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

June 13, 2008
November 3, 2009
June 2008
October 2009   (final data collection date for primary outcome measure)
Incremental AUC after a fat-rich meal of cholesterol concentration in chylomicron and VLDL fractions [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00699023 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Ezetimibe and Statins on Postprandial Lipemia in Type 2 Diabetes
Effects of Ezetimibe in Association With Statins on Postprandial Lipemia in Type 2 Diabetic Patients

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Postprandial Lipemia
  • Type 2 Diabetes
  • Drug: ezetimibe tablets
    ezetimibe tablets 10 mg/die
  • Drug: simvastatin tablets
    simvastatin tablets 20 mg/die
  • Drug: placebo
    placebo
  • Experimental: 1
    ezetimibe tablets 10 mg/die + simvastatin tablets 20 mg/die six weeks
    Interventions:
    • Drug: ezetimibe tablets
    • Drug: simvastatin tablets
  • Placebo Comparator: 2
    placebo + simvastatin tablets 20 mg/die six weeks
    Interventions:
    • Drug: simvastatin tablets
    • Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
40 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00699023
239/07
No
Angela A. Rivellese, MD, Department of Clinical and Experimental Medicine Federico II University Naples
Federico II University
Not Provided
Study Chair: Gabriele Riccardi, Prof Department of Clinical and Experimental Medicine, Federico II University Hospital, Naples, Italy
Federico II University
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP