CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 520 enrolled
Drug / intervention
sitagliptin 100 mg q.d./pioglitazone 30 mg q.d +1 moredrug
Likely dose
sitagliptin 100 mg q.d./pioglitazone 30 mg q.dfrom 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/NCT00397631
NCT00397631Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Initial Therapy With Coadministration of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus

Merck Sharp & Dohme LLC·interventional·Posted Nov 9, 2006·Updated May 12, 2017

In Brief

A Phase 3 clinical trial evaluating sitagliptin 100 mg q.d./pioglitazone 30 mg q.d and Comparator: placebo to match sitagliptin 100 mg q.d./pioglitazone 30 mg q.d. for Type 2 Diabetes Mellitus. Completed, enrolled 520 participants.

Detailed Summary

A clinical study to evaluate the safety and efficacy of the initial combination therapy with sitagliptin and pioglitazone in patients with type 2 diabetes mellitus not on treatment with insulin or oral antihyperglycemic therapy.

Study Details

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

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 9, 2006
Enrollment StartDec 19, 2006
Primary CompletionJun 28, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 19.6 years ago

Interventions

sitagliptin 100 mg q.d./pioglitazone 30 mg q.ddrug

Patients will receive initial combination therapy with blinded sitagliptin 100 mg q.d. and open- label pioglitazone 30 mg q.d. for up to 24 Weeks. Sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. will be administered as oral tablets.

Comparator: placebo to match sitagliptin 100 mg q.d./pioglitazone 30 mg q.d.drug

Patients will receive placebo to match sitagliptin 100 mg q.d. (blinded) and open label pioglitazone 30 mg q.d. for up to 24 Weeks. Placebo to match sitagliptin 100 mg q.d.(blinded) and open-label pioglitazone 30 mg q.d. will be administered as oral tablets.