Ezetimibe and Simvastatin in Dyslipidemia of Diabetes
This study has been completed.
Sponsor:
Mario Negri Institute for Pharmacological Research
Information provided by:
Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier:
NCT00157482
First received: September 8, 2005
Last updated: February 12, 2007
Last verified: December 2006
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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:
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 |
Show Detailed Description 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):
| 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 June 17, 2013