Trial Outcomes & Findings for A Placebo Controlled Safety and Efficacy Study of INT131 Besylate in Type 2 Diabetes, With an Active Comparator (NCT NCT00631007)
NCT ID: NCT00631007
Last Updated: 2010-09-13
Results Overview
HbA1c is measured as percent. Thus this change from baseline reflects the week 24 HbA1c percent minus the Week 0 HbA1c percent
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
367 participants
Primary outcome timeframe
Weeks 0-24
Results posted on
2010-09-13
Participant Flow
Patients 30 - 75 years of age with type 2 diabetes mellitus with inadequate glycemic control (HbA1c ≥7.5% and ≤ 10% and a Fasting Plasma Glucose \<240 mg/dL) at screening on sulfonylurea monotherapy or sulfonylurea plus metformin were eligible to enter the study.
Participant milestones
| Measure |
INT131 Besylate 0.5 mg
INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
|
INT131 Besylate 1 mg
INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
|
INT131 Besylate 2 mg
INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
|
INT131 Besylate 3 mg
INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
|
Pioglitazone HCl 45 mg
pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
|
Placebo
placebo administered once-daily
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
60
|
61
|
63
|
62
|
60
|
61
|
|
Overall Study
COMPLETED
|
49
|
50
|
53
|
53
|
48
|
46
|
|
Overall Study
NOT COMPLETED
|
11
|
11
|
10
|
9
|
12
|
15
|
Reasons for withdrawal
| Measure |
INT131 Besylate 0.5 mg
INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
|
INT131 Besylate 1 mg
INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
|
INT131 Besylate 2 mg
INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
|
INT131 Besylate 3 mg
INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
|
Pioglitazone HCl 45 mg
pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
|
Placebo
placebo administered once-daily
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
2
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
2
|
4
|
5
|
3
|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
0
|
0
|
2
|
|
Overall Study
Persistent Hyperglycemia
|
2
|
2
|
5
|
1
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
2
|
2
|
1
|
3
|
|
Overall Study
Other
|
2
|
1
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Placebo Controlled Safety and Efficacy Study of INT131 Besylate in Type 2 Diabetes, With an Active Comparator
Baseline characteristics by cohort
| Measure |
INT131 Besylate 0.5 mg
n=60 Participants
INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
|
INT131 Besylate 1 mg
n=61 Participants
INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
|
INT131 Besylate 2 mg
n=63 Participants
INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
|
INT131 Besylate 3 mg
n=61 Participants
INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
|
Pioglitazone HCl 45 mg
n=60 Participants
pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
|
Placebo
n=61 Participants
placebo administered once-daily
|
Total
n=366 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age Continuous
|
54.9 years
STANDARD_DEVIATION 8.48 • n=5 Participants
|
58.0 years
STANDARD_DEVIATION 9.18 • n=7 Participants
|
56.1 years
STANDARD_DEVIATION 7.98 • n=5 Participants
|
54.8 years
STANDARD_DEVIATION 9.76 • n=4 Participants
|
55.8 years
STANDARD_DEVIATION 10.40 • n=21 Participants
|
55.3 years
STANDARD_DEVIATION 10.93 • n=10 Participants
|
55.8 years
STANDARD_DEVIATION 9.50 • n=115 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
28 Participants
n=10 Participants
|
170 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
33 Participants
n=10 Participants
|
196 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
31 Participants
n=10 Participants
|
180 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
186 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
36 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
42 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
46 Participants
n=10 Participants
|
280 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
50 participants
n=7 Participants
|
52 participants
n=5 Participants
|
52 participants
n=4 Participants
|
51 participants
n=21 Participants
|
49 participants
n=10 Participants
|
305 participants
n=115 Participants
|
|
Region of Enrollment
Mexico
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
11 participants
n=5 Participants
|
9 participants
n=4 Participants
|
9 participants
n=21 Participants
|
12 participants
n=10 Participants
|
61 participants
n=115 Participants
|
|
Hemoglobin A1c
|
8.3 Percent
STANDARD_DEVIATION 0.76 • n=5 Participants
|
8.3 Percent
STANDARD_DEVIATION 0.71 • n=7 Participants
|
8.5 Percent
STANDARD_DEVIATION 0.69 • n=5 Participants
|
8.3 Percent
STANDARD_DEVIATION 0.65 • n=4 Participants
|
8.2 Percent
STANDARD_DEVIATION 0.67 • n=21 Participants
|
8.4 Percent
STANDARD_DEVIATION 0.80 • n=10 Participants
|
8.3 Percent
STANDARD_DEVIATION 0.72 • n=115 Participants
|
PRIMARY outcome
Timeframe: Weeks 0-24Population: Randomized subjects who took at least 1 dose of double blind treatment. To be included in analysis of change from baseline to week 24 with last observation carried forward, subjects must have had baseline measurement and at least 1 post baseline measurement.
HbA1c is measured as percent. Thus this change from baseline reflects the week 24 HbA1c percent minus the Week 0 HbA1c percent
Outcome measures
| Measure |
INT131 Besylate 0.5 mg
n=60 Participants
INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
|
INT131 Besylate 1 mg
n=59 Participants
INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
|
INT131 Besylate 2 mg
n=61 Participants
INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
|
INT131 Besylate 3 mg
n=60 Participants
INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
|
Pioglitazone HCl 45 mg
n=58 Participants
pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
|
Placebo
n=58 Participants
placebo administered once-daily
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward
|
-0.3 Percernt
Standard Deviation 0.86
|
-0.6 Percernt
Standard Deviation 0.72
|
-0.9 Percernt
Standard Deviation 0.97
|
-1.0 Percernt
Standard Deviation 0.80
|
-0.9 Percernt
Standard Deviation 0.94
|
-0.1 Percernt
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: Weeks 0-24Population: Randomized subjects who took at least 1 dose of double blind treatment. To be included in analysis of change from baseline to week 24 with last observation carried forward, subjects must have had baseline measurement and at least 1 post baseline measurement.
The change from baseline reflects the Week 24 FPG minus the Week 0 FPG with last observation carried forward.
Outcome measures
| Measure |
INT131 Besylate 0.5 mg
n=60 Participants
INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
|
INT131 Besylate 1 mg
n=59 Participants
INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
|
INT131 Besylate 2 mg
n=63 Participants
INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
|
INT131 Besylate 3 mg
n=61 Participants
INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
|
Pioglitazone HCl 45 mg
n=60 Participants
pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
|
Placebo
n=58 Participants
placebo administered once-daily
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 With Last Observation Carried Forward.
|
-0.3 mg/dL
Standard Deviation 58.73
|
-14.6 mg/dL
Standard Deviation 48.53
|
-28.9 mg/dL
Standard Deviation 44.20
|
-26.9 mg/dL
Standard Deviation 37.23
|
-33.2 mg/dL
Standard Deviation 37.17
|
4.6 mg/dL
Standard Deviation 41.71
|
Adverse Events
INT131 Besylate 0.5 mg
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
INT131 Besylate 1 mg
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
INT131 Besylate 2 mg
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
INT131 Besylate 3 mg
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Pioglitazone HCl 45 mg
Serious events: 4 serious events
Other events: 34 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
INT131 Besylate 0.5 mg
n=60 participants at risk
INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
|
INT131 Besylate 1 mg
n=61 participants at risk
INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
|
INT131 Besylate 2 mg
n=63 participants at risk
INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
|
INT131 Besylate 3 mg
n=61 participants at risk
INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
|
Pioglitazone HCl 45 mg
n=60 participants at risk
pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
|
Placebo
n=61 participants at risk
placebo administered once-daily
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
0.00%
0/63 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
1.6%
1/61 • Number of events 1 • Adverse events were collected from randomization to week 26.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
0.00%
0/63 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
1.7%
1/60 • Number of events 1 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
0.00%
0/63 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
1.6%
1/61 • Number of events 1 • Adverse events were collected from randomization to week 26.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
1.6%
1/61 • Number of events 1 • Adverse events were collected from randomization to week 26.
|
0.00%
0/63 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
0.00%
0/63 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
1.6%
1/61 • Number of events 1 • Adverse events were collected from randomization to week 26.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
0.00%
0/63 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
1.7%
1/60 • Number of events 1 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
0.00%
0/63 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
1.7%
1/60 • Number of events 1 • Adverse events were collected from randomization to week 26.
|
1.6%
1/61 • Number of events 1 • Adverse events were collected from randomization to week 26.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
0.00%
0/63 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
1.6%
1/61 • Number of events 1 • Adverse events were collected from randomization to week 26.
|
|
Infections and infestations
Influenza
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
1.6%
1/61 • Number of events 1 • Adverse events were collected from randomization to week 26.
|
0.00%
0/63 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
|
General disorders
Non-Cardiac chest pain
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
0.00%
0/63 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
1.7%
1/60 • Number of events 1 • Adverse events were collected from randomization to week 26.
|
1.6%
1/61 • Number of events 1 • Adverse events were collected from randomization to week 26.
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
0.00%
0/63 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
1.7%
1/60 • Number of events 1 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
|
Infections and infestations
Staphylococcal abscess
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
1.6%
1/63 • Number of events 2 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
|
Reproductive system and breast disorders
Spermatocele
|
1.7%
1/60 • Number of events 1 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
0.00%
0/63 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
Other adverse events
| Measure |
INT131 Besylate 0.5 mg
n=60 participants at risk
INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
|
INT131 Besylate 1 mg
n=61 participants at risk
INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
|
INT131 Besylate 2 mg
n=63 participants at risk
INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
|
INT131 Besylate 3 mg
n=61 participants at risk
INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
|
Pioglitazone HCl 45 mg
n=60 participants at risk
pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
|
Placebo
n=61 participants at risk
placebo administered once-daily
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.3%
2/60 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
6.3%
4/63 • Adverse events were collected from randomization to week 26.
|
4.9%
3/61 • Adverse events were collected from randomization to week 26.
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
3.3%
2/61 • Adverse events were collected from randomization to week 26.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.7%
4/60 • Adverse events were collected from randomization to week 26.
|
3.3%
2/61 • Adverse events were collected from randomization to week 26.
|
1.6%
1/63 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
5.0%
3/60 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
4.9%
3/61 • Adverse events were collected from randomization to week 26.
|
11.1%
7/63 • Adverse events were collected from randomization to week 26.
|
8.2%
5/61 • Adverse events were collected from randomization to week 26.
|
11.7%
7/60 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
|
Infections and infestations
Influenza
|
3.3%
2/60 • Adverse events were collected from randomization to week 26.
|
8.2%
5/61 • Adverse events were collected from randomization to week 26.
|
7.9%
5/63 • Adverse events were collected from randomization to week 26.
|
1.6%
1/61 • Adverse events were collected from randomization to week 26.
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
3.3%
2/61 • Adverse events were collected from randomization to week 26.
|
|
General disorders
Oedema peripheral
|
5.0%
3/60 • Adverse events were collected from randomization to week 26.
|
13.1%
8/61 • Adverse events were collected from randomization to week 26.
|
12.7%
8/63 • Adverse events were collected from randomization to week 26.
|
13.1%
8/61 • Adverse events were collected from randomization to week 26.
|
10.0%
6/60 • Adverse events were collected from randomization to week 26.
|
3.3%
2/61 • Adverse events were collected from randomization to week 26.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
1/60 • Adverse events were collected from randomization to week 26.
|
3.3%
2/61 • Adverse events were collected from randomization to week 26.
|
4.8%
3/63 • Adverse events were collected from randomization to week 26.
|
4.9%
3/61 • Adverse events were collected from randomization to week 26.
|
3.3%
2/60 • Adverse events were collected from randomization to week 26.
|
6.6%
4/61 • Adverse events were collected from randomization to week 26.
|
|
Infections and infestations
Urinary tract infection
|
3.3%
2/60 • Adverse events were collected from randomization to week 26.
|
13.1%
8/61 • Adverse events were collected from randomization to week 26.
|
4.8%
3/63 • Adverse events were collected from randomization to week 26.
|
4.9%
3/61 • Adverse events were collected from randomization to week 26.
|
6.7%
4/60 • Adverse events were collected from randomization to week 26.
|
8.2%
5/61 • Adverse events were collected from randomization to week 26.
|
|
Investigations
Weight gain
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
3.3%
2/61 • Adverse events were collected from randomization to week 26.
|
1.6%
1/63 • Adverse events were collected from randomization to week 26.
|
6.6%
4/61 • Adverse events were collected from randomization to week 26.
|
10.0%
6/60 • Adverse events were collected from randomization to week 26.
|
0.00%
0/61 • Adverse events were collected from randomization to week 26.
|
|
Gastrointestinal disorders
diarrhoea
|
1.7%
1/60 • Adverse events were collected from randomization to week 26.
|
3.3%
2/61 • Adverse events were collected from randomization to week 26.
|
3.2%
2/63 • Adverse events were collected from randomization to week 26.
|
4.9%
3/61 • Adverse events were collected from randomization to week 26.
|
5.0%
3/60 • Adverse events were collected from randomization to week 26.
|
6.6%
4/61 • Adverse events were collected from randomization to week 26.
|
|
Nervous system disorders
headache
|
0.00%
0/60 • Adverse events were collected from randomization to week 26.
|
8.2%
5/61 • Adverse events were collected from randomization to week 26.
|
4.8%
3/63 • Adverse events were collected from randomization to week 26.
|
8.2%
5/61 • Adverse events were collected from randomization to week 26.
|
5.0%
3/60 • Adverse events were collected from randomization to week 26.
|
8.2%
5/61 • Adverse events were collected from randomization to week 26.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator and Institution shall only be permitted to publish or present the results of that portion of the Study conducted at Institution with Sponsor's prior written consent, which consent may be withheld at Sponsor's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER