Trial Outcomes & Findings for Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes (NCT NCT02128932)

NCT ID: NCT02128932

Last Updated: 2019-06-13

Results Overview

Change in HbA1c from baseline to week 30.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1089 participants

Primary outcome timeframe

Week 0, week 30

Results posted on

2019-06-13

Participant Flow

The trial was conducted at196 sites in 14 countries. Argentina: 3 sites; Croatia: 3 sites; France: 5 sites; Germany: 11 sites; India: 12 sites; Macedonia: 3 sites; Mexico: 3 sites; Netherlands: 3 sites; Romania: 5 sites; Slovakia: 5 sites; Slovenia:3 sites; South Africa: 4 sites; United Kingdom: 13 sites; United States: 123 sites.

Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin ≥1500 mg or maximum tolerated dose and SU≥ half of maximum allowed dose according to national label) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose.

Participant milestones

Participant milestones
Measure	Semaglutide 0.5mg/Week Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.	Semaglutide 1.0 mg/Week Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.	Insulin Glargine Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to \<5.5 mmol/L (71- \<100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
Overall Study STARTED	362	360	360
Overall Study COMPLETED	335	341	342
Overall Study NOT COMPLETED	27	19	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Semaglutide 0.5mg/Week Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.	Semaglutide 1.0 mg/Week Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.	Insulin Glargine Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to \<5.5 mmol/L (71- \<100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
Overall Study Withdrawal by Subject	11	7	8
Overall Study Death	2	0	2
Overall Study Lost to Follow-up	2	1	1
Overall Study No reason for withdrawal	12	11	7

Baseline Characteristics

Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Semaglutide 0.5mg/Week n=362 Participants Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.	Semaglutide 1.0 mg/Week n=360 Participants Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.	Insulin Glargine n=360 Participants Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to \<5.5 mmol/L (71- \<100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day	Total n=1082 Participants Total of all reporting groups
Age, Continuous	56.5 years STANDARD_DEVIATION 10.3 • n=5 Participants	56.7 years STANDARD_DEVIATION 10.4 • n=7 Participants	56.2 years STANDARD_DEVIATION 10.6 • n=5 Participants	56.5 years STANDARD_DEVIATION 10.4 • n=4 Participants
Age, Customized 18-64 years	278 Participants n=5 Participants	281 Participants n=7 Participants	281 Participants n=5 Participants	840 Participants n=4 Participants
Age, Customized 65-74 years	72 Participants n=5 Participants	61 Participants n=7 Participants	67 Participants n=5 Participants	200 Participants n=4 Participants
Age, Customized 75-84 years	12 Participants n=5 Participants	18 Participants n=7 Participants	12 Participants n=5 Participants	42 Participants n=4 Participants
Age, Customized >=85 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	165 Participants n=5 Participants	178 Participants n=7 Participants	165 Participants n=5 Participants	508 Participants n=4 Participants
Sex: Female, Male Male	197 Participants n=5 Participants	182 Participants n=7 Participants	195 Participants n=5 Participants	574 Participants n=4 Participants
HbA1c	8.13 percentage STANDARD_DEVIATION 0.85 • n=5 Participants	8.25 percentage STANDARD_DEVIATION 0.94 • n=7 Participants	8.13 percentage STANDARD_DEVIATION 0.88 • n=5 Participants	8.17 percentage STANDARD_DEVIATION 0.89 • n=4 Participants
Fasting plasma glucose	172.4 mg/dL STANDARD_DEVIATION 50.52 • n=5 Participants	179.2 mg/dL STANDARD_DEVIATION 53.74 • n=7 Participants	174.2 mg/dL STANDARD_DEVIATION 49.06 • n=5 Participants	175.3 mg/dL STANDARD_DEVIATION 51.18 • n=4 Participants
Body weight	93.73 kg STANDARD_DEVIATION 21.39 • n=5 Participants	94.00 kg STANDARD_DEVIATION 22.48 • n=7 Participants	92.61 kg STANDARD_DEVIATION 21.52 • n=5 Participants	93.45 kg STANDARD_DEVIATION 21.79 • n=4 Participants
Diastolic Blood pressure	79.67 mmHg STANDARD_DEVIATION 8.04 • n=5 Participants	80.32 mmHg STANDARD_DEVIATION 8.32 • n=7 Participants	79.78 mmHg STANDARD_DEVIATION 9.20 • n=5 Participants	79.72 mmHg STANDARD_DEVIATION 8.53 • n=4 Participants
Systolic Blood Pressure	131.57 mmHg STANDARD_DEVIATION 14.06 • n=5 Participants	132.21 mmHg STANDARD_DEVIATION 16.05 • n=7 Participants	132.38 mmHg STANDARD_DEVIATION 15.77 • n=5 Participants	132.06 mmHg STANDARD_DEVIATION 15.31 • n=4 Participants

PRIMARY outcome

Timeframe: Week 0, week 30

Population: The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomized semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.

Change in HbA1c from baseline to week 30.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5mg/Week n=362 Participants Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.	Semaglutide 1.0 mg/Week n=360 Participants Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.	Insulin Glargine n=360 Participants Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to \<5.5 mmol/L (71- \<100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
Change in HbA1c From Baseline	-1.21 percentage Standard Error 0.05	-1.64 percentage Standard Error 0.05	-0.83 percentage Standard Error 0.05

SECONDARY outcome

Timeframe: Week 0, week 30

Population: The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.

Change in body weight from baseline to week 30.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5mg/Week n=362 Participants Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.	Semaglutide 1.0 mg/Week n=360 Participants Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.	Insulin Glargine n=360 Participants Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to \<5.5 mmol/L (71- \<100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
Change in Body Weight From Baseline	-3.47 Kg Standard Error 0.24	-5.17 Kg Standard Error 0.24	1.15 Kg Standard Error 0.23

SECONDARY outcome

Timeframe: Week 0, week 30

Change in fasting plasma glucose from baseline to week 30.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5mg/Week n=362 Participants Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.	Semaglutide 1.0 mg/Week n=360 Participants Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.	Insulin Glargine n=360 Participants Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to \<5.5 mmol/L (71- \<100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
Change in Fasting Plasma Glucose From Baseline	-36.74 mg/dL Standard Error 2.14	-49.21 mg/dL Standard Error 2.15	-38.18 mg/dL Standard Error 2.03

SECONDARY outcome

Timeframe: Week 0, week 30

Change in diastolic blood pressure from baseline to week 30.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5mg/Week n=362 Participants Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.	Semaglutide 1.0 mg/Week n=360 Participants Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.	Insulin Glargine n=360 Participants Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to \<5.5 mmol/L (71- \<100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
Change in Diastolic Blood Pressure.	-1.38 mmHg Standard Error 0.43	-0.98 mmHg Standard Error 0.44	-1.44 mmHg Standard Error 0.41

SECONDARY outcome

Timeframe: Week 0, week 30

Change in systolic blood pressure from baseline to week 30.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5mg/Week n=362 Participants Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.	Semaglutide 1.0 mg/Week n=360 Participants Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.	Insulin Glargine n=360 Participants Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to \<5.5 mmol/L (71- \<100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
Change in Systolic Blood Pressure.	-4.65 mmHg Standard Error 0.72	-5.17 mmHg Standard Error 0.73	-1.68 mmHg Standard Error 0.68

SECONDARY outcome

Timeframe: Week 0, week 30

The Short Form (SF)-36v2™ patient reported outcomes (PRO) questionnaire was used to assess the subject's overall health related quality of life (HRQoL. PRO questionnaire (SF-36v2™) measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 U.S. general population. The (SF-36v2™) values displayed are the estimated mean change from baseline to week 30.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5mg/Week n=362 Participants Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.	Semaglutide 1.0 mg/Week n=360 Participants Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.	Insulin Glargine n=360 Participants Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to \<5.5 mmol/L (71- \<100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ Bodily pain	0.95 T-scores Standard Error 0.51	1.76 T-scores Standard Error 0.51	0.90 T-scores Standard Error 0.48
Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ General Health	1.95 T-scores Standard Error 0.38	2.78 T-scores Standard Error 0.38	1.63 T-scores Standard Error 0.36
Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ Mental Component summary, MCS	1.23 T-scores Standard Error 0.47	1.33 T-scores Standard Error 0.47	0.25 T-scores Standard Error 0.44
Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ Mental Health	1.69 T-scores Standard Error 0.46	1.17 T-scores Standard Error 0.47	0.54 T-scores Standard Error 0.44
Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ Physical Component summary, PCS	1.18 T-scores Standard Error 0.36	2.09 T-scores Standard Error 0.36	1.18 T-scores Standard Error 0.34
Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ Physical Functioning	1.64 T-scores Standard Error 0.43	1.49 T-scores Standard Error 0.43	0.69 T-scores Standard Error 0.41
Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ Role-emotional	0.88 T-scores Standard Error 0.54	1.73 T-scores Standard Error 0.54	0.06 T-scores Standard Error 0.51
Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ Role-physical	0.90 T-scores Standard Error 0.46	1.97 T-scores Standard Error 0.46	0.78 T-scores Standard Error 0.43
Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ Social functioning	1.13 T-scores Standard Error 0.48	1.04 T-scores Standard Error 0.48	0.36 T-scores Standard Error 0.45
Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ Vitality	1.71 T-scores Standard Error 0.46	2.09 T-scores Standard Error 0.46	0.95 T-scores Standard Error 0.44

SECONDARY outcome

Timeframe: Week 0, week 30

The Diabetes Treatment Satisfaction Questionnaire (DTSQs) questionnaire was to be used to assess a subject's treatment satisfaction. This questionnaire contained 8 components and measured the treatment for diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment. The value presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. The values displayed are the estimated mean change from baseline to week 30.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5mg/Week n=362 Participants Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.	Semaglutide 1.0 mg/Week n=360 Participants Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.	Insulin Glargine n=360 Participants Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to \<5.5 mmol/L (71- \<100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
Change in Patient Reported Outcome Questionnaires. (PROs), Diabetes Treatment Satisfaction Questionnaire (DTSQs)	4.86 Score on a scale Standard Error 0.28	5.37 Score on a scale Standard Error 0.29	3.99 Score on a scale Standard Error 0.27

SECONDARY outcome

Timeframe: After 30 weeks treatment

Subjects who achieve HbA1c ≤6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) after 30 weeks of treatment

Outcome measures

Outcome measures
Measure	Semaglutide 0.5mg/Week n=362 Participants Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.	Semaglutide 1.0 mg/Week n=360 Participants Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.	Insulin Glargine n=360 Participants Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to \<5.5 mmol/L (71- \<100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Yes	135 Count of participants	195 Count of participants	63 Count of participants
Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) No	227 Count of participants	165 Count of participants	297 Count of participants

Adverse Events

Semaglutide 0.5mg/Week

Serious events: 22 serious events

Other events: 172 other events

Deaths: 0 deaths

Semaglutide 1.0 mg/Week

Serious events: 17 serious events

Other events: 192 other events

Deaths: 0 deaths

Insulin Glargine

Serious events: 18 serious events

Other events: 107 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Semaglutide 0.5mg/Week n=362 participants at risk Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.	Semaglutide 1.0 mg/Week n=360 participants at risk Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day.	Insulin Glargine n=360 participants at risk Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to \<5.5 mmol/L (71- \<100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
Musculoskeletal and connective tissue disorders Back pain	3.0% 11/362 • Number of events 11 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.	5.0% 18/360 • Number of events 20 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.	1.9% 7/360 • Number of events 10 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.
Metabolism and nutrition disorders Decreased appetite	6.9% 25/362 • Number of events 34 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.	6.4% 23/360 • Number of events 23 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.	0.28% 1/360 • Number of events 1 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.
Gastrointestinal disorders Diarrhoea	16.3% 59/362 • Number of events 67 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.	19.2% 69/360 • Number of events 118 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.	4.4% 16/360 • Number of events 18 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.
Gastrointestinal disorders Dyspepsia	3.3% 12/362 • Number of events 24 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.	6.7% 24/360 • Number of events 39 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.	0.56% 2/360 • Number of events 2 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.1% 4/362 • Number of events 4 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.	5.3% 19/360 • Number of events 20 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.	0.83% 3/360 • Number of events 4 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.
Nervous system disorders Headache	5.2% 19/362 • Number of events 40 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.	6.4% 23/360 • Number of events 33 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.	5.6% 20/360 • Number of events 26 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.
Investigations Lipase increased	9.9% 36/362 • Number of events 39 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.	8.3% 30/360 • Number of events 32 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.	4.2% 15/360 • Number of events 17 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.
Infections and infestations Nasopharyngitis	12.4% 45/362 • Number of events 58 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.	8.1% 29/360 • Number of events 37 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.	12.2% 44/360 • Number of events 51 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.
Gastrointestinal disorders Nausea	21.3% 77/362 • Number of events 101 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.	22.2% 80/360 • Number of events 117 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.	3.3% 12/360 • Number of events 15 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.
Infections and infestations Upper respiratory tract infection	2.8% 10/362 • Number of events 10 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.	3.9% 14/360 • Number of events 16 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.	6.7% 24/360 • Number of events 25 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.
Gastrointestinal disorders Vomiting	6.6% 24/362 • Number of events 28 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.	10.3% 37/360 • Number of events 119 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.	2.8% 10/360 • Number of events 12 • All adverse events presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days). A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the 'on-treatment' observation period.

Additional Information

Global Clinical Registry (GCR, 1452)

Novo Nordisk A/S

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 upto 60 days to protect intellectual property.
Publication restrictions are in place

Restriction type: OTHER