A Study of the Effects of Sitagliptin (MK0431) and Metformin on Incretin Hormone Concentrations (0431-050)(COMPLETED)
Overview[ - collapse ][ - ]
Purpose | This study will determine the effect of concomitant administration of sitagliptin and metformin on post-meal incretin hormone concentrations in healthy adults. |
---|---|
Condition | Type 2 Diabetes |
Intervention | Drug: sitagliptin phosphate Drug: Comparator: metformin Drug: Comparator: sitagliptin and metformin Drug: Comparator: placebo |
Phase | Phase 1 |
Sponsor | Merck Sharp & Dohme Corp. |
Responsible Party | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier | NCT00975052 |
First Received | September 10, 2009 |
Last Updated | March 7, 2014 |
Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | September 10, 2009 |
---|---|
Last Updated Date | March 7, 2014 |
Start Date | January 2006 |
Estimated Primary Completion Date | March 2006 |
Current Primary Outcome Measures | Weighted average active GLP-1 (glucagonlike peptide-1) concentrations [Time Frame: 4 hours after the postdose meal] [Designated as safety issue: No] |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | A Study of the Effects of Sitagliptin (MK0431) and Metformin on Incretin Hormone Concentrations (0431-050)(COMPLETED) |
---|---|
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 |
Brief Summary | This study will determine the effect of concomitant administration of sitagliptin and metformin on post-meal incretin hormone concentrations in healthy adults. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Type 2 Diabetes |
Intervention | Drug: sitagliptin phosphate 100 mg sitagliptin daily for two days in one out of four treatment periods Drug: Comparator: metformin 500 mg twice daily on Day 1 and 1000 mg once daily on Day 2 in one of four treatment periods. 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. Drug: Comparator: placebo Placebo only on Days 1 and 2 in one of four treatment periods. |
Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
---|---|
Estimated Enrollment | 16 |
Estimated Completion Date | March 2006 |
Estimated Primary Completion Date | March 2006 |
Eligibility Criteria | Inclusion Criteria: - Subject is in good health - Subject has been a nonsmoker for at least 6 months - Subject is willing to avoid strenuous activity from the screening visit until the end of the study - Subject agrees not to consume grapefruit products during the study and to avoid all fruit juices 24 hours before and after study drug administration Exclusion Criteria: - Any history of stroke or neurological disorder - Subject has a history of cardiovascular, blood, endocrine or liver diseases - Subject has a history of cancer |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00975052 |
---|---|
Other Study ID Numbers | 0431-050 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Merck Sharp & Dohme Corp. |
Study Sponsor | Merck Sharp & Dohme Corp. |
Collaborators | Not Provided |
Investigators | Study Director: Medical Monitor Merck Sharp & Dohme Corp. |
Verification Date | March 2014 |