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

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

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


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

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

Department of Clinical and Experimental Medicine, Federico II University Hospital,
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
Study Chair: Gabriele Riccardi, Prof Department of Clinical and Experimental Medicine, Federico II University Hospital, Naples, Italy
  More Information

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders
Hypolipidemic Agents
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 16, 2014