A Study of the Effects of Sitagliptin (MK0431) and Metformin on Incretin Hormone Concentrations (0431-050)(COMPLETED)
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
3 other identifiers
interventional
16
0 countries
N/A
Brief Summary
This study will determine the effect of concomitant administration of sitagliptin and metformin on post-meal incretin hormone concentrations in healthy adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 type-2-diabetes
Started Jan 2006
Shorter than P25 for phase_1 type-2-diabetes
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 10, 2009
CompletedFirst Posted
Study publicly available on registry
September 11, 2009
CompletedAugust 19, 2015
August 1, 2015
2 months
September 10, 2009
August 18, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Weighted average active GLP-1 (glucagonlike peptide-1) concentrations
4 hours after the postdose meal
Study Arms (4)
A
ACTIVE COMPARATORSitagliptin alone
B
ACTIVE COMPARATORMetformin alone
C
EXPERIMENTALSitagliptin and metformin concomitantly
D
PLACEBO COMPARATORPlacebo
Interventions
100 mg sitagliptin daily for two days in one out of four treatment periods
500 mg twice daily on Day 1 and 1000 mg once daily on Day 2 in one of four treatment periods.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Any history of stroke or neurological disorder
- Subject has a history of cardiovascular, blood, endocrine or liver diseases
- Subject has a history of cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Migoya EM, Bergeron R, Miller JL, Snyder RN, Tanen M, Hilliard D, Weiss B, Larson P, Gutierrez M, Jiang G, Liu F, Pryor KA, Yao J, Zhu L, Holst JJ, Deacon C, Herman G, Thornberry N, Amatruda J, Williams-Herman D, Wagner JA, SinhaRoy R. Dipeptidyl peptidase-4 inhibitors administered in combination with metformin result in an additive increase in the plasma concentration of active GLP-1. Clin Pharmacol Ther. 2010 Dec;88(6):801-8. doi: 10.1038/clpt.2010.184. Epub 2010 Nov 3.
PMID: 21048706RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2009
First Posted
September 11, 2009
Study Start
January 1, 2006
Primary Completion
March 1, 2006
Study Completion
March 1, 2006
Last Updated
August 19, 2015
Record last verified: 2015-08