Study to Compare the Effect of Vytorin (Simvastatin/Ezetimibe) 10/20mg Versus Atorvastatin 20mg on ApoB/ApoA1 Ratio in Subjects With Diabetes

• Status: Unknown status
• Trial end date: 2011-08-01

Summary

A single center, open label, randomized, clinical trial comparing ApoB/ApoA ratio of Vytorin 10/20mg vs atorvastatin 20mg treatment.

DM2 patients will be screened for inclusion criteria. Patients (n=66 in each arm) will be randomized to either Ezetimibe/simvastatin 10/20mg or atorvastatin 20mg after 4 week washout or TLC period. Primary and secondary endpoints will be assessed at week 12.

Primary endpoint:

1) change of ApoB/ApoA ratio at week 12.

Secondary endpoint:

1. Change of lipid parameters (TC, LDL-C, HDL-C, TG, apoB 48) at week 12.

2. Change of HbA1C at week 12.

3. Change of HOMA index at week 12

• HOMA =[Fasting insulin (mIU/L) × Fasting glucose (mmol/L)] / 22.5

4. Change of hsCRP at week 12

5. Safety assessment

Hypotheses:

• Three months treatment of Vytorin 10/20mg will be superior to atorvastatin 20mg in ApoB/ApoA ratio.

• In DM patients, Ezetimibe/Simvastatin Combination will be well-tolerated.

• Phase: Phase 4

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Atorvastatin; Atorvastatin Calcium; Ezetimibe; Ezetimibe, Simvastatin Drug Combination; Simvastatin