Clinical Trial: Dose Response Finding Study of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance (MK-0431-105)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II, Randomized, Placebo-Controlled, Parallel-group, Double-Blind, Dose Response Finding Clinical Trial to Study the Efficacy and Safety of MK-0431/ONO-5435 in Japanese Subjects With

Brief Summary: This study is being done to evaluate the safety, efficacy, and dose level of sitagliptin (MK-0431/ONO-5435) used once daily (qd) for Japanese subjects with impaired glucose tolerance who have inadequate glycemic control using diet and exercise therapy.

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome: Percent change in glucose total area under the concentration curve (AUC) for meal tolerance test (MTT) [ Time Frame: Baseline and Week 8 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Percent change in Glucose total AUC for 75g oral glucose tolerance test (OGTT) [ Time Frame: Baseline and Week 7 ]

Original Secondary Outcome: Same as current

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: July 28, 2011
Date Started: August 8, 2011
Date Completion:
Last Updated: April 10, 2017
Last Verified: April 2017