Ezetimibe and Statins on Postprandial Lipemia in Type 2 Diabetes

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether ezetimibe in association with statins is more effective than statins alone on postprandial lipemia in type 2 diabetic patients.

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

Details

• Lead Sponsor: Federico II University
• Treatments: Ezetimibe; Simvastatin

Criteria

Inclusion Criteria:

• Type 2 diabetes since at least two years

• Stable metabolic control (HbA1c<8.0%) for at least six months on diet or diet+oral hypoglycemic drugs (insulin secretagogues or metformin), not to be changed during the study period.

• BMI<30 kg/m2 and body weight stable during the last six months.

• Both sexes; only post-menopausal women.

• LDL-cholesterol >130 mg/dl, plasma triglycerides <400 mg/dl.

• No use of hypolipidemic drugs in the last three months.

Exclusion Criteria:

• Patient with renal (serum creatinine >1.5 mg/dl) or hepatic (serum transaminases >three times upper normal values) impairment.

• Patients with history of cardiovascular disease.

• Pre-menopausal women.

• Any other acute or chronic degenerative disease.

• Anemia (Hb<12 g/dl).

• Uncontrolled blood pressure.

• Use of any drugs able to interfere with the study medications