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

August 18, 2015 updated by: Merck Sharp & Dohme LLC

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

This study will determine the effect of concomitant administration of sitagliptin and metformin on post-meal incretin hormone concentrations in healthy adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: D
Placebo
Drug: Comparator: placebo
Placebo only on Days 1 and 2 in one of four treatment periods.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weighted average active GLP-1 (glucagonlike peptide-1) concentrations
Time Frame: 4 hours after the postdose meal
4 hours after the postdose meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

September 10, 2009

First Submitted That Met QC Criteria

September 10, 2009

First Posted (Estimate)

September 11, 2009

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 18, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0431-050
  • MK0431-050
  • 2009_661

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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