Trial Outcomes & Findings for Single Doses of MK-0941 in Type 2 Diabetics (MK-0941-027) (NCT NCT01106287)
NCT ID: NCT01106287
Last Updated: 2016-02-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
Up to 30 days after the last dose of study drug
Results posted on
2016-02-04
Participant Flow
Participant milestones
| Measure |
MK-0941 60/80/100/120 mg/Pbo
Treatment Sequence 1
|
MK-0941 60/80 mg/Pbo/MK-0941 120/140 mg
Treatment Sequence 2
|
MK-0941 60 mg/Pbo/MK-0941 100/120/140 mg
Treatment Sequence 3
|
Pbo/MK-0941 80/100 mg/Pbo/MK-0941 140 mg
Treatment Sequence 4
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
MK-0941 60/80/100/120 mg/Pbo
Treatment Sequence 1
|
MK-0941 60/80 mg/Pbo/MK-0941 120/140 mg
Treatment Sequence 2
|
MK-0941 60 mg/Pbo/MK-0941 100/120/140 mg
Treatment Sequence 3
|
Pbo/MK-0941 80/100 mg/Pbo/MK-0941 140 mg
Treatment Sequence 4
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Single Doses of MK-0941 in Type 2 Diabetics (MK-0941-027)
Baseline characteristics by cohort
| Measure |
MK-0941 60/80/100/120 mg/Pbo
n=4 Participants
Treatment Sequence 1
|
MK-0941 60/80/Pbo/ MK-0941 120/140 mg
n=3 Participants
Treatment Sequence 2
|
MK-0941 60 mg/Pbo/MK-0941 100/120/140 mg
n=3 Participants
Treatment Sequence 3
|
Pbo/MK-0941 80/100 mg/Pbo/MK-0941 140 mg
n=3 Participants
Treatment Sequence 4
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 7.19 • n=5 Participants
|
55.0 years
STANDARD_DEVIATION 7.81 • n=7 Participants
|
54.7 years
STANDARD_DEVIATION 12.10 • n=5 Participants
|
52.3 years
STANDARD_DEVIATION 7.51 • n=4 Participants
|
51.4 years
STANDARD_DEVIATION 8.64 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after the last dose of study drugPopulation: All participants receiving any dose of MK-0941 or placebo
Outcome measures
| Measure |
MK-0941 60 mg
n=10 Participants
All participants receiving a 60-mg dose of MK-0941
|
MK-0941 80 mg
n=9 Participants
All participants receiving a 80-mg dose of MK-0941
|
MK-0941 100 mg
n=9 Participants
All participants receiving a 100-mg dose of MK-0941
|
MK-0941 120 mg
n=9 Participants
All participants receiving a 120-mg dose of MK-0941
|
MK-0941 140 mg
n=9 Participants
All participants receiving a 140-mg dose of MK-0941
|
Placebo
n=13 Participants
All participants receiving placebo
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced One or More Adverse Events During the Study
Adverse Event
|
2 participants
|
6 participants
|
4 participants
|
9 participants
|
4 participants
|
5 participants
|
|
Number of Participants Who Experienced One or More Adverse Events During the Study
Drug-Related Adverse Event
|
1 participants
|
1 participants
|
2 participants
|
6 participants
|
3 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Up to 6 weeks after the first dose of study drugPopulation: All participants receiving any dose of MK-0941 of placebo.
Only treatment-emergent adverse events were examined for this outcome measure.
Outcome measures
| Measure |
MK-0941 60 mg
n=10 Participants
All participants receiving a 60-mg dose of MK-0941
|
MK-0941 80 mg
n=9 Participants
All participants receiving a 80-mg dose of MK-0941
|
MK-0941 100 mg
n=9 Participants
All participants receiving a 100-mg dose of MK-0941
|
MK-0941 120 mg
n=9 Participants
All participants receiving a 120-mg dose of MK-0941
|
MK-0941 140 mg
n=9 Participants
All participants receiving a 140-mg dose of MK-0941
|
Placebo
n=13 Participants
All participants receiving placebo
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
MK-0941 60 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MK-0941 80 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
MK-0941 100 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MK-0941 120 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
MK-0941 140 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MK-0941 60 mg
n=10 participants at risk
All participants receiving at least one dose of 60 mg of MK-0941
|
MK-0941 80 mg
n=9 participants at risk
All participants receiving at least one dose of 80 mg of MK-0941
|
MK-0941 100 mg
n=9 participants at risk
All participants receiving at least one dose of 100 mg of MK-0941
|
MK-0941 120 mg
n=9 participants at risk
All participants receiving at least one dose of 120 mg of MK-0941
|
MK-0941 140 mg
n=9 participants at risk
All participants receiving at least one dose of 140 mg of MK-0941
|
Placebo
n=13 participants at risk
All participants receiving placebo
|
|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
22.2%
2/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
22.2%
2/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
7.7%
1/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
General disorders
Application site irritation
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
7.7%
1/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
General disorders
Asthenia
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
General disorders
Oedema peripheral
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
General disorders
Puncture site pain
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
General disorders
Temperature intolerance
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
Infections and infestations
Cellulitus
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
10.0%
1/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
33.3%
3/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
1/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
22.2%
2/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
Nervous system disorders
Tremor
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
7.7%
1/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
Vascular disorders
Flushing
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
7.7%
1/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
|
Investigations
Blood glucose increased
|
0.00%
0/10 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
33.3%
3/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
11.1%
1/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
0.00%
0/9 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
7.7%
1/13 • Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
|
Additional Information
Vice President, Late Stage Development Group Leader
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