Ezetimibe and Statins on Postprandial Lipemia in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— EZE  

Official title:

Effects of Ezetimibe in Association With Statins on Postprandial Lipemia in Type 2 Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00699023
• Other study ID #: 239/07
• Status: Completed
• Phase: Phase 4
• First received: June 13, 2008
• Last updated: November 3, 2009
• Start date: June 2008
• Est. completion date: October 2009

Study information

• Verified date: November 2009
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hyperlipidemias
• Postprandial Lipemia
• Type 2 Diabetes

Intervention

Drug:
• ezetimibe tablets
ezetimibe tablets 10 mg/die
• simvastatin tablets
simvastatin tablets 20 mg/die
• placebo
placebo

Locations

Country	Name	City	State
Italy	Department of Clinical and Experimental Medicine, Federico II University Hospital,	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Annuzzi G, De Natale C, Iovine C, Patti L, Di Marino L, Coppola S, Del Prato S, Riccardi G, Rivellese AA. Insulin resistance is independently associated with postprandial alterations of triglyceride-rich lipoproteins in type 2 diabetes mellitus. Arterioscler Thromb Vasc Biol. 2004 Dec;24(12):2397-402. Epub 2004 Sep 30. — View Citation

Davidson MH, Toth PP. Combination therapy in the management of complex dyslipidemias. Curr Opin Lipidol. 2004 Aug;15(4):423-31. Review. — View Citation

Rivellese AA, De Natale C, Di Marino L, Patti L, Iovine C, Coppola S, Del Prato S, Riccardi G, Annuzzi G. Exogenous and endogenous postprandial lipid abnormalities in type 2 diabetic patients with optimal blood glucose control and optimal fasting triglyceride levels. J Clin Endocrinol Metab. 2004 May;89(5):2153-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental AUC after a fat-rich meal of cholesterol concentration in chylomicron and VLDL fractions		6 weeks	No
Secondary	Incremental AUC after a fat rich-meal of apo B48 concentration- marker of the number of intestinally derived lipoproteins- in chylomicron and VLDL		6 weeks	No
Secondary	Fasting LDL concentration		6 weeks	No
Secondary	Cholesterol/triglyceride ratio in postprandial chylomicrons and VLDL fractions.		6 weeks	No
Secondary	Postprandial LDL size		6 weeks	No
Secondary	Concentration and Composition of different lipoprotein subclasses in the fasting condition.		6 weeks	No