At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 547 enrolled
Drug / intervention
Pioglitazone +1 moredrug
Likely dose
Pioglitazone up to 45 mg orally once daily; Glimepiride up to 4 mg orally once daily (both optimized for glucose control)AI-extracted
Key inclusion· 6
- ✓Type 2 diabetes mellitus diagnosis
- ✓Angiographic evidence of coronary heart disease: ≥1 lesion with ≥20% reduction in lumen diameter in native coronary artery
- ✓Target coronary artery must not have undergone prior percutaneous coronary intervention or coronary artery bypass graft surgery
- ✓Target vessel not currently a candidate for intervention or likely candidate over next 72 weeks
Key exclusion· 8
- ✕Type 1 diabetes mellitus
- ✕NYHA class III or IV cardiac failure, LVEF <40%, or use of diuretics/ACE inhibitors for heart failure
- ✕Concurrent use of thiazolidinediones or sulfonylureas
- ✕Known or suspected malignancy or recurrence within past 5 years (except basal cell and Stage 1 squamous cell skin carcinoma)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, Randomized, Comparator-Controlled Study In Subjects With Type 2 Diabetes Mellitus Comparing the Effects of Pioglitazone HCl Versus Glimepiride on the Rate of Progression of Coronary Atherosclerotic Disease as Measured by Intravascular Ultrasound
In Brief
A Phase 3 clinical trial evaluating Pioglitazone and Glimepiride for Diabetes Mellitus. Completed, enrolled 547 participants across 79 sites in 4 countries.
Detailed Summary
The purpose of this study was to determine the efficacy of pioglitazone, once daily (QD), compared to glimepiride on atherosclerotic disease measured by intravascular ultrasound.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus
CountriesArgentina, Canada, Chile, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2003
First PostedSep 2005
Primary CompletionOct 2007
TodayJul 2026
First PostedSep 23, 2005
Enrollment StartJul 1, 2003
Primary CompletionOct 1, 2007
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 20.8 years ago
Interventions
Pioglitazonedrug
Up to 45 mg pioglitazone (optimized for glucose control), tablets, orally, once daily for up to 72 weeks.
Glimepiridedrug
Up to 4 mg of glimepiride (optimized for glucose control), tablets, orally, once daily for up to 72 weeks.