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

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

Completed

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sitagliptin phosphate

Drug

100 mg sitagliptin daily for two days in one out of four treatment periods

Comparator: Metformin

Drug

500 mg twice daily on Day 1 and 1000 mg once daily on Day 2 in one of four treatment periods.

Comparator: sitagliptin and metformin

Drug

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.

Comparator: placebo

Drug

Placebo only on Days 1 and 2 in one of four treatment periods.

Primary outcomes

Weighted average active GLP-1 (glucagonlike peptide-1) concentrations

Time frame: 4 hours after the postdose meal

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start: 2006
Primary completion: 2006
Study completion: 2006
First posted: Sep 11, 2009
Registry last updated: Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed