Effect of Thiazolidinedione Treatment Vascular Risk Markers

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine the effects of two diabetes medications, rosiglitazone and pioglitazone, on markers of vascular disease in subjects with type 2 diabetes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arkansas
• Treatments: 2,4-thiazolidinedione; Pioglitazone; Rosiglitazone

Criteria

Inclusion Criteria:

• Men and women of all races

• Age 40-65 years

• Diagnosis of type 2 diabetes

• hemoglobin A1C ≥ 7%

• eligible whether or not currently taking antihyperglycemic medications

Exclusion Criteria:

• History of rosiglitazone or pioglitazone use in the previous 3 months

• Known diagnosis of peripheral vascular disease or cardiac failure

• Recent history (within past 6 months) of ischemic stroke, myocardial infarction, percutaneous coronary intervention, or coronary artery bypass surgery

• Active liver disease or elevated serum transaminases (ALT >2.5x upper limit of normal)

• Current therapy with oral anticoagulants (warfarin, heparin, low molecular weight heparin), clopidogrel, or immunosuppressive agents

• Pregnancy or breastfeeding

• Any other condition, in the opinion of the investigator, that renders the subject unable to complete the study, that interferes with optimal participation in the study, or that produces significant risk to the subject