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

This study has been completed.
Sponsor:
Information provided by:
Federico II University
ClinicalTrials.gov Identifier:
NCT00699023
First received: June 13, 2008
Last updated: November 3, 2009
Last verified: November 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Ezetimibe in Association With Statins on Postprandial Lipemia in Type 2 Diabetic Patients

Resource links provided by NLM:


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
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Placebo Comparator: 2
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:
Responsible Party: Angela A. Rivellese, MD, Department of Clinical and Experimental Medicine Federico II University Naples
ClinicalTrials.gov Identifier: NCT00699023     History of Changes
Other Study ID Numbers: 239/07
Study First Received: June 13, 2008
Last Updated: November 3, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by Federico II University:
postprandial lipemia
type 2 diabetes
ezetimibe
hypercholesterolemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperlipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders
Simvastatin
Ezetimibe
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014