Study Evaluating the Efficacy and Safety of Simvastatin Alone Compared With Simvastatin Plus Ezetimibe in Type 2 Diabetic Patients (0653-021)(COMPLETED)

• Status: Completed
• Trial end date: 2003-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Ezetimibe; Simvastatin

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:

• 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