Trial Outcomes & Findings for A Pharmacokinetic Study of MK-0941 After Multiple Daily Doses in Subjects With Type 2 Diabetes (MK-0941-012)(COMPLETED) (NCT NCT00873821)
NCT ID: NCT00873821
Last Updated: 2015-03-09
Results Overview
An adverse experience was defined as any unfavorable and unintended change in the structure or function of the body temporally associated with the use of study drug. Adverse experiences were collected using Medical Dictionary for Regulatory Activities (MedDRA) version 13.0.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
44 participants
Primary outcome timeframe
2 months
Results posted on
2015-03-09
Participant Flow
Participant milestones
| Measure |
MK-0941
Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
|
Placebo
Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pharmacokinetic Study of MK-0941 After Multiple Daily Doses in Subjects With Type 2 Diabetes (MK-0941-012)(COMPLETED)
Baseline characteristics by cohort
| Measure |
MK-0941
n=22 Participants
Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
|
Placebo
n=22 Participants
Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
37 to 70 years
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: All study participants
An adverse experience was defined as any unfavorable and unintended change in the structure or function of the body temporally associated with the use of study drug. Adverse experiences were collected using Medical Dictionary for Regulatory Activities (MedDRA) version 13.0.
Outcome measures
| Measure |
MK-0941
n=22 Participants
Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
|
Placebo
n=22 Participants
Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
|
|---|---|---|
|
Number of Participants With Any Clinical Adverse Experience
|
18 participants
|
16 participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: All study participants
Laboratory adverse experiences were those related to changes in hematology, fasted blood chemistry, or urinalysis laboratory results. Adverse experiences were collected using MedDRA version 13.0.
Outcome measures
| Measure |
MK-0941
n=22 Participants
Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
|
Placebo
n=22 Participants
Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
|
|---|---|---|
|
Number of Participants With Any Laboratory Adverse Experience
|
3 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Baseline (predose Day 1) to Day 13Weighted mean plasma glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24
Outcome measures
| Measure |
MK-0941
n=22 Participants
Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
|
Placebo
n=22 Participants
Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
|
|---|---|---|
|
Change From Baseline to Day 13 in Weighted Mean Plasma Glucose Concentration
Baseline
|
196.4 mg/dL
Standard Deviation 47.6 • Interval 26.33 to 55.32
|
194.6 mg/dL
Standard Deviation 35.3
|
|
Change From Baseline to Day 13 in Weighted Mean Plasma Glucose Concentration
Change from baseline to Day 13
|
-56.4 mg/dL
Standard Deviation 33.9
|
-15.6 mg/dL
Standard Deviation 30.0
|
Adverse Events
MK-0941
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MK-0941
n=22 participants at risk
Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
|
Placebo
n=22 participants at risk
Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
|
|---|---|---|
|
Eye disorders
Vision blurred
|
4.5%
1/22 • 2 months
|
9.1%
2/22 • 2 months
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
2/22 • 2 months
|
4.5%
1/22 • 2 months
|
|
Gastrointestinal disorders
Diarrhoea
|
27.3%
6/22 • 2 months
|
18.2%
4/22 • 2 months
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
2/22 • 2 months
|
4.5%
1/22 • 2 months
|
|
Gastrointestinal disorders
Nausea
|
9.1%
2/22 • 2 months
|
13.6%
3/22 • 2 months
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
1/22 • 2 months
|
9.1%
2/22 • 2 months
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
2/22 • 2 months
|
4.5%
1/22 • 2 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
18.2%
4/22 • 2 months
|
9.1%
2/22 • 2 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.2%
4/22 • 2 months
|
4.5%
1/22 • 2 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/22 • 2 months
|
9.1%
2/22 • 2 months
|
|
Nervous system disorders
Dizziness
|
9.1%
2/22 • 2 months
|
4.5%
1/22 • 2 months
|
|
Nervous system disorders
Headache
|
27.3%
6/22 • 2 months
|
27.3%
6/22 • 2 months
|
|
Nervous system disorders
Tremor
|
13.6%
3/22 • 2 months
|
0.00%
0/22 • 2 months
|
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