Trial Outcomes & Findings for Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes. (NCT NCT02648204)

Last Updated: 2019-10-15

Results Overview

Results are based on HbA1c data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on-treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1201 participants

Primary outcome timeframe

Week 0, week 40

Results posted on

2019-10-15

Participant Flow

A total of 210 sites were approved for recruiting subjects, of which 196 sites randomized the subjects: Bulgaria: 6; Croatia: 6; Finland: 6; Germany: 6; Greece: 8; Hong Kong: 1; India: 22; Ireland: 5; Latvia: 3; Lithuania: 5; Portugal: 4; Romania: 7; Slovakia: 6; Spain: 8; United Kingdom: 8; United States: 95.

Participant milestones

Participant milestones
Measure	Semaglutide 0.5 mg Subjects received subcutaneous (s.c., under the skin) injections of semaglutide once weekly (OW) for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (week 1 to 4) followed by 0.5 mg for another 4 weeks (week 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (week 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Overall Study STARTED	301	300	300	300
Overall Study Exposed	301	300	299	299
Overall Study COMPLETED	279	279	287	284
Overall Study NOT COMPLETED	22	21	13	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Semaglutide 0.5 mg Subjects received subcutaneous (s.c., under the skin) injections of semaglutide once weekly (OW) for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (week 1 to 4) followed by 0.5 mg for another 4 weeks (week 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (week 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Overall Study Withdrawal by Subject	12	8	2	6
Overall Study Lost to Follow-up	5	8	4	6
Overall Study Missing follow-up information	4	4	4	2
Overall Study Death	1	1	2	2
Overall Study Adverse Event	0	0	1	0

Baseline Characteristics

Number of subjects analysed=subjects with available data of fasting plasma glucose at baseline

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Semaglutide 0.5 mg n=301 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=300 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=299 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=299 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Total n=1199 Participants Total of all reporting groups
Age, Continuous	56 years STANDARD_DEVIATION 10.9 • n=301 Participants	55 years STANDARD_DEVIATION 10.6 • n=300 Participants	55 years STANDARD_DEVIATION 10.4 • n=299 Participants	56 years STANDARD_DEVIATION 10.6 • n=299 Participants	56 years STANDARD_DEVIATION 10.6 • n=1199 Participants
Sex: Female, Male Female	169 Participants n=301 Participants	162 Participants n=300 Participants	160 Participants n=299 Participants	171 Participants n=299 Participants	662 Participants n=1199 Participants
Sex: Female, Male Male	132 Participants n=301 Participants	138 Participants n=300 Participants	139 Participants n=299 Participants	128 Participants n=299 Participants	537 Participants n=1199 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=301 Participants	35 Participants n=300 Participants	31 Participants n=299 Participants	43 Participants n=299 Participants	138 Participants n=1199 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	272 Participants n=301 Participants	265 Participants n=300 Participants	268 Participants n=299 Participants	256 Participants n=299 Participants	1061 Participants n=1199 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=301 Participants	0 Participants n=300 Participants	0 Participants n=299 Participants	0 Participants n=299 Participants	0 Participants n=1199 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=301 Participants	0 Participants n=300 Participants	0 Participants n=299 Participants	0 Participants n=299 Participants	0 Participants n=1199 Participants
Race (NIH/OMB) Asian	50 Participants n=301 Participants	38 Participants n=300 Participants	48 Participants n=299 Participants	55 Participants n=299 Participants	191 Participants n=1199 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=301 Participants	0 Participants n=300 Participants	0 Participants n=299 Participants	0 Participants n=299 Participants	0 Participants n=1199 Participants
Race (NIH/OMB) Black or African American	17 Participants n=301 Participants	18 Participants n=300 Participants	17 Participants n=299 Participants	18 Participants n=299 Participants	70 Participants n=1199 Participants
Race (NIH/OMB) White	233 Participants n=301 Participants	243 Participants n=300 Participants	232 Participants n=299 Participants	220 Participants n=299 Participants	928 Participants n=1199 Participants
Race (NIH/OMB) More than one race	0 Participants n=301 Participants	0 Participants n=300 Participants	0 Participants n=299 Participants	0 Participants n=299 Participants	0 Participants n=1199 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=301 Participants	1 Participants n=300 Participants	2 Participants n=299 Participants	6 Participants n=299 Participants	10 Participants n=1199 Participants
Glycosylated haemoglobin (Hb1Ac)	8.3 percentage of HbA1c STANDARD_DEVIATION 0.96 • n=301 Participants	8.2 percentage of HbA1c STANDARD_DEVIATION 0.92 • n=300 Participants	8.2 percentage of HbA1c STANDARD_DEVIATION 0.91 • n=299 Participants	8.2 percentage of HbA1c STANDARD_DEVIATION 0.89 • n=299 Participants	8.2 percentage of HbA1c STANDARD_DEVIATION 0.92 • n=1199 Participants
Body weight	96.4 kg STANDARD_DEVIATION 24.38 • n=301 Participants	95.5 kg STANDARD_DEVIATION 20.90 • n=300 Participants	95.6 kg STANDARD_DEVIATION 23.01 • n=299 Participants	93.4 kg STANDARD_DEVIATION 21.79 • n=299 Participants	95.2 kg STANDARD_DEVIATION 22.56 • n=1199 Participants
Fasting plasma glucose	9.8 mmol/L STANDARD_DEVIATION 2.54 • n=298 Participants • Number of subjects analysed=subjects with available data of fasting plasma glucose at baseline	9.8 mmol/L STANDARD_DEVIATION 2.58 • n=299 Participants • Number of subjects analysed=subjects with available data of fasting plasma glucose at baseline	9.7 mmol/L STANDARD_DEVIATION 2.65 • n=297 Participants • Number of subjects analysed=subjects with available data of fasting plasma glucose at baseline	9.6 mmol/L STANDARD_DEVIATION 2.29 • n=297 Participants • Number of subjects analysed=subjects with available data of fasting plasma glucose at baseline	9.7 mmol/L STANDARD_DEVIATION 2.52 • n=1191 Participants • Number of subjects analysed=subjects with available data of fasting plasma glucose at baseline

PRIMARY outcome

Timeframe: Week 0, week 40

Population: Analysis was based on FAS.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=301 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=300 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=299 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=299 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Change in HbA1c	-1.51 percentage of HbA1c Standard Error 0.06	-1.78 percentage of HbA1c Standard Error 0.06	-1.11 percentage of HbA1c Standard Error 0.05	-1.37 percentage of HbA1c Standard Error 0.06

SECONDARY outcome

Timeframe: Week 0, week 40

Population: Analysis was based on FAS. Number of subjects analysed=number of subjects with available data for body weight.

Results are based on body weight data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=301 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=300 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=299 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=298 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Change in Body Weight (kg)	-4.56 kg Standard Error 0.28	-6.53 kg Standard Error 0.28	-2.30 kg Standard Error 0.27	-2.98 kg Standard Error 0.27

SECONDARY outcome

Timeframe: Week 0, week 40

Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for fasting plasma glucose.

Results are based on fasting plasma glucose data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=298 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=299 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=297 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=297 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Change in Fasting Plasma Glucose	-2.18 mmol/L Standard Error 0.12	-2.83 mmol/L Standard Error 0.12	-1.87 mmol/L Standard Error 0.12	-2.25 mmol/L Standard Error 0.12

SECONDARY outcome

Timeframe: Week 0, week 40

Population: Analysis was based on FAS.

Results are based on systolic and diastolic blood pressure data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=301 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=300 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=299 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=299 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Change in Systolic and Diastolic Blood Pressure Systolic BP	-2.44 mmHg Standard Error 0.76	-4.88 mmHg Standard Error 0.77	-2.16 mmHg Standard Error 0.75	-2.86 mmHg Standard Error 0.75
Change in Systolic and Diastolic Blood Pressure Diastolic BP	-0.57 mmHg Standard Error 0.48	-2.05 mmHg Standard Error 0.49	-0.35 mmHg Standard Error 0.47	-0.03 mmHg Standard Error 0.47

SECONDARY outcome

Timeframe: Week 0, week 40

Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for diabetes treatment satisfaction questionnaire

The questionnaire contains 8 items and evaluates subjects' diabetes treatment in terms of convenience, flexibility and general feelings towards treatment. The result presented is 'Treatment Satisfaction' summary score (sum of 6 of the 8 items). Response options: 6 (best case) to 0 (worst case). Total scores range: 0-36. Higher scores=higher satisfaction. Results are based on data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This includes observations recorded at, or after the date of first dose of trial product and not after first occurrence of following: the end-date of the 'on-treatment' observation period or initiation of rescue medication

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=301 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=299 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=299 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=298 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Change in Overall Scores for Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire	4.60 units on a scale Standard Error 0.28	4.55 units on a scale Standard Error 0.29	4.52 units on a scale Standard Error 0.28	4.65 units on a scale Standard Error 0.28

SECONDARY outcome

Timeframe: After 40 weeks treatment

Population: Results are based on the FAS.

Percentage of subjects who achieved HbA1c target below or equal to 6.5% (48 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=301 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=300 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=299 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=299 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target Yes	49.2 percentage of subjects	66.7 percentage of subjects	34.1 percentage of subjects	47.2 percentage of subjects
HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target No	50.8 percentage of subjects	33.3 percentage of subjects	65.9 percentage of subjects	52.8 percentage of subjects

SECONDARY outcome

Timeframe: Week 0, week 40

Population: Analysis was based on FAS. Number of participants analysed=Number of participants analysed=number of participants with available data for 7-point self-measured plasma glucose.

SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are mean profile from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=295 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=295 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=296 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=296 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Change From Baseline in 7-point Self-measured Plasma Glucose (SMPG) Mean Profile	-2.43 mmol/L Standard Error 0.10	-2.95 mmol/L Standard Error 0.10	-1.99 mmol/L Standard Error 0.10	-2.32 mmol/L Standard Error 0.10

SECONDARY outcome

Timeframe: Week 0, week 40

Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for 7-point self-measured plasma glucose increment.

SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are plasma glucose incremental profile from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=295 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=292 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=296 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=296 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Change From Baseline 7-point Self-measured Plasma Glucose Increment	-0.77 mmol/L Standard Error 0.08	-0.93 mmol/L Standard Error 0.09	-0.44 mmol/L Standard Error 0.08	-0.63 mmol/L Standard Error 0.08

SECONDARY outcome

Timeframe: Week 0, week 40

Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for total cholesterol

Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=295 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=296 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=290 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=294 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Change in Fasting Blood Lipids (Total Cholesterol)	0.96 ratio to baseline Standard Error 0.01	0.97 ratio to baseline Standard Error 0.01	0.97 ratio to baseline Standard Error 0.01	0.99 ratio to baseline Standard Error 0.01

SECONDARY outcome

Timeframe: Week 0, week 40

Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for LDL cholesterol.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=293 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=295 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=290 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=294 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Change in Fasting Blood Lipids (Low Density Lipoprotein [LDL] Cholesterol)	0.97 ratio to baseline Standard Error 0.02	1.00 ratio to baseline Standard Error 0.02	0.97 ratio to baseline Standard Error 0.02	1.01 ratio to baseline Standard Error 0.02

SECONDARY outcome

Timeframe: Week 0, week 40

Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for HDL cholesterol.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=293 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=296 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=290 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=294 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Change in Fasting Blood Lipids (High Density Lipoprotein [HDL] Cholesterol)	0.99 ratio to baseline Standard Error 0.01	1.01 ratio to baseline Standard Error 0.01	1.00 ratio to baseline Standard Error 0.01	1.02 ratio to baseline Standard Error 0.01

SECONDARY outcome

Timeframe: Week 0, week 40

Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for triglycerides.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=293 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=296 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=290 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=294 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Change in Fasting Blood Lipids (Triglycerides)	0.91 ratio to baseline Standard Error 0.02	0.86 ratio to baseline Standard Error 0.02	0.91 ratio to baseline Standard Error 0.02	0.90 ratio to baseline Standard Error 0.02

SECONDARY outcome

Timeframe: Week 0, week 40

Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for BMI.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=301 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=300 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=299 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=298 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Change in Body Mass Index (BMI)	-1.63 kg/m^2 Standard Error 0.10	-2.33 kg/m^2 Standard Error 0.10	-0.82 kg/m^2 Standard Error 0.10	-1.08 kg/m^2 Standard Error 0.10

SECONDARY outcome

Timeframe: Week 0, week 40

Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for waist circumference.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=299 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=300 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=298 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=297 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Change in Waist Circumference	-4.27 cm Standard Error 0.34	-5.20 cm Standard Error 0.34	-2.36 cm Standard Error 0.33	-2.93 cm Standard Error 0.33

SECONDARY outcome

Timeframe: Week 0, week 40

Population: Analysis was based on FAS. Number analysed=number of participants with available data for SF-36.

The questionnaire contains 36 items across 8 domains and 2 summary scores. Score range: 0 (worst score) to 100 (best score). Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=301 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=300 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=299 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=299 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Change in Short Form Health Survey (SF-36v2™) Social functioning	1.18 units on a scale Standard Error 0.49	0.83 units on a scale Standard Error 0.49	0.78 units on a scale Standard Error 0.48	0.63 units on a scale Standard Error 0.48
Change in Short Form Health Survey (SF-36v2™) Role-emotional	1.11 units on a scale Standard Error 0.57	1.57 units on a scale Standard Error 0.58	1.04 units on a scale Standard Error 0.56	1.08 units on a scale Standard Error 0.57
Change in Short Form Health Survey (SF-36v2™) Mental health	1.89 units on a scale Standard Error 0.49	1.65 units on a scale Standard Error 0.49	1.43 units on a scale Standard Error 0.48	0.96 units on a scale Standard Error 0.48
Change in Short Form Health Survey (SF-36v2™) Physical component summary	1.21 units on a scale Standard Error 0.40	2.04 units on a scale Standard Error 0.40	1.93 units on a scale Standard Error 0.39	1.29 units on a scale Standard Error 0.39
Change in Short Form Health Survey (SF-36v2™) Mental component summary	1.45 units on a scale Standard Error 0.49	1.23 units on a scale Standard Error 0.49	0.95 units on a scale Standard Error 0.48	1.08 units on a scale Standard Error 0.48
Change in Short Form Health Survey (SF-36v2™) Physical functioning	1.25 units on a scale Standard Error 0.44	2.00 units on a scale Standard Error 0.44	2.17 units on a scale Standard Error 0.43	1.05 units on a scale Standard Error 0.43
Change in Short Form Health Survey (SF-36v2™) Role-physical	0.98 units on a scale Standard Error 0.48	2.03 units on a scale Standard Error 0.48	1.39 units on a scale Standard Error 0.47	0.82 units on a scale Standard Error 0.47
Change in Short Form Health Survey (SF-36v2™) Bodily pain	0.96 units on a scale Standard Error 0.52	1.54 units on a scale Standard Error 0.52	1.69 units on a scale Standard Error 0.51	0.77 units on a scale Standard Error 0.51
Change in Short Form Health Survey (SF-36v2™) General health	2.65 units on a scale Standard Error 0.43	2.52 units on a scale Standard Error 0.43	1.86 units on a scale Standard Error 0.42	2.73 units on a scale Standard Error 0.42
Change in Short Form Health Survey (SF-36v2™) Vitality	1.23 units on a scale Standard Error 0.50	1.97 units on a scale Standard Error 0.50	2.14 units on a scale Standard Error 0.49	1.83 units on a scale Standard Error 0.50

SECONDARY outcome

Timeframe: After 40 weeks of treatment

Population: Analysis was based on FAS.

Percentage of subjects who achieved HbA1c target below or equal to \<7.0% (53 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=301 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=300 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=299 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=299 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target Yes	68.4 percentage of subjects	78.7 percentage of subjects	52.2 percentage of subjects	66.6 percentage of subjects
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target No	31.6 percentage of subjects	21.3 percentage of subjects	47.8 percentage of subjects	33.4 percentage of subjects

SECONDARY outcome

Timeframe: After 40 weeks treatment

Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for body weight.

Percentage of subjects who achieved weight loss ≥5% after 40 weeks of treatment. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=301 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=300 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=299 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=298 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5% Yes	43.9 percentage of subjects	63.0 percentage of subjects	22.7 percentage of subjects	30.2 percentage of subjects
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5% No	56.1 percentage of subjects	37.0 percentage of subjects	77.3 percentage of subjects	69.8 percentage of subjects

SECONDARY outcome

Timeframe: After 40 weeks treatment

Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for body weight

Percentage of subjects who achieved weight loss ≥10% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=301 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=300 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=299 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=298 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10% Yes	14.3 percentage of subjects	26.7 percentage of subjects	3.3 percentage of subjects	7.7 percentage of subjects
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10% No	85.7 percentage of subjects	73.3 percentage of subjects	96.7 percentage of subjects	92.3 percentage of subjects

SECONDARY outcome

Timeframe: After 40 weeks of treatment

Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for this endpoint.

Percentage of subjects achieved (yes/no) HbA1c \<7.0% (53 mmol/mol) without severe or BG confirmed symptomatic hypoglycaemia episodes and no weight gain after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was subset of 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=301 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=300 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=299 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=298 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain Yes	64.5 percentage of subjects	74.0 percentage of subjects	44.1 percentage of subjects	58.4 percentage of subjects
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain No	35.5 percentage of subjects	26.0 percentage of subjects	55.9 percentage of subjects	41.6 percentage of subjects

SECONDARY outcome

Timeframe: After 40 weeks of treatment

Population: Analysis was based on FAS.

Percentage of subjects who achieved (yes/no) HbA1c reduction of ≥1% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=301 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=300 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=299 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=299 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% Yes	77.4 percentage of subjects	83.3 percentage of subjects	53.8 percentage of subjects	67.6 percentage of subjects
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% No	22.6 percentage of subjects	16.7 percentage of subjects	46.2 percentage of subjects	32.4 percentage of subjects

SECONDARY outcome

Timeframe: After 40 weeks treatment

Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for body weight

Percentage of subjects who achieved (yes/no) weight loss of ≥3% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=301 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=300 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=299 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=298 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3% Yes	64.5 percentage of subjects	76.7 percentage of subjects	36.5 percentage of subjects	44.6 percentage of subjects
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3% No	35.5 percentage of subjects	23.3 percentage of subjects	63.5 percentage of subjects	55.4 percentage of subjects

SECONDARY outcome

Timeframe: After 40 weeks treatment

Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for HbA1c and body weight.

Percentage of subjects who achieved (yes/no) HbA1c reduction ≥1% and weight loss ≥3% 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=301 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=300 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=299 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=298 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% and Weight Loss ≥3% Yes	53.2 percentage of subjects	68.3 percentage of subjects	25.1 percentage of subjects	34.9 percentage of subjects
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% and Weight Loss ≥3% No	46.8 percentage of subjects	31.7 percentage of subjects	74.9 percentage of subjects	65.1 percentage of subjects

SECONDARY outcome

Timeframe: 40 weeks + follow-up of 5 weeks

Population: Analysis was based on the safety analysis set which included all randomised subjects exposed to at least one dose of trial product.

A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days).

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=301 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=300 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=299 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=299 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Number of Treatment Emergent Adverse Events (TEAEs)	966 events	1015 events	802 events	957 events

SECONDARY outcome

Timeframe: 40 weeks + follow-up of 5 weeks

Population: Analysis was based on the safety analysis set which included all randomised subjects exposed to at least one dose of trial product.

A treatment emergent hypoglycaemic episode was defined as an episode with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association classification or BG-confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=301 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=300 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=299 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=299 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes	3 hypoglycaemic episodes	7 hypoglycaemic episodes	3 hypoglycaemic episodes	5 hypoglycaemic episodes

SECONDARY outcome

Timeframe: 40 weeks + follow-up of 5 weeks

Population: Analysis was based on the safety analysis set which included all randomised subjects exposed to at least one dose of trial product.

Percentage of subjects with treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes. A treatment emergent hypoglycaemic episode was defined as an episode with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association classification or BG-confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=301 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=300 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=299 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=299 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes	0.7 percentage of subjects	1.7 percentage of subjects	1.0 percentage of subjects	1.7 percentage of subjects

SECONDARY outcome

Timeframe: Week 0, week 40

Population: Analysis was based on safety analysis set. Number of participants analysed=number of participants with available data for amylase.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=295 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=296 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=292 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=294 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Change in Amylase	1.17 ratio to baseline Standard Error 0.02	1.22 ratio to baseline Standard Error 0.02	1.16 ratio to baseline Standard Error 0.02	1.20 ratio to baseline Standard Error 0.02

SECONDARY outcome

Timeframe: Week 0, week 40

Population: Analysis was based on safety analysis set. Number of participants analysed=number of participants with available data for lipase.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=295 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=296 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=291 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=293 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Change in Lipase	1.22 ratio to baseline Standard Error 0.04	1.32 ratio to baseline Standard Error 0.04	1.23 ratio to baseline Standard Error 0.04	1.29 ratio to baseline Standard Error 0.04

SECONDARY outcome

Timeframe: Week 0, week 40

Population: Analysis was based on safety analysis set.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=301 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=300 Participants Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=299 Participants Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=299 Participants Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Change in Pulse Rate	2.09 beats/min Standard Error 0.51	3.96 beats/min Standard Error 0.51	1.56 beats/min Standard Error 0.49	2.42 beats/min Standard Error 0.50

Adverse Events

Semaglutide 0.5 mg

Serious events: 17 serious events

Other events: 132 other events

Deaths: 0 deaths

Semaglutide 1.0 mg

Serious events: 23 serious events

Other events: 134 other events

Deaths: 1 deaths

Dulaglutide 0.75 mg

Serious events: 24 serious events

Other events: 106 other events

Deaths: 2 deaths

Dulaglutide 1.5 mg

Serious events: 22 serious events

Other events: 139 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Semaglutide 0.5 mg n=301 participants at risk Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40).	Semaglutide 1.0 mg n=300 participants at risk Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 0.75 mg n=299 participants at risk Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.	Dulaglutide 1.5 mg n=299 participants at risk Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period.
Gastrointestinal disorders Constipation	5.3% 16/301 • Number of events 18 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	4.7% 14/300 • Number of events 14 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	3.3% 10/299 • Number of events 10 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	5.0% 15/299 • Number of events 18 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)
Metabolism and nutrition disorders Decreased appetite	8.3% 25/301 • Number of events 26 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	9.0% 27/300 • Number of events 27 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	3.0% 9/299 • Number of events 12 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	10.4% 31/299 • Number of events 36 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)
Gastrointestinal disorders Diarrhoea	14.3% 43/301 • Number of events 79 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	13.7% 41/300 • Number of events 96 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	7.7% 23/299 • Number of events 42 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	17.7% 53/299 • Number of events 75 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)
Nervous system disorders Headache	8.3% 25/301 • Number of events 35 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	7.3% 22/300 • Number of events 30 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	4.0% 12/299 • Number of events 20 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	6.4% 19/299 • Number of events 30 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)
Investigations Lipase increased	6.3% 19/301 • Number of events 23 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	5.7% 17/300 • Number of events 17 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	5.4% 16/299 • Number of events 17 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	5.7% 17/299 • Number of events 20 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)
Infections and infestations Nasopharyngitis	5.0% 15/301 • Number of events 16 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	4.7% 14/300 • Number of events 16 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	5.7% 17/299 • Number of events 20 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	6.7% 20/299 • Number of events 24 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)
Gastrointestinal disorders Nausea	22.3% 67/301 • Number of events 144 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	21.0% 63/300 • Number of events 192 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	13.0% 39/299 • Number of events 66 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	20.1% 60/299 • Number of events 108 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)
Infections and infestations Upper respiratory tract infection	4.3% 13/301 • Number of events 18 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	3.3% 10/300 • Number of events 11 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	7.0% 21/299 • Number of events 26 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	5.4% 16/299 • Number of events 21 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)
Gastrointestinal disorders Vomiting	10.0% 30/301 • Number of events 50 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	10.3% 31/300 • Number of events 48 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	4.0% 12/299 • Number of events 16 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)	9.7% 29/299 • Number of events 40 • Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days) A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)

Additional Information

Clinical Reporting Anchor and Disclosure (1452)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
Publication restrictions are in place

Restriction type: OTHER