Trial Outcomes & Findings for The Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes (NCT NCT00422058)
NCT ID: NCT00422058
Last Updated: 2017-11-01
Results Overview
Calculated as mean body weight at week 20 - baseline
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
564 participants
Primary outcome timeframe
Week 0, week 20
Results posted on
2017-11-01
Participant Flow
19 sites in 8 countries: Denmark (3), Sweden (2), Finland (3), UK (3), Netherlands (1), Belgium (1), Spain (4) and Czech Republic (2)
Between screening and randomisation, eligible subjects were included in a 2-week single-blind run-in period in which all subjects were placed on a hypocaloric diet. The dose of liraglutide and placebo was increased during the first 4 weeks after randomisation until maintenance dose was reached. Orlistat dose was fixed from randomisation.
Participant milestones
| Measure |
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.2 mg/Lira 3.0 mg
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.8 mg/Lira 3.0 mg
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 2.4 mg/Lira 3.0 mg
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Liraglutide 3.0 mg
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Orlistat
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
|
|---|---|---|---|---|---|---|
|
Double-Blind, Week 0-20
STARTED
|
98
|
95
|
90
|
93
|
93
|
95
|
|
Double-Blind, Week 0-20
COMPLETED
|
79
|
85
|
74
|
73
|
82
|
79
|
|
Double-Blind, Week 0-20
NOT COMPLETED
|
19
|
10
|
16
|
20
|
11
|
16
|
|
Open-Label Extension, Week 20-104
STARTED
|
79
|
85
|
74
|
73
|
82
|
79
|
|
Open-Label Extension, Week 20-104
Enrolled in Extension
|
67
|
68
|
59
|
65
|
72
|
67
|
|
Open-Label Extension, Week 20-104
COMPLETED
|
47
|
46
|
38
|
45
|
47
|
45
|
|
Open-Label Extension, Week 20-104
NOT COMPLETED
|
32
|
39
|
36
|
28
|
35
|
34
|
Reasons for withdrawal
| Measure |
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.2 mg/Lira 3.0 mg
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.8 mg/Lira 3.0 mg
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 2.4 mg/Lira 3.0 mg
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Liraglutide 3.0 mg
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Orlistat
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
|
|---|---|---|---|---|---|---|
|
Double-Blind, Week 0-20
Adverse Event
|
3
|
4
|
5
|
9
|
5
|
3
|
|
Double-Blind, Week 0-20
Protocol Violation
|
3
|
2
|
2
|
3
|
2
|
2
|
|
Double-Blind, Week 0-20
Lack of Efficacy
|
2
|
1
|
1
|
0
|
0
|
1
|
|
Double-Blind, Week 0-20
Other
|
11
|
3
|
8
|
8
|
4
|
10
|
|
Open-Label Extension, Week 20-104
Not giving consent for extension
|
12
|
17
|
15
|
8
|
10
|
12
|
|
Open-Label Extension, Week 20-104
Adverse Event
|
3
|
4
|
7
|
4
|
4
|
0
|
|
Open-Label Extension, Week 20-104
Protocol Violation
|
1
|
2
|
3
|
1
|
5
|
3
|
|
Open-Label Extension, Week 20-104
Lack of Efficacy
|
3
|
2
|
5
|
2
|
0
|
1
|
|
Open-Label Extension, Week 20-104
Other
|
13
|
14
|
6
|
13
|
16
|
18
|
Baseline Characteristics
The Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes
Baseline characteristics by cohort
| Measure |
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg
n=98 Participants
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.2 mg/Lira 3.0 mg
n=95 Participants
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.8 mg/Lira 3.0 mg
n=90 Participants
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 2.4 mg/Lira 3.0 mg
n=93 Participants
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Liraglutide 3.0 mg
n=93 Participants
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Orlistat
n=95 Participants
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
|
Total
n=564 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
45.86 years
STANDARD_DEVIATION 10.28 • n=39 Participants
|
47.18 years
STANDARD_DEVIATION 9.72 • n=41 Participants
|
45.53 years
STANDARD_DEVIATION 10.9 • n=35 Participants
|
45.01 years
STANDARD_DEVIATION 11.09 • n=31 Participants
|
45.91 years
STANDARD_DEVIATION 10.71 • n=146 Participants
|
45.94 years
STANDARD_DEVIATION 9.11 • n=19 Participants
|
45.91 years
STANDARD_DEVIATION 10.29 • n=147 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=39 Participants
|
73 Participants
n=41 Participants
|
68 Participants
n=35 Participants
|
71 Participants
n=31 Participants
|
70 Participants
n=146 Participants
|
73 Participants
n=19 Participants
|
429 Participants
n=147 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=39 Participants
|
22 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
22 Participants
n=31 Participants
|
23 Participants
n=146 Participants
|
22 Participants
n=19 Participants
|
135 Participants
n=147 Participants
|
|
Race/Ethnicity, Customized
White
|
97 participants
n=39 Participants
|
94 participants
n=41 Participants
|
88 participants
n=35 Participants
|
91 participants
n=31 Participants
|
92 participants
n=146 Participants
|
93 participants
n=19 Participants
|
555 participants
n=147 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
0 participants
n=39 Participants
|
0 participants
n=41 Participants
|
0 participants
n=35 Participants
|
0 participants
n=31 Participants
|
0 participants
n=146 Participants
|
1 participants
n=19 Participants
|
1 participants
n=147 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
1 participants
n=39 Participants
|
0 participants
n=41 Participants
|
2 participants
n=35 Participants
|
1 participants
n=31 Participants
|
1 participants
n=146 Participants
|
1 participants
n=19 Participants
|
6 participants
n=147 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=39 Participants
|
1 participants
n=41 Participants
|
0 participants
n=35 Participants
|
1 participants
n=31 Participants
|
0 participants
n=146 Participants
|
0 participants
n=19 Participants
|
2 participants
n=147 Participants
|
|
BMI
|
34.9 kg/m^2
STANDARD_DEVIATION 2.8 • n=39 Participants
|
34.8 kg/m^2
STANDARD_DEVIATION 2.6 • n=41 Participants
|
35.0 kg/m^2
STANDARD_DEVIATION 2.6 • n=35 Participants
|
35.0 kg/m^2
STANDARD_DEVIATION 2.8 • n=31 Participants
|
34.8 kg/m^2
STANDARD_DEVIATION 2.8 • n=146 Participants
|
34.1 kg/m^2
STANDARD_DEVIATION 2.6 • n=19 Participants
|
34.8 kg/m^2
STANDARD_DEVIATION 2.7 • n=147 Participants
|
|
Weight
|
97.3 kg
STANDARD_DEVIATION 12.3 • n=39 Participants
|
96.2 kg
STANDARD_DEVIATION 13.5 • n=41 Participants
|
98.0 kg
STANDARD_DEVIATION 12.5 • n=35 Participants
|
98.4 kg
STANDARD_DEVIATION 13.0 • n=31 Participants
|
97.6 kg
STANDARD_DEVIATION 13.7 • n=146 Participants
|
96.0 kg
STANDARD_DEVIATION 11.7 • n=19 Participants
|
97.2 kg
STANDARD_DEVIATION 12.8 • n=147 Participants
|
|
Waist circumference
|
108.3 cm
STANDARD_DEVIATION 10.0 • n=39 Participants
|
108.8 cm
STANDARD_DEVIATION 10.4 • n=41 Participants
|
108.2 cm
STANDARD_DEVIATION 9.5 • n=35 Participants
|
110.2 cm
STANDARD_DEVIATION 10.7 • n=31 Participants
|
108.9 cm
STANDARD_DEVIATION 8.3 • n=146 Participants
|
107.6 cm
STANDARD_DEVIATION 9.7 • n=19 Participants
|
108.7 cm
STANDARD_DEVIATION 9.8 • n=147 Participants
|
|
HbA1c
|
5.60 percentage (%) of total haemoglobin
STANDARD_DEVIATION 0.38 • n=39 Participants
|
5.58 percentage (%) of total haemoglobin
STANDARD_DEVIATION 0.33 • n=41 Participants
|
5.60 percentage (%) of total haemoglobin
STANDARD_DEVIATION 0.40 • n=35 Participants
|
5.54 percentage (%) of total haemoglobin
STANDARD_DEVIATION 0.33 • n=31 Participants
|
5.57 percentage (%) of total haemoglobin
STANDARD_DEVIATION 0.40 • n=146 Participants
|
5.55 percentage (%) of total haemoglobin
STANDARD_DEVIATION 0.32 • n=19 Participants
|
5.60 percentage (%) of total haemoglobin
STANDARD_DEVIATION 0.4 • n=147 Participants
|
|
Blood pressure
Systolic
|
123.6 mmHg
STANDARD_DEVIATION 11.1 • n=39 Participants
|
127.0 mmHg
STANDARD_DEVIATION 13.1 • n=41 Participants
|
123.4 mmHg
STANDARD_DEVIATION 13.0 • n=35 Participants
|
126.2 mmHg
STANDARD_DEVIATION 13.9 • n=31 Participants
|
124.3 mmHg
STANDARD_DEVIATION 11.3 • n=146 Participants
|
122.7 mmHg
STANDARD_DEVIATION 13.5 • n=19 Participants
|
124.5 mmHg
STANDARD_DEVIATION 12.7 • n=147 Participants
|
|
Blood pressure
Diastolic
|
76.8 mmHg
STANDARD_DEVIATION 8.5 • n=39 Participants
|
79.7 mmHg
STANDARD_DEVIATION 9.1 • n=41 Participants
|
77.9 mmHg
STANDARD_DEVIATION 7.9 • n=35 Participants
|
78.6 mmHg
STANDARD_DEVIATION 8.2 • n=31 Participants
|
77.8 mmHg
STANDARD_DEVIATION 8.3 • n=146 Participants
|
76.9 mmHg
STANDARD_DEVIATION 7.9 • n=19 Participants
|
77.9 mmHg
STANDARD_DEVIATION 8.4 • n=147 Participants
|
PRIMARY outcome
Timeframe: Week 0, week 20Population: ITT (intention to treat) analysis set using LOCF (last observation carried forward) is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product.
Calculated as mean body weight at week 20 - baseline
Outcome measures
| Measure |
Lira 1.2 mg/Lira 3.0 mg
n=94 Participants
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.8 mg/Lira 3.0 mg
n=90 Participants
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 2.4 mg/Lira 3.0 mg
n=92 Participants
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Liraglutide 3.0 mg
n=92 Participants
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Orlistat
n=95 Participants
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
|
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg
n=98 Participants
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Body Weight at Week 20
Baseline
|
96.4 kg
Standard Deviation 13.4
|
98.0 kg
Standard Deviation 12.5
|
98.4 kg
Standard Deviation 13.1
|
97.5 kg
Standard Deviation 13.8
|
96.0 kg
Standard Deviation 11.7
|
97.3 kg
Standard Deviation 12.3
|
|
Mean Change From Baseline in Body Weight at Week 20
Change at Week 20
|
-5.1 kg
Standard Deviation 3.5
|
-5.9 kg
Standard Deviation 5.0
|
-6.6 kg
Standard Deviation 4.6
|
-7.6 kg
Standard Deviation 4.6
|
-4.4 kg
Standard Deviation 4.1
|
-3.0 kg
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Week 0, week 104Population: ITT (intention to treat) analysis set using LOCF (last observation carried forward) is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product.
Calculated as mean body weight at week 104 - baseline
Outcome measures
| Measure |
Lira 1.2 mg/Lira 3.0 mg
n=94 Participants
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.8 mg/Lira 3.0 mg
n=90 Participants
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 2.4 mg/Lira 3.0 mg
n=92 Participants
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Liraglutide 3.0 mg
n=92 Participants
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Orlistat
n=95 Participants
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
|
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg
n=98 Participants
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Body Weight at Week 104
Baseline
|
96.4 kg
Standard Deviation 13.4
|
98.0 kg
Standard Deviation 12.5
|
98.4 kg
Standard Deviation 13.1
|
97.5 kg
Standard Deviation 13.8
|
96.0 kg
Standard Deviation 11.7
|
97.3 kg
Standard Deviation 12.3
|
|
Mean Change From Baseline in Body Weight at Week 104
Change at Week 104
|
-4.9 kg
Standard Deviation 5.8
|
-5.6 kg
Standard Deviation 6.5
|
-6.4 kg
Standard Deviation 7.2
|
-8.2 kg
Standard Deviation 7.1
|
-3.8 kg
Standard Deviation 6.4
|
-5.4 kg
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Week 0, week 20Population: ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product
Calculated as mean fasting plasma glucose at week 20 - baseline
Outcome measures
| Measure |
Lira 1.2 mg/Lira 3.0 mg
n=88 Participants
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.8 mg/Lira 3.0 mg
n=84 Participants
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 2.4 mg/Lira 3.0 mg
n=89 Participants
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Liraglutide 3.0 mg
n=86 Participants
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Orlistat
n=89 Participants
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
|
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg
n=92 Participants
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose at Week 20
Baseline
|
5.30 mmol/L
Standard Deviation 0.61
|
5.29 mmol/L
Standard Deviation 0.56
|
5.27 mmol/L
Standard Deviation 0.57
|
5.36 mmol/L
Standard Deviation 0.61
|
5.3 mmol/L
Standard Deviation 0.51
|
5.42 mmol/L
Standard Deviation 0.81
|
|
Change From Baseline in Fasting Plasma Glucose at Week 20
Change at Week 20
|
-0.39 mmol/L
Standard Deviation 0.45
|
-0.44 mmol/L
Standard Deviation 0.63
|
-0.38 mmol/L
Standard Deviation 0.48
|
-0.44 mmol/L
Standard Deviation 0.44
|
-0.10 mmol/L
Standard Deviation 0.41
|
-0.09 mmol/L
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: Week 0, week 104Population: ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product
Calculated as mean fasting plasma glucose at week 104 - baseline
Outcome measures
| Measure |
Lira 1.2 mg/Lira 3.0 mg
n=88 Participants
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.8 mg/Lira 3.0 mg
n=84 Participants
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 2.4 mg/Lira 3.0 mg
n=89 Participants
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Liraglutide 3.0 mg
n=86 Participants
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Orlistat
n=89 Participants
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
|
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg
n=92 Participants
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose at Week 104
Baseline
|
5.30 mmol/L
Standard Deviation 0.61
|
5.29 mmol/L
Standard Deviation 0.56
|
5.27 mmol/L
Standard Deviation 0.57
|
5.36 mmol/L
Standard Deviation 0.61
|
5.30 mmol/L
Standard Deviation 0.51
|
5.42 mmol/L
Standard Deviation 0.81
|
|
Change From Baseline in Fasting Plasma Glucose at Week 104
Change at Week 104
|
-0.09 mmol/L
Standard Deviation 0.53
|
-0.09 mmol/L
Standard Deviation 0.64
|
-0.20 mmol/L
Standard Deviation 0.50
|
-0.23 mmol/L
Standard Deviation 0.50
|
0.02 mmol/L
Standard Deviation 0.48
|
-0.22 mmol/L
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: Week 0, week 20Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Calculated as mean fasting insulin at week 20 - baseline
Outcome measures
| Measure |
Lira 1.2 mg/Lira 3.0 mg
n=84 Participants
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.8 mg/Lira 3.0 mg
n=73 Participants
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 2.4 mg/Lira 3.0 mg
n=73 Participants
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Liraglutide 3.0 mg
n=81 Participants
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Orlistat
n=79 Participants
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
|
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg
n=77 Participants
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Insulin at Week 20
Baseline
|
82.9 pmol/L
Standard Deviation 43.0
|
85.7 pmol/L
Standard Deviation 49.5
|
88.7 pmol/L
Standard Deviation 43.3
|
89.1 pmol/L
Standard Deviation 51.9
|
85.5 pmol/L
Standard Deviation 48.3
|
99.5 pmol/L
Standard Deviation 129.2
|
|
Change From Baseline in Fasting Insulin at Week 20
Change at Week 20
|
8.7 pmol/L
Standard Deviation 105.3
|
-0.7 pmol/L
Standard Deviation 48.2
|
-3.9 pmol/L
Standard Deviation 53.2
|
-12.3 pmol/L
Standard Deviation 43.3
|
-16.7 pmol/L
Standard Deviation 60.6
|
-15.0 pmol/L
Standard Deviation 34.0
|
SECONDARY outcome
Timeframe: Week 0, week 104Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Calculated as mean fasting insulin at week 104 - baseline
Outcome measures
| Measure |
Lira 1.2 mg/Lira 3.0 mg
n=42 Participants
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.8 mg/Lira 3.0 mg
n=33 Participants
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 2.4 mg/Lira 3.0 mg
n=42 Participants
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Liraglutide 3.0 mg
n=44 Participants
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Orlistat
n=39 Participants
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
|
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg
n=44 Participants
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Insulin at Week 104
Baseline
|
82.9 pmol/L
Standard Deviation 43.0
|
85.7 pmol/L
Standard Deviation 49.5
|
88.7 pmol/L
Standard Deviation 43.3
|
89.1 pmol/L
Standard Deviation 51.9
|
85.5 pmol/L
Standard Deviation 48.3
|
99.5 pmol/L
Standard Deviation 129.2
|
|
Change From Baseline in Fasting Insulin at Week 104
Change at Week 104
|
-13.5 pmol/L
Standard Deviation 39.7
|
18.6 pmol/L
Standard Deviation 102.6
|
-2.1 pmol/L
Standard Deviation 47.3
|
-19.6 pmol/L
Standard Deviation 44.3
|
-15.3 pmol/L
Standard Deviation 39.8
|
0.7 pmol/L
Standard Deviation 53.6
|
SECONDARY outcome
Timeframe: Week 0, week 20Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 20 - baseline
Outcome measures
| Measure |
Lira 1.2 mg/Lira 3.0 mg
n=84 Participants
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.8 mg/Lira 3.0 mg
n=70 Participants
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 2.4 mg/Lira 3.0 mg
n=70 Participants
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Liraglutide 3.0 mg
n=79 Participants
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Orlistat
n=78 Participants
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
|
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg
n=73 Participants
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
|---|---|---|---|---|---|---|
|
Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20
Baseline
|
5.58 percentage (%) of total haemoglobin
Standard Deviation 0.33
|
5.60 percentage (%) of total haemoglobin
Standard Deviation 0.40
|
5.54 percentage (%) of total haemoglobin
Standard Deviation 0.34
|
5.57 percentage (%) of total haemoglobin
Standard Deviation 0.40
|
5.55 percentage (%) of total haemoglobin
Standard Deviation 0.32
|
5.60 percentage (%) of total haemoglobin
Standard Deviation 0.38
|
|
Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20
Change at Week 20
|
-0.14 percentage (%) of total haemoglobin
Standard Deviation 0.21
|
-0.21 percentage (%) of total haemoglobin
Standard Deviation 0.25
|
-0.22 percentage (%) of total haemoglobin
Standard Deviation 0.25
|
-0.24 percentage (%) of total haemoglobin
Standard Deviation 0.29
|
0.00 percentage (%) of total haemoglobin
Standard Deviation 0.21
|
0.01 percentage (%) of total haemoglobin
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: Week 0, week 104Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 104 - baseline
Outcome measures
| Measure |
Lira 1.2 mg/Lira 3.0 mg
n=45 Participants
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.8 mg/Lira 3.0 mg
n=36 Participants
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 2.4 mg/Lira 3.0 mg
n=45 Participants
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Liraglutide 3.0 mg
n=47 Participants
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Orlistat
n=45 Participants
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
|
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg
n=46 Participants
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
|---|---|---|---|---|---|---|
|
Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104
Baseline
|
5.58 percentage (%) of total haemoglobin
Standard Deviation 0.33
|
5.60 percentage (%) of total haemoglobin
Standard Deviation 0.40
|
5.54 percentage (%) of total haemoglobin
Standard Deviation 0.34
|
5.57 percentage (%) of total haemoglobin
Standard Deviation 0.40
|
5.55 percentage (%) of total haemoglobin
Standard Deviation 0.32
|
5.60 percentage (%) of total haemoglobin
Standard Deviation 0.38
|
|
Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104
Change at Week 104
|
-0.25 percentage (%) of total haemoglobin
Standard Deviation 0.26
|
-0.30 percentage (%) of total haemoglobin
Standard Deviation 0.22
|
-0.25 percentage (%) of total haemoglobin
Standard Deviation 0.30
|
-0.35 percentage (%) of total haemoglobin
Standard Deviation 0.32
|
-0.18 percentage (%) of total haemoglobin
Standard Deviation 0.37
|
-0.32 percentage (%) of total haemoglobin
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Week 0, week 20Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 20-baseline. High hsCRP level is associated with greater cardiovascular risk
Outcome measures
| Measure |
Lira 1.2 mg/Lira 3.0 mg
n=83 Participants
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.8 mg/Lira 3.0 mg
n=74 Participants
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 2.4 mg/Lira 3.0 mg
n=72 Participants
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Liraglutide 3.0 mg
n=79 Participants
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Orlistat
n=79 Participants
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
|
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg
n=75 Participants
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
|---|---|---|---|---|---|---|
|
Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20
Baseline
|
5.1 mg/L
Standard Deviation 6.1
|
4.4 mg/L
Standard Deviation 4.5
|
4.0 mg/L
Standard Deviation 4.2
|
3.8 mg/L
Standard Deviation 7.4
|
4.6 mg/L
Standard Deviation 4.5
|
3.6 mg/L
Standard Deviation 4.2
|
|
Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20
Change at Week 20
|
0.1 mg/L
Standard Deviation 8.1
|
-0.8 mg/L
Standard Deviation 2.9
|
0.5 mg/L
Standard Deviation 4.7
|
-1.1 mg/L
Standard Deviation 7.2
|
-0.3 mg/L
Standard Deviation 4.2
|
0.8 mg/L
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: Week 0, week 104Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 104- baseline. High hsCRP level is associated with greater cardiovascular risk
Outcome measures
| Measure |
Lira 1.2 mg/Lira 3.0 mg
n=45 Participants
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.8 mg/Lira 3.0 mg
n=38 Participants
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 2.4 mg/Lira 3.0 mg
n=45 Participants
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Liraglutide 3.0 mg
n=45 Participants
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Orlistat
n=45 Participants
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
|
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg
n=46 Participants
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
|---|---|---|---|---|---|---|
|
Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104
Change at Week 104
|
-1.6 mg/L
Standard Deviation 6.0
|
-0.6 mg/L
Standard Deviation 8.6
|
-0.9 mg/L
Standard Deviation 3.2
|
-2.1 mg/L
Standard Deviation 9.3
|
2.4 mg/L
Standard Deviation 19.4
|
-0.5 mg/L
Standard Deviation 2.6
|
|
Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104
Baseline
|
5.1 mg/L
Standard Deviation 6.1
|
4.4 mg/L
Standard Deviation 4.5
|
4.0 mg/L
Standard Deviation 4.2
|
3.8 mg/L
Standard Deviation 7.4
|
4.6 mg/L
Standard Deviation 4.5
|
3.6 mg/L
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Week 0, week 20Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 20-baseline. High PAI-1 is associated with greater cardiovascular risk
Outcome measures
| Measure |
Lira 1.2 mg/Lira 3.0 mg
n=69 Participants
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.8 mg/Lira 3.0 mg
n=61 Participants
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 2.4 mg/Lira 3.0 mg
n=60 Participants
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Liraglutide 3.0 mg
n=72 Participants
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Orlistat
n=65 Participants
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
|
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg
n=68 Participants
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
|---|---|---|---|---|---|---|
|
Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20
Baseline
|
19.5 U/mL
Standard Deviation 9.9
|
19.7 U/mL
Standard Deviation 9.8
|
17.6 U/mL
Standard Deviation 8.7
|
19.0 U/mL
Standard Deviation 9.1
|
17.4 U/mL
Standard Deviation 8.2
|
21.6 U/mL
Standard Deviation 9.3
|
|
Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20
Change at Week 20
|
-2.0 U/mL
Standard Deviation 7.8
|
-3.5 U/mL
Standard Deviation 9.5
|
-2.3 U/mL
Standard Deviation 9.5
|
-4.5 U/mL
Standard Deviation 8.5
|
-1.2 U/mL
Standard Deviation 8.8
|
-3.0 U/mL
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: Week 0, week 104Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 104-baseline. High PAI-1 is associated with greater cardiovascular risk
Outcome measures
| Measure |
Lira 1.2 mg/Lira 3.0 mg
n=36 Participants
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.8 mg/Lira 3.0 mg
n=29 Participants
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 2.4 mg/Lira 3.0 mg
n=37 Participants
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Liraglutide 3.0 mg
n=39 Participants
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Orlistat
n=41 Participants
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
|
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg
n=39 Participants
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
|---|---|---|---|---|---|---|
|
Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104
Baseline
|
19.5 U/mL
Standard Deviation 9.9
|
19.7 U/mL
Standard Deviation 9.8
|
17.6 U/mL
Standard Deviation 8.7
|
19.0 U/mL
Standard Deviation 9.1
|
17.4 U/mL
Standard Deviation 8.2
|
21.6 U/mL
Standard Deviation 9.3
|
|
Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104
Change at Week 104
|
-0.3 U/mL
Standard Deviation 9.1
|
-0.8 U/mL
Standard Deviation 9.8
|
0.3 U/mL
Standard Deviation 9.9
|
0.4 U/mL
Standard Deviation 10.9
|
2.9 U/mL
Standard Deviation 7.4
|
-1.4 U/mL
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Week 0, week 20Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Calculated as mean fibrinogen at week 20 - baseline. High fibrinogen is associated with greater cardiovascular risk
Outcome measures
| Measure |
Lira 1.2 mg/Lira 3.0 mg
n=71 Participants
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.8 mg/Lira 3.0 mg
n=62 Participants
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 2.4 mg/Lira 3.0 mg
n=61 Participants
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Liraglutide 3.0 mg
n=73 Participants
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Orlistat
n=67 Participants
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
|
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg
n=68 Participants
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Fibrinogen at Week 20
Baseline
|
3.67 g/L
Standard Deviation 0.76
|
3.75 g/L
Standard Deviation 0.72
|
3.64 g/L
Standard Deviation 0.72
|
3.61 g/L
Standard Deviation 0.68
|
3.68 g/L
Standard Deviation 0.82
|
3.60 g/L
Standard Deviation 0.67
|
|
Change From Baseline in Fibrinogen at Week 20
Change at Week 20
|
0.01 g/L
Standard Deviation 0.50
|
0.02 g/L
Standard Deviation 0.61
|
0.10 g/L
Standard Deviation 0.69
|
0.05 g/L
Standard Deviation 0.55
|
-0.12 g/L
Standard Deviation 0.75
|
-0.06 g/L
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: Week 0, week 104Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Calculated as mean fibrinogen at week 104 - baseline. High fibrinogen is associated with greater cardiovascular risk
Outcome measures
| Measure |
Lira 1.2 mg/Lira 3.0 mg
n=38 Participants
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.8 mg/Lira 3.0 mg
n=29 Participants
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 2.4 mg/Lira 3.0 mg
n=36 Participants
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Liraglutide 3.0 mg
n=39 Participants
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Orlistat
n=41 Participants
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
|
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg
n=39 Participants
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Fibrinogen at Week 104
Baseline
|
3.67 g/L
Standard Deviation 0.76
|
3.75 g/L
Standard Deviation 0.72
|
3.64 g/L
Standard Deviation 0.72
|
3.61 g/L
Standard Deviation 0.68
|
3.68 g/L
Standard Deviation 0.82
|
3.60 g/L
Standard Deviation 0.67
|
|
Change From Baseline in Fibrinogen at Week 104
Change at Week 104
|
-0.14 g/L
Standard Deviation 0.73
|
-0.15 g/L
Standard Deviation 0.98
|
-0.24 g/L
Standard Deviation 0.74
|
-0.22 g/L
Standard Deviation 0.82
|
-0.39 g/L
Standard Deviation 1.24
|
-0.10 g/L
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: Week 0, week 20Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Calculated as mean adiponectin at week 20-baseline. A low adiponectin level is associated with greater cardiovascular risk
Outcome measures
| Measure |
Lira 1.2 mg/Lira 3.0 mg
n=82 Participants
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.8 mg/Lira 3.0 mg
n=72 Participants
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 2.4 mg/Lira 3.0 mg
n=70 Participants
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Liraglutide 3.0 mg
n=79 Participants
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Orlistat
n=77 Participants
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
|
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg
n=77 Participants
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Adiponectin at Week 20
Baseline
|
5.8 mcg/mL
Standard Deviation 3.8
|
6.7 mcg/mL
Standard Deviation 4.6
|
6.2 mcg/mL
Standard Deviation 4.6
|
6.1 mcg/mL
Standard Deviation 4.0
|
5.4 mcg/mL
Standard Deviation 4.7
|
5.1 mcg/mL
Standard Deviation 3.8
|
|
Change From Baseline in Adiponectin at Week 20
Change at Week 20
|
1.2 mcg/mL
Standard Deviation 5.0
|
1.7 mcg/mL
Standard Deviation 6.9
|
1.6 mcg/mL
Standard Deviation 5.7
|
2.3 mcg/mL
Standard Deviation 4.6
|
1.7 mcg/mL
Standard Deviation 4.4
|
2.3 mcg/mL
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: Week 0, week 104Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Calculated as mean adiponectin at week 104-baseline. A low adiponectin level is associated with greater cardiovascular risk
Outcome measures
| Measure |
Lira 1.2 mg/Lira 3.0 mg
n=36 Participants
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.8 mg/Lira 3.0 mg
n=27 Participants
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 2.4 mg/Lira 3.0 mg
n=39 Participants
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Liraglutide 3.0 mg
n=35 Participants
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Orlistat
n=39 Participants
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
|
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg
n=39 Participants
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Adiponectin at Week 104
Baseline
|
5.8 mcg/mL
Standard Deviation 3.8
|
6.7 mcg/mL
Standard Deviation 4.6
|
6.2 mcg/mL
Standard Deviation 4.6
|
6.1 mcg/mL
Standard Deviation 4.0
|
5.4 mcg/mL
Standard Deviation 4.7
|
5.1 mcg/mL
Standard Deviation 3.8
|
|
Change From Baseline in Adiponectin at Week 104
Change at Week 104
|
3.3 mcg/mL
Standard Deviation 3.8
|
1.3 mcg/mL
Standard Deviation 3.9
|
3.4 mcg/mL
Standard Deviation 5.4
|
3.2 mcg/mL
Standard Deviation 4.1
|
3.1 mcg/mL
Standard Deviation 4.2
|
3.5 mcg/mL
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Week 0, week 20Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Calculated as mean waist circumference at week 20-baseline.
Outcome measures
| Measure |
Lira 1.2 mg/Lira 3.0 mg
n=93 Participants
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.8 mg/Lira 3.0 mg
n=83 Participants
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 2.4 mg/Lira 3.0 mg
n=85 Participants
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Liraglutide 3.0 mg
n=85 Participants
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Orlistat
n=87 Participants
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
|
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg
n=90 Participants
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Waist Circumference at Week 20
Baseline
|
109.0 cm
Standard Deviation 10.3
|
108.2 cm
Standard Deviation 9.5
|
110.4 cm
Standard Deviation 10.6
|
108.7 cm
Standard Deviation 8.3
|
107.6 cm
Standard Deviation 9.7
|
108.3 cm
Standard Deviation 10.0
|
|
Change From Baseline in Waist Circumference at Week 20
Change at Week 20
|
-5.8 cm
Standard Deviation 6.1
|
-5.9 cm
Standard Deviation 5.3
|
-7.2 cm
Standard Deviation 5.8
|
-7.9 cm
Standard Deviation 5.5
|
-6.0 cm
Standard Deviation 5.4
|
-4.2 cm
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: Week 0, week 104Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Calculated as mean waist circumference at week 104-baseline.
Outcome measures
| Measure |
Lira 1.2 mg/Lira 3.0 mg
n=46 Participants
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.8 mg/Lira 3.0 mg
n=38 Participants
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 2.4 mg/Lira 3.0 mg
n=45 Participants
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Liraglutide 3.0 mg
n=47 Participants
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Orlistat
n=45 Participants
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
|
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg
n=47 Participants
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Waist Circumference at Week 104
Baseline
|
109.0 cm
Standard Deviation 10.3
|
108.2 cm
Standard Deviation 9.5
|
110.4 cm
Standard Deviation 10.6
|
108.7 cm
Standard Deviation 8.3
|
107.6 cm
Standard Deviation 9.7
|
108.3 cm
Standard Deviation 10.0
|
|
Change From Baseline in Waist Circumference at Week 104
Change at Week 104
|
-8.6 cm
Standard Deviation 7.5
|
-9.0 cm
Standard Deviation 8.7
|
-10.4 cm
Standard Deviation 7.8
|
-9.8 cm
Standard Deviation 7.5
|
-9.5 cm
Standard Deviation 7.3
|
-10.0 cm
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: Week 0, week 20Population: ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product
Calculated as mean blood pressure at week 20-baseline.
Outcome measures
| Measure |
Lira 1.2 mg/Lira 3.0 mg
n=88 Participants
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.8 mg/Lira 3.0 mg
n=85 Participants
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 2.4 mg/Lira 3.0 mg
n=89 Participants
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Liraglutide 3.0 mg
n=89 Participants
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Orlistat
n=90 Participants
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
|
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg
n=94 Participants
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Blood Pressure at Week 20
Baseline (Systolic )
|
127.2 mmHg
Standard Deviation 13.1
|
123.4 mmHg
Standard Deviation 13.0
|
126.3 mmHg
Standard Deviation 13.9
|
124.3 mmHg
Standard Deviation 11.3
|
122.7 mmHg
Standard Deviation 13.5
|
123.6 mmHg
Standard Deviation 11.1
|
|
Change From Baseline in Blood Pressure at Week 20
Change at Week 20 (Systolic)
|
-6.1 mmHg
Standard Deviation 11.1
|
-4.8 mmHg
Standard Deviation 12.7
|
-9.1 mmHg
Standard Deviation 12.3
|
-6.4 mmHg
Standard Deviation 10.0
|
-4.3 mmHg
Standard Deviation 10.9
|
-3.2 mmHg
Standard Deviation 13.3
|
|
Change From Baseline in Blood Pressure at Week 20
Baseline (Diastolic)
|
79.71 mmHg
Standard Deviation 9.12
|
77.91 mmHg
Standard Deviation 7.92
|
78.53 mmHg
Standard Deviation 8.23
|
77.84 mmHg
Standard Deviation 8.38
|
76.94 mmHg
Standard Deviation 7.94
|
76.78 mmHg
Standard Deviation 8.50
|
|
Change From Baseline in Blood Pressure at Week 20
Change at Week 20 (Diastolic)
|
-1.53 mmHg
Standard Deviation 9.15
|
-1.61 mmHg
Standard Deviation 8.04
|
-1.39 mmHg
Standard Deviation 7.79
|
-2.37 mmHg
Standard Deviation 7.71
|
-1.96 mmHg
Standard Deviation 7.82
|
-0.32 mmHg
Standard Deviation 7.52
|
SECONDARY outcome
Timeframe: Week 0, week 104Population: ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product
Calculated as mean blood pressure at week 104-baseline.
Outcome measures
| Measure |
Lira 1.2 mg/Lira 3.0 mg
n=88 Participants
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.8 mg/Lira 3.0 mg
n=85 Participants
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 2.4 mg/Lira 3.0 mg
n=89 Participants
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Liraglutide 3.0 mg
n=89 Participants
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Orlistat
n=90 Participants
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
|
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg
n=94 Participants
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Blood Pressure at Week 104
Change at Week 104 (Systolic)
|
-4.0 mmHg
Standard Deviation 13.4
|
-3.8 mmHg
Standard Deviation 16.0
|
-6.5 mmHg
Standard Deviation 12.6
|
-5.6 mmHg
Standard Deviation 11.7
|
-2.0 mmHg
Standard Deviation 11.7
|
-2.0 mmHg
Standard Deviation 13.8
|
|
Change From Baseline in Blood Pressure at Week 104
Baseline (Diastolic)
|
79.71 mmHg
Standard Deviation 9.12
|
77.91 mmHg
Standard Deviation 7.92
|
78.53 mmHg
Standard Deviation 8.23
|
77.84 mmHg
Standard Deviation 8.38
|
76.94 mmHg
Standard Deviation 7.94
|
76.78 mmHg
Standard Deviation 8.50
|
|
Change From Baseline in Blood Pressure at Week 104
Baseline (Systolic )
|
127.2 mmHg
Standard Deviation 13.1
|
123.4 mmHg
Standard Deviation 13.0
|
126.3 mmHg
Standard Deviation 13.9
|
124.3 mmHg
Standard Deviation 11.3
|
122.7 mmHg
Standard Deviation 13.5
|
123.6 mmHg
Standard Deviation 11.1
|
|
Change From Baseline in Blood Pressure at Week 104
Change at Week 104 (Diastolic)
|
-0.98 mmHg
Standard Deviation 9.81
|
-1.00 mmHg
Standard Deviation 9.37
|
-1.99 mmHg
Standard Deviation 9.61
|
-1.92 mmHg
Standard Deviation 9.41
|
-1.11 mmHg
Standard Deviation 8.36
|
1.64 mmHg
Standard Deviation 8.47
|
Adverse Events
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg
Serious events: 6 serious events
Other events: 90 other events
Deaths: 0 deaths
Lira 1.2 mg/Lira 3.0 mg
Serious events: 9 serious events
Other events: 90 other events
Deaths: 0 deaths
Lira 1.8 mg/Lira 3.0 mg
Serious events: 10 serious events
Other events: 86 other events
Deaths: 0 deaths
Lira 2.4 mg/Lira 3.0 mg
Serious events: 7 serious events
Other events: 89 other events
Deaths: 0 deaths
Liraglutide 3.0 mg
Serious events: 10 serious events
Other events: 90 other events
Deaths: 0 deaths
Orlistat
Serious events: 6 serious events
Other events: 89 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg
n=98 participants at risk
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.2 mg/Lira 3.0 mg
n=95 participants at risk
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.8 mg/Lira 3.0 mg
n=90 participants at risk
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 2.4 mg/Lira 3.0 mg
n=93 participants at risk
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Liraglutide 3.0 mg
n=93 participants at risk
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Orlistat
n=95 participants at risk
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
|
|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/90 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/93 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/93 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/93 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
1/98 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/90 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Congenital, familial and genetic disorders
Thyroglossal cyst
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/93 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Ear and labyrinth disorders
Vestibular neuronitis
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/93 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Eye disorders
Retinal detachment
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/90 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/93 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/90 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/93 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/95 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/90 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/93 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/95 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/95 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/93 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Vascular disorders
Hypertension
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/95 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
2.2%
2/93 • Number of events 2 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/95 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/93 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/95 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Gastrointestinal disorders
Hernial eventration
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/90 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/93 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/93 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/93 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Hepatobiliary disorders
Cholecystitis
|
1.0%
1/98 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/90 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/93 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/95 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/90 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/93 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/95 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Infections and infestations
Abscess limb
|
1.0%
1/98 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/93 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/95 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Infections and infestations
Cellulitis
|
1.0%
1/98 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/95 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/90 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/93 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/90 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/93 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Injury, poisoning and procedural complications
Anaesthetic complication
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/95 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/95 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Injury, poisoning and procedural complications
Foreign body trauma
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/93 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/95 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.0%
1/98 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
1.0%
1/98 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/95 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Musculoskeletal and connective tissue disorders
Ligament calcification
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/93 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/93 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/95 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/93 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
1.1%
1/90 • Number of events 1 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
Other adverse events
| Measure |
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg
n=98 participants at risk
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.2 mg/Lira 3.0 mg
n=95 participants at risk
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 1.8 mg/Lira 3.0 mg
n=90 participants at risk
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Lira 2.4 mg/Lira 3.0 mg
n=93 participants at risk
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Liraglutide 3.0 mg
n=93 participants at risk
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
|
Orlistat
n=95 participants at risk
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
6.7%
6/90 • Number of events 6 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
5.3%
5/95 • Number of events 5 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Gastrointestinal disorders
Abdominal distension
|
5.1%
5/98 • Number of events 5 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
5.3%
5/95 • Number of events 5 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Gastrointestinal disorders
Abdominal pain
|
6.1%
6/98 • Number of events 6 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
6.7%
6/90 • Number of events 6 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
7.4%
7/95 • Number of events 10 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.1%
5/98 • Number of events 6 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
6.3%
6/95 • Number of events 9 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
5.4%
5/93 • Number of events 6 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
7.5%
7/93 • Number of events 9 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
8.4%
8/95 • Number of events 10 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Gastrointestinal disorders
Constipation
|
15.3%
15/98 • Number of events 19 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
21.1%
20/95 • Number of events 24 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
13.3%
12/90 • Number of events 14 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
23.7%
22/93 • Number of events 29 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
20.4%
19/93 • Number of events 23 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
7.4%
7/95 • Number of events 9 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Gastrointestinal disorders
Diarrhoea
|
20.4%
20/98 • Number of events 27 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
15.8%
15/95 • Number of events 23 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
17.8%
16/90 • Number of events 21 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
19.4%
18/93 • Number of events 20 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
19.4%
18/93 • Number of events 21 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
34.7%
33/95 • Number of events 49 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
6.3%
6/95 • Number of events 7 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Gastrointestinal disorders
Dyspepsia
|
10.2%
10/98 • Number of events 12 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
9.5%
9/95 • Number of events 10 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
10.0%
9/90 • Number of events 9 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
10.8%
10/93 • Number of events 19 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
10.8%
10/93 • Number of events 10 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
5.3%
5/95 • Number of events 6 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
5.6%
5/90 • Number of events 5 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
6.7%
6/90 • Number of events 6 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
12.6%
12/95 • Number of events 13 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Gastrointestinal disorders
Nausea
|
29.6%
29/98 • Number of events 40 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
36.8%
35/95 • Number of events 47 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
37.8%
34/90 • Number of events 40 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
41.9%
39/93 • Number of events 61 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
50.5%
47/93 • Number of events 76 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
8.4%
8/95 • Number of events 9 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Gastrointestinal disorders
Steatorrhoea
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
5.3%
5/95 • Number of events 5 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
7.8%
7/90 • Number of events 9 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
6/98 • Number of events 7 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
12.6%
12/95 • Number of events 15 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
14.4%
13/90 • Number of events 24 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
17.2%
16/93 • Number of events 20 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
14.0%
13/93 • Number of events 16 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
General disorders
Fatigue
|
8.2%
8/98 • Number of events 9 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
7.4%
7/95 • Number of events 7 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
8.9%
8/90 • Number of events 8 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
8.6%
8/93 • Number of events 8 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
14.0%
13/93 • Number of events 13 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
General disorders
Oedema peripheral
|
6.1%
6/98 • Number of events 7 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
7.8%
7/90 • Number of events 7 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
5.4%
5/93 • Number of events 6 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
6.3%
6/95 • Number of events 6 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Infections and infestations
Cystitis
|
6.1%
6/98 • Number of events 6 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Infections and infestations
Gastroenteritis
|
13.3%
13/98 • Number of events 13 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
13.7%
13/95 • Number of events 16 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
22.2%
20/90 • Number of events 31 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
16.1%
15/93 • Number of events 19 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
22.6%
21/93 • Number of events 26 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
21.1%
20/95 • Number of events 24 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Infections and infestations
Gastroenteritis viral
|
5.1%
5/98 • Number of events 5 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Infections and infestations
Influenza
|
10.2%
10/98 • Number of events 16 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
25.3%
24/95 • Number of events 37 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
12.2%
11/90 • Number of events 17 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
18.3%
17/93 • Number of events 23 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
23.7%
22/93 • Number of events 39 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
26.3%
25/95 • Number of events 39 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Infections and infestations
Nasopharyngitis
|
41.8%
41/98 • Number of events 85 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
38.9%
37/95 • Number of events 69 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
37.8%
34/90 • Number of events 71 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
45.2%
42/93 • Number of events 80 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
40.9%
38/93 • Number of events 74 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
27.4%
26/95 • Number of events 46 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Infections and infestations
Pharyngitis
|
5.1%
5/98 • Number of events 6 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
5.4%
5/93 • Number of events 5 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
8.4%
8/95 • Number of events 13 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
8.9%
8/90 • Number of events 10 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
8.6%
8/93 • Number of events 11 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
5.4%
5/93 • Number of events 10 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
6.3%
6/95 • Number of events 7 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Infections and infestations
Tooth infection
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
5.3%
5/95 • Number of events 6 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
9.2%
9/98 • Number of events 13 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
10.5%
10/95 • Number of events 11 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
8.9%
8/90 • Number of events 16 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
12.9%
12/93 • Number of events 13 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
14.0%
13/93 • Number of events 20 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
13.7%
13/95 • Number of events 16 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Infections and infestations
Urinary Tract Infection
|
5.1%
5/98 • Number of events 8 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
5.3%
5/95 • Number of events 6 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Injury, poisoning and procedural complications
Joint sprain
|
5.1%
5/98 • Number of events 7 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
7.4%
7/95 • Number of events 8 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Investigations
Blood insulin increased
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
5.3%
5/95 • Number of events 5 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Investigations
Blood TSH increased
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
5.6%
5/90 • Number of events 7 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.1%
5/98 • Number of events 5 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
14/98 • Number of events 15 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
9.5%
9/95 • Number of events 10 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
10.8%
10/93 • Number of events 12 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
5.4%
5/93 • Number of events 5 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
7.4%
7/95 • Number of events 9 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
14/98 • Number of events 15 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
9.5%
9/95 • Number of events 10 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
17.8%
16/90 • Number of events 20 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
17.2%
16/93 • Number of events 17 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
12.9%
12/93 • Number of events 18 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
16.8%
16/95 • Number of events 21 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
5.3%
5/95 • Number of events 5 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
5.4%
5/93 • Number of events 9 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.1%
6/98 • Number of events 6 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
7.5%
7/93 • Number of events 9 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.2%
9/98 • Number of events 10 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
5.3%
5/95 • Number of events 7 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
10.0%
9/90 • Number of events 9 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
6.5%
6/93 • Number of events 6 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
7.5%
7/93 • Number of events 8 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
6.3%
6/95 • Number of events 6 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Nervous system disorders
Dizziness
|
12.2%
12/98 • Number of events 12 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
7.4%
7/95 • Number of events 8 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
6.7%
6/90 • Number of events 8 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
6.5%
6/93 • Number of events 8 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
9.7%
9/93 • Number of events 9 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Nervous system disorders
Headache
|
23.5%
23/98 • Number of events 37 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
24.2%
23/95 • Number of events 41 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
17.8%
16/90 • Number of events 23 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
24.7%
23/93 • Number of events 54 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
23.7%
22/93 • Number of events 25 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
16.8%
16/95 • Number of events 26 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
7.5%
7/93 • Number of events 8 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.2%
8/98 • Number of events 8 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
7.4%
7/95 • Number of events 8 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
6.3%
6/95 • Number of events 6 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
5.3%
5/95 • Number of events 5 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/90 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
7.5%
7/93 • Number of events 7 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
9.5%
9/95 • Number of events 10 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/98 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
7.8%
7/90 • Number of events 7 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/93 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
0.00%
0/95 • The adverse events were collected over 104 weeks.
Safety analysis set consists of all subjects exposed to trial product(s).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Novo Nordisk acknowledges the Investigator's right to publish the entire results of the trial. Any such scientific paper, presentation, communication or other information concerning the investigation described in this protocol, must be submitted in writing to Novo Nordisk's Trial Manager prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.
- Publication restrictions are in place
Restriction type: OTHER