A Study of the Effects of Sitagliptin (MK0431) and Metformin on Incretin Hormone Concentrations (0431-050)(COMPLETED)
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|ClinicalTrials.gov Identifier: NCT00975052|
Recruitment Status : Completed
First Posted : September 11, 2009
Last Update Posted : August 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: sitagliptin phosphate Drug: Comparator: metformin Drug: Comparator: sitagliptin and metformin Drug: Comparator: placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Placebo-Controlled, Double-Blind, Double-Dummy, Four-Period Crossover Study to Assess the Effects of Concomitant Administration of MK0431 and Metformin Alone and in Combination on Post-Meal Incretin Hormone Concentrations in Healthy Adult Subjects|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||March 2006|
Active Comparator: A
Drug: sitagliptin phosphate
100 mg sitagliptin daily for two days in one out of four treatment periods
Active Comparator: B
Drug: Comparator: metformin
500 mg twice daily on Day 1 and 1000 mg once daily on Day 2 in one of four treatment periods.
Sitagliptin and metformin concomitantly
Drug: Comparator: sitagliptin and metformin
100 mg sitagliptin once daily and 500 mg metformin twice daily on Day 1 and 100 mg sitagliptin once daily and 1000 mg metformin once daily on Day 2 in one of four treatment periods.
Placebo Comparator: D
Drug: Comparator: placebo
Placebo only on Days 1 and 2 in one of four treatment periods.
- Weighted average active GLP-1 (glucagonlike peptide-1) concentrations [ Time Frame: 4 hours after the postdose meal ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975052
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|