Trial Outcomes & Findings for Dose-Range Finding Study for MK0893 (0893-008) (NCT NCT00479466)
NCT ID: NCT00479466
Last Updated: 2015-09-09
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
342 participants
Primary outcome timeframe
Week 12
Results posted on
2015-09-09
Participant Flow
Participant milestones
| Measure |
Placebo
|
MK0893 20 mg
|
MK0893 40 mg
|
MK0893 60 mg
|
MK0893 80 mg
|
Metformin HCL
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
57
|
57
|
57
|
58
|
56
|
57
|
|
Overall Study
COMPLETED
|
44
|
49
|
54
|
55
|
48
|
53
|
|
Overall Study
NOT COMPLETED
|
13
|
8
|
3
|
3
|
8
|
4
|
Reasons for withdrawal
| Measure |
Placebo
|
MK0893 20 mg
|
MK0893 40 mg
|
MK0893 60 mg
|
MK0893 80 mg
|
Metformin HCL
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
1
|
0
|
1
|
2
|
0
|
|
Overall Study
Hyperglycemia
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
0
|
2
|
2
|
|
Overall Study
Physician Decision
|
2
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
0
|
2
|
3
|
1
|
Baseline Characteristics
Dose-Range Finding Study for MK0893 (0893-008)
Baseline characteristics by cohort
| Measure |
Placebo
n=57 Participants
|
MK0893 20 mg
n=57 Participants
|
MK0893 40 mg
n=57 Participants
|
MK0893 60 mg
n=58 Participants
|
MK0893 80 mg
n=56 Participants
|
Metformin HCL
n=57 Participants
|
Total
n=342 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 10.2 • n=93 Participants
|
55.6 years
STANDARD_DEVIATION 8.2 • n=4 Participants
|
53.7 years
STANDARD_DEVIATION 8.2 • n=27 Participants
|
56.1 years
STANDARD_DEVIATION 7.9 • n=483 Participants
|
53.5 years
STANDARD_DEVIATION 10.4 • n=36 Participants
|
55.1 years
STANDARD_DEVIATION 8.2 • n=10 Participants
|
54.7 years
STANDARD_DEVIATION 8.9 • n=115 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
26 Participants
n=483 Participants
|
31 Participants
n=36 Participants
|
30 Participants
n=10 Participants
|
168 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
32 Participants
n=483 Participants
|
25 Participants
n=36 Participants
|
27 Participants
n=10 Participants
|
174 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: All participants who received at least one dose of study therapy, had a baseline measurement, and had at least one post-randomization measurement.
Outcome measures
| Measure |
Placebo
n=54 Participants
|
MK0893 20 mg
n=55 Participants
|
MK0893 40 mg
n=57 Participants
|
MK0893 60 mg
n=57 Participants
|
MK0893 80 mg
n=54 Participants
|
Metformin HCL
n=57 Participants
|
|---|---|---|---|---|---|---|
|
Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)
|
-1.8 mg/dL
Interval -11.4 to 7.8
|
-32.4 mg/dL
Interval -41.7 to -23.2
|
-48.4 mg/dL
Interval -57.4 to -39.5
|
-53.0 mg/dL
Interval -61.9 to -44.1
|
-63.0 mg/dL
Interval -72.4 to -53.7
|
-37.3 mg/dL
Interval -46.3 to -28.4
|
SECONDARY outcome
Timeframe: Week 12Population: All participants who received at least one dose of study therapy, had a baseline measurement, and had at least one post-randomization measurement.
Outcome measures
| Measure |
Placebo
n=48 Participants
|
MK0893 20 mg
n=51 Participants
|
MK0893 40 mg
n=57 Participants
|
MK0893 60 mg
n=57 Participants
|
MK0893 80 mg
n=52 Participants
|
Metformin HCL
n=56 Participants
|
|---|---|---|---|---|---|---|
|
Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c)
|
0.54 mg/dL
Interval 0.27 to 0.82
|
-0.60 mg/dL
Interval -0.87 to -0.33
|
-0.99 mg/dL
Interval -1.25 to -0.73
|
-1.14 mg/dL
Interval -1.4 to -0.89
|
-1.52 mg/dL
Interval -1.79 to -1.25
|
-0.78 mg/dL
Interval -1.04 to -0.52
|
SECONDARY outcome
Timeframe: Week 12Population: All participants who received at least one dose of study therapy, had a baseline measurement, and had at least one post-randomization measurement.
Outcome measures
| Measure |
Placebo
n=41 Participants
|
MK0893 20 mg
n=47 Participants
|
MK0893 40 mg
n=55 Participants
|
MK0893 60 mg
n=54 Participants
|
MK0893 80 mg
n=47 Participants
|
Metformin HCL
n=53 Participants
|
|---|---|---|---|---|---|---|
|
Change From Baseline to Week 12 in 2-Hour Post Prandial Glucose (PPG)
|
-8.1 mg/dL
Interval -24.6 to 8.4
|
-64.9 mg/dL
Interval -80.3 to -49.5
|
-78.1 mg/dL
Interval -92.4 to -63.8
|
-95.5 mg/dL
Interval -110.0 to -80.9
|
-109.7 mg/dL
Interval -125.1 to -94.3
|
-68.9 mg/dL
Interval -83.4 to -54.3
|
Adverse Events
Placebo
Serious events: 5 serious events
Other events: 16 other events
Deaths: 0 deaths
MK0893 20 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
MK0893 40 mg
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
MK0893 60 mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
MK0893 80 mg
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Metformin HCL
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=57 participants at risk
|
MK0893 20 mg
n=57 participants at risk
|
MK0893 40 mg
n=57 participants at risk
|
MK0893 60 mg
n=58 participants at risk
|
MK0893 80 mg
n=56 participants at risk
|
Metformin HCL
n=57 participants at risk
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/57
|
0.00%
0/57
|
1.8%
1/57 • Number of events 1
|
0.00%
0/58
|
0.00%
0/56
|
0.00%
0/57
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.8%
1/57 • Number of events 1
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/58
|
0.00%
0/56
|
0.00%
0/57
|
|
General disorders
Chest pain
|
3.5%
2/57 • Number of events 2
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/58
|
0.00%
0/56
|
0.00%
0/57
|
|
Infections and infestations
Pulmonary tuberculosis
|
1.8%
1/57 • Number of events 1
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/58
|
0.00%
0/56
|
0.00%
0/57
|
|
Investigations
Blood bilirubin increased
|
1.8%
1/57 • Number of events 1
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/58
|
0.00%
0/56
|
0.00%
0/57
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
0.00%
0/57
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
0.00%
0/57
|
Other adverse events
| Measure |
Placebo
n=57 participants at risk
|
MK0893 20 mg
n=57 participants at risk
|
MK0893 40 mg
n=57 participants at risk
|
MK0893 60 mg
n=58 participants at risk
|
MK0893 80 mg
n=56 participants at risk
|
Metformin HCL
n=57 participants at risk
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/57
|
1.8%
1/57 • Number of events 1
|
5.3%
3/57 • Number of events 3
|
0.00%
0/58
|
0.00%
0/56
|
1.8%
1/57 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
3.5%
2/57 • Number of events 4
|
1.8%
1/57 • Number of events 1
|
3.5%
2/57 • Number of events 2
|
3.4%
2/58 • Number of events 2
|
1.8%
1/56 • Number of events 1
|
7.0%
4/57 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
1.8%
1/57 • Number of events 1
|
0.00%
0/57
|
5.3%
3/57 • Number of events 3
|
5.2%
3/58 • Number of events 3
|
1.8%
1/56 • Number of events 1
|
7.0%
4/57 • Number of events 9
|
|
Infections and infestations
Influenza
|
3.5%
2/57 • Number of events 2
|
3.5%
2/57 • Number of events 2
|
5.3%
3/57 • Number of events 3
|
1.7%
1/58 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
1.8%
1/57 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
3/57 • Number of events 3
|
1.8%
1/57 • Number of events 1
|
7.0%
4/57 • Number of events 4
|
5.2%
3/58 • Number of events 3
|
5.4%
3/56 • Number of events 3
|
1.8%
1/57 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
1.8%
1/57 • Number of events 1
|
3.5%
2/57 • Number of events 2
|
3.5%
2/57 • Number of events 2
|
5.2%
3/58 • Number of events 3
|
5.4%
3/56 • Number of events 3
|
3.5%
2/57 • Number of events 2
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
3.5%
2/57 • Number of events 3
|
3.5%
2/57 • Number of events 2
|
0.00%
0/57
|
6.9%
4/58 • Number of events 4
|
1.8%
1/56 • Number of events 1
|
0.00%
0/57
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.0%
4/57 • Number of events 4
|
0.00%
0/57
|
3.5%
2/57 • Number of events 2
|
0.00%
0/58
|
1.8%
1/56 • Number of events 1
|
0.00%
0/57
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.5%
2/57 • Number of events 2
|
3.5%
2/57 • Number of events 2
|
0.00%
0/57
|
3.4%
2/58 • Number of events 2
|
0.00%
0/56
|
5.3%
3/57 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/57
|
0.00%
0/57
|
3.5%
2/57 • Number of events 2
|
5.2%
3/58 • Number of events 3
|
0.00%
0/56
|
0.00%
0/57
|
|
Nervous system disorders
Dizziness
|
1.8%
1/57 • Number of events 1
|
5.3%
3/57 • Number of events 4
|
3.5%
2/57 • Number of events 2
|
0.00%
0/58
|
0.00%
0/56
|
3.5%
2/57 • Number of events 2
|
|
Nervous system disorders
Headache
|
8.8%
5/57 • Number of events 6
|
1.8%
1/57 • Number of events 1
|
7.0%
4/57 • Number of events 5
|
8.6%
5/58 • Number of events 7
|
1.8%
1/56 • Number of events 1
|
7.0%
4/57 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
1/57 • Number of events 1
|
0.00%
0/57
|
7.0%
4/57 • Number of events 4
|
0.00%
0/58
|
0.00%
0/56
|
0.00%
0/57
|
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
- Publication restrictions are in place
Restriction type: LTE60