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

Organon and Co214 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

214

Conditions

Diabetes Mellitus, Type 2

Interventions

MK0653, ezetimibe / Duration of Treatment: 30 WeeksDRUG

Comparator : ezetimibe (+) simvastatin / Duration of Treatment: 30 WeeksDRUG

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percent change in fasting LDL-C from baseline to the average of the Week 6/Week 12 measurements

Time frame: 6 & 12 Weeks

Secondary Outcomes

Well tolerated in patients in Diabetic patients

Time frame: 30 Weeks

Data from ClinicalTrials.gov

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