Study Evaluating the Efficacy and Safety of Simvastatin Alone Compared With Simvastatin Plus Ezetimibe in Type 2 Diabetic Patients (0653-021)(COMPLETED)
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00551876
- Lead Sponsor
- Organon and Co
- Brief Summary
The purpose of this study is to determine if the addition of ezetimibe 10 mg daily to ongoing 20 mg simvastatin daily will reduce LDL Cholesterol to a greater extent than increasing the dose of simvastatin to 40 mg daily in Type 2 diabetics treated with Thiazolidinediones (TZD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 214
Inclusion Criteria
- Men or women age between 30 and 75 with Type 2 diabetes mellitus who are treated with pioglitazone or rosiglitazone
- Additionally, patients must have an LDL-C >100 mg/dL at Visit 1 or prior to initiation of statin therapy
Exclusion Criteria
- Patients taking sliding scale insulin, selected lipid lowering medications, oral anticoagulants and cyclical sex hormones
- Patients with heart disease, kidney disease, liver disease, uncontrolled high blood pressure, and insulin dependent diabetes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percent change in fasting LDL-C from baseline to the average of the Week 6/Week 12 measurements 6 & 12 Weeks
- Secondary Outcome Measures
Name Time Method Well tolerated in patients in Diabetic patients 30 Weeks