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.
ConditionType 2 Diabetes
InterventionDrug: sitagliptin phosphate
Drug: Comparator: metformin
Drug: Comparator: sitagliptin and metformin
Drug: Comparator: placebo
PhasePhase 1
SponsorMerck Sharp & Dohme Corp.
Responsible PartyMerck Sharp & Dohme Corp.
ClinicalTrials.gov IdentifierNCT00975052
First ReceivedSeptember 10, 2009
Last UpdatedMarch 7, 2014
Last verifiedMarch 2014

Tracking Information[ + expand ][ + ]

First Received DateSeptember 10, 2009
Last Updated DateMarch 7, 2014
Start DateJanuary 2006
Estimated Primary Completion DateMarch 2006
Current Primary Outcome MeasuresWeighted average active GLP-1 (glucagonlike peptide-1) concentrations [Time Frame: 4 hours after the postdose meal] [Designated as safety issue: No]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleA Study of the Effects of Sitagliptin (MK0431) and Metformin on Incretin Hormone Concentrations (0431-050)(COMPLETED)
Official TitleA 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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionType 2 Diabetes
InterventionDrug: 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)
  • Active Comparator: A
    Sitagliptin alone
  • Active Comparator: B
    Metformin alone
  • Experimental: C
    Sitagliptin and metformin concomitantly
  • Placebo Comparator: D
    Placebo

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment16
Estimated Completion DateMarch 2006
Estimated Primary Completion DateMarch 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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT00975052
Other Study ID Numbers0431-050
Has Data Monitoring CommitteeNot Provided
Information Provided ByMerck Sharp & Dohme Corp.
Study SponsorMerck Sharp & Dohme Corp.
CollaboratorsNot Provided
Investigators Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Verification DateMarch 2014