Status:
COMPLETED
Ezetimibe and Statins on Postprandial Lipemia in Type 2 Diabetes
Lead Sponsor:
Federico II University
Conditions:
Postprandial Lipemia
Type 2 Diabetes
Eligibility:
All Genders
40-65 years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00699023
Start Date
June 1 2008
End Date
October 1 2009
Last Update
November 4 2009
Active Locations (1)
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1
Department of Clinical and Experimental Medicine, Federico II University Hospital,
Naples, Naples, Italy, 80131