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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00975052
First received: September 10, 2009
Last updated: March 7, 2014
Last verified: March 2014
  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:


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 ] [ 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 10, 2009
Last Updated: March 7, 2014
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
Gastric Inhibitory Polypeptide
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
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014