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Ezetimibe and Simvastatin in Dyslipidemia of Diabetes

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.
ClinicalTrials.gov Identifier: NCT00157482
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : February 13, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Ezetimibe Drug: Simvastatin Phase 2

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : January 2005
Estimated Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. LDL-cholesterol, at 16 weeks of treatment. LDL-cholesterol is measured at -4, 0, 8, 12 and 16 weeks.

Secondary Outcome Measures :
  1. Total cholesterol, apolipoprotein A1 and B, lipoprotein and triglycerides, at -4, 0, 8, 12 and 16 weeks
  2. Explorative
  3. Urinary albumin excretion, at -4, 0, 8 and 16 weeks

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00157482     History of Changes
Other Study ID Numbers: ESD
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: February 13, 2007
Last Verified: December 2006

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Simvastatin
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors