We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00699023
First Posted: June 17, 2008
Last Update Posted: November 4, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federico II University
June 13, 2008
June 17, 2008
November 4, 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 ]
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 ]
  • Fasting LDL concentration [ Time Frame: 6 weeks ]
  • Cholesterol/triglyceride ratio in postprandial chylomicrons and VLDL fractions. [ Time Frame: 6 weeks ]
  • Postprandial LDL size [ Time Frame: 6 weeks ]
  • Concentration and Composition of different lipoprotein subclasses in the fasting condition. [ Time Frame: 6 weeks ]
  • 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 ]
  • Fasting LDL concentration [ Time Frame: 6 weeks ]
  • Cholesterol/triglyceride ratio in postprandial chylomicrons and VLDL fractions. [ Time Frame: 6 weeks ]
  • Postprandial LDL size. [ Time Frame: 6 weeks ]
  • Concentration and Composition of different lipoprotein subclasses in the fasting condition. [ Time Frame: 6 weeks ]
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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Sexes Eligible for Study: All
40 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00699023
239/07
No
Not Provided
Not Provided
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
To Top