A Pharmacokinetic Study of MK-0941 After Multiple Daily Doses in Subjects With Type 2 Diabetes (MK-0941-012)(COMPLETED)
|ClinicalTrials.gov Identifier: NCT00873821|
Recruitment Status : Completed
First Posted : April 2, 2009
Results First Posted : July 11, 2012
Last Update Posted : March 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: MK-0941 Drug: Comparator: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK0941 After Multiple Daily Administration in Subjects With Type 2 Diabetes|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
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 Comparator: 2
Drug: Comparator: 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.
- Number of Participants With Any Clinical Adverse Experience [ Time Frame: 2 months ]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.
- Number of Participants With Any Laboratory Adverse Experience [ Time Frame: 2 months ]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.
- Change From Baseline to Day 13 in Weighted Mean Plasma Glucose Concentration [ Time Frame: Baseline (predose Day 1) to Day 13 ]Weighted mean plasma glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00873821
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|