CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 395 enrolled
Drug / intervention
Comparator: Sitagliptin phosphate +1 moredrug
Likely dose
Comparator: Sitagliptin phosphate 100 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/NCT00813995
NCT00813995Phase 3Completed
CompareCT.gov

A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin 100 mg Once Daily in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy

Merck Sharp & Dohme LLC·interventional·Posted Dec 23, 2008·Updated May 12, 2017

In Brief

A Phase 3 clinical trial evaluating Comparator: Sitagliptin phosphate and Comparator: Placebo for Type 2 Diabetes Mellitus. Completed, enrolled 395 participants.

Detailed Summary

A study to assess the safety and efficacy of the addition of sitagliptin compared to placebo in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 23, 2008
Enrollment StartDec 9, 2008
Primary CompletionAug 9, 2010
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 17.5 years ago

Interventions

Comparator: Sitagliptin phosphatedrug

All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate 100 mg tablets once daily (q.d.) and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks.

Comparator: Placebodrug

All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate placebo tablets q.d. and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks.