Trial Outcomes & Findings for A Multiple Dose Investigational Drug Study in Patients With Type 2 Diabetes (MK-0941-005) (NCT NCT00511667)
NCT ID: NCT00511667
Last Updated: 2016-08-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
70 participants
Primary outcome timeframe
Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)
Results posted on
2016-08-24
Participant Flow
Participant milestones
| Measure |
MK-0941
All participants receiving any dose of MK-0941
|
Placebo
All participants receiving any dose of placebo
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
18
|
|
Overall Study
COMPLETED
|
40
|
15
|
|
Overall Study
NOT COMPLETED
|
12
|
3
|
Reasons for withdrawal
| Measure |
MK-0941
All participants receiving any dose of MK-0941
|
Placebo
All participants receiving any dose of placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Site terminated
|
6
|
1
|
|
Overall Study
Other
|
2
|
1
|
Baseline Characteristics
A Multiple Dose Investigational Drug Study in Patients With Type 2 Diabetes (MK-0941-005)
Baseline characteristics by cohort
| Measure |
MK-0941
n=52 Participants
All participants receiving any dose of MK-0941
|
Placebo
n=18 Participants
All participants receiving any dose of placebo
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
29 to 70 years
|
52 participants
n=5 Participants
|
18 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)Outcome measures
| Measure |
MK-0941
n=52 Participants
All participants receiving any dose of MK-0941
|
Placebo
n=18 Participants
All participants receiving any dose of placebo
|
Panel C: MK-0941 40 mg Day 7
MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
|
Panel D: MK-0941 40 mg Day 13
MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
|
Panel E: MK-0941 60 mg
MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
|
|---|---|---|---|---|---|
|
Participants With Any Clinical Adverse Experience
|
51.9 percentage of of participants
|
61.1 percentage of of participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)Outcome measures
| Measure |
MK-0941
n=52 Participants
All participants receiving any dose of MK-0941
|
Placebo
n=18 Participants
All participants receiving any dose of placebo
|
Panel C: MK-0941 40 mg Day 7
MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
|
Panel D: MK-0941 40 mg Day 13
MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
|
Panel E: MK-0941 60 mg
MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
|
|---|---|---|---|---|---|
|
Participants Discontinued Because of Any Clinical Adverse Experience
Hyperglycemia
|
1 participants
|
0 participants
|
—
|
—
|
—
|
|
Participants Discontinued Because of Any Clinical Adverse Experience
All other adverse experiences
|
0 participants
|
0 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)Outcome measures
| Measure |
MK-0941
n=8 Participants
All participants receiving any dose of MK-0941
|
Placebo
n=7 Participants
All participants receiving any dose of placebo
|
Panel C: MK-0941 40 mg Day 7
n=6 Participants
MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
|
Panel D: MK-0941 40 mg Day 13
n=3 Participants
MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
|
Panel E: MK-0941 60 mg
n=4 Participants
MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve (AUC0-24) of MK-0941 After Multiple Doses of MK0941
|
2343.29 nM-hr
Standard Deviation 253.73
|
3789.25 nM-hr
Standard Deviation 1002.05
|
8387.74 nM-hr
Standard Deviation 2102.17
|
7673.77 nM-hr
Standard Deviation 3616.45
|
8692.07 nM-hr
Standard Deviation 2681.37
|
SECONDARY outcome
Timeframe: Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)Outcome measures
| Measure |
MK-0941
n=8 Participants
All participants receiving any dose of MK-0941
|
Placebo
n=7 Participants
All participants receiving any dose of placebo
|
Panel C: MK-0941 40 mg Day 7
n=6 Participants
MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
|
Panel D: MK-0941 40 mg Day 13
n=3 Participants
MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
|
Panel E: MK-0941 60 mg
n=4 Participants
MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
|
|---|---|---|---|---|---|
|
Maximum Concentration (Cmax) of MK-0941 After Multiple Doses of MK-0941
|
228.35 nM
Standard Deviation 88.54
|
364.96 nM
Standard Deviation 151.25
|
841.57 nM
Standard Deviation 348.34
|
648.49 nM
Standard Deviation 159.73
|
1145.81 nM
Standard Deviation 330.56
|
SECONDARY outcome
Timeframe: Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)Outcome measures
| Measure |
MK-0941
n=8 Participants
All participants receiving any dose of MK-0941
|
Placebo
n=7 Participants
All participants receiving any dose of placebo
|
Panel C: MK-0941 40 mg Day 7
n=6 Participants
MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
|
Panel D: MK-0941 40 mg Day 13
n=3 Participants
MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
|
Panel E: MK-0941 60 mg
n=4 Participants
MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
|
|---|---|---|---|---|---|
|
Time to Maximum Concentration (Tmax) of MK-0941 After Multiple Doses of MK-0941
|
1.5 hours
Full Range 6.43 • Interval 1.0 to 4.0
|
1.0 hours
Full Range 9.35 • Interval 1.0 to 2.0
|
1.0 hours
Full Range 34.95 • Interval 1.0 to 4.0
|
1.0 hours
Full Range 24.27 • Interval 1.0 to 1.0
|
2.0 hours
Full Range 82.68 • Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)Outcome measures
| Measure |
MK-0941
n=8 Participants
All participants receiving any dose of MK-0941
|
Placebo
n=7 Participants
All participants receiving any dose of placebo
|
Panel C: MK-0941 40 mg Day 7
n=6 Participants
MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
|
Panel D: MK-0941 40 mg Day 13
n=3 Participants
MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
|
Panel E: MK-0941 60 mg
n=4 Participants
MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
|
|---|---|---|---|---|---|
|
Apparent Terminal Elimination Half-life (T1/2) of MK-0941 After Multiple Doses of MK0941
|
10.4 hours
Standard Deviation 5.2
|
11.4 hours
Standard Deviation 2.2
|
8.4 hours
Standard Deviation 6.3
|
10.1 hours
Standard Deviation 3.5
|
11.4 hours
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)Outcome measures
| Measure |
MK-0941
n=8 Participants
All participants receiving any dose of MK-0941
|
Placebo
n=7 Participants
All participants receiving any dose of placebo
|
Panel C: MK-0941 40 mg Day 7
n=6 Participants
MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
|
Panel D: MK-0941 40 mg Day 13
n=3 Participants
MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
|
Panel E: MK-0941 60 mg
n=4 Participants
MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
|
|---|---|---|---|---|---|
|
Concentration of MK-0941 at 24 Hours (C24hr) After Multiple Doses of MK-0941
|
26.75 nM
Standard Deviation 6.43
|
42.99 nM
Standard Deviation 9.35
|
95.07 nM
Standard Deviation 34.95
|
76.89 nM
Standard Deviation 24.27
|
149.30 nM
Standard Deviation 82.68
|
Adverse Events
MK-0941
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MK-0941
n=52 participants at risk
All participants receiving any dose of MK-0941
|
Placebo
n=18 participants at risk
All participants receiving any dose of placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.8%
3/52 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
0.00%
0/18 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
|
Eye disorders
Eye pain
|
0.00%
0/52 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
5.6%
1/18 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
|
Eye disorders
Eye pruritus
|
1.9%
1/52 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
5.6%
1/18 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/52 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
5.6%
1/18 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/52 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
11.1%
2/18 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/52 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
5.6%
1/18 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
2/52 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
5.6%
1/18 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/52 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
5.6%
1/18 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
19.2%
10/52 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
0.00%
0/18 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/52 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
5.6%
1/18 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/52 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
5.6%
1/18 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.8%
3/52 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
5.6%
1/18 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
|
Nervous system disorders
Dizziness
|
9.6%
5/52 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
5.6%
1/18 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
|
Nervous system disorders
Headache
|
21.2%
11/52 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
27.8%
5/18 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/52 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
5.6%
1/18 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.9%
1/52 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
5.6%
1/18 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/52 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
5.6%
1/18 • Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme
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