At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 672 enrolled
Drug / intervention
Glipizide +1 moredrug
Likely dose
Not stated in record
Key inclusion· 5
- ✓Age 30-80 years (male or female)
- ✓Established type 2 diabetes mellitus diagnosis per ADA, WHO, or national guidelines
- ✓Undergoing coronary angiography for evaluation of suspected or previously diagnosed CAD, or undergoing PCI
- ✓HbA1c >7.0% and ≤10.0% if drug-naïve; HbA1c >6.5% and ≤8.5% if on prior antihyperglycemic therapy
Key exclusion· 21
- ✕Type 1 diabetes or history of diabetic ketoacidosis
- ✕TZD or PPAR-γ agonist exposure within 6 months prior to screening
- ✕Triple OAD therapy or high-dose dual combination OAD therapy
- ✕Chronic insulin use in the last 6 months (except during pregnancy or acute episodes)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, 18 Month, Multicenter, Randomized, Double-Blind, Active-Controlled Clinical Trial to Compare Rosiglitazone Versus Glipizide on the Progression of Atherosclerosis in Subjects With Type 2 Diabetes Mellitus and Cardiovascular Disease (APPROACH)
In Brief
A Phase 3 clinical trial evaluating Glipizide and rosiglitazone maleate for Atherosclerosis. Completed, enrolled 672 participants across 156 sites in 20 countries.
Detailed Summary
The purpose of this study is to test the safety and effectiveness of rosiglitazone against a sulfonylurea in reducing or slowing the development of atherosclerosis in the blood vessels of the heart.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtherosclerosis
CountriesArgentina, Brazil, Canada, Czechia, France, Germany, Greece, Hong Kong, India, Italy, Latvia, Mexico, Netherlands, Poland, Russia, South Korea, Spain, Sweden, Thailand, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2005
First PostedJul 2005
Primary CompletionAug 2008
TodayJul 2026
First PostedJul 1, 2005
Enrollment StartJan 1, 2005
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 21.0 years ago
Interventions
Glipizidedrug
oral anti-diabetic medication
rosiglitazone maleatedrug
oral antidiabetic medication