Trial Outcomes & Findings for Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to Basal Insulin Alone or Basal Insulin in Combination With Metformin in Subjects With Type 2 Diabetes (NCT NCT02305381)

Last Updated: 2019-06-11

Results Overview

Estimated mean change from baseline in HbA1c at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \[\<= 8.0% or \> 8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

397 participants

Primary outcome timeframe

Week 0, week 30

Results posted on

2019-06-11

Participant Flow

The trial was conducted at 90 sites in 5 countries, as follows: Germany: 10 sites; Japan: 6 sites; Serbia: 4 sites; Slovakia: 5 sites; United States: 65.

Participant milestones

Participant milestones
Measure	Semaglutide 0.5 mg Subjects received semaglutide 0.25 mg subcutaneous (sc) injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.	Semaglutide 1.0 mg Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30.Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.	Placebo Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Overall Study STARTED	132	132	133
Overall Study Exposed	132	131	133
Overall Study Premature Discontinuation of Treatment	14	16	13
Overall Study COMPLETED	127	127	126
Overall Study NOT COMPLETED	5	5	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Semaglutide 0.5 mg Subjects received semaglutide 0.25 mg subcutaneous (sc) injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.	Semaglutide 1.0 mg Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30.Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.	Placebo Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Overall Study Unclassified	5	5	7

Baseline Characteristics

Number of participants analysed=participants with available data for insulin dose at baseline.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Semaglutide 0.5 mg n=132 Participants Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.	Semaglutide 1.0 mg n=131 Participants Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.	Placebo n=133 Participants Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.	Total n=396 Participants Total of all reporting groups
Age, Continuous	59.1 years STANDARD_DEVIATION 10.3 • n=132 Participants	58.5 years STANDARD_DEVIATION 9.0 • n=131 Participants	58.8 years STANDARD_DEVIATION 10.9 • n=133 Participants	58.8 years STANDARD_DEVIATION 10.1 • n=396 Participants
Age, Customized Adults (18-64 years)	93 participants n=132 Participants	102 participants n=131 Participants	86 participants n=133 Participants	281 participants n=396 Participants
Age, Customized From 65-84 years	39 participants n=132 Participants	29 participants n=131 Participants	46 participants n=133 Participants	114 participants n=396 Participants
Age, Customized 85 years and over	0 participants n=132 Participants	0 participants n=131 Participants	1 participants n=133 Participants	1 participants n=396 Participants
Sex: Female, Male Female	58 Participants n=132 Participants	54 Participants n=131 Participants	62 Participants n=133 Participants	174 Participants n=396 Participants
Sex: Female, Male Male	74 Participants n=132 Participants	77 Participants n=131 Participants	71 Participants n=133 Participants	222 Participants n=396 Participants
Glycosylated haemoglobin	8.36 percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.83 • n=132 Participants	8.31 percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.82 • n=131 Participants	8.42 percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.88 • n=133 Participants	8.37 percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.84 • n=396 Participants
Body weight	92.74 kg STANDARD_DEVIATION 19.57 • n=132 Participants	92.49 kg STANDARD_DEVIATION 22.23 • n=131 Participants	89.88 kg STANDARD_DEVIATION 21.06 • n=133 Participants	91.70 kg STANDARD_DEVIATION 20.97 • n=396 Participants
Fasting plasma glucose	161.0 mg/dL STANDARD_DEVIATION 62.38 • n=132 Participants	152.5 mg/dL STANDARD_DEVIATION 50.91 • n=131 Participants	154.1 mg/dL STANDARD_DEVIATION 46.66 • n=133 Participants	155.9 mg/dL STANDARD_DEVIATION 53.68 • n=396 Participants
Insulin dose	35.00 international unit n=131 Participants • Number of participants analysed=participants with available data for insulin dose at baseline.	36.00 international unit n=131 Participants • Number of participants analysed=participants with available data for insulin dose at baseline.	36.00 international unit n=133 Participants • Number of participants analysed=participants with available data for insulin dose at baseline.	36.00 international unit n=395 Participants • Number of participants analysed=participants with available data for insulin dose at baseline.
Diastolic Blood Pressure	78.89 mm Hg STANDARD_DEVIATION 9.72 • n=132 Participants	78.73 mm Hg STANDARD_DEVIATION 9.98 • n=131 Participants	79.35 mm Hg STANDARD_DEVIATION 9.71 • n=133 Participants	78.99 mm Hg STANDARD_DEVIATION 9.79 • n=396 Participants
Systolic Blood Pressure	134.87 mm Hg STANDARD_DEVIATION 15.00 • n=132 Participants	134.40 mm Hg STANDARD_DEVIATION 16.32 • n=131 Participants	134.99 mm Hg STANDARD_DEVIATION 16.68 • n=133 Participants	134.76 mm Hg STANDARD_DEVIATION 15.98 • n=396 Participants
Diabetes Treatment Satisfaction Questionnaire	28.86 scores on scale STANDARD_DEVIATION 6.35 • n=132 Participants	28.62 scores on scale STANDARD_DEVIATION 6.45 • n=131 Participants	27.54 scores on scale STANDARD_DEVIATION 6.55 • n=133 Participants	28.34 scores on scale STANDARD_DEVIATION 6.46 • n=396 Participants

PRIMARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=132 Participants Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.	Semaglutide 1.0 mg n=131 Participants Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.	Placebo n=133 Participants Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Change in HbA1c (Glycosylated Haemoglobin)	-1.45 percentage of glycosylated hemoglobin Standard Error 0.09	-1.85 percentage of glycosylated hemoglobin Standard Error 0.09	-0.09 percentage of glycosylated hemoglobin Standard Error 0.09

SECONDARY outcome

Timeframe: Week 0, week 30

Population: Full analysis set.

Estimated mean change from baseline in body weight at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \[\<= 8.0% or \> 8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=132 Participants Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.	Semaglutide 1.0 mg n=131 Participants Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.	Placebo n=133 Participants Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Change in Body Weight	-3.67 kg Standard Error 0.36	-6.42 kg Standard Error 0.36	-1.36 kg Standard Error 0.37

SECONDARY outcome

Timeframe: week 0, week 30

Population: Full analysis set.

Estimated mean change from baseline in FPG at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \[\<= 8.0% or \> 8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=132 Participants Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.	Semaglutide 1.0 mg n=131 Participants Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.	Placebo n=133 Participants Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Change in Fasting Plasma Glucose (FPG)	-29.14 mg/dL Standard Error 3.74	-42.38 mg/dL Standard Error 3.76	-8.51 mg/dL Standard Error 4.02

SECONDARY outcome

Timeframe: week 0, week 30

Population: Full analysis set

Estimated mean change from baseline in insulin dose at week 30 was measured in terms of ratio to baseline. Responses at week 30 are analysed using an Analysis of covariance model with treatment, country and stratification variable (HbA1c level at screening \[\<= 8.0% or \> 8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using last observation carried forward.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=132 Participants Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.	Semaglutide 1.0 mg n=131 Participants Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.	Placebo n=133 Participants Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Change in Insulin Dose	0.90 ratio Standard Error 0.01	0.85 ratio Standard Error 0.01	0.96 ratio Standard Error 0.01

SECONDARY outcome

Timeframe: week 0, week 30

Population: Full analysis set

Estimated mean change from baseline in systolic and diastolic blood pressure at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \[\<= 8.0% or \> 8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=132 Participants Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.	Semaglutide 1.0 mg n=131 Participants Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.	Placebo n=133 Participants Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Change in Systolic and Diastolic Blood Pressure Diastolic blood pressure	-1.84 mm Hg Standard Error 0.73	-1.50 mm Hg Standard Error 0.74	-2.17 mm Hg Standard Error 0.79
Change in Systolic and Diastolic Blood Pressure Systolic blood pressure	-4.29 mm Hg Standard Error 1.26	-7.27 mm Hg Standard Error 1.27	-0.99 mm Hg Standard Error 1.34

SECONDARY outcome

Timeframe: week 0, week 30

Population: Full analysis set

The DTSQs questionnaire was used to assess subjects' treatment satisfaction and contained 8 components and evaluates the diabetes treatment (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings towards the treatment. The result 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 post-baseline responses are analysed using an ANCOVA model with treatment, country and stratification variables (HbA1c level at screening \[\<= 8.0% or \> 8.0%\] and use of metformin \[yes or no\]) as fixed factors and baseline value as covariate. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using last observation carried forward.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=132 Participants Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.	Semaglutide 1.0 mg n=131 Participants Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.	Placebo n=133 Participants Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Patient Reported Outcomes, Diabetes Treatment Satisfaction Questionnaire (DTSQ)	2.73 scores on a scale Standard Error 0.46	3.47 scores on a scale Standard Error 0.46	1.25 scores on a scale Standard Error 0.50

SECONDARY outcome

Timeframe: After 30 weeks treatment

Population: Full analysis set

Percentage of subjects with HbA1C below 7.0% after 30 weeks treatment. Missing data imputed from a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \[\<= 8.0% or \> 8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=132 Participants Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.	Semaglutide 1.0 mg n=131 Participants Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.	Placebo n=133 Participants Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target	60.6 percentage of subjects	78.6 percentage of subjects	10.5 percentage of subjects

SECONDARY outcome

Timeframe: After 30 weeks treatment

Population: Full analysis set.

Percentage of participants with HbA1c below or equal to 6.5% after 30 weeks treatment. Missing data imputed from a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \[\<= 8.0% or \> 8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit.

Outcome measures

Outcome measures
Measure	Semaglutide 0.5 mg n=132 Participants Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.	Semaglutide 1.0 mg n=131 Participants Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.	Placebo n=133 Participants Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target	40.9 percentage of subjects	61.1 percentage of subjects	4.5 percentage of subjects

Adverse Events

Semaglutide 0.5 mg

Serious events: 8 serious events

Other events: 52 other events

Deaths: 0 deaths

Semaglutide 1.0 mg

Serious events: 12 serious events

Other events: 54 other events

Deaths: 0 deaths

Placebo

Serious events: 9 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Semaglutide 0.5 mg n=132 participants at risk Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.	Semaglutide 1.0 mg n=131 participants at risk Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.	Placebo n=133 participants at risk Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Metabolism and nutrition disorders Decreased appetite	3.8% 5/132 • Number of events 5 • From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks). 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% 7/131 • Number of events 7 • From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks). 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.	0.75% 1/133 • Number of events 1 • From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks). 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	4.5% 6/132 • Number of events 6 • From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks). 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.	6.9% 9/131 • Number of events 9 • From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks). 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.	1.5% 2/133 • Number of events 2 • From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks). 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	9.1% 12/132 • Number of events 15 • From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks). 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% 7/131 • Number of events 7 • From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks). 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.	3.0% 4/133 • Number of events 4 • From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks). 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	8.3% 11/132 • Number of events 14 • From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks). 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.	4.6% 6/131 • Number of events 6 • From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks). 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.	10.5% 14/133 • Number of events 16 • From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks). 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	11.4% 15/132 • Number of events 21 • From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks). 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.	16.8% 22/131 • Number of events 23 • From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks). 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.	4.5% 6/133 • Number of events 6 • From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks). 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	6.1% 8/132 • Number of events 10 • From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks). 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.	0.76% 1/131 • Number of events 1 • From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks). 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.	3.0% 4/133 • Number of events 4 • From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks). 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 Urinary tract infection	1.5% 2/132 • Number of events 3 • From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks). 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.	3.1% 4/131 • Number of events 5 • From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks). 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.	6.0% 8/133 • Number of events 11 • From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks). 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	6.1% 8/132 • Number of events 9 • From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks). 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.	11.5% 15/131 • Number of events 17 • From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks). 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.	3.0% 4/133 • Number of events 4 • From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks). 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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. At the end of the trial, one or more manuscripts for publication will be prepared collaboratively between Investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for less than 60 days to protect intellectual property.
Publication restrictions are in place

Restriction type: OTHER