Trial Outcomes & Findings for Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED) (NCT NCT00767000)
NCT ID: NCT00767000
Last Updated: 2015-02-19
Results Overview
Least square means change from baseline in HbA1c. HbA1c represents the percentage of glycated hemoglobin. A negative number means reduction in HbA1c level.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
813 participants
Primary outcome timeframe
Baseline and Weeks 14, 54, 106, and 158
Results posted on
2015-02-19
Participant Flow
Participant milestones
| Measure |
MK-0941 10 mg
MK-0941 10 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 20 mg
MK-0941 20 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 30 mg
MK-0941 30 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 40 mg
MK-0941 40 mg three times daily plus insulin once daily with or without metformin
|
Placebo
Placebo three times daily plus insulin once daily with or without metformin
|
|---|---|---|---|---|---|
|
54-week Study
STARTED
|
119
|
117
|
117
|
229
|
231
|
|
54-week Study
COMPLETED
|
11
|
4
|
8
|
4
|
7
|
|
54-week Study
NOT COMPLETED
|
108
|
113
|
109
|
225
|
224
|
|
Optional 104-week Extension
STARTED
|
7
|
3
|
7
|
2
|
4
|
|
Optional 104-week Extension
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Optional 104-week Extension
NOT COMPLETED
|
7
|
3
|
7
|
2
|
4
|
Reasons for withdrawal
| Measure |
MK-0941 10 mg
MK-0941 10 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 20 mg
MK-0941 20 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 30 mg
MK-0941 30 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 40 mg
MK-0941 40 mg three times daily plus insulin once daily with or without metformin
|
Placebo
Placebo three times daily plus insulin once daily with or without metformin
|
|---|---|---|---|---|---|
|
54-week Study
Adverse Event
|
4
|
6
|
6
|
8
|
4
|
|
54-week Study
Creaninine/creatinine clearance
|
2
|
1
|
2
|
2
|
4
|
|
54-week Study
Hyperglycemia
|
0
|
0
|
1
|
0
|
1
|
|
54-week Study
Hypoglycemia
|
0
|
1
|
0
|
0
|
0
|
|
54-week Study
Interruption of study medication
|
0
|
0
|
1
|
0
|
0
|
|
54-week Study
Lack of Efficacy
|
2
|
0
|
1
|
0
|
5
|
|
54-week Study
Lost to Follow-up
|
4
|
0
|
1
|
4
|
2
|
|
54-week Study
Physician Decision
|
4
|
0
|
1
|
1
|
1
|
|
54-week Study
Progressive disease
|
0
|
0
|
1
|
0
|
0
|
|
54-week Study
Protocol Violation
|
0
|
0
|
1
|
2
|
0
|
|
54-week Study
Withdrawal by Subject
|
2
|
3
|
5
|
11
|
13
|
|
54-week Study
Study terminated by sponsor
|
90
|
102
|
89
|
196
|
194
|
|
54-week Study
Reason not reported
|
0
|
0
|
0
|
1
|
0
|
|
Optional 104-week Extension
Study terminated by sponsor
|
7
|
3
|
7
|
2
|
4
|
Baseline Characteristics
Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED)
Baseline characteristics by cohort
| Measure |
MK-0941 10 mg
n=119 Participants
MK-0941 10 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 20 mg
n=117 Participants
MK-0941 20 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 30 mg
n=117 Participants
MK-0941 30 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 40 mg
n=229 Participants
MK-0941 40 mg three times daily plus insulin once daily with or without metformin
|
Placebo
n=231 Participants
Placebo three times daily plus insulin once daily with or without metformin
|
Total
n=813 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
26 to 71 years
|
119 participants
n=99 Participants
|
117 participants
n=107 Participants
|
117 participants
n=206 Participants
|
229 participants
n=7 Participants
|
231 participants
n=31 Participants
|
813 participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
123 Participants
n=7 Participants
|
115 Participants
n=31 Participants
|
416 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
106 Participants
n=7 Participants
|
116 Participants
n=31 Participants
|
397 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline and Weeks 14, 54, 106, and 158Population: Full analysis set. The additional participants added to the MK-0941 40 mg and placebo arms to enhance evaluation of safety were not included in the analysis.
Least square means change from baseline in HbA1c. HbA1c represents the percentage of glycated hemoglobin. A negative number means reduction in HbA1c level.
Outcome measures
| Measure |
Placebo
n=115 Participants
Placebo three times daily plus insulin once daily with or without metformin
|
MK-0941 10 mg
n=118 Participants
MK-0941 10 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 20 mg
n=117 Participants
MK-0941 20 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 30 mg
n=117 Participants
MK-0941 30 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 40 mg
n=118 Participants
MK-0941 40 mg three times daily plus insulin once daily with or without metformin
|
|---|---|---|---|---|---|
|
Change in Hemoglobin A1c (HbA1c) Level
Week 14
|
-0.08 Percent HbA1c
Interval -0.28 to 0.13
|
-0.59 Percent HbA1c
Interval -0.8 to -0.38
|
-0.72 Percent HbA1c
Interval -0.92 to -0.52
|
-0.89 Percent HbA1c
Interval -1.1 to -0.69
|
-0.83 Percent HbA1c
Interval -1.03 to -0.62
|
|
Change in Hemoglobin A1c (HbA1c) Level
Week 54 (no participants analyzed)
|
NA Percent HbA1c
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA Percent HbA1c
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA Percent HbA1c
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA Percent HbA1c
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA Percent HbA1c
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
|
Change in Hemoglobin A1c (HbA1c) Level
Week 106 (no participants analyzed)
|
NA Percent HbA1c
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA Percent HbA1c
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA Percent HbA1c
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA Percent HbA1c
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA Percent HbA1c
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
|
Change in Hemoglobin A1c (HbA1c) Level
Week 158 (no participants analyzed)
|
NA Percent HbA1c
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA Percent HbA1c
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA Percent HbA1c
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA Percent HbA1c
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA Percent HbA1c
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
PRIMARY outcome
Timeframe: Entire study including 54-week study and 104-week extensionPopulation: Full analysis set. Includes additional participants enrolled in the MK-0941 40 mg and placebo groups to enhance evaluation of the safety profile of MK-0941.
Outcome measures
| Measure |
Placebo
n=231 Participants
Placebo three times daily plus insulin once daily with or without metformin
|
MK-0941 10 mg
n=119 Participants
MK-0941 10 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 20 mg
n=117 Participants
MK-0941 20 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 30 mg
n=117 Participants
MK-0941 30 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 40 mg
n=229 Participants
MK-0941 40 mg three times daily plus insulin once daily with or without metformin
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced at Least One Adverse Event
|
65.4 percentage of participants
|
80.7 percentage of participants
|
79.5 percentage of participants
|
80.3 percentage of participants
|
65.5 percentage of participants
|
PRIMARY outcome
Timeframe: Entire study including 54-week study and 104-week extensionOutcome measures
| Measure |
Placebo
n=231 Participants
Placebo three times daily plus insulin once daily with or without metformin
|
MK-0941 10 mg
n=119 Participants
MK-0941 10 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 20 mg
n=117 Participants
MK-0941 20 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 30 mg
n=117 Participants
MK-0941 30 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 40 mg
n=229 Participants
MK-0941 40 mg three times daily plus insulin once daily with or without metformin
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event
|
1.7 percentage of participants
|
3.4 percentage of participants
|
5.1 percentage of participants
|
6.8 percentage of participants
|
3.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 14, 54, 106, and 158Population: Full analysis set. The additional participants added to the MK-0941 40 mg and placebo arms to enhance evaluation of safety were not included in the analysis.
Least squares mean change from baseline in 2-hour post meal glucose level.
Outcome measures
| Measure |
Placebo
n=111 Participants
Placebo three times daily plus insulin once daily with or without metformin
|
MK-0941 10 mg
n=112 Participants
MK-0941 10 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 20 mg
n=114 Participants
MK-0941 20 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 30 mg
n=113 Participants
MK-0941 30 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 40 mg
n=115 Participants
MK-0941 40 mg three times daily plus insulin once daily with or without metformin
|
|---|---|---|---|---|---|
|
Change in the Two-hour Post Meal Glucose Level
Week 14
|
-2.4 mg/dL
Interval -16.0 to 11.2
|
-39.0 mg/dL
Interval -52.0 to -25.1
|
-29.2 mg/dL
Interval -42.5 to -15.9
|
-37.4 mg/dL
Interval -51.2 to -23.6
|
-39.3 mg/dL
Interval -53.1 to -25.5
|
|
Change in the Two-hour Post Meal Glucose Level
Week 54 (no participants analyzed)
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
|
Change in the Two-hour Post Meal Glucose Level
Week 106 (no participants analyzed)
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
|
Change in the Two-hour Post Meal Glucose Level
Week 158 (no participants analyzed)
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
SECONDARY outcome
Timeframe: Baseline and Weeks 14, 54, 106, and 158Population: Full analysis set. The additional participants added to the MK-0941 40 mg and placebo arms to enhance evaluation of safety were not included in the analysis.
Least squares mean change from baseline in fasting plasma glucose.
Outcome measures
| Measure |
Placebo
n=115 Participants
Placebo three times daily plus insulin once daily with or without metformin
|
MK-0941 10 mg
n=118 Participants
MK-0941 10 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 20 mg
n=117 Participants
MK-0941 20 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 30 mg
n=117 Participants
MK-0941 30 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 40 mg
n=118 Participants
MK-0941 40 mg three times daily plus insulin once daily with or without metformin
|
|---|---|---|---|---|---|
|
Change in the Fasting Plasma Glucose Level
Week 14
|
-11.8 mg/dL
Interval -21.4 to -2.1
|
-10.0 mg/dL
Interval -19.9 to 0.0
|
-1.5 mg/dL
Interval -10.9 to 7.9
|
-21.1 mg/dL
Interval -30.9 to -11.2
|
-5.0 mg/dL
Interval -14.9 to 4.8
|
|
Change in the Fasting Plasma Glucose Level
Week 54 (no participants analyzed)
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
|
Change in the Fasting Plasma Glucose Level
Week 106 (no participants analyzed)
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
|
Change in the Fasting Plasma Glucose Level
Week 158 (no participants analyzed)
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
NA mg/dL
Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 54, 106, or 158
|
SECONDARY outcome
Timeframe: Weeks 106 and 158Population: Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 106 or 158
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 54, 106 and 158Population: Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 106 or 158
Outcome measures
Outcome data not reported
Adverse Events
MK-0941 10 mg
Serious events: 11 serious events
Other events: 74 other events
Deaths: 0 deaths
MK-0941 20 mg
Serious events: 12 serious events
Other events: 75 other events
Deaths: 0 deaths
MK-0941 30 mg
Serious events: 11 serious events
Other events: 78 other events
Deaths: 0 deaths
MK-0941 40 mg
Serious events: 13 serious events
Other events: 120 other events
Deaths: 0 deaths
Placebo
Serious events: 8 serious events
Other events: 101 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK-0941 10 mg
n=119 participants at risk
MK-0941 10 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 20 mg
n=117 participants at risk
MK-0941 20 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 30 mg
n=117 participants at risk
MK-0941 30 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 40 mg
n=229 participants at risk
MK-0941 40 mg three times daily plus insulin once daily with or without metformin
|
Placebo
n=231 participants at risk
Placebo three times daily plus insulin once daily with or without metformin
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.84%
1/119 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.43%
1/231 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Cardiac disorders
Angina pectoris
|
1.7%
2/119 • Number of events 2 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Cardiac disorders
Atrial fibrillation
|
0.84%
1/119 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.44%
1/229 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Cardiac disorders
Atrial flutter
|
0.84%
1/119 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.85%
1/117 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
1.7%
2/117 • Number of events 2 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.43%
1/231 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Cardiac disorders
Palpitations
|
0.84%
1/119 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Eye disorders
Cataract
|
0.84%
1/119 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Eye disorders
Macular hole
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.85%
1/117 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Eye disorders
Macular oedema
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.85%
1/117 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.85%
1/117 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.44%
1/229 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.85%
1/117 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.44%
1/229 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.85%
1/117 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
General disorders
Chest pain
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.85%
1/117 • Number of events 2 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
General disorders
Cyst rupture
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.85%
1/117 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
General disorders
Death
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.44%
1/229 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.44%
1/229 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.44%
1/229 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Infections and infestations
Anal abscess
|
0.84%
1/119 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Infections and infestations
Cellulitis
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.44%
1/229 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Infections and infestations
Gangrene
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.43%
1/231 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.85%
1/117 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.85%
1/117 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.44%
1/229 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.85%
1/117 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.44%
1/229 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Infections and infestations
Viral infection
|
0.84%
1/119 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Infections and infestations
Wound infection
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.44%
1/229 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.43%
1/231 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.85%
1/117 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.85%
1/117 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
1.7%
2/117 • Number of events 2 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.44%
1/229 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.44%
1/229 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.85%
1/117 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.44%
1/229 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.84%
1/119 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage 0
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.85%
1/117 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage I
|
0.84%
1/119 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.44%
1/229 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.43%
1/231 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.85%
1/117 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.85%
1/117 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.43%
1/231 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.85%
1/117 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.44%
1/229 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Nervous system disorders
Headache
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.85%
1/117 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Nervous system disorders
Syncope
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.85%
1/117 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.43%
1/231 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.44%
1/229 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.43%
1/231 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
1.7%
2/117 • Number of events 2 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Reproductive system and breast disorders
Ovarian mass
|
0.84%
1/119 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.85%
1/117 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.85%
1/117 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Vascular disorders
Hypertension
|
0.84%
1/119 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/229 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/119 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/117 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.44%
1/229 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.00%
0/231 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
Other adverse events
| Measure |
MK-0941 10 mg
n=119 participants at risk
MK-0941 10 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 20 mg
n=117 participants at risk
MK-0941 20 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 30 mg
n=117 participants at risk
MK-0941 30 mg three times daily plus insulin once daily with or without metformin
|
MK-0941 40 mg
n=229 participants at risk
MK-0941 40 mg three times daily plus insulin once daily with or without metformin
|
Placebo
n=231 participants at risk
Placebo three times daily plus insulin once daily with or without metformin
|
|---|---|---|---|---|---|
|
Eye disorders
Cataract
|
8.4%
10/119 • Number of events 13 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
10.3%
12/117 • Number of events 16 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
14.5%
17/117 • Number of events 22 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
4.4%
10/229 • Number of events 11 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
8.7%
20/231 • Number of events 20 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Eye disorders
Diabetic retinopathy
|
2.5%
3/119 • Number of events 3 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
5.1%
6/117 • Number of events 8 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
5.1%
6/117 • Number of events 8 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
1.7%
4/229 • Number of events 4 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
1.3%
3/231 • Number of events 3 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
7/119 • Number of events 9 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
6.0%
7/117 • Number of events 9 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
3.4%
4/117 • Number of events 4 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
3.5%
8/229 • Number of events 13 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
4.8%
11/231 • Number of events 22 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Infections and infestations
Influenza
|
5.0%
6/119 • Number of events 7 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
3.4%
4/117 • Number of events 4 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
6.8%
8/117 • Number of events 9 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
4.4%
10/229 • Number of events 14 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
3.5%
8/231 • Number of events 10 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
8/119 • Number of events 10 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
11.1%
13/117 • Number of events 14 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
10.3%
12/117 • Number of events 12 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
5.2%
12/229 • Number of events 16 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
4.3%
10/231 • Number of events 12 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Infections and infestations
Upper respiratory tract infection
|
8.4%
10/119 • Number of events 11 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
5.1%
6/117 • Number of events 7 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
9.4%
11/117 • Number of events 16 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
4.8%
11/229 • Number of events 14 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
2.6%
6/231 • Number of events 7 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
47.9%
57/119 • Number of events 425 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
49.6%
58/117 • Number of events 475 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
48.7%
57/117 • Number of events 719 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
41.0%
94/229 • Number of events 690 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
29.0%
67/231 • Number of events 350 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
7/119 • Number of events 7 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.85%
1/117 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
0.85%
1/117 • Number of events 1 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
1.3%
3/229 • Number of events 3 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
2.6%
6/231 • Number of events 6 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
|
Nervous system disorders
Headache
|
3.4%
4/119 • Number of events 8 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
10.3%
12/117 • Number of events 12 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
4.3%
5/117 • Number of events 6 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
5.7%
13/229 • Number of events 16 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
3.0%
7/231 • Number of events 8 • Adverse events were collected for the entire study including the 54-week study and 104-week extension
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER