CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 242 enrolled
Drug / intervention
Placebo for Sitagliptin 25 mg +3 moredrug
Likely dose
Placebo for Sitagliptin 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01405911
NCT01405911Phase 2Completed
CompareCT.gov

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

Merck Sharp & Dohme LLC·interventional·Posted Jul 29, 2011·Updated Jan 18, 2020

In Brief

A Phase 2 clinical trial evaluating Placebo for Sitagliptin 25 mg, Placebo for Sitagliptin 50 mg, and 2 other interventions for Glucose Intolerance. Completed, enrolled 242 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlucose Intolerance
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 29, 2011
Enrollment StartAug 16, 2011
Primary CompletionApr 9, 2012
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.9 years ago

Interventions

Placebo for Sitagliptin 25 mgdrug

1 tablet orally once daily before breakfast for 8 weeks

Placebo for Sitagliptin 50 mgdrug

1 tablet orally once daily before breakfast for 8 weeks

Sitagliptin 25 mgdrug

1 tablet orally once daily before breakfast for 8 weeks

Sitagliptin 50 mgdrug

1 tablet orally once daily before breakfast for 8 weeks