Trial Outcomes & Findings for Dose-response, Safety and Efficacy of Oral Semaglutide Versus Placebo and Versus Liraglutide, All as Monotherapy in Japanese Subjects With Type 2 Diabetes (NCT NCT03018028)
NCT ID: NCT03018028
Last Updated: 2021-01-15
Results Overview
Change from baseline (week 0) to week 26 in glycosylated haemoglobin (HbA1c). The endpoint was analysed based on data from the on-treatment without rescue medication observation period. On-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. The endpoint was also evaluated based on data from the in-trial observation period. In-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
243 participants
Primary outcome timeframe
Week 0, week 26
Results posted on
2021-01-15
Participant Flow
The trial was conducted at 16 sites in Japan. Japanese participants with type 2 diabetes (T2D) treated with either diet and exercise alone or with oral anti-diabetic drug (OAD) monotherapy for at least 30 days prior to screening were enrolled in the study.
Data presented in "participant flow" is based on the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Participant milestones
| Measure |
Oral Semaglutide 3 mg
Participants received 3.0 milligrams (mg) of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
49
|
49
|
48
|
48
|
49
|
|
Overall Study
Full Analysis Set (FAS)
|
49
|
49
|
48
|
48
|
49
|
|
Overall Study
Safety Analysis Set (SAS)
|
49
|
49
|
48
|
48
|
49
|
|
Overall Study
COMPLETED
|
46
|
49
|
47
|
46
|
49
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
Oral Semaglutide 3 mg
Participants received 3.0 milligrams (mg) of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
1
|
2
|
0
|
Baseline Characteristics
Dose-response, Safety and Efficacy of Oral Semaglutide Versus Placebo and Versus Liraglutide, All as Monotherapy in Japanese Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Total
n=243 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
58 Years
STANDARD_DEVIATION 9 • n=5 Participants
|
60 Years
STANDARD_DEVIATION 10 • n=7 Participants
|
61 Years
STANDARD_DEVIATION 9 • n=5 Participants
|
59 Years
STANDARD_DEVIATION 10 • n=4 Participants
|
59 Years
STANDARD_DEVIATION 9 • n=21 Participants
|
59 Years
STANDARD_DEVIATION 9 • n=10 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
52 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
191 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
243 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
49 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
243 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Baseline HbA1c
|
8.1 Percentage of HbA1c
STANDARD_DEVIATION 0.8 • n=5 Participants
|
8.3 Percentage of HbA1c
STANDARD_DEVIATION 1.0 • n=7 Participants
|
8.0 Percentage of HbA1c
STANDARD_DEVIATION 0.9 • n=5 Participants
|
8.3 Percentage of HbA1c
STANDARD_DEVIATION 0.8 • n=4 Participants
|
8.3 Percentage of HbA1c
STANDARD_DEVIATION 1.1 • n=21 Participants
|
8.2 Percentage of HbA1c
STANDARD_DEVIATION 0.9 • n=10 Participants
|
PRIMARY outcome
Timeframe: Week 0, week 26Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
Change from baseline (week 0) to week 26 in glycosylated haemoglobin (HbA1c). The endpoint was analysed based on data from the on-treatment without rescue medication observation period. On-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. The endpoint was also evaluated based on data from the in-trial observation period. In-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in HbA1c (Week 26)
On-treatment without rescue medication
|
-1.1 Percentage point of HbA1c
Standard Deviation 0.8
|
-1.7 Percentage point of HbA1c
Standard Deviation 0.8
|
-1.7 Percentage point of HbA1c
Standard Deviation 0.8
|
-1.4 Percentage point of HbA1c
Standard Deviation 1.1
|
-0.2 Percentage point of HbA1c
Standard Deviation 0.7
|
|
Change in HbA1c (Week 26)
In-trial observation period
|
-1.1 Percentage point of HbA1c
Standard Deviation 0.8
|
-1.6 Percentage point of HbA1c
Standard Deviation 0.8
|
-1.7 Percentage point of HbA1c
Standard Deviation 0.9
|
-1.4 Percentage point of HbA1c
Standard Deviation 1.1
|
-0.4 Percentage point of HbA1c
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Week 0, week 52Population: Overall number of participants analyzed = number of participants with available data.
Change from baseline (week 0) to week 52 in HbA1c. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=38 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=43 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=41 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=41 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=34 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in HbA1c (Week 52)
|
-1.0 Percentage of HbA1c
Standard Deviation 0.9
|
-1.4 Percentage of HbA1c
Standard Deviation 0.9
|
-1.5 Percentage of HbA1c
Standard Deviation 0.8
|
-1.3 Percentage of HbA1c
Standard Deviation 1.0
|
0.1 Percentage of HbA1c
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
Change from baseline (week 0) in body weight. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in Body Weight (kg)
Week 26
|
-0.4 Kilogram (kg)
Standard Deviation 1.9
|
-1.2 Kilogram (kg)
Standard Deviation 1.9
|
-2.4 Kilogram (kg)
Standard Deviation 3.0
|
0.1 Kilogram (kg)
Standard Deviation 1.6
|
-1.1 Kilogram (kg)
Standard Deviation 1.6
|
|
Change in Body Weight (kg)
Week 52
|
0.0 Kilogram (kg)
Standard Deviation 2.4
|
-0.8 Kilogram (kg)
Standard Deviation 2.1
|
-2.9 Kilogram (kg)
Standard Deviation 3.9
|
0.5 Kilogram (kg)
Standard Deviation 2.0
|
-1.0 Kilogram (kg)
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
Change from baseline (week 0) in fasting plasma glucose. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in Fasting Plasma Glucose
Week 26
|
-1.62 Millimoles per liter (mmol/L)
Standard Deviation 1.74
|
-1.60 Millimoles per liter (mmol/L)
Standard Deviation 1.74
|
-2.37 Millimoles per liter (mmol/L)
Standard Deviation 1.84
|
-2.48 Millimoles per liter (mmol/L)
Standard Deviation 1.76
|
-0.37 Millimoles per liter (mmol/L)
Standard Deviation 1.50
|
|
Change in Fasting Plasma Glucose
Week 52
|
-1.13 Millimoles per liter (mmol/L)
Standard Deviation 1.82
|
-1.60 Millimoles per liter (mmol/L)
Standard Deviation 1.22
|
-2.29 Millimoles per liter (mmol/L)
Standard Deviation 1.62
|
-2.28 Millimoles per liter (mmol/L)
Standard Deviation 2.09
|
0.33 Millimoles per liter (mmol/L)
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
Change from baseline (week 0) in mean 7-point self-measured plasma glucose (SMPG) profile. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile
Week 26
|
-2.2 mmol/L
Standard Deviation 2.2
|
-2.6 mmol/L
Standard Deviation 1.8
|
-3.1 mmol/L
Standard Deviation 2.1
|
-2.8 mmol/L
Standard Deviation 2.1
|
-0.8 mmol/L
Standard Deviation 1.7
|
|
Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile
Week 52
|
-1.7 mmol/L
Standard Deviation 1.7
|
-2.2 mmol/L
Standard Deviation 1.9
|
-3.1 mmol/L
Standard Deviation 2.1
|
-2.3 mmol/L
Standard Deviation 2.5
|
-0.0 mmol/L
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Week 0, week 26 and week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
Change from baseline (week 0) in the average of the post-prandial increments over all meals. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in Mean Postprandial Increment Over All Meals in SMPG
Week 26
|
-0.7 mmol/L
Standard Deviation 2.1
|
-1.2 mmol/L
Standard Deviation 2.3
|
-2.0 mmol/L
Standard Deviation 2.3
|
-1.1 mmol/L
Standard Deviation 2.1
|
-0.5 mmol/L
Standard Deviation 2.4
|
|
Change in Mean Postprandial Increment Over All Meals in SMPG
Week 52
|
-0.5 mmol/L
Standard Deviation 2.4
|
-0.9 mmol/L
Standard Deviation 2.4
|
-2.0 mmol/L
Standard Deviation 2.1
|
-0.6 mmol/L
Standard Deviation 2.2
|
-0.1 mmol/L
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Week 0, week 26 and week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
Relative change (%) from baseline (week 0) in body weight (kg). Data based on on-treatment without resue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in Body Weight (%)
Week 26
|
-0.64 Percentage change
Standard Deviation 2.65
|
-1.63 Percentage change
Standard Deviation 2.78
|
-3.54 Percentage change
Standard Deviation 4.33
|
0.08 Percentage change
Standard Deviation 2.23
|
-1.58 Percentage change
Standard Deviation 2.27
|
|
Change in Body Weight (%)
Week 52
|
-0.03 Percentage change
Standard Deviation 3.25
|
-1.23 Percentage change
Standard Deviation 3.09
|
-4.42 Percentage change
Standard Deviation 5.91
|
0.68 Percentage change
Standard Deviation 2.73
|
-1.42 Percentage change
Standard Deviation 2.47
|
SECONDARY outcome
Timeframe: Week 0, week 26 and week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
Change from baseline (week 0) in body mass index (BMI). BMI was calculated based on body weight and height based on the formulae: BMI kg/m\^2 = body weight (kg)/(Height (m) x Height (m)). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in Body Mass Index
Week 26
|
-0.1 Kilogram per square meter (kg/m^2)
Standard Deviation 0.7
|
-0.4 Kilogram per square meter (kg/m^2)
Standard Deviation 0.7
|
-0.9 Kilogram per square meter (kg/m^2)
Standard Deviation 1.1
|
0.0 Kilogram per square meter (kg/m^2)
Standard Deviation 0.6
|
-0.4 Kilogram per square meter (kg/m^2)
Standard Deviation 0.6
|
|
Change in Body Mass Index
Week 52
|
0.0 Kilogram per square meter (kg/m^2)
Standard Deviation 0.9
|
-0.3 Kilogram per square meter (kg/m^2)
Standard Deviation 0.8
|
-1.1 Kilogram per square meter (kg/m^2)
Standard Deviation 1.5
|
0.2 Kilogram per square meter (kg/m^2)
Standard Deviation 0.7
|
-0.4 Kilogram per square meter (kg/m^2)
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Week 0, week 26 and week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
Change from baseline (week 0) in waist circumference. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in Waist Circumference
Week 26
|
0.5 Centimeters (cm)
Standard Deviation 3.9
|
-0.6 Centimeters (cm)
Standard Deviation 2.8
|
-1.3 Centimeters (cm)
Standard Deviation 3.8
|
0.0 Centimeters (cm)
Standard Deviation 2.7
|
-0.5 Centimeters (cm)
Standard Deviation 2.1
|
|
Change in Waist Circumference
Week 52
|
0.2 Centimeters (cm)
Standard Deviation 4.5
|
-1.0 Centimeters (cm)
Standard Deviation 2.8
|
-2.7 Centimeters (cm)
Standard Deviation 4.8
|
1.0 Centimeters (cm)
Standard Deviation 3.7
|
-0.9 Centimeters (cm)
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Week 0, week 26 and week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
Change from baseline (week 0) in total cholesterol (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in Total Cholesterol (Ratio to Baseline)
Week 26
|
0.92 Ratio of total cholesterol
Geometric Coefficient of Variation 9.6
|
0.93 Ratio of total cholesterol
Geometric Coefficient of Variation 14.7
|
0.89 Ratio of total cholesterol
Geometric Coefficient of Variation 12.6
|
0.94 Ratio of total cholesterol
Geometric Coefficient of Variation 9.6
|
1.00 Ratio of total cholesterol
Geometric Coefficient of Variation 12.3
|
|
Change in Total Cholesterol (Ratio to Baseline)
Week 52
|
0.99 Ratio of total cholesterol
Geometric Coefficient of Variation 8.8
|
0.95 Ratio of total cholesterol
Geometric Coefficient of Variation 10.6
|
0.93 Ratio of total cholesterol
Geometric Coefficient of Variation 13.9
|
0.95 Ratio of total cholesterol
Geometric Coefficient of Variation 9.0
|
1.01 Ratio of total cholesterol
Geometric Coefficient of Variation 15.0
|
SECONDARY outcome
Timeframe: Week 0, week 26 and week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
Change from baseline (week 0) in high density lipoprotein (HDL) cholesterol (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in HDL Cholesterol (Ratio to Baseline)
Week 26
|
0.97 Ratio of HDL cholesterol
Geometric Coefficient of Variation 13.8
|
0.98 Ratio of HDL cholesterol
Geometric Coefficient of Variation 14.7
|
0.96 Ratio of HDL cholesterol
Geometric Coefficient of Variation 10.0
|
0.99 Ratio of HDL cholesterol
Geometric Coefficient of Variation 11.5
|
1.03 Ratio of HDL cholesterol
Geometric Coefficient of Variation 11.7
|
|
Change in HDL Cholesterol (Ratio to Baseline)
Week 52
|
1.05 Ratio of HDL cholesterol
Geometric Coefficient of Variation 12.2
|
1.01 Ratio of HDL cholesterol
Geometric Coefficient of Variation 14.2
|
0.99 Ratio of HDL cholesterol
Geometric Coefficient of Variation 12.2
|
0.98 Ratio of HDL cholesterol
Geometric Coefficient of Variation 11.0
|
1.04 Ratio of HDL cholesterol
Geometric Coefficient of Variation 10.5
|
SECONDARY outcome
Timeframe: Week 0, week 26 and week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
Change from baseline (week 0) in low density lipoprotein (LDL) cholesterol (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in LDL Cholesterol (Ratio to Baseline)
Week 26
|
0.87 Ratio of LDL cholesterol
Geometric Coefficient of Variation 14.6
|
0.89 Ratio of LDL cholesterol
Geometric Coefficient of Variation 22.7
|
0.85 Ratio of LDL cholesterol
Geometric Coefficient of Variation 18.2
|
0.91 Ratio of LDL cholesterol
Geometric Coefficient of Variation 13.4
|
1.03 Ratio of LDL cholesterol
Geometric Coefficient of Variation 19.8
|
|
Change in LDL Cholesterol (Ratio to Baseline)
Week 52
|
0.99 Ratio of LDL cholesterol
Geometric Coefficient of Variation 13.1
|
0.96 Ratio of LDL cholesterol
Geometric Coefficient of Variation 15.5
|
0.91 Ratio of LDL cholesterol
Geometric Coefficient of Variation 20.4
|
0.95 Ratio of LDL cholesterol
Geometric Coefficient of Variation 12.3
|
1.06 Ratio of LDL cholesterol
Geometric Coefficient of Variation 23.0
|
SECONDARY outcome
Timeframe: Week 0, week 26 and week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
Change from baseline (week 0) in very low density lipoprotein (VLDL) cholesterol (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in VLDL Cholesterol (Ratio to Baseline)
Week 26
|
1.02 Ratio of VLDL cholesterol
Geometric Coefficient of Variation 37.7
|
0.94 Ratio of VLDL cholesterol
Geometric Coefficient of Variation 37.2
|
0.93 Ratio of VLDL cholesterol
Geometric Coefficient of Variation 36.4
|
0.99 Ratio of VLDL cholesterol
Geometric Coefficient of Variation 33.1
|
0.87 Ratio of VLDL cholesterol
Geometric Coefficient of Variation 42.4
|
|
Change in VLDL Cholesterol (Ratio to Baseline)
Week 52
|
0.86 Ratio of VLDL cholesterol
Geometric Coefficient of Variation 32.3
|
0.84 Ratio of VLDL cholesterol
Geometric Coefficient of Variation 33.3
|
0.86 Ratio of VLDL cholesterol
Geometric Coefficient of Variation 45.3
|
0.87 Ratio of VLDL cholesterol
Geometric Coefficient of Variation 35.0
|
0.81 Ratio of VLDL cholesterol
Geometric Coefficient of Variation 45.6
|
SECONDARY outcome
Timeframe: Week 0, week 26 and week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
Change from baseline (week 0) in triglycerides (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in Triglycerides (Ratio to Baseline)
Week 26
|
1.03 Ratio of triglycerides
Geometric Coefficient of Variation 40.2
|
0.94 Ratio of triglycerides
Geometric Coefficient of Variation 38.3
|
0.93 Ratio of triglycerides
Geometric Coefficient of Variation 36.5
|
0.99 Ratio of triglycerides
Geometric Coefficient of Variation 33.5
|
0.87 Ratio of triglycerides
Geometric Coefficient of Variation 41.7
|
|
Change in Triglycerides (Ratio to Baseline)
Week 52
|
0.86 Ratio of triglycerides
Geometric Coefficient of Variation 32.3
|
0.84 Ratio of triglycerides
Geometric Coefficient of Variation 33.3
|
0.86 Ratio of triglycerides
Geometric Coefficient of Variation 45.4
|
0.87 Ratio of triglycerides
Geometric Coefficient of Variation 35.5
|
0.82 Ratio of triglycerides
Geometric Coefficient of Variation 44.7
|
SECONDARY outcome
Timeframe: Week 0, week 26 and week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
Change from baseline (week 0) in fasting insulin (measured as picomoles per liter \[pmol/L\]) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in Fasting Insulin (Ratio to Baseline)
Week 26
|
1.19 Ratio of insulin
Geometric Coefficient of Variation 31.9
|
1.27 Ratio of insulin
Geometric Coefficient of Variation 49.0
|
1.10 Ratio of insulin
Geometric Coefficient of Variation 47.5
|
1.14 Ratio of insulin
Geometric Coefficient of Variation 37.1
|
0.92 Ratio of insulin
Geometric Coefficient of Variation 32.2
|
|
Change in Fasting Insulin (Ratio to Baseline)
Week 52
|
1.07 Ratio of insulin
Geometric Coefficient of Variation 32.2
|
1.16 Ratio of insulin
Geometric Coefficient of Variation 38.5
|
1.04 Ratio of insulin
Geometric Coefficient of Variation 47.2
|
1.06 Ratio of insulin
Geometric Coefficient of Variation 35.9
|
0.93 Ratio of insulin
Geometric Coefficient of Variation 28.8
|
SECONDARY outcome
Timeframe: Week 0, week 26 and week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
Change from baseline (week 0) in fasting C-peptide (measured as nanomoles per liter \[nmol/L\]) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in Fasting C-peptide (Ratio to Baseline)
Week 26
|
1.15 Ratio of C-peptide
Geometric Coefficient of Variation 23.2
|
1.24 Ratio of C-peptide
Geometric Coefficient of Variation 32.8
|
1.17 Ratio of C-peptide
Geometric Coefficient of Variation 35.0
|
1.18 Ratio of C-peptide
Geometric Coefficient of Variation 23.3
|
0.98 Ratio of C-peptide
Geometric Coefficient of Variation 20.7
|
|
Change in Fasting C-peptide (Ratio to Baseline)
Week 52
|
1.12 Ratio of C-peptide
Geometric Coefficient of Variation 24.9
|
1.19 Ratio of C-peptide
Geometric Coefficient of Variation 21.9
|
1.10 Ratio of C-peptide
Geometric Coefficient of Variation 34.2
|
1.11 Ratio of C-peptide
Geometric Coefficient of Variation 24.1
|
0.99 Ratio of C-peptide
Geometric Coefficient of Variation 20.6
|
SECONDARY outcome
Timeframe: Week 0, week 26 and week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
Change from baseline (week 0) in fasting glucagon (measured as picograms per milliliter \[pg/mL\]) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in Fasting Glucagon (Ratio to Baseline)
Week 26
|
0.95 Ratio of glucagon
Geometric Coefficient of Variation 16.3
|
0.89 Ratio of glucagon
Geometric Coefficient of Variation 25.1
|
0.85 Ratio of glucagon
Geometric Coefficient of Variation 22.9
|
0.91 Ratio of glucagon
Geometric Coefficient of Variation 18.7
|
0.95 Ratio of glucagon
Geometric Coefficient of Variation 16.0
|
|
Change in Fasting Glucagon (Ratio to Baseline)
Week 52
|
0.97 Ratio of glucagon
Geometric Coefficient of Variation 14.7
|
0.95 Ratio of glucagon
Geometric Coefficient of Variation 19.1
|
0.92 Ratio of glucagon
Geometric Coefficient of Variation 19.8
|
0.93 Ratio of glucagon
Geometric Coefficient of Variation 18.4
|
0.96 Ratio of glucagon
Geometric Coefficient of Variation 14.2
|
SECONDARY outcome
Timeframe: Week 0, week 26 and week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
Change from baseline (week 0) in fasting pro-insulin (measured as pmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in Fasting Pro-insulin (Ratio to Baseline)
Week 26
|
0.69 Ratio of pro-insulin
Geometric Coefficient of Variation 52.7
|
0.68 Ratio of pro-insulin
Geometric Coefficient of Variation 56.1
|
0.51 Ratio of pro-insulin
Geometric Coefficient of Variation 77.8
|
0.61 Ratio of pro-insulin
Geometric Coefficient of Variation 49.0
|
0.85 Ratio of pro-insulin
Geometric Coefficient of Variation 34.6
|
|
Change in Fasting Pro-insulin (Ratio to Baseline)
Week 52
|
0.83 Ratio of pro-insulin
Geometric Coefficient of Variation 46.6
|
0.78 Ratio of pro-insulin
Geometric Coefficient of Variation 41.7
|
0.56 Ratio of pro-insulin
Geometric Coefficient of Variation 68.6
|
0.72 Ratio of pro-insulin
Geometric Coefficient of Variation 49.4
|
1.04 Ratio of pro-insulin
Geometric Coefficient of Variation 37.9
|
SECONDARY outcome
Timeframe: Week 0, week 26 and week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
Change from baseline (week 0) in fasting pro-insulin/insulin ratio is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in Fasting Pro-insulin/Insulin Ratio (Ratio to Baseline)
Week 26
|
0.59 Ratio of pro-insulin/insulin ratio
Geometric Coefficient of Variation 42.7
|
0.54 Ratio of pro-insulin/insulin ratio
Geometric Coefficient of Variation 34.2
|
0.49 Ratio of pro-insulin/insulin ratio
Geometric Coefficient of Variation 42.4
|
0.55 Ratio of pro-insulin/insulin ratio
Geometric Coefficient of Variation 40.3
|
0.92 Ratio of pro-insulin/insulin ratio
Geometric Coefficient of Variation 29.1
|
|
Change in Fasting Pro-insulin/Insulin Ratio (Ratio to Baseline)
Week 52
|
0.78 Ratio of pro-insulin/insulin ratio
Geometric Coefficient of Variation 39.1
|
0.67 Ratio of pro-insulin/insulin ratio
Geometric Coefficient of Variation 42.2
|
0.56 Ratio of pro-insulin/insulin ratio
Geometric Coefficient of Variation 39.6
|
0.69 Ratio of pro-insulin/insulin ratio
Geometric Coefficient of Variation 39.3
|
1.11 Ratio of pro-insulin/insulin ratio
Geometric Coefficient of Variation 29.2
|
SECONDARY outcome
Timeframe: Week 0, week 26 and week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
Change from baseline (week 0) in insulin resistance (measured as percentage of insulin resistance) by homeostatic model assessment index of insulin resistance (HOMA-IR) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in Insulin Resistance (HOMA-IR) (Ratio to Baseline)
Week 26
|
0.98 Ratio of insulin resistance
Geometric Coefficient of Variation 44.7
|
1.02 Ratio of insulin resistance
Geometric Coefficient of Variation 66.0
|
0.83 Ratio of insulin resistance
Geometric Coefficient of Variation 58.5
|
0.86 Ratio of insulin resistance
Geometric Coefficient of Variation 46.3
|
0.88 Ratio of insulin resistance
Geometric Coefficient of Variation 43.8
|
|
Change in Insulin Resistance (HOMA-IR) (Ratio to Baseline)
Week 52
|
0.93 Ratio of insulin resistance
Geometric Coefficient of Variation 44.9
|
0.95 Ratio of insulin resistance
Geometric Coefficient of Variation 42.9
|
0.78 Ratio of insulin resistance
Geometric Coefficient of Variation 62.0
|
0.82 Ratio of insulin resistance
Geometric Coefficient of Variation 51.2
|
0.97 Ratio of insulin resistance
Geometric Coefficient of Variation 38.6
|
SECONDARY outcome
Timeframe: Week 0, week 26 and week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
Change from baseline (week 0) in beta-cell function (measured as percentage of beta-cell function) by homeostatic model assessment index of beta-cell function is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in Beta-cell Function (HOMA-B) (Ratio to Baseline)
Week 26
|
1.71 Ratio of beta-cell function
Geometric Coefficient of Variation 38.6
|
1.93 Ratio of beta-cell function
Geometric Coefficient of Variation 41.2
|
1.95 Ratio of beta-cell function
Geometric Coefficient of Variation 42.7
|
1.89 Ratio of beta-cell function
Geometric Coefficient of Variation 40.2
|
1.00 Ratio of beta-cell function
Geometric Coefficient of Variation 32.7
|
|
Change in Beta-cell Function (HOMA-B) (Ratio to Baseline)
Week 52
|
1.36 Ratio of beta-cell function
Geometric Coefficient of Variation 40.6
|
1.75 Ratio of beta-cell function
Geometric Coefficient of Variation 47.2
|
1.86 Ratio of beta-cell function
Geometric Coefficient of Variation 35.3
|
1.69 Ratio of beta-cell function
Geometric Coefficient of Variation 42.2
|
0.89 Ratio of beta-cell function
Geometric Coefficient of Variation 29.2
|
SECONDARY outcome
Timeframe: Week 26 and week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
Participants who achieved HbA1c \<7.0% (53 millimoles per mole \[mmol/mol\]) according to American Diabetes Association (ADA) target, at week 26 and week 52. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no)
Week 52 · Yes
|
19 Participants
|
29 Participants
|
33 Participants
|
20 Participants
|
4 Participants
|
|
Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no)
Week 26 · Yes
|
24 Participants
|
33 Participants
|
35 Participants
|
24 Participants
|
6 Participants
|
|
Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no)
Week 26 · No
|
19 Participants
|
12 Participants
|
9 Participants
|
21 Participants
|
35 Participants
|
|
Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no)
Week 52 · No
|
19 Participants
|
14 Participants
|
8 Participants
|
21 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Week 26 and week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
Participants who achieved HbA1c below or equal to 6.5% (48 mmol/mol), American Association of Clinical Endocrinologists target (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No)
Week 26 · Yes
|
13 Participants
|
24 Participants
|
28 Participants
|
16 Participants
|
2 Participants
|
|
Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No)
Week 52 · No
|
27 Participants
|
23 Participants
|
17 Participants
|
30 Participants
|
33 Participants
|
|
Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No)
Week 26 · No
|
30 Participants
|
21 Participants
|
16 Participants
|
29 Participants
|
39 Participants
|
|
Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No)
Week 52 · Yes
|
11 Participants
|
20 Participants
|
24 Participants
|
11 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 26 and week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value \<3.1 mmol/L (56 milligrams per deciliter \[mg/dL\]) with symptoms consistent with hypoglycaemia. Number of participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No)
Week 26 · Yes
|
15 Participants
|
26 Participants
|
30 Participants
|
15 Participants
|
4 Participants
|
|
Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No)
Week 26 · No
|
28 Participants
|
19 Participants
|
14 Participants
|
30 Participants
|
37 Participants
|
|
Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No)
Week 52 · Yes
|
12 Participants
|
24 Participants
|
28 Participants
|
9 Participants
|
4 Participants
|
|
Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No)
Week 52 · No
|
26 Participants
|
19 Participants
|
13 Participants
|
32 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Week 26 and week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
Participants who achieved above or equal to 1% (10.9 mmol/mol) reduction in HbA1c and losing 3% or more of baseline body weight (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3%
Week 26 · No
|
36 Participants
|
34 Participants
|
23 Participants
|
40 Participants
|
38 Participants
|
|
Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3%
Week 26 · Yes
|
7 Participants
|
11 Participants
|
21 Participants
|
5 Participants
|
3 Participants
|
|
Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3%
Week 52 · Yes
|
8 Participants
|
7 Participants
|
20 Participants
|
2 Participants
|
1 Participants
|
|
Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3%
Week 52 · No
|
30 Participants
|
36 Participants
|
21 Participants
|
39 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Week 26 and week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
Participants losing 5% or more of baseline body weight (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No)
Week 26 · Yes
|
1 Participants
|
5 Participants
|
16 Participants
|
0 Participants
|
3 Participants
|
|
Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No)
Week 26 · No
|
42 Participants
|
40 Participants
|
28 Participants
|
45 Participants
|
38 Participants
|
|
Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No)
Week 52 · Yes
|
1 Participants
|
5 Participants
|
17 Participants
|
2 Participants
|
2 Participants
|
|
Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No)
Week 52 · No
|
37 Participants
|
38 Participants
|
24 Participants
|
39 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Week 26 and week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
Participants losing 10% or more of baseline body weight (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No)
Week 26 · Yes
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No)
Week 26 · No
|
43 Participants
|
45 Participants
|
41 Participants
|
45 Participants
|
41 Participants
|
|
Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No)
Week 52 · Yes
|
0 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No)
Week 52 · No
|
38 Participants
|
42 Participants
|
35 Participants
|
41 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Weeks 0 - 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants.
Presented results are the number of participants who had taken additional anti-diabetic medication anytime from week 0 to week 52. 'Additional anti-diabetic medication': use of new anti-diabetic medication for more than 21 days with the initiation at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Time to Additional Anti-diabetic Medication
Up to Week 26
|
3 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
|
Time to Additional Anti-diabetic Medication
Up to Week 52
|
8 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Weeks 0 - 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants.
Presented results are the number of participants who had taken rescue medication anytime from week 0 to week 52. 'Rescue medication': use of new anti-diabetic medication as add-on to trial product and used for more than 21 days with the initiation at or after randomisation and before last day on trial product. Time to rescue medication was estimated based on data from on-treatment without rescue medication observation period.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Time to Rescue Medication
Up to Week 26
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
|
Time to Rescue Medication
Up to Week 52
|
7 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Weeks 0 - 57Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) with onset in the on-treatment observation period (time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any, and excluding any period after premature trial product discontinuation) assessed up to approximately 57 weeks (52 weeks treatment period + 5 weeks follow-up period).
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Number of Treatment-emergent Adverse Events (TEAEs)
|
119 Adverse events
|
111 Adverse events
|
96 Adverse events
|
116 Adverse events
|
106 Adverse events
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 52Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
Change in amylase (measured as units per liter \[U/L\]) is presented as ratio to baseline. Data based on on-treatment observation period is presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in Amylase (Ratio to Baseine)
Week 26
|
1.03 Ratio of amylase
Geometric Coefficient of Variation 20.1
|
1.10 Ratio of amylase
Geometric Coefficient of Variation 20.7
|
1.16 Ratio of amylase
Geometric Coefficient of Variation 30.9
|
1.07 Ratio of amylase
Geometric Coefficient of Variation 18.7
|
1.02 Ratio of amylase
Geometric Coefficient of Variation 18.9
|
|
Change in Amylase (Ratio to Baseine)
Week 52
|
1.06 Ratio of amylase
Geometric Coefficient of Variation 18.9
|
1.10 Ratio of amylase
Geometric Coefficient of Variation 17.8
|
1.12 Ratio of amylase
Geometric Coefficient of Variation 18.0
|
1.06 Ratio of amylase
Geometric Coefficient of Variation 18.2
|
1.02 Ratio of amylase
Geometric Coefficient of Variation 16.7
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 52Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
Change in lipase (measured as U/L) is presented as ratio to baseline. Data based on on-treatment observation period is presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in Lipase (Ratio to Baseine)
Week 26
|
1.25 Ratio of lipase
Geometric Coefficient of Variation 41.7
|
1.35 Ratio of lipase
Geometric Coefficient of Variation 34.5
|
1.61 Ratio of lipase
Geometric Coefficient of Variation 67.4
|
1.47 Ratio of lipase
Geometric Coefficient of Variation 52.1
|
1.04 Ratio of lipase
Geometric Coefficient of Variation 48.5
|
|
Change in Lipase (Ratio to Baseine)
Week 52
|
1.29 Ratio of lipase
Geometric Coefficient of Variation 34.2
|
1.41 Ratio of lipase
Geometric Coefficient of Variation 45.8
|
1.47 Ratio of lipase
Geometric Coefficient of Variation 45.9
|
1.60 Ratio of lipase
Geometric Coefficient of Variation 46.8
|
1.03 Ratio of lipase
Geometric Coefficient of Variation 38.7
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 52Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
Change from baseline in pulse rate. Data based on on-treatment observation period is presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in Pulse Rate
Week 26
|
1 Beats per minute (beats/min)
Standard Deviation 7
|
2 Beats per minute (beats/min)
Standard Deviation 9
|
2 Beats per minute (beats/min)
Standard Deviation 8
|
2 Beats per minute (beats/min)
Standard Deviation 9
|
0 Beats per minute (beats/min)
Standard Deviation 8
|
|
Change in Pulse Rate
Week 52
|
1 Beats per minute (beats/min)
Standard Deviation 7
|
3 Beats per minute (beats/min)
Standard Deviation 7
|
4 Beats per minute (beats/min)
Standard Deviation 10
|
2 Beats per minute (beats/min)
Standard Deviation 9
|
0 Beats per minute (beats/min)
Standard Deviation 7
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 52Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
Change from baseline in blood pressure (systolic \[sBP\] and diastolic \[dBP\]). Data based on on-treatment observation period is presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in Blood Pressure
Week 52: dBP
|
-1 Millimeters of mercury (mmHg)
Standard Deviation 8
|
-0 Millimeters of mercury (mmHg)
Standard Deviation 7
|
-0 Millimeters of mercury (mmHg)
Standard Deviation 7
|
-0 Millimeters of mercury (mmHg)
Standard Deviation 10
|
-2 Millimeters of mercury (mmHg)
Standard Deviation 8
|
|
Change in Blood Pressure
Week 26: sBP
|
-3 Millimeters of mercury (mmHg)
Standard Deviation 13
|
-5 Millimeters of mercury (mmHg)
Standard Deviation 12
|
-2 Millimeters of mercury (mmHg)
Standard Deviation 12
|
-1 Millimeters of mercury (mmHg)
Standard Deviation 13
|
-4 Millimeters of mercury (mmHg)
Standard Deviation 11
|
|
Change in Blood Pressure
Week 52: sBP
|
-0 Millimeters of mercury (mmHg)
Standard Deviation 12
|
-1 Millimeters of mercury (mmHg)
Standard Deviation 10
|
-1 Millimeters of mercury (mmHg)
Standard Deviation 10
|
1 Millimeters of mercury (mmHg)
Standard Deviation 15
|
-3 Millimeters of mercury (mmHg)
Standard Deviation 9
|
|
Change in Blood Pressure
Week 26: dBP
|
-0 Millimeters of mercury (mmHg)
Standard Deviation 9
|
-2 Millimeters of mercury (mmHg)
Standard Deviation 7
|
1 Millimeters of mercury (mmHg)
Standard Deviation 6
|
-1 Millimeters of mercury (mmHg)
Standard Deviation 9
|
-3 Millimeters of mercury (mmHg)
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 52Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
Electrocardiogram (ECG) was evaluated and interpreted by the investigator and categorised as normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). The number of participants who had shifted from normal, abnormal NCS or abnormal CS ECG results from baseline (week 0) to week 26, week 52 is presented. Data based on in-trial observation period is presented. In-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in ECG Evaluation
Abnormal CS (week 0) to abnormal CS (week 26)
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Change in ECG Evaluation
Normal (week 0) to normal (week 52)
|
37 Participants
|
40 Participants
|
36 Participants
|
37 Participants
|
39 Participants
|
|
Change in ECG Evaluation
Normal (week 0) to abnormal CS (week 26)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in ECG Evaluation
Abnormal NCS (week 0) to normal (week 26)
|
3 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Change in ECG Evaluation
Abnormal NCS (week 0) to abnormal NCS (week 26)
|
3 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
|
Change in ECG Evaluation
Abnormal NCS (week 0) to abnormal CS (week 26)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in ECG Evaluation
Abnormal CS (week 0) to normal (week 26)
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in ECG Evaluation
Normal (week 0) to normal (week 26)
|
34 Participants
|
41 Participants
|
39 Participants
|
38 Participants
|
39 Participants
|
|
Change in ECG Evaluation
Normal (week 0) to abnormal NCS (week 26)
|
4 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Change in ECG Evaluation
Normal (week 0) to abnormal CS (week 52)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in ECG Evaluation
Abnormal CS (week 0) to abnormal NCS (week 26)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in ECG Evaluation
Normal (week 0) to abnormal NCS (week 52)
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Change in ECG Evaluation
Abnormal NCS (week 0) to normal (week 52)
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Change in ECG Evaluation
Abnormal NCS (week 0) to abnormal NCS (week 52)
|
3 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
|
Change in ECG Evaluation
Abnormal NCS (week 0) to abnormal CS (week 52)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in ECG Evaluation
Abnormal CS (week 0) to abnormal CS (week 52)
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change in ECG Evaluation
Abnormal CS (week 0) to normal (week 52)
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Change in ECG Evaluation
Abnormal CS (week 0) to abnormal NCS (week 52)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week -8), week 26, week 52Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
Physical examination included examination of cardiovascular system, nervous system (central and peripheral), gastrointestinal system including mouth, general appearence, head and neck (head, ears, eyes, nose, throat, neck), lymph node palpation, musculoskeletal system, respiratory system, skin and thyroid gland. Physical examination was performed by the investigator and categorised as normal, abnormal NCS or abnormal CS. Data based on in-trial observation period is presented. In-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in Physical Examination
Week -8: Nervous system- Abnormal CS
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week -8: Gastrointestinal sys- Normal
|
46 Participants
|
47 Participants
|
47 Participants
|
47 Participants
|
48 Participants
|
|
Change in Physical Examination
Week -8: Gastrointestinal sys- Abnormal NCS
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Physical Examination
Week -8: Gastrointestinal sys- Abnormal CS
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Change in Physical Examination
Week 26: Gastrointestinal sys - Normal
|
44 Participants
|
47 Participants
|
45 Participants
|
44 Participants
|
48 Participants
|
|
Change in Physical Examination
Week 52: Skin- Abnormal CS
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Change in Physical Examination
Week 26: Gastrointestinal sys- Abnormal CS
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Change in Physical Examination
Week 52: Gastrointestinal sys- Abnormal NCS
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Change in Physical Examination
Week 52: Gastrointestinal sys- Abnormal CS
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Change in Physical Examination
Week 52: General appearance- Abnormal NCS
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Change in Physical Examination
Week 52: General appearance- Abnormal CS
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week -8: Head and neck- Normal
|
44 Participants
|
45 Participants
|
44 Participants
|
45 Participants
|
46 Participants
|
|
Change in Physical Examination
Week 26: Head and neck- Normal
|
43 Participants
|
47 Participants
|
43 Participants
|
44 Participants
|
44 Participants
|
|
Change in Physical Examination
Week 26: Head and neck- Abnormal CS
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Change in Physical Examination
Week -8: Lymph node- Normal
|
49 Participants
|
49 Participants
|
48 Participants
|
48 Participants
|
49 Participants
|
|
Change in Physical Examination
Week 26: Lymph node- Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week 26: Lymph node- Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week 52: Lymph node- Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week -8: Musculoskeletal- Abnormal NCS
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Change in Physical Examination
Week -8: Musculoskeletal- Abnormal CS
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Change in Physical Examination
Week -8: Respiratory sys- Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change in Physical Examination
Week 26: Respiratory sys- Normal
|
46 Participants
|
48 Participants
|
45 Participants
|
44 Participants
|
49 Participants
|
|
Change in Physical Examination
Week 52: Respiratory sys- Normal
|
46 Participants
|
49 Participants
|
45 Participants
|
44 Participants
|
49 Participants
|
|
Change in Physical Examination
Week 52: Respiratory sys- Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change in Physical Examination
Week 52: Respiratory sys- Abnormal CS
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week 26: Skin- Abnormal CS
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Change in Physical Examination
Week 52: Skin- Normal
|
44 Participants
|
47 Participants
|
44 Participants
|
45 Participants
|
46 Participants
|
|
Change in Physical Examination
Week -8: Thyroid- Abnormal CS
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week 26: Head and neck- Abnormal NCS
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Change in Physical Examination
Week -8: Cardiovascular- Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week -8: Nervous system- Normal
|
48 Participants
|
48 Participants
|
48 Participants
|
48 Participants
|
48 Participants
|
|
Change in Physical Examination
Week -8: Nervous system- Abnormal NCS
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Physical Examination
Week 26: Cardiovascular- Normal
|
46 Participants
|
49 Participants
|
47 Participants
|
45 Participants
|
49 Participants
|
|
Change in Physical Examination
Week 26: Cardiovascular- Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week 26: Cardiovascular- Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week 52: Cardiovascular- Normal
|
46 Participants
|
49 Participants
|
47 Participants
|
45 Participants
|
49 Participants
|
|
Change in Physical Examination
Week 52: Cardiovascular- Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week 52: Cardiovascular- Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week 26: Nervous system- Normal
|
45 Participants
|
48 Participants
|
47 Participants
|
45 Participants
|
48 Participants
|
|
Change in Physical Examination
Week 26: Nervous system- Abnormal NCS
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Physical Examination
Week 52: Nervous system- Normal
|
45 Participants
|
48 Participants
|
47 Participants
|
45 Participants
|
48 Participants
|
|
Change in Physical Examination
Week 52: Nervous system- Abnormal NCS
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Physical Examination
Week 52: Nervous system- Abnormal CS
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week 26: Nervous system- Abnormal CS
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week 26: Gastrointestinal sys- Abnormal NCS
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Change in Physical Examination
Week 52: Gastrointestinal sys- Normal
|
43 Participants
|
45 Participants
|
45 Participants
|
44 Participants
|
47 Participants
|
|
Change in Physical Examination
Week -8: General appearance- Normal
|
47 Participants
|
47 Participants
|
47 Participants
|
47 Participants
|
46 Participants
|
|
Change in Physical Examination
Week -8: General appearance- Abnormal NCS
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Change in Physical Examination
Week -8: General appearance- Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week 26: General appearance- Normal
|
44 Participants
|
47 Participants
|
45 Participants
|
44 Participants
|
46 Participants
|
|
Change in Physical Examination
Week 26: General appearance- Abnormal NCS
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Change in Physical Examination
Week 26: General appearance- Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week 52: General appearance- Normal
|
43 Participants
|
48 Participants
|
46 Participants
|
44 Participants
|
46 Participants
|
|
Change in Physical Examination
Week -8: Head and neck- Abnormal NCS
|
5 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Change in Physical Examination
Week -8: Head and neck- Abnormal CS
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week 52: Head and neck- Normal
|
42 Participants
|
47 Participants
|
43 Participants
|
44 Participants
|
44 Participants
|
|
Change in Physical Examination
Week 52: Head and neck- Abnormal NCS
|
4 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Change in Physical Examination
Week 52: Head and neck- Abnormal CS
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Change in Physical Examination
Week -8: Lymph node- Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week -8: Lymph node- Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week 26: Lymph node- Normal
|
46 Participants
|
49 Participants
|
47 Participants
|
45 Participants
|
49 Participants
|
|
Change in Physical Examination
Week 52: Lymph node- Normal
|
46 Participants
|
49 Participants
|
47 Participants
|
45 Participants
|
49 Participants
|
|
Change in Physical Examination
Week 52: Lymph node- Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week -8: Musculoskeletal- Normal
|
47 Participants
|
44 Participants
|
47 Participants
|
48 Participants
|
44 Participants
|
|
Change in Physical Examination
Week 26: Musculoskeletal- Normal
|
42 Participants
|
45 Participants
|
46 Participants
|
43 Participants
|
42 Participants
|
|
Change in Physical Examination
Week 26: Musculoskeletal- Abnormal NCS
|
4 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
|
Change in Physical Examination
Week 26: Musculoskeletal- Abnormal CS
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Change in Physical Examination
Week 52: Musculoskeletal- Normal
|
41 Participants
|
45 Participants
|
46 Participants
|
45 Participants
|
43 Participants
|
|
Change in Physical Examination
Week 52: Musculoskeletal- Abnormal NCS
|
5 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
|
Change in Physical Examination
Week 52: Musculoskeletal- Abnormal CS
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week -8: Respiratory sys- Normal
|
49 Participants
|
49 Participants
|
46 Participants
|
47 Participants
|
49 Participants
|
|
Change in Physical Examination
Week -8: Respiratory sys- Abnormal CS
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week 26: Respiratory sys- Abnormal NCS
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change in Physical Examination
Week 26: Respiratory sys- Abnormal CS
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week -8: Skin- Normal
|
46 Participants
|
48 Participants
|
45 Participants
|
47 Participants
|
45 Participants
|
|
Change in Physical Examination
Week -8: Skin- Abnormal NCS
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Change in Physical Examination
Week -8: Skin- Abnormal CS
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Change in Physical Examination
Week 26: Skin- Normal
|
44 Participants
|
47 Participants
|
44 Participants
|
43 Participants
|
45 Participants
|
|
Change in Physical Examination
Week 26: Skin- Abnormal NCS
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Change in Physical Examination
Week 52: Skin- Abnormal NCS
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Change in Physical Examination
Week -8: Thyroid - Normal
|
48 Participants
|
48 Participants
|
48 Participants
|
48 Participants
|
49 Participants
|
|
Change in Physical Examination
Week -8: Thyroid- Abnormal NCS
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week 26: Thyroid- Normal
|
45 Participants
|
48 Participants
|
47 Participants
|
45 Participants
|
49 Participants
|
|
Change in Physical Examination
Week 26: Thyroid- Abnormal NCS
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week 26: Thyroid- Abnormal CS
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week 52: Thyroid- Normal
|
45 Participants
|
48 Participants
|
47 Participants
|
45 Participants
|
49 Participants
|
|
Change in Physical Examination
Week 52: Thyroid- Abnormal NCS
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week 52: Thyroid- Abnormal CS
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Week -8: Cardiovascular- Normal
|
49 Participants
|
49 Participants
|
48 Participants
|
48 Participants
|
49 Participants
|
|
Change in Physical Examination
Week -8: Cardiovascular- Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week -8, Week 52Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
Eye examination was performed by the investigator and categorised as normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). Data based on in-trial observation period is presented. In-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in Eye Examination Category
Week -8: Left eye- Normal
|
39 Participants
|
45 Participants
|
37 Participants
|
37 Participants
|
39 Participants
|
|
Change in Eye Examination Category
Week 52: Left eye- Normal
|
36 Participants
|
46 Participants
|
38 Participants
|
37 Participants
|
41 Participants
|
|
Change in Eye Examination Category
Week 52: Right eye- Abnormal NCS
|
2 Participants
|
2 Participants
|
7 Participants
|
5 Participants
|
3 Participants
|
|
Change in Eye Examination Category
Week -8: Left eye- Abnormal NCS
|
4 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
|
Change in Eye Examination Category
Week -8: Left eye- Abnormal CS
|
6 Participants
|
2 Participants
|
7 Participants
|
5 Participants
|
5 Participants
|
|
Change in Eye Examination Category
Week 52: Left eye- Abnormal NCS
|
4 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
|
Change in Eye Examination Category
Week 52: Left eye- Abnormal CS
|
6 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
|
Change in Eye Examination Category
Week -8: Right eye- Normal
|
42 Participants
|
46 Participants
|
36 Participants
|
38 Participants
|
39 Participants
|
|
Change in Eye Examination Category
Week -8: Right eye- Abnormal NCS
|
2 Participants
|
2 Participants
|
5 Participants
|
7 Participants
|
4 Participants
|
|
Change in Eye Examination Category
Week -8: Right eye- Abnormal CS
|
5 Participants
|
1 Participants
|
7 Participants
|
3 Participants
|
6 Participants
|
|
Change in Eye Examination Category
Week 52: Right eye- Normal
|
39 Participants
|
44 Participants
|
36 Participants
|
39 Participants
|
44 Participants
|
|
Change in Eye Examination Category
Week 52: Right eye- Abnormal CS
|
5 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 0 - 57Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.
Number of participants with the presence or absence (yes/no) of anti-semaglutide binding antibodies in blood anytime post-baseline (week 0) and up to week 57. This endpoint is applicable only to the reporting groups "Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg". Data based on the in-trial observation period was presented. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Anti-semaglutide Binding Antibodies (Yes/no)
Yes
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Anti-semaglutide Binding Antibodies (Yes/no)
No
|
49 Participants
|
48 Participants
|
47 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 - 57Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.
Number of participants with the presence or absence (yes/no) of anti-semaglutide neutralising antibodies in blood anytime post-baseline (week 0) and up to week 57. This endpoint is applicable only to the reporting groups "Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg". Data based on the in-trial observation period is presented. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Anti-semaglutide Neutralising Antibodies (Yes/no)
No
|
49 Participants
|
49 Participants
|
48 Participants
|
—
|
—
|
|
Anti-semaglutide Neutralising Antibodies (Yes/no)
Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 - 57Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.
Number of participants with the presence or absence (yes/no) of anti-semaglutide binding antibodies cross reacting with native GLP-1 in blood anytime post-baseline (week 0) and up to week 57. This endpoint is applicable only to the reporting groups "Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg". Data based on the in-trial observation period was presented. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)
Yes
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)
No
|
49 Participants
|
49 Participants
|
47 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 - 57Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.
Number of participants with the presence or absence (yes/no) of anti-semaglutide neutralising antibodies cross reacting with native GLP-1 in blood anytime post-baseline (week 0) and up to week 57. This endpoint is applicable only to the reporting groups "Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg". Data based on the in-trial observation period was presented. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)
Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)
No
|
49 Participants
|
49 Participants
|
48 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 0-57Population: "Overall number of participants analyzed"=number of participants who were found positive for anti-semaglutide antibodies.
This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (weeks 0-57). Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=1 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=1 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Anti-semaglutide Binding Antibody Levels
Week 8
|
—
|
1.58 %B/T
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Anti-semaglutide Binding Antibody Levels
Week 38
|
—
|
—
|
2.40 %B/T
Standard Deviation 0.00
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 - 57Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.
Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Data based on on-treatment observation period was presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
2 Episodes
|
0 Episodes
|
SECONDARY outcome
Timeframe: Weeks 0 - 57Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.
Number of participants with treatment emergent severe or blood glucose-confirmed symptomatic hypoglycaemic episodes. Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Data based on on-treatment observation period was presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 26 and week 52Population: Overall number of participants analyzed = number of participants with available data.
Semaglutide plasma concentration is presented. Samples for pharmacokinetic (PK) analysis were drawn at any time during the visit except for the visit at week 26 where samples were taken both pre-dose and 60-90 minutes post dosing. This endpoint is applicable only to the reporting groups, "Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg". Data based on on-treatment observation period was presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=45 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=45 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Semaglutide Plasma Concentration
Week 26 pre-dose
|
3.7 Nanomoles per liter (nmol/L)
Geometric Coefficient of Variation 96.7
|
9.5 Nanomoles per liter (nmol/L)
Geometric Coefficient of Variation 80.1
|
20.6 Nanomoles per liter (nmol/L)
Geometric Coefficient of Variation 92.5
|
—
|
—
|
|
Semaglutide Plasma Concentration
Week 26 post-dose
|
5.3 Nanomoles per liter (nmol/L)
Geometric Coefficient of Variation 92.9
|
13.9 Nanomoles per liter (nmol/L)
Geometric Coefficient of Variation 86.3
|
30.7 Nanomoles per liter (nmol/L)
Geometric Coefficient of Variation 80.9
|
—
|
—
|
|
Semaglutide Plasma Concentration
Week 52
|
3.2 Nanomoles per liter (nmol/L)
Geometric Coefficient of Variation 89.1
|
9.2 Nanomoles per liter (nmol/L)
Geometric Coefficient of Variation 96.9
|
20.0 Nanomoles per liter (nmol/L)
Geometric Coefficient of Variation 148.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data. On-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in the sub-domain scores is presented. A positive change score indicates an improvement since baseline. Data based on on-treatment without rescue medication observation period is presented.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in SF-36: Sub-domains
Week 26: Physical Functioning
|
-0.22 Score on a scale
Standard Deviation 2.53
|
-0.09 Score on a scale
Standard Deviation 1.93
|
0.04 Score on a scale
Standard Deviation 2.71
|
0.09 Score on a scale
Standard Deviation 2.01
|
-0.14 Score on a scale
Standard Deviation 2.63
|
|
Change in SF-36: Sub-domains
Week 52: Physical Functioning
|
-0.31 Score on a scale
Standard Deviation 3.63
|
0.30 Score on a scale
Standard Deviation 2.37
|
-0.00 Score on a scale
Standard Deviation 3.42
|
-0.09 Score on a scale
Standard Deviation 2.11
|
-0.00 Score on a scale
Standard Deviation 2.96
|
|
Change in SF-36: Sub-domains
Week 52: Role-Physical
|
-2.14 Score on a scale
Standard Deviation 5.94
|
0.15 Score on a scale
Standard Deviation 4.84
|
-0.86 Score on a scale
Standard Deviation 4.69
|
-0.59 Score on a scale
Standard Deviation 3.55
|
-0.58 Score on a scale
Standard Deviation 3.99
|
|
Change in SF-36: Sub-domains
Week 52: Bodily Pain
|
-2.43 Score on a scale
Standard Deviation 9.02
|
-0.16 Score on a scale
Standard Deviation 7.78
|
0.03 Score on a scale
Standard Deviation 8.30
|
0.98 Score on a scale
Standard Deviation 7.09
|
-0.79 Score on a scale
Standard Deviation 8.10
|
|
Change in SF-36: Sub-domains
Week 52: Vitality
|
-1.93 Score on a scale
Standard Deviation 6.84
|
-0.82 Score on a scale
Standard Deviation 6.63
|
-1.06 Score on a scale
Standard Deviation 6.08
|
-0.13 Score on a scale
Standard Deviation 6.17
|
-1.60 Score on a scale
Standard Deviation 7.55
|
|
Change in SF-36: Sub-domains
Week 52: Social Functioning
|
-0.78 Score on a scale
Standard Deviation 4.67
|
-0.58 Score on a scale
Standard Deviation 3.92
|
0.00 Score on a scale
Standard Deviation 5.30
|
-0.48 Score on a scale
Standard Deviation 4.53
|
-1.16 Score on a scale
Standard Deviation 5.72
|
|
Change in SF-36: Sub-domains
Week 26: Social Functioning
|
-0.11 Score on a scale
Standard Deviation 4.25
|
0.77 Score on a scale
Standard Deviation 3.94
|
-0.45 Score on a scale
Standard Deviation 5.62
|
-0.66 Score on a scale
Standard Deviation 5.12
|
-1.20 Score on a scale
Standard Deviation 6.52
|
|
Change in SF-36: Sub-domains
Week 26: Role-Physical
|
-1.79 Score on a scale
Standard Deviation 4.91
|
0.00 Score on a scale
Standard Deviation 3.48
|
0.05 Score on a scale
Standard Deviation 3.31
|
0.10 Score on a scale
Standard Deviation 3.51
|
-0.86 Score on a scale
Standard Deviation 5.70
|
|
Change in SF-36: Sub-domains
Week 26: Bodily Pain
|
-2.02 Score on a scale
Standard Deviation 8.92
|
-0.89 Score on a scale
Standard Deviation 5.93
|
1.18 Score on a scale
Standard Deviation 6.21
|
0.48 Score on a scale
Standard Deviation 7.09
|
-0.19 Score on a scale
Standard Deviation 6.19
|
|
Change in SF-36: Sub-domains
Week 26: General Health
|
-2.43 Score on a scale
Standard Deviation 4.49
|
0.52 Score on a scale
Standard Deviation 4.29
|
0.41 Score on a scale
Standard Deviation 4.33
|
-0.00 Score on a scale
Standard Deviation 5.87
|
-0.08 Score on a scale
Standard Deviation 6.06
|
|
Change in SF-36: Sub-domains
Week 52: General Health
|
-0.99 Score on a scale
Standard Deviation 5.07
|
-1.24 Score on a scale
Standard Deviation 5.38
|
-0.47 Score on a scale
Standard Deviation 4.00
|
0.62 Score on a scale
Standard Deviation 6.34
|
-0.99 Score on a scale
Standard Deviation 6.96
|
|
Change in SF-36: Sub-domains
Week 26: Role-Emotional
|
-1.60 Score on a scale
Standard Deviation 8.21
|
-0.00 Score on a scale
Standard Deviation 6.03
|
0.35 Score on a scale
Standard Deviation 5.39
|
-0.09 Score on a scale
Standard Deviation 5.72
|
-1.12 Score on a scale
Standard Deviation 5.80
|
|
Change in SF-36: Sub-domains
Week 26: Vitality
|
-2.85 Score on a scale
Standard Deviation 5.85
|
-0.48 Score on a scale
Standard Deviation 4.83
|
-1.49 Score on a scale
Standard Deviation 4.93
|
-0.18 Score on a scale
Standard Deviation 6.07
|
-1.99 Score on a scale
Standard Deviation 9.66
|
|
Change in SF-36: Sub-domains
Week 52: Role-Emotional
|
-0.70 Score on a scale
Standard Deviation 5.94
|
0.18 Score on a scale
Standard Deviation 2.63
|
-0.47 Score on a scale
Standard Deviation 5.86
|
-0.19 Score on a scale
Standard Deviation 4.67
|
-1.80 Score on a scale
Standard Deviation 8.31
|
|
Change in SF-36: Sub-domains
Week 26: Mental Health
|
-1.90 Score on a scale
Standard Deviation 9.00
|
0.77 Score on a scale
Standard Deviation 5.56
|
-2.36 Score on a scale
Standard Deviation 6.23
|
1.71 Score on a scale
Standard Deviation 6.70
|
-2.17 Score on a scale
Standard Deviation 6.81
|
|
Change in SF-36: Sub-domains
Week 52: Mental Health
|
-2.41 Score on a scale
Standard Deviation 7.63
|
-0.52 Score on a scale
Standard Deviation 7.38
|
-1.69 Score on a scale
Standard Deviation 5.12
|
0.72 Score on a scale
Standard Deviation 5.82
|
-1.31 Score on a scale
Standard Deviation 6.49
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data. On-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Change in short form 36 v2.0 acute domain PCS from baseline (week 0) to week 56. SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. It consists of 2 component summary measures that further summarize 8 health domain scales. The PCS measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. Data based on on-treatment without rescue medication observation period is presented.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in SF-36: Physical Component Summary (PCS)
Week 52
|
-1.28 Score on a scale
Standard Deviation 6.03
|
-0.12 Score on a scale
Standard Deviation 4.30
|
0.02 Score on a scale
Standard Deviation 4.05
|
0.10 Score on a scale
Standard Deviation 3.42
|
-0.10 Score on a scale
Standard Deviation 4.03
|
|
Change in SF-36: Physical Component Summary (PCS)
Week 26
|
-1.33 Score on a scale
Standard Deviation 4.56
|
-0.38 Score on a scale
Standard Deviation 3.28
|
0.93 Score on a scale
Standard Deviation 3.49
|
-0.14 Score on a scale
Standard Deviation 3.21
|
0.20 Score on a scale
Standard Deviation 4.11
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data. On-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Change in short form 36 v2.0 acute domain MCS from baseline (week 0) to week 56. SF- 36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The MCS measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. Data based on on-treatment without rescue medication observation period is presented.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change in SF-36: Mental Component Summary (MCS)
Week 26
|
-1.81 Score on a scale
Standard Deviation 7.23
|
0.56 Score on a scale
Standard Deviation 5.62
|
-1.61 Score on a scale
Standard Deviation 4.14
|
0.49 Score on a scale
Standard Deviation 5.09
|
-2.18 Score on a scale
Standard Deviation 7.42
|
|
Change in SF-36: Mental Component Summary (MCS)
Week 52
|
-1.56 Score on a scale
Standard Deviation 6.63
|
-0.58 Score on a scale
Standard Deviation 5.02
|
-1.16 Score on a scale
Standard Deviation 4.80
|
0.10 Score on a scale
Standard Deviation 4.44
|
-1.94 Score on a scale
Standard Deviation 7.43
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data. On-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Diabetes Therapy-Related QOL (DTR-QOL) questionnaire is a 29-item patient-reported survey of patient health that measures the influence of diabetes treatment on HRQoL on 4 domains on individual scale ranges: "Burden on social activities and daily activities", "Anxiety and dissatisfaction with treatment", "Hypoglycemia" and "Satisfaction with treatment" on a 7-point graded response scale. Higher item scores indicate a higher level of HRQoL for items 1-25. For items 26-29 a higher score indicates a lower level of HRQoL. The domain score is calculated from the mean score of the attribute items, and the scoring range is converted to 0 - 100. The total score, after simple addition of the item scores, is converted to 0 - 100 (best-case response = 100; worstcase response = 0). Data based on on-treatment without rescue medication observation period is presented.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change From Baseline in DTR-QOL: Total Score
Week 26
|
6.67 Score on a scale
Standard Deviation 15.81
|
7.98 Score on a scale
Standard Deviation 11.47
|
11.22 Score on a scale
Standard Deviation 12.99
|
9.77 Score on a scale
Standard Deviation 14.46
|
4.18 Score on a scale
Standard Deviation 14.13
|
|
Change From Baseline in DTR-QOL: Total Score
Week 52
|
6.97 Score on a scale
Standard Deviation 14.47
|
5.52 Score on a scale
Standard Deviation 12.29
|
8.02 Score on a scale
Standard Deviation 14.09
|
7.12 Score on a scale
Standard Deviation 15.09
|
0.57 Score on a scale
Standard Deviation 16.53
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 52Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
DTR-QOL questionnaire is a 29-item patient-reported survey of patient health that measures the the influence of diabetes treatment on HRQoL. DTR-QOL questionnaire measured the HRQoL on 4 domains on individual scale ranges: "Burden on social activities and daily activities", "Anxiety and dissatisfaction with treatment", "Hypoglycemia" and "Satisfaction with treatment" on a 7-point graded response scale. Higher item scores indicate a higher level of HRQoL for items 1-25. For items 26-29 a higher score indicates a lower level of HRQoL. The domain score is calculated from the mean score of the attribute items, and the scoring range is converted to 0 - 100. W26 and W52 refer to week 26 and week 52 respectively. Data based on on-treatment without rescue medication observation period was presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Outcome measures
| Measure |
Oral Semaglutide 3 mg
n=49 Participants
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 Participants
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 Participants
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 Participants
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Change From Baseline in DTR-QOL: Sub-domains
W26: Anxiety and dissatisfaction with treatment
|
6.49 Score on a scale
Standard Deviation 18.32
|
10.46 Score on a scale
Standard Deviation 15.27
|
14.68 Score on a scale
Standard Deviation 17.01
|
13.52 Score on a scale
Standard Deviation 20.99
|
1.83 Score on a scale
Standard Deviation 17.91
|
|
Change From Baseline in DTR-QOL: Sub-domains
Week 52: Hypoglycemia
|
5.81 Score on a scale
Standard Deviation 19.07
|
1.26 Score on a scale
Standard Deviation 18.51
|
8.13 Score on a scale
Standard Deviation 20.15
|
4.47 Score on a scale
Standard Deviation 22.94
|
6.00 Score on a scale
Standard Deviation 16.26
|
|
Change From Baseline in DTR-QOL: Sub-domains
W26: Burden on social and daily activities
|
5.75 Score on a scale
Standard Deviation 20.31
|
5.87 Score on a scale
Standard Deviation 13.06
|
7.90 Score on a scale
Standard Deviation 16.55
|
10.11 Score on a scale
Standard Deviation 17.38
|
6.91 Score on a scale
Standard Deviation 19.59
|
|
Change From Baseline in DTR-QOL: Sub-domains
W52: Burden on social and daily activities
|
9.31 Score on a scale
Standard Deviation 17.06
|
5.49 Score on a scale
Standard Deviation 15.19
|
3.94 Score on a scale
Standard Deviation 19.66
|
7.60 Score on a scale
Standard Deviation 18.73
|
2.90 Score on a scale
Standard Deviation 23.08
|
|
Change From Baseline in DTR-QOL: Sub-domains
W52: Anxiety and dissatisfaction with treatment
|
4.93 Score on a scale
Standard Deviation 19.32
|
5.04 Score on a scale
Standard Deviation 16.52
|
10.52 Score on a scale
Standard Deviation 16.04
|
7.01 Score on a scale
Standard Deviation 20.45
|
-2.94 Score on a scale
Standard Deviation 22.27
|
|
Change From Baseline in DTR-QOL: Sub-domains
Week 26: Hypoglycemia
|
8.33 Score on a scale
Standard Deviation 23.50
|
3.15 Score on a scale
Standard Deviation 18.08
|
9.19 Score on a scale
Standard Deviation 20.95
|
3.80 Score on a scale
Standard Deviation 26.53
|
7.42 Score on a scale
Standard Deviation 20.30
|
|
Change From Baseline in DTR-QOL: Sub-domains
Week 26: Satisfaction with treatment
|
8.33 Score on a scale
Standard Deviation 16.39
|
14.72 Score on a scale
Standard Deviation 23.21
|
17.14 Score on a scale
Standard Deviation 25.10
|
7.13 Score on a scale
Standard Deviation 25.60
|
-3.25 Score on a scale
Standard Deviation 24.96
|
|
Change From Baseline in DTR-QOL: Sub-domains
Week 52: Satisfaction with treatment
|
4.61 Score on a scale
Standard Deviation 23.47
|
10.85 Score on a scale
Standard Deviation 24.74
|
16.16 Score on a scale
Standard Deviation 26.80
|
8.43 Score on a scale
Standard Deviation 22.64
|
-5.39 Score on a scale
Standard Deviation 21.09
|
Adverse Events
Oral Semaglutide 3 mg
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Oral Semaglutide 7 mg
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Oral Semaglutide 14 mg
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Liraglutide 0.9 mg
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oral Semaglutide 3 mg
n=49 participants at risk
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 participants at risk
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 participants at risk
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 participants at risk
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 participants at risk
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Eye disorders
Cataract
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/48 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/48 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.0%
1/49 • Number of events 1 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/48 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/48 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.0%
1/49 • Number of events 1 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
2.0%
1/49 • Number of events 1 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/48 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/48 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/48 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/48 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.0%
1/49 • Number of events 1 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/48 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/48 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.0%
1/49 • Number of events 1 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/48 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/48 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.0%
1/49 • Number of events 1 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.0%
1/49 • Number of events 1 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/48 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/48 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.0%
1/49 • Number of events 1 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/48 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/48 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
2.0%
1/49 • Number of events 1 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/48 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/48 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.0%
1/49 • Number of events 1 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/48 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/48 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
Other adverse events
| Measure |
Oral Semaglutide 3 mg
n=49 participants at risk
Participants received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 7 mg
n=49 participants at risk
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Oral Semaglutide 14 mg
n=48 participants at risk
Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
Liraglutide 0.9 mg
n=48 participants at risk
Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg.
|
Placebo
n=49 participants at risk
Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.0%
1/49 • Number of events 1 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
6.1%
3/49 • Number of events 3 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.1%
1/48 • Number of events 1 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.2%
2/48 • Number of events 2 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.0%
1/49 • Number of events 1 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.1%
2/49 • Number of events 2 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
6.2%
3/48 • Number of events 3 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
6.2%
3/48 • Number of events 3 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
6.1%
3/49 • Number of events 3 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Gastrointestinal disorders
Constipation
|
10.2%
5/49 • Number of events 5 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
12.2%
6/49 • Number of events 9 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
12.5%
6/48 • Number of events 6 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
18.8%
9/48 • Number of events 11 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
6.1%
3/49 • Number of events 3 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
12.5%
6/48 • Number of events 6 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
6.2%
3/48 • Number of events 5 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Gastrointestinal disorders
Dental caries
|
2.0%
1/49 • Number of events 2 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
6.1%
3/49 • Number of events 3 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.1%
1/48 • Number of events 1 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/48 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.1%
2/49 • Number of events 2 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.2%
4/49 • Number of events 8 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.0%
1/49 • Number of events 2 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
6.2%
3/48 • Number of events 3 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.2%
2/48 • Number of events 2 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.0%
1/49 • Number of events 1 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.2%
4/49 • Number of events 4 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.1%
1/48 • Number of events 1 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.1%
1/48 • Number of events 1 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Infections and infestations
Influenza
|
6.1%
3/49 • Number of events 3 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.0%
1/49 • Number of events 1 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.1%
1/48 • Number of events 1 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.2%
2/48 • Number of events 2 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.1%
2/49 • Number of events 2 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Infections and infestations
Nasopharyngitis
|
20.4%
10/49 • Number of events 12 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
16.3%
8/49 • Number of events 12 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
18.8%
9/48 • Number of events 19 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
29.2%
14/48 • Number of events 21 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
28.6%
14/49 • Number of events 24 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Gastrointestinal disorders
Nausea
|
4.1%
2/49 • Number of events 2 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
10.2%
5/49 • Number of events 6 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
8.3%
4/48 • Number of events 4 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/48 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.0%
1/49 • Number of events 1 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
10.2%
5/49 • Number of events 5 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/49 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/48 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.1%
1/48 • Number of events 1 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.1%
2/49 • Number of events 2 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
3/49 • Number of events 3 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
6.1%
3/49 • Number of events 3 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/48 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
0.00%
0/48 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
2.0%
1/49 • Number of events 1 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
8.2%
4/49 • Number of events 5 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
6.1%
3/49 • Number of events 3 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.2%
2/48 • Number of events 3 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
4.2%
2/48 • Number of events 4 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
6.1%
3/49 • Number of events 3 • Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
|
Additional Information
Clinical Reporting Anchor and Disclosure (1452)
Novo Nordisk A/S
Phone: (+1) 866-867-7178
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER