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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00975052
First Posted: September 11, 2009
Last Update Posted: August 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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 (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
Placebo
Drug: Comparator: placebo
Placebo only on Days 1 and 2 in one of four treatment periods.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975052


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

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00975052     History of Changes
Other Study ID Numbers: 0431-050
MK0431-050
2009_661
First Submitted: September 10, 2009
First Posted: September 11, 2009
Last Update Posted: August 19, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Metformin
Sitagliptin Phosphate
Hormones
Gastric Inhibitory Polypeptide
Incretins
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