 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.	16.2% 17/105 • Number of events 18 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.
Gastrointestinal disorders Diarrhoea	14.3% 15/105 • Number of events 20 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.	4.8% 5/105 • Number of events 6 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.
Gastrointestinal disorders Nausea	9.5% 10/105 • Number of events 12 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.	3.8% 4/105 • Number of events 5 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.
Infections and infestations Viral upper respiratory tract infection	20.0% 21/105 • Number of events 27 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.	22.9% 24/105 • Number of events 30 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.
Gastrointestinal disorders Vomiting	8.6% 9/105 • Number of events 11 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.	1.9% 2/105 • Number of events 2 • Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment. Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.

Additional Information

Clinical Reporting Anchor and Disclosure (1452)

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