Ezetimibe and Simvastatin in Dyslipidemia of Diabetes - Full Text View

Sponsor:	Mario Negri Institute for Pharmacological Research
Information provided by:	Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier:	NCT00157482

Purpose

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 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Diagnostic
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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Cholesterol Diabetes Diabetes Type 2

Drug Information available for: Simvastatin Ezetimibe

U.S. FDA Resources

Further study details as provided by Mario Negri Institute for Pharmacological Research:

Primary Outcome Measures:

LDL-cholesterol, at 16 weeks of treatment. LDL-cholesterol is measured at -4, 0, 8, 12 and 16 weeks.

Secondary Outcome Measures:

Total cholesterol, apolipoprotein A1 and B, lipoprotein and triglycerides, at -4, 0, 8, 12 and 16 weeks
Explorative
Urinary albumin excretion, at -4, 0, 8 and 16 weeks

Estimated Enrollment:	108
Study Start Date:	January 2005
Estimated Study Completion Date:	December 2006

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Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetes mellitus with stable antidiabetic treatment since at least three months
Total cholesterol concentrations >135mg/dl and/or concomitant lipid lowering therapy with HMGCoA inhibitors
Serum creatinine ≤1.5mg/dl
Urinary albumin excretion rate < 200μg/min
Written informed consent

Exclusion Criteria:

History of myocardial infarction, stroke or hospital admission for angina within the previous 6 months
History of percutaneous transluminal coronary angioplasty or coronary artery bypass grafting
Clinically manifest heart failure (grade III or above according to New York Heart Association criteria)
Poor glycemic control (HbA1C >11%)
Primary hyperlipidemia
Uncontrolled thyroid diseases
Infectious disease within 4 weeks of starting
Acute liver disease or hepatic dysfunction
Inflammatory muscle disease or evidence of muscle problems
Concurrent treatment with systemic steroids, androgens, cyclosporin and other immunosuppressive drugs, fibrates, high-dose niacin or cholestyramine
Pregnancy or lactating
Women of childbearing potential without following a scientifically accepted form of contraception
Life-threatening conditions or terminal concomitant diseases other than diabetes
Specific contraindications or history of hypersensitivity to the study drugs or other statins
Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequence of the trial
Evidence of an uncooperative attitude
Any evidence that patient will not be able to complete the trial follow-up

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157482

Locations

Italy
ASl of Ponte San Pietro - Diabetologic Unit
Ponte San Pietro, Bergamo, Italy, 24036
Clinical Research Center for Rare Diseases
Ranica, Bergamo, Italy, 24020
Hospital "Treviglio Caravaggio " - Diabetologic Unit
Treviglio, Bergamo, Italy, 24047
Hospital "Ospedali Riuniti di Bergamo" - Diabetologic Unit
Bergamo, Italy, 24128

Sponsors and Collaborators

Mario Negri Institute for Pharmacological Research

Investigators

Principal Investigator:

Piero Ruggenenti, MD

Mario Negri Institute

More Information

No publications provided by Mario Negri Institute for Pharmacological Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ruggenenti P, Cattaneo D, Rota S, Iliev I, Parvanova A, Diadei O, Ene-Iordache B, Ferrari S, Bossi AC, Trevisan R, Belviso A, Remuzzi G; Ezetimibe and Simvastatin in Dyslipidemia of Diabetes (ESD) Study Group. Effects of combined ezetimibe and simvastatin therapy as compared with simvastatin alone in patients with type 2 diabetes: a prospective randomized double-blind clinical trial. Diabetes Care. 2010 Sep;33(9):1954-6. Epub 2010 Jun 21.

ClinicalTrials.gov Identifier:	NCT00157482 History of Changes
Other Study ID Numbers:	ESD
Study First Received:	September 8, 2005
Last Updated:	February 12, 2007
Health Authority:	Italy: Ministry of Health

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
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 May 24, 2012