Trial Outcomes & Findings for Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes (NCT NCT02054897)
NCT ID: NCT02054897
Last Updated: 2019-06-12
Results Overview
Change from baseline (week 0) in HbA1c was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
388 participants
Primary outcome timeframe
Week 0, week 30
Results posted on
2019-06-12
Participant Flow
Out of 87 sites, selected for recruitment, 72 sites in 8 countries randomised subjects: Canada: 7 sites; Italy: 6 sites; Japan: 5 sites; Mexico: 2 sites; Russian Federation: 8 sites; South Africa: 8 sites; United Kingdom: 4 sites; United States: 32 sites.
Participant milestones
| Measure |
Semaglutide 0.5 mg
Subjects were given 0.25 mg semaglutide once weekly subcutaneous (s.c.; under the skin) injections for 4 weeks followed by 0.5 mg semaglutide once weekly for the remaining 26 weeks of the treatment period.
|
Semaglutide 1.0 mg
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
|
Placebo
Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.
1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.
2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.
|
|---|---|---|---|
|
Overall Study
STARTED
|
129
|
130
|
129
|
|
Overall Study
Exposed
|
128
|
130
|
129
|
|
Overall Study
COMPLETED
|
119
|
123
|
117
|
|
Overall Study
NOT COMPLETED
|
10
|
7
|
12
|
Reasons for withdrawal
| Measure |
Semaglutide 0.5 mg
Subjects were given 0.25 mg semaglutide once weekly subcutaneous (s.c.; under the skin) injections for 4 weeks followed by 0.5 mg semaglutide once weekly for the remaining 26 weeks of the treatment period.
|
Semaglutide 1.0 mg
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
|
Placebo
Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.
1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.
2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
2
|
|
Overall Study
Missing follow-up information
|
3
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
7
|
|
Overall Study
Randomized but not exposed
|
1
|
0
|
0
|
Baseline Characteristics
Number of subjects analysed=subjects with data available for fasting plasma glucose at baseline.
Baseline characteristics by cohort
| Measure |
Semaglutide 0.5 mg
n=128 Participants
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
|
Semaglutide 1.0 mg
n=130 Participants
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
|
Placebo
n=129 Participants
Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.
1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.
2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.
|
Total
n=387 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.6 Years
STANDARD_DEVIATION 11.1 • n=128 Participants
|
52.7 Years
STANDARD_DEVIATION 11.9 • n=130 Participants
|
53.9 Years
STANDARD_DEVIATION 11.0 • n=129 Participants
|
53.7 Years
STANDARD_DEVIATION 11.3 • n=387 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=128 Participants
|
50 Participants
n=130 Participants
|
59 Participants
n=129 Participants
|
177 Participants
n=387 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=128 Participants
|
80 Participants
n=130 Participants
|
70 Participants
n=129 Participants
|
210 Participants
n=387 Participants
|
|
Glycosylated haemoglobin (HbA1c)
|
8.09 percentage of HbA1c
STANDARD_DEVIATION 0.89 • n=128 Participants
|
8.12 percentage of HbA1c
STANDARD_DEVIATION 0.81 • n=130 Participants
|
7.95 percentage of HbA1c
STANDARD_DEVIATION 0.85 • n=129 Participants
|
8.05 percentage of HbA1c
STANDARD_DEVIATION 0.85 • n=387 Participants
|
|
Fasting plasma glucose
|
9.66 mmol/L
STANDARD_DEVIATION 2.77 • n=125 Participants • Number of subjects analysed=subjects with data available for fasting plasma glucose at baseline.
|
9.90 mmol/L
STANDARD_DEVIATION 2.50 • n=129 Participants • Number of subjects analysed=subjects with data available for fasting plasma glucose at baseline.
|
9.68 mmol/L
STANDARD_DEVIATION 2.77 • n=127 Participants • Number of subjects analysed=subjects with data available for fasting plasma glucose at baseline.
|
9.75 mmol/L
STANDARD_DEVIATION 2.67 • n=381 Participants • Number of subjects analysed=subjects with data available for fasting plasma glucose at baseline.
|
|
Body weight
|
89.81 kilogram(s)
STANDARD_DEVIATION 22.96 • n=128 Participants
|
96.87 kilogram(s)
STANDARD_DEVIATION 25.59 • n=130 Participants
|
89.05 kilogram(s)
STANDARD_DEVIATION 22.16 • n=129 Participants
|
91.93 kilogram(s)
STANDARD_DEVIATION 23.83 • n=387 Participants
|
|
Diastolic blood pressure
|
79.52 mmHg
STANDARD_DEVIATION 9.06 • n=128 Participants
|
79.25 mmHg
STANDARD_DEVIATION 8.52 • n=130 Participants
|
79.14 mmHg
STANDARD_DEVIATION 8.39 • n=129 Participants
|
79.30 mmHg
STANDARD_DEVIATION 8.64 • n=387 Participants
|
|
Systolic blood pressure
|
127.87 mmHg
STANDARD_DEVIATION 13.15 • n=128 Participants
|
128.89 mmHg
STANDARD_DEVIATION 12.92 • n=130 Participants
|
129.57 mmHg
STANDARD_DEVIATION 13.50 • n=129 Participants
|
128.78 mmHg
STANDARD_DEVIATION 13.18 • n=387 Participants
|
PRIMARY outcome
Timeframe: Week 0, week 30Population: Full analysis set
Change from baseline (week 0) in HbA1c was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Outcome measures
| Measure |
Semaglutide 0.5 mg
n=128 Participants
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
|
Semaglutide 1.0 mg
n=130 Participants
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
|
Placebo
n=129 Participants
Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.
1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.
2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.
|
|---|---|---|---|
|
Change in HbA1c (Glycosylated Haemoglobin)
|
-1.47 Percentage of HbA1c
Standard Deviation 1.02
|
-1.56 Percentage of HbA1c
Standard Deviation 1.26
|
-0.00 Percentage of HbA1c
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: Week 0, week 30Population: Full analysis set
Change from baseline (week 0) in body weight was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Outcome measures
| Measure |
Semaglutide 0.5 mg
n=128 Participants
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
|
Semaglutide 1.0 mg
n=130 Participants
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
|
Placebo
n=129 Participants
Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.
1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.
2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.
|
|---|---|---|---|
|
Change in Body Weight
|
-3.68 kilogram(s)
Standard Deviation 4.03
|
-4.67 kilogram(s)
Standard Deviation 5.19
|
-0.89 kilogram(s)
Standard Deviation 3.46
|
SECONDARY outcome
Timeframe: Week 0, week 30Population: Full analysis set. Number of subject analysed=subjects who contributed to the analysis.
Change from baseline (week 0) in FPG was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Outcome measures
| Measure |
Semaglutide 0.5 mg
n=125 Participants
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
|
Semaglutide 1.0 mg
n=129 Participants
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
|
Placebo
n=127 Participants
Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.
1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.
2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.
|
|---|---|---|---|
|
Change in Fasting Plasma Glucose (FPG)
|
-2.41 mmol/L
Standard Deviation 2.55
|
-2.39 mmol/L
Standard Deviation 2.74
|
-0.55 mmol/L
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Week 0, week 30Population: Full analysis set
Change from baseline (week 0) in systolic and diastolic blood pressure was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Outcome measures
| Measure |
Semaglutide 0.5 mg
n=128 Participants
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
|
Semaglutide 1.0 mg
n=130 Participants
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
|
Placebo
n=129 Participants
Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.
1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.
2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.
|
|---|---|---|---|
|
Change in Systolic and Diastolic Blood Pressure
Systolic blood pressure
|
-2.29 mmHg
Standard Deviation 12.58
|
-2.74 mmHg
Standard Deviation 11.58
|
-2.01 mmHg
Standard Deviation 11.23
|
|
Change in Systolic and Diastolic Blood Pressure
Diastolic blood pressure
|
-0.73 mmHg
Standard Deviation 6.88
|
0.22 mmHg
Standard Deviation 7.6
|
0.60 mmHg
Standard Deviation 7.59
|
SECONDARY outcome
Timeframe: At 30 weeks of treatmentPopulation: Full analysis set
Percentage of subjects who achieve (yes/no): HbA1c below 7.0% (53 mmol/mol) American Diabetes Association target after 30 weeks' treatment. Missing HbA1c data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Outcome measures
| Measure |
Semaglutide 0.5 mg
n=128 Participants
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
|
Semaglutide 1.0 mg
n=130 Participants
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
|
Placebo
n=129 Participants
Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.
1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.
2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.
|
|---|---|---|---|
|
Subjects Who Achieve (Yes/no):HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association Target
Yes
|
74.2 Percentage of subjects
|
72.3 Percentage of subjects
|
24.8 Percentage of subjects
|
|
Subjects Who Achieve (Yes/no):HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association Target
No
|
25.8 Percentage of subjects
|
27.7 Percentage of subjects
|
75.2 Percentage of subjects
|
SECONDARY outcome
Timeframe: At 30 weeks of treatmentPopulation: Full analysis set
Percentage of subjects who achieve (yes/no): HbA1c below 6.5% (48 mmol/mol) American Diabetes Association target after 30 weeks' treatment. Missing HbA1c data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Outcome measures
| Measure |
Semaglutide 0.5 mg
n=128 Participants
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
|
Semaglutide 1.0 mg
n=130 Participants
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
|
Placebo
n=129 Participants
Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.
1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.
2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.
|
|---|---|---|---|
|
Subjects Who Achieve (Yes/no):HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target
Yes
|
59.4 Percentage of subjects
|
60.0 Percentage of subjects
|
13.2 Percentage of subjects
|
|
Subjects Who Achieve (Yes/no):HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target
No
|
40.6 Percentage of subjects
|
40.0 Percentage of subjects
|
86.8 Percentage of subjects
|
Adverse Events
Semaglutide 0.5 mg
Serious events: 7 serious events
Other events: 53 other events
Deaths: 0 deaths
Semaglutide 1.0 mg
Serious events: 7 serious events
Other events: 47 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Semaglutide 0.5 mg
n=128 participants at risk
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
|
Semaglutide 1.0 mg
n=130 participants at risk
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
|
Placebo
n=129 participants at risk
Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.
1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.
2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/128 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.77%
1/130 • Number of events 1 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/129 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/128 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/130 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.78%
1/129 • Number of events 1 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.78%
1/128 • Number of events 1 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/130 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/129 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/128 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.77%
1/130 • Number of events 1 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/129 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.78%
1/128 • Number of events 1 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/130 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/129 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Surgical and medical procedures
Coronary revascularisation
|
0.00%
0/128 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.77%
1/130 • Number of events 1 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/129 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Infections and infestations
Cystitis
|
0.78%
1/128 • Number of events 1 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/130 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/129 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Infections and infestations
Encephalitis
|
0.78%
1/128 • Number of events 1 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/130 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/129 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Surgical and medical procedures
Gastric bypass
|
0.00%
0/128 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
1.5%
2/130 • Number of events 2 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/129 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/128 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/130 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.78%
1/129 • Number of events 2 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Gastrointestinal disorders
Gastritis
|
0.78%
1/128 • Number of events 1 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/130 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/129 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
General disorders
Inflammation
|
0.00%
0/128 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/130 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.78%
1/129 • Number of events 1 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Infections and infestations
Lobar pneumonia
|
0.78%
1/128 • Number of events 1 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/130 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/129 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Psychiatric disorders
Mental disorder
|
0.78%
1/128 • Number of events 1 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/130 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/129 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/128 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/130 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.78%
1/129 • Number of events 1 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.78%
1/128 • Number of events 1 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/130 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/129 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/128 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.77%
1/130 • Number of events 1 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/129 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.78%
1/128 • Number of events 1 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/130 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/129 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/128 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.77%
1/130 • Number of events 1 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/129 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/128 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/130 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.78%
1/129 • Number of events 1 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.78%
1/128 • Number of events 1 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/130 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/129 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/128 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.77%
1/130 • Number of events 1 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.00%
0/129 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
Other adverse events
| Measure |
Semaglutide 0.5 mg
n=128 participants at risk
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
|
Semaglutide 1.0 mg
n=130 participants at risk
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
|
Placebo
n=129 participants at risk
Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.
1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.
2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
6.2%
8/128 • Number of events 9 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
3.8%
5/130 • Number of events 5 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
0.78%
1/129 • Number of events 2 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
16/128 • Number of events 27 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
10.8%
14/130 • Number of events 19 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
2.3%
3/129 • Number of events 3 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.5%
7/128 • Number of events 13 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
3.8%
5/130 • Number of events 5 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
2.3%
3/129 • Number of events 3 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Nervous system disorders
Headache
|
11.7%
15/128 • Number of events 43 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
6.9%
9/130 • Number of events 18 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
6.2%
8/129 • Number of events 13 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Investigations
Lipase increased
|
6.2%
8/128 • Number of events 10 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
3.8%
5/130 • Number of events 5 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
3.9%
5/129 • Number of events 5 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Infections and infestations
Nasopharyngitis
|
4.7%
6/128 • Number of events 7 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
4.6%
6/130 • Number of events 9 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
5.4%
7/129 • Number of events 9 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Gastrointestinal disorders
Nausea
|
20.3%
26/128 • Number of events 44 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
23.8%
31/130 • Number of events 46 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
7.8%
10/129 • Number of events 12 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
|
Gastrointestinal disorders
Vomiting
|
3.9%
5/128 • Number of events 11 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
6.9%
9/130 • Number of events 15 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
1.6%
2/129 • Number of events 2 • From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property
- Publication restrictions are in place
Restriction type: OTHER