drugset / Trial / NCT00854503

Metabolic and Vascular Effects of Statins in Untreated Dyslipidemic Diabetic Patients

NCT00854503

Phase 3 Completed 30 enrolled University of Rome Tor Vergata
RandomizedCrossoverSingle-blindTreatment

Summary

Type 2 diabetes (T2D), because of impaired glucose regulation and consequent hyperglycemia, promotes the development of coronary heart disease. Secondary dyslipidemia is often associated with T2D and enhances the risk of cardiovascular complications. HMG-CoA reductase inhibitors (statins) are selectively administrated for the treatment of dyslipidemia, leading to a significant reduction of cardiovascular risk. More recently, revisions to guidelines have established a lower therapeutic LDL cholesterol goal for diabetic patients, requiring the administration of higher dose of statin. However, it is unclear whether high dose statin therapy could affect glycemic control in diabetic patients. Moreover, data regarding the effects of statins on insulin-resistance and endothelial function are controversial.

Timeline

Start
2008-09
Primary completion
2010-03
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Rosuvastatin Small molecule 20 mg Oral
Comparator Simvastatin Small molecule 20 mg Oral