Trial Outcomes & Findings for A Research Study to Compare Two Doses of Semaglutide Taken Once Weekly in People With Type 2 Diabetes (NCT NCT03989232)
NCT ID: NCT03989232
Last Updated: 2023-02-13
Results Overview
Change from baseline (week 0) to week 40 in glycosylated haemoglobin (HbA1c) was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first; and 'In-trial' observation period which started at the date of randomisation and ended at the first of the following dates, both inclusive: end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
961 participants
Primary outcome timeframe
Week 0, week 40
Results posted on
2023-02-13
Participant Flow
The trial was conducted at 125 sites in Bulgaria (9), Canada (8), Czech Republic (4), Greece (6), Hungary (12), Japan (2), Poland (10), Slovakia (11), Ukraine (5) and the United States (58). In addition to these sites, 4 sites in the US screened but did not randomize participants, and 3 sites were approved by the IRB/IEC but did not screen or assign any participants to treatment.
Participants with type 2 diabetes (T2D) treated with stable doses of metformin only, or metformin in combination with sulfonylurea (SU), in need of the treatment intensification were randomized 1:1 to once-weekly treatment with semaglutide 2.0 milligrams (mg) or once-weekly treatment with semaglutide 1.0 mg.
Participant milestones
| Measure |
Semaglutide 1.0 mg
Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
|
Semaglutide 2.0 mg
Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
481
|
480
|
|
Overall Study
Exposed
|
480
|
479
|
|
Overall Study
Safety Analysis Set (SAS)
|
480
|
479
|
|
Overall Study
Full Analysis Set (FAS)
|
481
|
480
|
|
Overall Study
COMPLETED
|
471
|
462
|
|
Overall Study
NOT COMPLETED
|
10
|
18
|
Reasons for withdrawal
| Measure |
Semaglutide 1.0 mg
Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
|
Semaglutide 2.0 mg
Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
10
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
|
Overall Study
Death
|
1
|
2
|
Baseline Characteristics
A Research Study to Compare Two Doses of Semaglutide Taken Once Weekly in People With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Semaglutide 1.0 mg
n=481 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
|
Semaglutide 2.0 mg
n=480 Participants
Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
|
Total
n=961 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.2 Years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
57.9 Years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
58.0 Years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
197 Participants
n=5 Participants
|
201 Participants
n=7 Participants
|
398 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
284 Participants
n=5 Participants
|
279 Participants
n=7 Participants
|
563 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
59 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
422 Participants
n=5 Participants
|
428 Participants
n=7 Participants
|
850 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
36 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
17 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
427 Participants
n=5 Participants
|
420 Participants
n=7 Participants
|
847 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0, week 40Population: The FAS included all randomized participants. Number analyzed=number of participants contributed to the analysis.
Change from baseline (week 0) to week 40 in glycosylated haemoglobin (HbA1c) was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first; and 'In-trial' observation period which started at the date of randomisation and ended at the first of the following dates, both inclusive: end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up.
Outcome measures
| Measure |
Semaglutide 1.0 mg
n=481 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
|
Semaglutide 2.0 mg
n=480 Participants
Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
|
|---|---|---|
|
Change in HbA1c
On-treatment without rescue medication
|
-2.0 Percentage change
Standard Deviation 1.0
|
-2.2 Percentage change
Standard Deviation 1.0
|
|
Change in HbA1c
In-trial
|
-1.9 Percentage change
Standard Deviation 1.0
|
-2.2 Percentage change
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Week 0, week 40Population: The FAS included all randomized participants. Number analyzed=number of participants contributed to the analysis.
Change from baseline (week 0) to week 40 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first; and 'In-trial' observation period which started at the date of randomisation and ended at the first of the following dates, both inclusive: end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up.
Outcome measures
| Measure |
Semaglutide 1.0 mg
n=481 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
|
Semaglutide 2.0 mg
n=480 Participants
Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
|
|---|---|---|
|
Change in Body Weight
On-treatment without rescue medication
|
-6.0 Kilogram (kg)
Standard Deviation 5.8
|
-7.0 Kilogram (kg)
Standard Deviation 5.8
|
|
Change in Body Weight
In-trial
|
-5.7 Kilogram (kg)
Standard Deviation 5.9
|
-6.7 Kilogram (kg)
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Week 0, week 40Population: The FAS included all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.
Change from baseline (week 0) to week 40 in FPG was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.
Outcome measures
| Measure |
Semaglutide 1.0 mg
n=423 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
|
Semaglutide 2.0 mg
n=429 Participants
Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
|
|---|---|---|
|
Change in Fasting Plasma Glucose (FPG)
|
-3.2 Millimoles per liter (mmol/L)
Standard Deviation 2.8
|
-3.4 Millimoles per liter (mmol/L)
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Week 0, week 40Population: The FAS included all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.
Change from baseline (week 0) to week 40 in BMI was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.
Outcome measures
| Measure |
Semaglutide 1.0 mg
n=425 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
|
Semaglutide 2.0 mg
n=434 Participants
Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
|
|---|---|---|
|
Change in Body Mass Index (BMI)
|
-2.1 Kilogram per squaremeter (Kg/m^2)
Standard Deviation 2.1
|
-2.5 Kilogram per squaremeter (Kg/m^2)
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Week 0, week 40Population: The FAS included all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.
Change from baseline (week 0) to week 40 in waist circumference was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.
Outcome measures
| Measure |
Semaglutide 1.0 mg
n=423 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
|
Semaglutide 2.0 mg
n=433 Participants
Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
|
|---|---|---|
|
Change in Waist Circumference
|
-5.2 Centimeter (cm)
Standard Deviation 6.1
|
-5.9 Centimeter (cm)
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: Week 40Population: The FAS included all randomized participants.
Percentage of participants who achieved HbA1c \< 7.0% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing HbA1c assessment at week 40 was imputed using observed data from participants within same treatment group.
Outcome measures
| Measure |
Semaglutide 1.0 mg
n=481 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
|
Semaglutide 2.0 mg
n=480 Participants
Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
|
|---|---|---|
|
Participants Who Achieved HbA1c < 7.0%
|
57.5 Percentage of participants
|
67.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 40Population: The FAS included all randomized participants.
Percentage of participants who achieved HbA1c ≤ 6.5% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing HbA1c assessment at week 40 was imputed using observed data from participants within same treatment group.
Outcome measures
| Measure |
Semaglutide 1.0 mg
n=481 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
|
Semaglutide 2.0 mg
n=480 Participants
Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
|
|---|---|---|
|
Participants Who Achieved HbA1c ≤ 6.5%
|
38.5 Percentage of participants
|
51.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 40Population: The FAS included all randomized participants.
Percentage of participants who achieved weight loss ≥5% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing body weight assessment at week 40 was imputed using observed data from participants within same treatment group.
Outcome measures
| Measure |
Semaglutide 1.0 mg
n=481 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
|
Semaglutide 2.0 mg
n=480 Participants
Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
|
|---|---|---|
|
Participants Who Achieved Weight Loss ≥5%
|
51.3 Percentage of participants
|
59.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 40Population: The FAS included all randomized participants.
Percentage of participants who achieved weight loss ≥10% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing body weight assessment at week 40 was imputed using observed data from participants within same treatment group.
Outcome measures
| Measure |
Semaglutide 1.0 mg
n=481 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
|
Semaglutide 2.0 mg
n=480 Participants
Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
|
|---|---|---|
|
Participants Who Achieved Weight Loss ≥10%
|
22.6 Percentage of participants
|
28.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 0 to week 47Population: The SAS included all participants exposed to at least one dose of trial product.
Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that required assistance from another person for recovery and blood glucose-confirmed by a plasma glucose value \<3.1 mmol/L (56 milligrams per deciliter (mg/dL)) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period, which started at the date of first dose of trial product and ended at the first date of any of the following: the follow-up visit (week 47), the treatment discontinuation follow-up visit (end of treatment + 7 weeks), the date of last dose of trial product +49 days or the end-date for the 'in-trial' observation period.
Outcome measures
| Measure |
Semaglutide 1.0 mg
n=480 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
|
Semaglutide 2.0 mg
n=479 Participants
Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
|
|---|---|---|
|
Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
|
28 Episodes
|
21 Episodes
|
SECONDARY outcome
Timeframe: Week 0, week 40Population: The SAS included all participants exposed to at least one dose of trial product. Overall number of participants analyzed=number of participants contributed to the analysis.
Change from baseline (week 0) to week 40 in pulse rate is presented. Results are based on the 'on-treatment' observation period, which started at the date of first dose of trial product and ended at the endpoint-specific end-date.
Outcome measures
| Measure |
Semaglutide 1.0 mg
n=444 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
|
Semaglutide 2.0 mg
n=442 Participants
Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
|
|---|---|---|
|
Change in Pulse Rate
|
2.8 Beats per minute
Standard Deviation 10.0
|
3.3 Beats per minute
Standard Deviation 9.5
|
Adverse Events
Semaglutide 1.0 mg
Serious events: 25 serious events
Other events: 126 other events
Deaths: 1 deaths
Semaglutide 2.0 mg
Serious events: 21 serious events
Other events: 132 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Semaglutide 1.0 mg
n=480 participants at risk
Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
|
Semaglutide 2.0 mg
n=479 participants at risk
Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.21%
1/480 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.42%
2/480 • Number of events 2 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.42%
2/479 • Number of events 2 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.42%
2/480 • Number of events 2 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.21%
1/479 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/480 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.21%
1/479 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.21%
1/480 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/480 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.21%
1/479 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/480 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.21%
1/479 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Vascular disorders
Aortic dilatation
|
0.21%
1/480 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/480 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.21%
1/479 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.21%
1/480 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/480 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.21%
1/479 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.21%
1/480 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/480 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.21%
1/479 • Number of events 2 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/480 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.21%
1/479 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.21%
1/480 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
General disorders
Chest discomfort
|
0.00%
0/480 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.21%
1/479 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.21%
1/480 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.21%
1/480 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/480 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.21%
1/479 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/480 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.21%
1/479 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Cardiac disorders
Coronary artery disease
|
0.21%
1/480 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.21%
1/479 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.62%
3/480 • Number of events 3 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
General disorders
Death; reason unknown
|
0.00%
0/480 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.21%
1/479 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.42%
2/480 • Number of events 2 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.21%
1/480 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.21%
1/480 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Infections and infestations
Gangrene
|
0.00%
0/480 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.21%
1/479 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Renal and urinary disorders
Glomerulonephritis membranous
|
0.00%
0/480 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.21%
1/479 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/480 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.21%
1/479 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/480 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.21%
1/479 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.21%
1/480 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.42%
2/480 • Number of events 2 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.21%
1/480 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.21%
1/480 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/480 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.21%
1/479 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Nervous system disorders
Migraine
|
0.21%
1/480 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.21%
1/480 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Gastrointestinal disorders
Nausea
|
0.21%
1/480 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Nervous system disorders
Neuromyelitis optica spectrum disorder
|
0.21%
1/480 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/480 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.21%
1/479 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/480 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.21%
1/479 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.21%
1/480 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.21%
1/480 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/480 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.21%
1/479 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.21%
1/480 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/480 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.21%
1/479 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/480 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.21%
1/479 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Investigations
Smear cervix abnormal
|
0.00%
0/480 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.21%
1/479 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.21%
1/480 • Number of events 3 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the cervix
|
0.21%
1/480 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/480 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.21%
1/479 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Investigations
Transaminases increased
|
0.21%
1/480 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.21%
1/480 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/480 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.21%
1/479 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Gastrointestinal disorders
Vomiting
|
0.21%
1/480 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Investigations
Weight decreased
|
0.21%
1/480 • Number of events 1 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
0.00%
0/479 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
Other adverse events
| Measure |
Semaglutide 1.0 mg
n=480 participants at risk
Participants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks.
|
Semaglutide 2.0 mg
n=479 participants at risk
Participants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks.
|
|---|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.8%
18/480 • Number of events 18 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
6.1%
29/479 • Number of events 29 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.8%
42/480 • Number of events 83 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
9.4%
45/479 • Number of events 51 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.2%
25/480 • Number of events 26 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
3.3%
16/479 • Number of events 17 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Gastrointestinal disorders
Nausea
|
14.6%
70/480 • Number of events 98 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
14.4%
69/479 • Number of events 98 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
32/480 • Number of events 40 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
7.7%
37/479 • Number of events 55 • Weeks 0-47
All presented AEs are TEAEs. A TEAE was defined as an event that had onset during the on-treatment period. Results are based on the SAS which comprised of all participants exposed to at least one dose of trial product.
|
Additional Information
Clinical Transparency and Medical Writing Office (1452)
Novo Nordisk A/S
Phone: (+1) 866-867-7178
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER