Ezetimibe and Statins on Postprandial Lipemia in Type 2 Diabetes (EZE)

Federico II University

Status and phase

Completed

Phase 4

Conditions

Postprandial Lipemia

Type 2 Diabetes

Treatments

Drug: ezetimibe tablets

Drug: simvastatin tablets

Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00699023

239/07

Details and patient eligibility

About

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.

Enrollment

13 estimated patients

Sex

All

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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