Primary Outcome Measures:
- Effect of treatment on the nominal change in percent atheroma volume of the identified target coronary artery segment from baseline after 18 months of treatment as measured by intravascular ultrasound (IVUS) imaging of the coronary arteries. [ Time Frame: 18 Months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Compare the effect of pioglitazone HCl and glimepiride on the nominal change in total atheroma volume [ Time Frame: 18 Months ] [ Designated as safety issue: Yes ]
- Compare the effect of pioglitazone HCl and glimepiride on the occurrence of cardiovascular events as a composite of cardiovascular mortality, nonfatal myocardial infarction, nonfatal stroke. [ Time Frame: 18 Months ] [ Designated as safety issue: Yes ]
- Compare the effect of pioglitazone HCl and glimepiride on the occurrence of cardiovascular events as a composite of cardiovascular mortality, nonfatal MI, nonfatal stroke and coronary revascularization. [ Time Frame: 18 Months ] [ Designated as safety issue: Yes ]
- Compare the effect of pioglitazone HCl and glimepiride on the occurrence of carotid endarterectomy/carotid stenting, hospitalization for unstable angina, and hospitalization for congestive heart failure (CHF). [ Time Frame: 18 Months ] [ Designated as safety issue: Yes ]
Subjects with type 2 diabetes requiring angiography will have the IVUS procedure performed at baseline and again following 18 months of treatment. Subjects who meet eligibility criteria will be titrated up to a maximum of 45 mg/day pioglitazone HCl or 4 mg/day glimepiride. Subjects will make 11 visits to the study center. During study visits, subjects will have weight, and vital signs assessed as well as abdominal and hip girth. Physical exams will be done at baseline, 12 months, and 18 months. ECG will be done at baseline and 18 months. Lab assessments will be done at each visit. Completed blood count, chemistries, urinalysis and markers of atherosclerosis will be drawn at baseline, and months 6, 12 and 18. At each visit, information will be collected regarding adverse events the subject may have experienced and any medications the subject is taking. Compliance with study medication will also be assessed at each visit.
Purpose
