At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 4,373 enrolled
Drug / intervention
Pioglitazone +1 moredrug
Likely dose
Pioglitazone 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.
PROspective PioglitAzone Clinical Trial In MacroVascular Events: A Macrovascular Outcome Study in Type 2 Diabetic Patients Comparing Pioglitazone With Placebo in Addition to Existing Therapy
In Brief
A Phase 3 clinical trial evaluating Pioglitazone and Placebo for Diabetes Mellitus. Completed, enrolled 4,373 participants across 19 sites in 19 countries.
Detailed Summary
The purpose of this study is to determine whether pioglitazone, once daily (QD), can delay the time to death, heart attack, acute coronary syndrome, heart bypass surgery, stroke, leg bypass surgery or amputation in patients with type 2 diabetes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus
CountriesAustria, Belgium, Czechia, Denmark, Estonia, Finland, France, Germany, Hungary, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Slovakia, Sweden, Switzerland, United Kingdom
CollaboratorsEli Lilly and Company
Timeline
Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2001
Primary CompletionJan 2005
First PostedSep 2005
TodayJul 2026
First PostedSep 15, 2005
Enrollment StartMay 1, 2001
Primary CompletionJan 1, 2005
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 20.8 years ago
Interventions
Pioglitazonedrug
Pioglitazone 15 mg to 45 mg, tablets, orally, once daily for up to 48 months.
Placebodrug
Pioglitazone placebo-matching tablets, orally, once daily for up to 48 months