NCT01405911

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

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 Impaired Glucose Tolerance Who Have Inadequate Glycemic Control on Diet/Exercise Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Glucose Intolerance

Interventions

Type	Name	Description
DRUG	Placebo for Sitagliptin 25 mg	1 tablet orally once daily before breakfast for 8 weeks
DRUG	Placebo for Sitagliptin 50 mg	1 tablet orally once daily before breakfast for 8 weeks
DRUG	Sitagliptin 25 mg	1 tablet orally once daily before breakfast for 8 weeks
DRUG	Sitagliptin 50 mg	1 tablet orally once daily before breakfast for 8 weeks

Timeline

• Start date: 2011-08-16
• Primary completion: 2012-04-09
• Completion: 2012-04-09
• First posted: 2011-07-29
• Last updated: 2020-01-18
• Results posted: 2019-12-26