PERISCOPE
PI is Dr. Webel
Coordinator is Kathy
Primary Objective: To compare the effect of treatment with pioglitazone HCL vs. glimepiride on the percent change in coronary artery atheroma volume in subjects with type 2 diabetes using intravascular ultrasound (IVUS) imaging of the coronary arteries.
Main Inclusion:
1) ages 35-85 inclusive
2) type 2 diabetes
3) naïve to, not currently taking or currently treated with monotherapy or combination therapy
4) presenting for cardiac cath with or without PCI
5) have angiographic evidence or CHD as defined by at least 1 lesion in a native coronary with > 20% reduction in lumen diameter
Main Exclusions:
- type 1 diabetes
- currently taking or taking within 12 weeks of randomization any thiazolidinediones (TZD)
- NYHA class III or IV (LVEF < 40%)
- ALT > 2.5 X ULN
- BMI > 48kg/m2
- Anticipated cardiac intervention or CABG following screening angiography
- Uncontrolled HTN
- Anemia
- Triglycerides > 500 mg/dl
- Clinically significant valvular disease
- Taking 3 or more antidiabetic therapies at screening
- Unstable clinical status
- Taking excluded medications (eg, prednisone, niacin)
Actions:
- patient to sign consent before cath
- EKG preferable day of cath
- IVUS of a vessel after any PCI during index cath (procedure posted in lab)
- study labs including urine drawn during cath
