Ezetimibe and Simvastatin in Dyslipidemia of Diabetes
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
1 other identifier
interventional
108
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 type-2-diabetes
Started Jan 2005
Typical duration for phase_2 type-2-diabetes
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedFebruary 13, 2007
December 1, 2006
September 8, 2005
February 12, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
LDL-cholesterol, at 16 weeks of treatment. LDL-cholesterol is measured at -4, 0, 8, 12 and 16 weeks.
Secondary Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Hospital "Ospedali Riuniti di Bergamo" - Diabetologic Unit
Bergamo, Bergamo, 24128, Italy
ASl of Ponte San Pietro - Diabetologic Unit
Ponte San Pietro, Bergamo, 24036, Italy
Clinical Research Center for Rare Diseases
Ranica, Bergamo, 24020, Italy
Hospital "Treviglio Caravaggio " - Diabetologic Unit
Treviglio, Bergamo, 24047, Italy
Related Publications (1)
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. doi: 10.2337/dc10-0320. Epub 2010 Jun 21.
PMID: 20566677DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Piero Ruggenenti, MD
Mario Negri Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
January 1, 2005
Study Completion
December 1, 2006
Last Updated
February 13, 2007
Record last verified: 2006-12