Study to Compare the Effect of Vytorin (Simvastatin/Ezetimibe) 10/20mg Versus Atorvastatin 20mg on ApoB/ApoA1 Ratio in Subjects With Diabetes
Recruitment status was: Not yet recruiting
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.
1) change of ApoB/ApoA ratio at week 12.
- Change of lipid parameters (TC, LDL-C, HDL-C, TG, apoB 48) at week 12.
- Change of HbA1C at week 12.
Change of HOMA index at week 12
- HOMA =[Fasting insulin (mIU/L) × Fasting glucose (mmol/L)] / 22.5
- Change of hsCRP at week 12
- Safety assessment
- 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.
Type 2 Diabetes Mellitus Without Insulin Treatment
Drug: atorvastatin 20mg
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single Center, Open Label, Randomized Study to Compare the Effect of Vytorin (Simvastatin/Ezetimibe) 10/20mg Versus Atorvastatin 20mg on ApoB/ApoA1 Ratio in Subjects With Diabetes|
- change of ApoB/ApoA1 [ Time Frame: after 12 weeks' treatment ] [ Designated as safety issue: No ]change of ApoB/ApoA1
- change of lipid profile [ Time Frame: 12weeks ] [ Designated as safety issue: No ]change of total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride, and APO B48
- change of HbA1c [ Time Frame: 12weeks ] [ Designated as safety issue: No ]change of HbA1c
- change of HOMA index [ Time Frame: 12weeks ] [ Designated as safety issue: No ]HOMA =[Fasting insulin (mIU/L) × Fasting glucose (mmol/L)] / 22.5
- change of hsCRP [ Time Frame: 12weeks ] [ Designated as safety issue: No ]change of hsCRP
- safety [ Time Frame: during 12weeks of treatment ] [ Designated as safety issue: Yes ]CK elevation, Liver funtion test abnormality, and muscle realted adverse reactions and symptoms
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||August 2011|
|Estimated Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Experimental: simvastatin/ezetimibe (vytorin) group
vytorin 10/20mg po once daily for 12weeks
simvastatin/ezetimibe 10/20mg once daily for 12weeks
Active Comparator: atorvastatin group
atorvastatin 20mg po once daily for 12weeks
Drug: atorvastatin 20mg
atorvastatin 20mg once daily for 12weeks
Please refer to this study by its ClinicalTrials.gov identifier: NCT01185236
|Korea, Republic of|
|Seoul national university hospital|
|Seoul, Korea, Republic of, 110744|