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Sponsored by: |
Mario Negri Institute for Pharmacological Research |
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Information provided by: | Mario Negri Institute for Pharmacological Research |
ClinicalTrials.gov Identifier: | NCT00157482 |
Diabetes mellitus is becoming a global epidemic burden. Its chronic cardiovascular complications, myocardial infarction and stroke, are the main causes of death in diabetic patients. It was found that low density lipoprotein (LDL) cholesterol concentration is related to the increased coronary disease risk that could be successfully reduced by cholesterol-lowering therapy. Furthermore, preliminary evidence suggests that ameliorating dyslipidemia may be renoprotective in diabetic patients with proteinuria.
Ezetimibe is the first selective inhibitor of cholesterol absorption and it has demonstrated a high efficacy in lowering cholesterol concentration and an excellent safety profile. Preliminary data suggest that ezetimibe, combined with a drug that blocks the cholesterol synthesis (statins), could be even more effective in decreasing cholesterol concentration. The aim of this study is to evaluate whether ezetimibe-simvastatin combined therapy is superior to simvastatin monotherapy in ameliorating the lipid profile and albuminuria in type 2 diabetic patients.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes |
Drug: Ezetimibe Drug: Simvastatin |
Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Prospective, Double-Blind Study to Evaluate the Effects on Lipid Profile of Combined Ezetimibe and Simvastatin Therapy as Compared to Simvastatin Alone in People With Type 2 Diabetes |
Estimated Enrollment: | 108 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | December 2006 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy | |
Hospital "Ospedali Riuniti di Bergamo" - Diabetologic Unit | |
Bergamo, Italy, 24128 | |
Italy, Bergamo | |
Clinical Research Center for Rare Diseases | |
Ranica, Bergamo, Italy, 24020 | |
Hospital "Treviglio Caravaggio " - Diabetologic Unit | |
Treviglio, Bergamo, Italy, 24047 | |
ASl of Ponte San Pietro - Diabetologic Unit | |
Ponte San Pietro, Bergamo, Italy, 24036 |
Principal Investigator: | Piero Ruggenenti, MD | Mario Negri Institute |
Study ID Numbers: | ESD |
Study First Received: | September 8, 2005 |
Last Updated: | February 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00157482 |
Health Authority: | Italy: Ministry of Health |
Metabolic Diseases Simvastatin Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Ezetimibe Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Dyslipidemias |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |