At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 600 enrolled
Drug / intervention
Pioglitazone and metformin +2 moredrug
Likely dose
Pioglitazone and metformin 15 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.
A Phase 3b, Double-Blind, Randomized Study to Determine the Efficacy and Safety of Pioglitazone HCl and Metformin HCl Fixed-Dose Combination Therapy Compared to Pioglitazone HCl Monotherapy and to Metformin HCl Monotherapy in the Treatment of Subjects With Type 2 Diabetes
In Brief
A Phase 3 clinical trial evaluating Pioglitazone and metformin, Pioglitazone, and 1 other intervention for Diabetes Mellitus. Completed, enrolled 600 participants across 77 sites in 4 countries.
Detailed Summary
The purpose of this study is to determine the efficacy of pioglitazone, twice daily (BID), combined with metformin versus pioglitazone taken alone and metformin taken alone in treating Type 2 Diabetes Mellitus.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus
CountriesChile, Mexico, Puerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2007
Primary CompletionAug 2008
First PostedAug 2008
TodayJul 2026
First PostedAug 4, 2008
Enrollment StartJun 1, 2007
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.9 years ago
Interventions
Pioglitazone and metformindrug
Pioglitazone 15 mg /metformin 850 mg combination, tablets, orally, twice daily for up to 24 weeks.
Pioglitazonedrug
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks.
Metformindrug
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.