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

Merck Sharp & Dohme LLC16 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Type 2 Diabetes

Interventions

sitagliptin phosphateDRUG

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

Comparator: metforminDRUG

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

Comparator: sitagliptin and metforminDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 4 hours after the postdose meal

Data from ClinicalTrials.gov

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