Trial Outcomes & Findings for A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide (NCT NCT00696657)
NCT ID: NCT00696657
Last Updated: 2019-08-14
Results Overview
Change from baseline in HbA1c was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the last observation carried forward (LOCF) approach.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
415 participants
Primary outcome timeframe
After 12 weeks of treatment.
Results posted on
2019-08-14
Participant Flow
The trial was conducted at 80 sites in 14 countries: Austria (8), Bulgaria (6), Finland (6), France (5), Germany (7), Hungary (5), India (4), Italy (6), Serbia (3), South Africa (3), Spain (6), Switzerland (4), Turkey (5), and United Kingdom (12).
Study Design: This was a 9 armed parallel group trial. Subjects were randomised in a 1:1:1:1:1:1:1:1:1 manner to receive one of five doses of blinded semaglutide once-weekly (0.1 mg, 0.2 mg, 0.4 mg, 0.8 mg, 0.8 mg T \[with titration\] and 1.6 mg T \[with titration\]) or blinded placebo once-weekly or open-label liraglutide 1.2 mg or 1.8 mg once-daily.
Participant milestones
| Measure |
Placebo
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected subcutaneously (s.c.; under the skin) in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
46
|
47
|
44
|
49
|
44
|
45
|
45
|
45
|
50
|
|
Overall Study
EXPOSED
|
46
|
47
|
43
|
48
|
44
|
43
|
45
|
45
|
50
|
|
Overall Study
COMPLETED
|
45
|
42
|
36
|
38
|
34
|
33
|
30
|
42
|
41
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
8
|
11
|
10
|
12
|
15
|
3
|
9
|
Reasons for withdrawal
| Measure |
Placebo
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected subcutaneously (s.c.; under the skin) in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal criteria
|
1
|
3
|
2
|
2
|
0
|
0
|
1
|
1
|
2
|
|
Overall Study
Unclassified
|
0
|
1
|
3
|
2
|
4
|
2
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
3
|
7
|
6
|
9
|
14
|
2
|
5
|
Baseline Characteristics
A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide
Baseline characteristics by cohort
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Total
n=411 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.3 Years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
55.2 Years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
54.7 Years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
53.8 Years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
55.0 Years
STANDARD_DEVIATION 9.7 • n=21 Participants
|
55.9 Years
STANDARD_DEVIATION 7.9 • n=10 Participants
|
56.4 Years
STANDARD_DEVIATION 10.5 • n=115 Participants
|
54.8 Years
STANDARD_DEVIATION 9.2 • n=6 Participants
|
54.3 Years
STANDARD_DEVIATION 10.1 • n=6 Participants
|
55.0 Years
STANDARD_DEVIATION 9.8 • n=64 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
14 Participants
n=6 Participants
|
15 Participants
n=6 Participants
|
144 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
27 Participants
n=10 Participants
|
26 Participants
n=115 Participants
|
31 Participants
n=6 Participants
|
35 Participants
n=6 Participants
|
267 Participants
n=64 Participants
|
|
Glycosylated haemoglobin (HbA1c)
|
8.1 Percentage (%) of HbA1c
STANDARD_DEVIATION 0.8 • n=5 Participants
|
8.2 Percentage (%) of HbA1c
STANDARD_DEVIATION 0.9 • n=7 Participants
|
8.2 Percentage (%) of HbA1c
STANDARD_DEVIATION 0.9 • n=5 Participants
|
8.1 Percentage (%) of HbA1c
STANDARD_DEVIATION 0.9 • n=4 Participants
|
8.2 Percentage (%) of HbA1c
STANDARD_DEVIATION 0.9 • n=21 Participants
|
8.0 Percentage (%) of HbA1c
STANDARD_DEVIATION 0.8 • n=10 Participants
|
8.0 Percentage (%) of HbA1c
STANDARD_DEVIATION 0.7 • n=115 Participants
|
8.0 Percentage (%) of HbA1c
STANDARD_DEVIATION 0.8 • n=6 Participants
|
8.1 Percentage (%) of HbA1c
STANDARD_DEVIATION 0.7 • n=6 Participants
|
8.1 Percentage (%) of HbA1c
STANDARD_DEVIATION 0.8 • n=64 Participants
|
|
Systolic blood pressure (SBP)
|
130.9 mmHg
STANDARD_DEVIATION 13.1 • n=5 Participants
|
129.4 mmHg
STANDARD_DEVIATION 11.6 • n=7 Participants
|
129.3 mmHg
STANDARD_DEVIATION 13.4 • n=5 Participants
|
134.0 mmHg
STANDARD_DEVIATION 12.9 • n=4 Participants
|
132.6 mmHg
STANDARD_DEVIATION 13.3 • n=21 Participants
|
130.3 mmHg
STANDARD_DEVIATION 13.0 • n=10 Participants
|
131.1 mmHg
STANDARD_DEVIATION 10.7 • n=115 Participants
|
128.0 mmHg
STANDARD_DEVIATION 10.2 • n=6 Participants
|
130.4 mmHg
STANDARD_DEVIATION 13.9 • n=6 Participants
|
130.7 mmHg
STANDARD_DEVIATION 12.5 • n=64 Participants
|
|
Diastolic blood pressure (DBP)
|
79.1 mmHg
STANDARD_DEVIATION 8.3 • n=5 Participants
|
79.1 mmHg
STANDARD_DEVIATION 6.5 • n=7 Participants
|
79.3 mmHg
STANDARD_DEVIATION 7.6 • n=5 Participants
|
81.9 mmHg
STANDARD_DEVIATION 7.5 • n=4 Participants
|
80.8 mmHg
STANDARD_DEVIATION 7.9 • n=21 Participants
|
79.4 mmHg
STANDARD_DEVIATION 9.3 • n=10 Participants
|
80.9 mmHg
STANDARD_DEVIATION 8.9 • n=115 Participants
|
80.0 mmHg
STANDARD_DEVIATION 9.2 • n=6 Participants
|
78.9 mmHg
STANDARD_DEVIATION 7.7 • n=6 Participants
|
79.9 mmHg
STANDARD_DEVIATION 8.1 • n=64 Participants
|
|
Pulse
|
70.4 Beats/min
STANDARD_DEVIATION 9.2 • n=5 Participants
|
74.2 Beats/min
STANDARD_DEVIATION 8.0 • n=7 Participants
|
72.8 Beats/min
STANDARD_DEVIATION 9.0 • n=5 Participants
|
74.3 Beats/min
STANDARD_DEVIATION 9.2 • n=4 Participants
|
74.7 Beats/min
STANDARD_DEVIATION 8.7 • n=21 Participants
|
74.2 Beats/min
STANDARD_DEVIATION 10.2 • n=10 Participants
|
73.9 Beats/min
STANDARD_DEVIATION 9.7 • n=115 Participants
|
72.3 Beats/min
STANDARD_DEVIATION 7.5 • n=6 Participants
|
74.6 Beats/min
STANDARD_DEVIATION 10.8 • n=6 Participants
|
73.5 Beats/min
STANDARD_DEVIATION 9.2 • n=64 Participants
|
PRIMARY outcome
Timeframe: After 12 weeks of treatment.Population: The full analysis set included all randomised subjects who had been exposed to at least 1 dose of the trial product (placebo/semaglutide/liraglutide). Four subjects mistakenly received a different treatment instead of the randomised treatment. The randomised treatment was applied regardless of the treatment actually received.
Change from baseline in HbA1c was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the last observation carried forward (LOCF) approach.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=44 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=45 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
HbA1c
|
-0.5 Percentage (%) of HbA1c
Standard Deviation 0.8
|
-0.6 Percentage (%) of HbA1c
Standard Deviation 0.7
|
-0.9 Percentage (%) of HbA1c
Standard Deviation 0.9
|
-1.0 Percentage (%) of HbA1c
Standard Deviation 0.8
|
-1.4 Percentage (%) of HbA1c
Standard Deviation 0.8
|
-1.4 Percentage (%) of HbA1c
Standard Deviation 1.0
|
-1.5 Percentage (%) of HbA1c
Standard Deviation 0.8
|
-1.1 Percentage (%) of HbA1c
Standard Deviation 0.7
|
-1.3 Percentage (%) of HbA1c
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: After 12 weeks of treatment.Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
The results of adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=45 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With an Adverse Events
|
43.5 Percentage (%) of subjects
|
59.6 Percentage (%) of subjects
|
55.8 Percentage (%) of subjects
|
72.9 Percentage (%) of subjects
|
85.7 Percentage (%) of subjects
|
72.1 Percentage (%) of subjects
|
93.6 Percentage (%) of subjects
|
55.6 Percentage (%) of subjects
|
62.0 Percentage (%) of subjects
|
SECONDARY outcome
Timeframe: After 12 weeks of treatmentPopulation: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
The results of hypoglycaemic episode presented here are treatment emergent. Hypoglycaemic episodes were defined as treatment emergent if they had onset on or after the first day of randomised treatment (in week 0) and no later than 5 weeks after the last date on trial product (week 17). Hypoglycaemic episodes are classified as follows: Major: If the subject was not able to treat himself or herself and was needed to be administered food, glucagon or intravenous (i.v.) glucose by another person. Minor: If the subject was able to treat himself or herself and measured plasma glucose was \<3.1 mmol/L (56 mg/dL). Symptoms only: If the subject was able to treat himself or herself and measured plasma glucose was \>=3.1 mmol/L (56 mg/dL) or no plasma glucose measurement was done.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With Hypoglycaemic Episode
Major
|
0 Percentage (%) of subjects
|
0 Percentage (%) of subjects
|
0 Percentage (%) of subjects
|
0 Percentage (%) of subjects
|
0 Percentage (%) of subjects
|
0 Percentage (%) of subjects
|
0 Percentage (%) of subjects
|
0 Percentage (%) of subjects
|
0 Percentage (%) of subjects
|
|
Percentage of Subjects With Hypoglycaemic Episode
Minor
|
0 Percentage (%) of subjects
|
4.3 Percentage (%) of subjects
|
0 Percentage (%) of subjects
|
4.2 Percentage (%) of subjects
|
0 Percentage (%) of subjects
|
2.3 Percentage (%) of subjects
|
0 Percentage (%) of subjects
|
4.4 Percentage (%) of subjects
|
2.0 Percentage (%) of subjects
|
|
Percentage of Subjects With Hypoglycaemic Episode
Symptoms only
|
2.2 Percentage (%) of subjects
|
2.1 Percentage (%) of subjects
|
2.3 Percentage (%) of subjects
|
0 Percentage (%) of subjects
|
0 Percentage (%) of subjects
|
0 Percentage (%) of subjects
|
6.4 Percentage (%) of subjects
|
8.9 Percentage (%) of subjects
|
2.0 Percentage (%) of subjects
|
SECONDARY outcome
Timeframe: Week 0, week 12.Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
A standard 12 lead electrocardiogram (ECG) with a 10-second rhythm strip was performed at screening (week -2) and at the end of treatment (week 12). The time frame should be read as "week -2, week 12". Change from baseline in ECG was measured in terms of number of subjects in each category (normal, abnormal, not clinically significant \[NCS\] or abnormal clinically significant \[CS\]) at week -2 and week 12 (i.e., change in each category in terms of number of subjects from week -2 to week 12).
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in ECG
Week -2: Abnormal, NCS
|
4 Participants
|
14 Participants
|
6 Participants
|
12 Participants
|
10 Participants
|
15 Participants
|
8 Participants
|
6 Participants
|
9 Participants
|
|
Change From Baseline in ECG
Week -2: Normal
|
42 Participants
|
33 Participants
|
37 Participants
|
34 Participants
|
31 Participants
|
28 Participants
|
37 Participants
|
39 Participants
|
41 Participants
|
|
Change From Baseline in ECG
Week -2: Abnormal, CS
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in ECG
Week 12: Normal
|
39 Participants
|
32 Participants
|
34 Participants
|
36 Participants
|
29 Participants
|
33 Participants
|
36 Participants
|
37 Participants
|
42 Participants
|
|
Change From Baseline in ECG
Week 12: Abnormal, NCS
|
6 Participants
|
14 Participants
|
3 Participants
|
7 Participants
|
7 Participants
|
9 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
|
Change From Baseline in ECG
Week 12: Abnormal, CS
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in ECG
Week 12: ECG not done (ND)
|
1 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 0, week 12Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in pulse was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Vital Signs (Pulse)
|
0.5 Beats/minute
Standard Deviation 8.9
|
-0.0 Beats/minute
Standard Deviation 7.6
|
0.5 Beats/minute
Standard Deviation 13.8
|
1.5 Beats/minute
Standard Deviation 8.5
|
1.5 Beats/minute
Standard Deviation 9.6
|
2.9 Beats/minute
Standard Deviation 11.9
|
3.9 Beats/minute
Standard Deviation 12.6
|
4.4 Beats/minute
Standard Deviation 10.2
|
2.1 Beats/minute
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: Week 0, week 12Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in systolic blood pressure (SBP) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Vital Signs (Blood Pressure; SBP)
|
-3.2 mmHg
Standard Deviation 14.8
|
3.3 mmHg
Standard Deviation 11.0
|
-2.5 mmHg
Standard Deviation 14.1
|
-3.6 mmHg
Standard Deviation 13.1
|
-6.7 mmHg
Standard Deviation 14.9
|
-7.7 mmHg
Standard Deviation 13.0
|
-5.9 mmHg
Standard Deviation 11.6
|
-2.9 mmHg
Standard Deviation 12.0
|
-5.4 mmHg
Standard Deviation 14.0
|
SECONDARY outcome
Timeframe: Week 0, week 12Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in diastolic blood pressure (DBP) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Vital Signs (Blood Pressure; DBP)
|
-2.3 mmHg
Standard Deviation 9.8
|
1.5 mmHg
Standard Deviation 7.9
|
-0.4 mmHg
Standard Deviation 8.5
|
-1.5 mmHg
Standard Deviation 9.7
|
-1.5 mmHg
Standard Deviation 7.9
|
-2.3 mmHg
Standard Deviation 9.7
|
-3.0 mmHg
Standard Deviation 7.7
|
-2.1 mmHg
Standard Deviation 10.0
|
-0.0 mmHg
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: Week 0, week 12Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in basophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils)
|
-0.0 Billion cells/litre (10^9/L)
Standard Deviation 0.0
|
0.0 Billion cells/litre (10^9/L)
Standard Deviation 0.0
|
-0.0 Billion cells/litre (10^9/L)
Standard Deviation 0.0
|
0.0 Billion cells/litre (10^9/L)
Standard Deviation 0.0
|
-0.0 Billion cells/litre (10^9/L)
Standard Deviation 0.0
|
-0.0 Billion cells/litre (10^9/L)
Standard Deviation 0.0
|
-0.0 Billion cells/litre (10^9/L)
Standard Deviation 0.0
|
0.0 Billion cells/litre (10^9/L)
Standard Deviation 0.0
|
0.0 Billion cells/litre (10^9/L)
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Week 0, week 12Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in eosinophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils)
|
-0.0 Billion cells/litre (10^9/L)
Standard Deviation 0.2
|
0.0 Billion cells/litre (10^9/L)
Standard Deviation 0.2
|
-0.0 Billion cells/litre (10^9/L)
Standard Deviation 0.1
|
0.0 Billion cells/litre (10^9/L)
Standard Deviation 0.1
|
-0.0 Billion cells/litre (10^9/L)
Standard Deviation 0.2
|
0.0 Billion cells/litre (10^9/L)
Standard Deviation 0.3
|
0.1 Billion cells/litre (10^9/L)
Standard Deviation 0.2
|
0.0 Billion cells/litre (10^9/L)
Standard Deviation 0.2
|
-0.0 Billion cells/litre (10^9/L)
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Week 0, week 12Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in haematocrit (the proportion of blood that consists of red blood cells) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit)
|
-0.01 Litre/litre (L/L)
Standard Deviation 0.02
|
-0.01 Litre/litre (L/L)
Standard Deviation 0.03
|
-0.01 Litre/litre (L/L)
Standard Deviation 0.03
|
0.00 Litre/litre (L/L)
Standard Deviation 0.03
|
-0.01 Litre/litre (L/L)
Standard Deviation 0.02
|
-0.00 Litre/litre (L/L)
Standard Deviation 0.03
|
-0.00 Litre/litre (L/L)
Standard Deviation 0.03
|
0.00 Litre/litre (L/L)
Standard Deviation 0.03
|
-0.01 Litre/litre (L/L)
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: Week 0, week 12Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in haemoglobin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin)
|
0.1 Gram/litre (g/L)
Standard Deviation 6.3
|
-0.4 Gram/litre (g/L)
Standard Deviation 5.9
|
-1.2 Gram/litre (g/L)
Standard Deviation 9.3
|
2.8 Gram/litre (g/L)
Standard Deviation 9.5
|
-0.3 Gram/litre (g/L)
Standard Deviation 7.7
|
1.5 Gram/litre (g/L)
Standard Deviation 6.9
|
1.0 Gram/litre (g/L)
Standard Deviation 7.1
|
2.1 Gram/litre (g/L)
Standard Deviation 6.7
|
1.1 Gram/litre (g/L)
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: Week 0, week 12Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in lymphocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes)
|
-0.1 Billion cells/litre (10^9/L)
Standard Deviation 0.6
|
0.0 Billion cells/litre (10^9/L)
Standard Deviation 0.4
|
-0.1 Billion cells/litre (10^9/L)
Standard Deviation 0.6
|
0.2 Billion cells/litre (10^9/L)
Standard Deviation 0.9
|
-0.0 Billion cells/litre (10^9/L)
Standard Deviation 0.7
|
-0.1 Billion cells/litre (10^9/L)
Standard Deviation 0.7
|
0.1 Billion cells/litre (10^9/L)
Standard Deviation 0.5
|
0.0 Billion cells/litre (10^9/L)
Standard Deviation 0.4
|
-0.1 Billion cells/litre (10^9/L)
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Week 0, week 12Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in monocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Monocytes)
|
0.1 Billion cells/litre (10^9/L)
Standard Deviation 0.1
|
0.0 Billion cells/litre (10^9/L)
Standard Deviation 0.2
|
-0.0 Billion cells/litre (10^9/L)
Standard Deviation 0.2
|
0.1 Billion cells/litre (10^9/L)
Standard Deviation 0.1
|
0.1 Billion cells/litre (10^9/L)
Standard Deviation 0.2
|
0.0 Billion cells/litre (10^9/L)
Standard Deviation 0.1
|
0.1 Billion cells/litre (10^9/L)
Standard Deviation 0.2
|
0.1 Billion cells/litre (10^9/L)
Standard Deviation 0.2
|
0.1 Billion cells/litre (10^9/L)
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Week 0, week 12Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in neutrophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Neutrophils)
|
0.1 Billion cells/litre (10^9/L)
Standard Deviation 1.7
|
0.0 Billion cells/litre (10^9/L)
Standard Deviation 1.3
|
-0.1 Billion cells/litre (10^9/L)
Standard Deviation 1.4
|
0.3 Billion cells/litre (10^9/L)
Standard Deviation 1.3
|
-0.1 Billion cells/litre (10^9/L)
Standard Deviation 1.6
|
0.5 Billion cells/litre (10^9/L)
Standard Deviation 1.1
|
0.5 Billion cells/litre (10^9/L)
Standard Deviation 1.4
|
0.3 Billion cells/litre (10^9/L)
Standard Deviation 1.0
|
0.3 Billion cells/litre (10^9/L)
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Week 0, week 12Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in thrombocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Thrombocytes)
|
9.0 Billion cells/litre (10^9/L)
Standard Deviation 35.5
|
16.1 Billion cells/litre (10^9/L)
Standard Deviation 30.2
|
10.8 Billion cells/litre (10^9/L)
Standard Deviation 38.4
|
10.7 Billion cells/litre (10^9/L)
Standard Deviation 47.9
|
5.4 Billion cells/litre (10^9/L)
Standard Deviation 30.7
|
5.5 Billion cells/litre (10^9/L)
Standard Deviation 50.6
|
15.9 Billion cells/litre (10^9/L)
Standard Deviation 51.9
|
10.1 Billion cells/litre (10^9/L)
Standard Deviation 37.1
|
16.7 Billion cells/litre (10^9/L)
Standard Deviation 41.9
|
SECONDARY outcome
Timeframe: Week 0, week 12Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in erythrocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Erythrocytes)
|
-0.04 Trillion cells/litre (10^12/L)
Standard Deviation 0.21
|
-0.06 Trillion cells/litre (10^12/L)
Standard Deviation 0.21
|
-0.03 Trillion cells/litre (10^12/L)
Standard Deviation 0.31
|
0.08 Trillion cells/litre (10^12/L)
Standard Deviation 0.32
|
-0.05 Trillion cells/litre (10^12/L)
Standard Deviation 0.25
|
0.03 Trillion cells/litre (10^12/L)
Standard Deviation 0.24
|
0.04 Trillion cells/litre (10^12/L)
Standard Deviation 0.24
|
0.04 Trillion cells/litre (10^12/L)
Standard Deviation 0.23
|
0.02 Trillion cells/litre (10^12/L)
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: Week 0, week 12Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in leukocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Leukocytes)
|
0.05 Billion cells/litre (10^9/L)
Standard Deviation 2.00
|
0.04 Billion cells/litre (10^9/L)
Standard Deviation 1.39
|
-0.16 Billion cells/litre (10^9/L)
Standard Deviation 1.46
|
0.59 Billion cells/litre (10^9/L)
Standard Deviation 1.50
|
0.14 Billion cells/litre (10^9/L)
Standard Deviation 1.78
|
0.41 Billion cells/litre (10^9/L)
Standard Deviation 1.44
|
0.70 Billion cells/litre (10^9/L)
Standard Deviation 1.64
|
0.40 Billion cells/litre (10^9/L)
Standard Deviation 1.15
|
0.26 Billion cells/litre (10^9/L)
Standard Deviation 1.59
|
SECONDARY outcome
Timeframe: Week 0, week 12.Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in albumin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Albumin)
|
0.402 g/L
Standard Deviation 2.188
|
0.130 g/L
Standard Deviation 2.505
|
-0.091 g/L
Standard Deviation 1.700
|
-0.177 g/L
Standard Deviation 2.331
|
0.303 g/L
Standard Deviation 2.207
|
0.607 g/L
Standard Deviation 2.034
|
0.271 g/L
Standard Deviation 2.586
|
0.916 g/L
Standard Deviation 1.933
|
0.846 g/L
Standard Deviation 2.097
|
SECONDARY outcome
Timeframe: Week 0, week 12.Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in alkaline phosphatase was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Alkaline Phosphatase)
|
-0.52 U/L
Standard Deviation 8.78
|
-1.66 U/L
Standard Deviation 14.11
|
-2.37 U/L
Standard Deviation 11.87
|
-2.35 U/L
Standard Deviation 9.87
|
-1.39 U/L
Standard Deviation 12.24
|
-2.81 U/L
Standard Deviation 7.09
|
-3.98 U/L
Standard Deviation 9.02
|
-1.89 U/L
Standard Deviation 12.24
|
-4.25 U/L
Standard Deviation 10.90
|
SECONDARY outcome
Timeframe: Week 0, week 12.Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in aspartate aminotransferase (AST) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; AST)
|
-1.09 U/L
Standard Deviation 5.80
|
1.23 U/L
Standard Deviation 8.93
|
0.24 U/L
Standard Deviation 6.55
|
-1.81 U/L
Standard Deviation 9.54
|
-0.37 U/L
Standard Deviation 4.75
|
-2.60 U/L
Standard Deviation 7.38
|
-4.07 U/L
Standard Deviation 8.13
|
-0.16 U/L
Standard Deviation 6.12
|
-2.13 U/L
Standard Deviation 13.48
|
SECONDARY outcome
Timeframe: Week 0, week 12.Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in alanine aminotransferase (ALAT) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; ALAT)
|
-2.41 U/L
Standard Deviation 11.49
|
0.83 U/L
Standard Deviation 8.23
|
0.68 U/L
Standard Deviation 10.38
|
-4.21 U/L
Standard Deviation 15.15
|
-2.13 U/L
Standard Deviation 12.48
|
-6.19 U/L
Standard Deviation 12.26
|
-6.55 U/L
Standard Deviation 12.05
|
-0.88 U/L
Standard Deviation 8.96
|
-1.83 U/L
Standard Deviation 10.42
|
SECONDARY outcome
Timeframe: Week 0, week 12.Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in total bilirubin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Total Bilirubin)
|
0.7 umol/L
Standard Deviation 3.6
|
-0.4 umol/L
Standard Deviation 2.8
|
0.6 umol/L
Standard Deviation 4.4
|
0.8 umol/L
Standard Deviation 3.7
|
0.7 umol/L
Standard Deviation 3.3
|
1.3 umol/L
Standard Deviation 5.4
|
0.4 umol/L
Standard Deviation 3.8
|
-0.5 umol/L
Standard Deviation 4.7
|
0.2 umol/L
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Week 0, week 12.Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in calcium, total was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Total)
|
0.0 mmol/L
Standard Deviation 0.1
|
-0.0 mmol/L
Standard Deviation 0.1
|
-0.0 mmol/L
Standard Deviation 0.1
|
-0.0 mmol/L
Standard Deviation 0.1
|
0.0 mmol/L
Standard Deviation 0.1
|
0.0 mmol/L
Standard Deviation 0.1
|
-0.0 mmol/L
Standard Deviation 0.1
|
-0.0 mmol/L
Standard Deviation 0.1
|
0.0 mmol/L
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Week 0, week 12.Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in calcium, ionised was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Ionised)
|
0.00 mmol/L
Standard Deviation 0.09
|
-0.01 mmol/L
Standard Deviation 0.11
|
-0.04 mmol/L
Standard Deviation 0.14
|
-0.01 mmol/L
Standard Deviation 0.07
|
-0.01 mmol/L
Standard Deviation 0.13
|
0.01 mmol/L
Standard Deviation 0.09
|
-0.02 mmol/L
Standard Deviation 0.13
|
-0.02 mmol/L
Standard Deviation 0.11
|
-0.01 mmol/L
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: Week 0, week 12.Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in creatinine was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Creatinine)
|
-1.02 umol/L
Standard Deviation 7.206
|
0.936 umol/L
Standard Deviation 6.291
|
-0.349 umol/L
Standard Deviation 11.22
|
-2.31 umol/L
Standard Deviation 8.866
|
-0.658 umol/L
Standard Deviation 11.08
|
-1.67 umol/L
Standard Deviation 9.511
|
2.089 umol/L
Standard Deviation 7.099
|
0.841 umol/L
Standard Deviation 11.21
|
-0.917 umol/L
Standard Deviation 6.270
|
SECONDARY outcome
Timeframe: Week 0, week 12.Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in potassium was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Potassium)
|
0.07 mmol/L
Standard Deviation 0.37
|
0.08 mmol/L
Standard Deviation 0.57
|
0.06 mmol/L
Standard Deviation 0.42
|
-0.02 mmol/L
Standard Deviation 0.44
|
0.04 mmol/L
Standard Deviation 0.61
|
-0.02 mmol/L
Standard Deviation 0.48
|
-0.07 mmol/L
Standard Deviation 0.46
|
0.10 mmol/L
Standard Deviation 0.50
|
-0.12 mmol/L
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: Week 0, week 12.Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in sodium was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Sodium)
|
0.1 mmol/L
Standard Deviation 2.3
|
0.0 mmol/L
Standard Deviation 1.7
|
-0.1 mmol/L
Standard Deviation 2.6
|
-0.1 mmol/L
Standard Deviation 2.7
|
0.4 mmol/L
Standard Deviation 2.4
|
0.2 mmol/L
Standard Deviation 2.7
|
0.5 mmol/L
Standard Deviation 2.7
|
0.7 mmol/L
Standard Deviation 2.8
|
0.6 mmol/L
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Week 0, week 12.Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in urea was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Urea)
|
-0.1 mmol/L
Standard Deviation 1.2
|
0.1 mmol/L
Standard Deviation 1.4
|
-0.1 mmol/L
Standard Deviation 1.3
|
-0.4 mmol/L
Standard Deviation 1.3
|
-0.3 mmol/L
Standard Deviation 1.6
|
-0.5 mmol/L
Standard Deviation 1.3
|
-0.5 mmol/L
Standard Deviation 1.3
|
-0.1 mmol/L
Standard Deviation 1.3
|
-0.4 mmol/L
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Week 0, week 12Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in urine-glucose was measured in terms of number of subjects in each category (negative, positive, \>=55 mmol/L, or missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12).
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose)
Week 0: Negative
|
31 Participants
|
26 Participants
|
23 Participants
|
35 Participants
|
23 Participants
|
28 Participants
|
32 Participants
|
30 Participants
|
22 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose)
Week 0: Positive
|
13 Participants
|
18 Participants
|
15 Participants
|
11 Participants
|
15 Participants
|
10 Participants
|
12 Participants
|
10 Participants
|
20 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose)
Week 0: Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose)
Week 12: Positive
|
8 Participants
|
15 Participants
|
8 Participants
|
8 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
7 Participants
|
6 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose)
Week 12: >=55 mmol/L
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose)
Week 12: Missing
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose)
Week 0: >=55 mmol/L
|
1 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose)
Week 12: Negative
|
34 Participants
|
28 Participants
|
28 Participants
|
35 Participants
|
30 Participants
|
39 Participants
|
39 Participants
|
35 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Week 0, week 12Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in urine-haemoglobin was measured in terms of number of subjects in each category (negative, trace, small, moderate/large and missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12).
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin)
Week 0: Negative
|
45 Participants
|
45 Participants
|
41 Participants
|
45 Participants
|
38 Participants
|
39 Participants
|
43 Participants
|
43 Participants
|
45 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin)
Week 0: Trace
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin)
Week 0: Small
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin)
Week 0: Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin)
Week 12: Negative
|
42 Participants
|
45 Participants
|
38 Participants
|
42 Participants
|
30 Participants
|
38 Participants
|
39 Participants
|
43 Participants
|
44 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin)
Week 12: Trace
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin)
Week 12: Small
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin)
Week 12: Large
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin)
Week 12: Missing
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin)
Week 0: Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 0, week 12Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in urine-ketone was measured in terms of number of subjects in each category (negative, positive, \>=55 mmol/L and missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12).
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones)
Week 0: Negative
|
45 Participants
|
47 Participants
|
39 Participants
|
46 Participants
|
41 Participants
|
41 Participants
|
45 Participants
|
42 Participants
|
46 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones)
Week 0: Positive
|
0 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones)
Week 0: Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones)
Week 12: Positive
|
1 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones)
Week 12: Missing
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones)
Week 12: Negative
|
43 Participants
|
44 Participants
|
35 Participants
|
44 Participants
|
34 Participants
|
40 Participants
|
38 Participants
|
41 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Week 0, week 12Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in urine-pH was measured in terms of number of subjects in each category (pH=6.0, 6.5, 7.0, 7.5, 8.0, \>=8.5 and missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12).
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)
Week 0: 7.0
|
11 Participants
|
12 Participants
|
8 Participants
|
10 Participants
|
12 Participants
|
8 Participants
|
12 Participants
|
14 Participants
|
19 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)
Week 0: 6.0
|
16 Participants
|
13 Participants
|
19 Participants
|
11 Participants
|
10 Participants
|
11 Participants
|
14 Participants
|
8 Participants
|
12 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)
Week 0: 6.5
|
13 Participants
|
18 Participants
|
15 Participants
|
21 Participants
|
13 Participants
|
13 Participants
|
10 Participants
|
16 Participants
|
11 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)
Week 0: 7.5
|
4 Participants
|
3 Participants
|
0 Participants
|
5 Participants
|
5 Participants
|
8 Participants
|
7 Participants
|
3 Participants
|
2 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)
Week 0: 8.0
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)
Week 0: >=8.5
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)
Week 0: Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)
Week 12: 6.0
|
11 Participants
|
14 Participants
|
19 Participants
|
9 Participants
|
10 Participants
|
8 Participants
|
13 Participants
|
9 Participants
|
10 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)
Week 12: 6.5
|
15 Participants
|
14 Participants
|
9 Participants
|
14 Participants
|
7 Participants
|
10 Participants
|
11 Participants
|
13 Participants
|
14 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)
Week 12: 7.0
|
15 Participants
|
13 Participants
|
6 Participants
|
11 Participants
|
11 Participants
|
15 Participants
|
10 Participants
|
16 Participants
|
15 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)
Week 12: 7.5
|
3 Participants
|
2 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)
Week 12: 8.0
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)
Week 12: >=8.5
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)
Week 12: Missing
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 0, week 12Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in urine-protein was measured in terms of number of subjects in each category at week 0 (negative, 0.3 g/L, 1.0 g/L and missing) and week 12 (negative, trace, 0.3 g/L, 1.0 g/L, \>=3.0 g/L and missing). i.e., change in each category in terms of number of subjects from week 0 to week 12.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein)
Week 0: Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein)
Week 0: Negative
|
45 Participants
|
47 Participants
|
41 Participants
|
44 Participants
|
39 Participants
|
40 Participants
|
46 Participants
|
41 Participants
|
45 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein)
Week 0: 0.3
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein)
Week 0: 1.0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein)
Week 12: Negative
|
40 Participants
|
43 Participants
|
35 Participants
|
41 Participants
|
31 Participants
|
36 Participants
|
39 Participants
|
40 Participants
|
41 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein)
Week 12: Trace
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein)
Week 12: 0.3
|
4 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein)
Week 12: 1.0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein)
Week 12: >=3.0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein)
Week 12: Missing
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 0, week 12.Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Change from baseline in calcitonin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 Participants
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 Participants
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Calcitonin
|
0.43 ng/L
Standard Deviation 1.85
|
0.48 ng/L
Standard Deviation 1.82
|
-0.48 ng/L
Standard Deviation 4.29
|
0.62 ng/L
Standard Deviation 1.68
|
0.45 ng/L
Standard Deviation 1.79
|
0.87 ng/L
Standard Deviation 1.56
|
0.76 ng/L
Standard Deviation 1.78
|
0.55 ng/L
Standard Deviation 2.66
|
0.01 ng/L
Standard Deviation 2.07
|
SECONDARY outcome
Timeframe: After 12 weeks of treatmentPopulation: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
Antibodies were measured after 12-week of treatment at week 17; percentage of participants with positive anti-semaglutide antibodies are presented here. Assessments of antibodies were not done for subjects allocated to the open-label liraglutide treatment arms.
Outcome measures
| Measure |
Placebo
n=46 Participants
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 Participants
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 Participants
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 Participants
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 Participants
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 Participants
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 Participants
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Developing Anti-semaglutide Antibodies
|
0 Percentage (%) of participants
|
0 Percentage (%) of participants
|
0 Percentage (%) of participants
|
0 Percentage (%) of participants
|
0 Percentage (%) of participants
|
0 Percentage (%) of participants
|
3 Percentage (%) of participants
|
—
|
—
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Semaglutide 0.1 mg
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Semaglutide 0.2 mg
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Semaglutide 0.4 mg
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
Semaglutide 0.8 mg
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Semaglutide 0.8 mg (With Titration)
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Semaglutide 1.6 mg (With Titration)
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
Liraglutide 1.2 mg
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Liraglutide 1.8 mg
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=46 participants at risk
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 participants at risk
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 participants at risk
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 participants at risk
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 participants at risk
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 participants at risk
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11-week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 participants at risk
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 participants at risk
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 participants at risk
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/46 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/47 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.3%
1/43 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/48 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/42 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/47 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/45 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/50 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/46 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/47 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/48 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/42 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.3%
1/43 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/47 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/45 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/50 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/46 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.1%
1/47 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/48 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/42 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/47 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/45 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/50 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/46 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/47 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/48 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/42 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.3%
1/43 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/47 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/45 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/50 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/46 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/47 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/48 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/42 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.1%
1/47 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/45 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/50 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/46 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/47 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/48 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/42 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.1%
1/47 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/45 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/50 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
|
Vascular disorders
Hypertension
|
0.00%
0/46 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/47 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.1%
1/48 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/42 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/47 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/45 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/50 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/46 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/47 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.1%
1/48 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/42 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/47 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/45 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/50 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.2%
1/46 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/47 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/48 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/42 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/47 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/45 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/50 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
Other adverse events
| Measure |
Placebo
n=46 participants at risk
Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.1 mg
n=47 participants at risk
Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.2 mg
n=43 participants at risk
Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.4 mg
n=48 participants at risk
Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg
n=42 participants at risk
Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 0.8 mg (With Titration)
n=43 participants at risk
Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11-week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Semaglutide 1.6 mg (With Titration)
n=47 participants at risk
Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.2 mg
n=45 participants at risk
Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
Liraglutide 1.8 mg
n=50 participants at risk
Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/46 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
6.4%
3/47 • Number of events 3 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.1%
1/48 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
9.5%
4/42 • Number of events 4 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/47 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.2%
1/45 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/50 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
|
General disorders
Asthenia
|
0.00%
0/46 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/47 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
4.2%
2/48 • Number of events 2 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
7.1%
3/42 • Number of events 5 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
7.0%
3/43 • Number of events 3 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
10.6%
5/47 • Number of events 6 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/45 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/50 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/46 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/47 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
4.7%
2/43 • Number of events 2 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
4.2%
2/48 • Number of events 5 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.4%
1/42 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
7.0%
3/43 • Number of events 8 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
6.4%
3/47 • Number of events 3 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
6.7%
3/45 • Number of events 4 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.0%
1/50 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.2%
1/46 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
4.3%
2/47 • Number of events 2 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
4.7%
2/43 • Number of events 2 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
8.3%
4/48 • Number of events 4 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
23.8%
10/42 • Number of events 13 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
20.9%
9/43 • Number of events 10 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
48.9%
23/47 • Number of events 24 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
8.9%
4/45 • Number of events 4 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
12.0%
6/50 • Number of events 6 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/46 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/47 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/48 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.4%
1/42 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/47 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/45 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
6.0%
3/50 • Number of events 3 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/46 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
10.6%
5/47 • Number of events 6 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
4.7%
2/43 • Number of events 3 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
14.6%
7/48 • Number of events 11 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
19.0%
8/42 • Number of events 12 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
16.3%
7/43 • Number of events 8 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
23.4%
11/47 • Number of events 14 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
4.4%
2/45 • Number of events 2 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
14.0%
7/50 • Number of events 9 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
|
Nervous system disorders
Dizziness
|
2.2%
1/46 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
6.4%
3/47 • Number of events 3 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
4.2%
2/48 • Number of events 2 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.4%
1/42 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/47 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
4.4%
2/45 • Number of events 2 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/50 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.2%
1/46 • Number of events 2 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
10.6%
5/47 • Number of events 5 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
8.3%
4/48 • Number of events 6 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
9.5%
4/42 • Number of events 6 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
9.3%
4/43 • Number of events 7 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
12.8%
6/47 • Number of events 8 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
11.1%
5/45 • Number of events 6 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
8.0%
4/50 • Number of events 6 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
|
General disorders
Fatigue
|
2.2%
1/46 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.1%
1/47 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
6.2%
3/48 • Number of events 9 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/42 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
12.8%
6/47 • Number of events 22 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/45 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
4.0%
2/50 • Number of events 2 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/46 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/47 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.1%
1/48 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/42 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
4.3%
2/47 • Number of events 2 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/45 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
6.0%
3/50 • Number of events 4 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
|
Nervous system disorders
Headache
|
6.5%
3/46 • Number of events 3 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
14.9%
7/47 • Number of events 11 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
7.0%
3/43 • Number of events 3 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
8.3%
4/48 • Number of events 10 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
11.9%
5/42 • Number of events 11 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.3%
1/43 • Number of events 2 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
6.4%
3/47 • Number of events 5 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
8.9%
4/45 • Number of events 8 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
4.0%
2/50 • Number of events 2 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
|
Vascular disorders
Hypertension
|
8.7%
4/46 • Number of events 4 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.1%
1/47 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.1%
1/48 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.4%
1/42 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.3%
1/43 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.1%
1/47 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.2%
1/45 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
4.0%
2/50 • Number of events 2 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/46 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/47 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.1%
1/48 • Number of events 2 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/42 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.3%
1/43 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/47 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
6.7%
3/45 • Number of events 3 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/50 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
|
Infections and infestations
Nasopharyngitis
|
8.7%
4/46 • Number of events 4 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
12.8%
6/47 • Number of events 7 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/43 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
8.3%
4/48 • Number of events 6 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
4.8%
2/42 • Number of events 3 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
4.7%
2/43 • Number of events 2 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
6.4%
3/47 • Number of events 4 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.2%
1/45 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
4.0%
2/50 • Number of events 2 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
|
Gastrointestinal disorders
Nausea
|
4.3%
2/46 • Number of events 2 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
8.5%
4/47 • Number of events 4 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
11.6%
5/43 • Number of events 8 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
27.1%
13/48 • Number of events 18 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
59.5%
25/42 • Number of events 38 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
39.5%
17/43 • Number of events 46 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
57.4%
27/47 • Number of events 61 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
24.4%
11/45 • Number of events 14 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
8.0%
4/50 • Number of events 4 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/46 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/47 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
7.0%
3/43 • Number of events 3 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/48 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.4%
1/42 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
2.3%
1/43 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
4.3%
2/47 • Number of events 2 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/45 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/50 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/46 • Number of events 1 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
0.00%
0/47 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
7.0%
3/43 • Number of events 5 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
14.6%
7/48 • Number of events 10 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
40.5%
17/42 • Number of events 22 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
30.2%
13/43 • Number of events 20 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
27.7%
13/47 • Number of events 19 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
8.9%
4/45 • Number of events 5 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
12.0%
6/50 • Number of events 8 • The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
The results are based on the safety analysis set, which included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T.
|
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