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A Study of the Effects of Sitagliptin (MK0431) and Metformin on Incretin Hormone Concentrations

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00975052
First received: September 10, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Weighted average active GLP-1 (glucagonlike peptide-1) concentrations [ Time Frame: 4 hours after the postdose meal ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00975052

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00975052     History of Changes
Other Study ID Numbers: 2009_661, MK0431-050
Study First Received: September 10, 2009
Last Updated: September 10, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Metformin
Incretins
Hypoglycemic Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013