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

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.

Timeline

Start

2010-09

Primary completion

2011-08

Completion

2011-08

Publications

• Lee JH, Kang HJ, Kim HS, Sohn DW, Oh BH, Park YB. Effects of ezetimibe/simvastatin 10/20 mg vs. atorvastatin 20 mg on apolipoprotein B/apolipoprotein A1 in Korean patients with type 2 diabetes mellitus: results of a randomized controlled trial. Am J Cardiovasc Drugs. 2013 Oct;13(5):343-51. doi: 10.1007/s40256-013-0031-6.

Drugs

Indications