Study to Compare the Effect of Vytorin (Simvastatin/Ezetimibe) 10/20mg Versus Atorvastatin 20mg on ApoB/ApoA1 Ratio in Subjects With Diabetes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01185236|
Recruitment Status : Unknown
Verified August 2010 by Seoul National University Hospital.
Recruitment status was: Not yet recruiting
First Posted : August 19, 2010
Last Update Posted : August 19, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus Without Insulin Treatment||Drug: simvastatin/ezetimibe Drug: atorvastatin 20mg||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||August 2011|
|Estimated Study Completion Date :||August 2011|
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
- change of ApoB/ApoA1 [ Time Frame: after 12 weeks' treatment ]change of ApoB/ApoA1
- change of lipid profile [ Time Frame: 12weeks ]change of total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride, and APO B48
- change of HbA1c [ Time Frame: 12weeks ]change of HbA1c
- change of HOMA index [ Time Frame: 12weeks ]HOMA =[Fasting insulin (mIU/L) × Fasting glucose (mmol/L)] / 22.5
- change of hsCRP [ Time Frame: 12weeks ]change of hsCRP
- safety [ Time Frame: during 12weeks of treatment ]CK elevation, Liver funtion test abnormality, and muscle realted adverse reactions and symptoms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01185236
|Contact: Hyun-Jae Kangemail@example.com|
|Korea, Republic of|
|Seoul national university hospital||Not yet recruiting|
|Seoul, Korea, Republic of, 110744|
|Principal Investigator: Hyun-Jae Kang|