NCT00975052CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 16
- Primary Endpoint
- Weighted average active GLP-1 (glucagonlike peptide-1) concentrations
Study Overview
Brief Summary
This study will determine the effect of concomitant administration of sitagliptin and metformin on post-meal incretin hormone concentrations in healthy adults.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
A
Active Comparator
Sitagliptin alone
Intervention: sitagliptin phosphate (Drug)
Outcomes
Primary Outcomes
Weighted average active GLP-1 (glucagonlike peptide-1) concentrations
Time Frame: 4 hours after the postdose meal
Secondary Outcomes
No secondary outcomes reported
Investigators
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