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A Study of the Effects of Sitagliptin (MK0431) and Metformin on Incretin Hormone Concentrations (0431-050)(COMPLETED)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: September 10, 2009
Last updated: August 18, 2015
Last verified: August 2015
This study will determine the effect of concomitant administration of sitagliptin and metformin on post-meal incretin hormone concentrations in healthy adults.

Condition Intervention Phase
Type 2 Diabetes
Drug: sitagliptin phosphate
Drug: Comparator: metformin
Drug: Comparator: sitagliptin and metformin
Drug: Comparator: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Weighted average active GLP-1 (glucagonlike peptide-1) concentrations [ Time Frame: 4 hours after the postdose meal ]

Enrollment: 16
Study Start Date: January 2006
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Sitagliptin alone
Drug: sitagliptin phosphate
100 mg sitagliptin daily for two days in one out of four treatment periods
Active Comparator: B
Metformin alone
Drug: Comparator: metformin
500 mg twice daily on Day 1 and 1000 mg once daily on Day 2 in one of four treatment periods.
Experimental: C
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.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00975052

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00975052     History of Changes
Other Study ID Numbers: 0431-050
Study First Received: September 10, 2009
Last Updated: August 18, 2015

Additional relevant MeSH terms:
Sitagliptin Phosphate
Gastric Inhibitory Polypeptide
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents processed this record on April 25, 2017