CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,615 enrolled
Drug / intervention
Sitagliptin phosphate +4 moredrug
Likely dose
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/NCT00722371
NCT00722371Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind Study of the Co-Administration of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Merck Sharp & Dohme LLC·interventional·Posted Jul 25, 2008·Updated May 12, 2017

In Brief

A Phase 3 clinical trial evaluating Sitagliptin phosphate, Pioglitazone hydrochloride, and 3 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 1,615 participants.

Detailed Summary

A study to evaluate the efficacy and safety of sitagliptin and pioglitazone co-administration in comparison with sitagliptin and pioglitazone monotherapy in patients with type 2 diabetes.

Study Details

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

Timeline

Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 25, 2008
Enrollment StartSep 5, 2008
Primary CompletionOct 26, 2010
Study CompletionMar 25, 2011
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 17.9 years ago

Interventions

Sitagliptin phosphatedrug

Sitagliptin 100 mg tablet (blinded) orally once daily for 54 weeks.

Pioglitazone hydrochloridedrug

Pioglitazone 15 mg, 30 mg, or 45 mg tablets or capsules (blinded) orally once daily for 54 weeks. Participants randomized to receive pioglitazone 45 mg as monotherapy or in combination with sitagliptin were to start on pioglitazone 30 mg at Week 1 and undergo uptitration to pioglitazone 45 mg at Week 4.

Matching placebo to sitagliptindrug

Matching placebo to sitagliptin orally once daily for 54 weeks.

Matching placebo to pioglitazonedrug

Matching placebo to pioglitazone tablets or capsules orally once daily for 54 weeks.

Metformindrug

Metformin 500 mg (open-label) was to be initiated as rescue therapy to participants not meeting specific glycemic goals. The dose of metformin may have been uptitrated and adjusted, at the discretion of the investigator, up to the maximum approved dose in the country of origin.