Study Evaluating the Efficacy and Safety of Simvastatin Alone Compared With Simvastatin Plus Ezetimibe in Type 2 Diabetic Patients (0653-021)(COMPLETED)
Status and phase
Completed
Phase 3
Conditions
Diabetes Mellitus, Type 2
Treatments
Drug: Comparator : ezetimibe (+) simvastatin / Duration of Treatment: 30 Weeks
Drug: MK0653, ezetimibe / Duration of Treatment: 30 Weeks
Details and patient eligibility
About
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).
Enrollment
214 patients
Sex
All
Ages
30 to 75 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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