Diabetes Mellitus, Type 2
Conditions
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).
Interventions
DRUGMK0653, ezetimibe / Duration of Treatment: 30 Weeks
DRUGComparator : ezetimibe (+) simvastatin / Duration of Treatment: 30 Weeks
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in fasting LDL-C from baseline to the average of the Week 6/Week 12 measurements | 6 & 12 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Well tolerated in patients in Diabetic patients | 30 Weeks |
Outcome results
None listed