Ezetimibe and Statins on Postprandial Lipemia in Type 2 Diabetes - Full Text View

Sponsored by:	Federico II University
Information provided by:	Federico II University
ClinicalTrials.gov Identifier:	NCT00699023

Purpose

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.

Condition	Intervention	Phase
Postprandial Lipemia Type 2 Diabetes	Drug: ezetimibe tablets Drug: simvastatin tablets Drug: placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Efficacy Study
Official Title:	Effects of Ezetimibe in Association With Statins on Postprandial Lipemia in Type 2 Diabetic Patients

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Diabetes Statins

Drug Information available for: Simvastatin Ezetimibe

U.S. FDA Resources

Further study details as provided by Federico II University:

Primary Outcome Measures:

incremental AUC after a fat-rich meal of cholesterol concentration in chylomicron and VLDL fractions [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

incremental AUC after a fat rich-meal of apo B48 concentration- marker of the number of intestinally derived lipoproteins- in chylomicron and VLDL [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
fasting LDL concentration [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Cholesterol/triglyceride ratio in postprandial chylomicrons and VLDL fractions. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Postprandial LDL size. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Concentration and Composition of different lipoprotein subclasses in the fasting condition. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	13
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental ezetimibe tablets 10 mg/die + simvastatin tablets 20 mg/die six weeks	Drug: ezetimibe tablets ezetimibe tablets 10 mg/die Drug: simvastatin tablets simvastatin tablets 20 mg/die
2: Placebo Comparator placebo + simvastatin tablets 20 mg/die six weeks	Drug: simvastatin tablets simvastatin tablets 20 mg/die Drug: placebo placebo

Eligibility

Ages Eligible for Study:	40 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699023

Locations

Italy
Department of Clinical and Experimental Medicine, Federico II University Hospital,
Naples, Italy, 80131

Sponsors and Collaborators

Federico II University

Investigators

Study Chair:

Gabriele Riccardi, Prof

Department of Clinical and Experimental Medicine, Federico II University Hospital, Naples, Italy

More Information

Publications:

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.

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.

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

Responsible Party:	Department of Clinical and Experimental Medicine Federico II University Naples ( Angela A. Rivellese, MD )
Study ID Numbers:	239/07
Study First Received:	June 13, 2008
Last Updated:	July 1, 2009
ClinicalTrials.gov Identifier:	NCT00699023 History of Changes
Health Authority:	Italy: Ethics Committee

Keywords provided by Federico II University:

postprandial lipemia
type 2 diabetes
ezetimibe
hypercholesterolemia

Study placed in the following topic categories:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Simvastatin
Antilipemic Agents
Diabetes Mellitus
Endocrine System Diseases
Ezetimibe
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Diabetes Mellitus, Type 2
Endocrinopathy
Glucose Metabolism Disorders
Hypercholesterolemia
Metabolic Disorder
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors

Ezetimibe
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on August 28, 2009