Study Evaluating the Efficacy and Safety of Simvastatin Alone Compared With Simvastatin Plus Ezetimibe in Type 2 Diabetic Patients
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: MK0653, ezetimibe / Duration of Treatment: 30 Weeks (Drug); Comparator : ezetimibe (+) simvastatin / Duration of Treatment: 30 Weeks (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
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).
Clinical Details
Official title: A Randomized, Double-Blind, Parallel, Multicenter Study to Evaluate the Efficacy and Safety of Simvastatin Monotherapy Compared With Simvastatin Plus Ezetimibe (SCH 58235) in Type 2 Diabetic Patients Treated With Thiazolidinediones
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Percent change in fasting LDL-C from baseline to the average of the Week 6/Week 12 measurements
Secondary outcome: Well tolerated in patients in Diabetic patients
Eligibility
Minimum age: 30 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Related publications: Gaudiani LM, Lewin A, Meneghini L, Perevozskaya I, Plotkin D, Mitchel Y, Shah S. Efficacy and safety of ezetimibe co-administered with simvastatin in thiazolidinedione-treated type 2 diabetic patients. Diabetes Obes Metab. 2005 Jan;7(1):88-97.
Starting date: December 2001
Last updated: November 28, 2007
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