Study Evaluating the Efficacy and Safety of Simvastatin Alone Compared With Simvastatin Plus Ezetimibe in Type 2 Diabetic Patients (0653-021)(COMPLETED)
Study Details
Study Description
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Outcome Measures
Primary Outcome Measures
- Percent change in fasting LDL-C from baseline to the average of the Week 6/Week 12 measurements [6 & 12 Weeks]
Secondary Outcome Measures
- Well tolerated in patients in Diabetic patients [30 Weeks]
Eligibility Criteria
Criteria
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:
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Organon and Co
Investigators
- Study Director: Medical Monitor, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
- 0653-021
- MK0653-021
- 2006_554