Status:
COMPLETED
Ezetimibe and Simvastatin in Dyslipidemia of Diabetes
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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...
Detailed Description
INTRODUCTION Diabetes mellitus contributes substantially to the global burden of disease, with an estimated 150 million people affected worldwide and its prevalence is expected to double by 2025. Myo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00157482
Start Date
January 1 2005
End Date
December 1 2006
Last Update
February 13 2007
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital "Ospedali Riuniti di Bergamo" - Diabetologic Unit
Bergamo, Bergamo, Italy, 24128
2
ASl of Ponte San Pietro - Diabetologic Unit
Ponte San Pietro, Bergamo, Italy, 24036
3
Clinical Research Center for Rare Diseases
Ranica, Bergamo, Italy, 24020
4
Hospital "Treviglio Caravaggio " - Diabetologic Unit
Treviglio, Bergamo, Italy, 24047