CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 317 enrolled
Drug / intervention
Sitagliptin 100 mg q.d.+ Pioglitazone 45 mg q.d. +2 moredrug
Likely dose
Sitagliptin 100 mg q.d.+ Pioglitazone 45 mg q.d.from 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/NCT01028391
NCT01028391Phase 3Completed
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A 30-Week Extension to: 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 Dec 9, 2009·Updated May 12, 2017

In Brief

A Phase 3 clinical trial evaluating Sitagliptin 100 mg q.d.+ Pioglitazone 45 mg q.d., Pioglitazone 45 mg q.d. + Sitagliptin 100 mg placebo q.d., and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 317 participants.

Detailed Summary

A 30-week extension to a 24-week study assessing the hemoglobin A1c (HbA1c)- and fasting plasma glucose (FPG)-lowering efficacy of the combination of sitagliptin and pioglitazone in patients with type 2 diabetes mellitus (T2DM) with inadequate glycemic control.

Study Details

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

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 9, 2009
Enrollment StartSep 1, 2007
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.6 years ago

Interventions

Sitagliptin 100 mg q.d.+ Pioglitazone 45 mg q.d.drug

Patients will receive combination therapy with blinded sitagliptin 100 mg q.d. (q.d. = once daily) and open-label pioglitazone 45 mg q.d. during the up to 30 week extension study. Sitagliptin 100 mg q.d. and pioglitazone 45 mg q.d. will be administered as oral tablets.

Pioglitazone 45 mg q.d. + Sitagliptin 100 mg placebo q.d.drug

Patients will receive placebo to match sitagliptin 100 mg q.d. (blinded) and open-label pioglitazone 45 mg q.d. during the up to 30 week extension study. The placebo to match sitagliptin 100 mg q.d. (blinded) and open-label pioglitazone 45 mg q.d. will be administered as oral tablets.

Metformindrug

Patients not meeting specific glycemic goals during the 30-week extension study will receive open-label metformin at a dose determined by the investigator.