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

Study Overview
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Brief Summary
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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: 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 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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus Without Insulin Treatment

Intervention / Treatment
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* Drug: simvastatin/ezetimibe
* Drug: atorvastatin 20mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 DM Hypercholesterolemia (baseline screening LDL-C > 100 mg/dL) In case of medication, stable doses of oral hypoglycemic agents for at least three months HbA1c <8.5% Age: 20-80 Exclusion Criteria: Chronic renal failure: creatinine > 3.0 mg/dL Serious liver disease (> x3 LFT UNL) Congestive heart failure Stroke or MI/coronary intervention during the preceding 3 months. CK > x 2.5 UNL Unstable hypo/hyperthyroidism Pregnant/lactating woman, or woman intending to become pregnant Subject with any clinically significant condition or situation, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: simvastatin/ezetimibe (vytorin) group<br>vytorin 10/20mg po once daily for 12weeks | Drug: simvastatin/ezetimibe<br>* simvastatin/ezetimibe 10/20mg once daily for 12weeks<br>|
| Active Comparator: atorvastatin group<br>atorvastatin 20mg po once daily for 12weeks | Drug: atorvastatin 20mg<br>* atorvastatin 20mg once daily for 12weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of ApoB/ApoA1 | change of ApoB/ApoA1 | after 12 weeks' treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of lipid profile | change of total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride, and APO B48 | 12weeks | 
| change of HbA1c | change of HbA1c | 12weeks | 
| change of HOMA index | HOMA =[Fasting insulin (mIU/L) × Fasting glucose (mmol/L)] / 22.5 | 12weeks | 
| change of hsCRP | change of hsCRP | 12weeks | 
| safety | CK elevation, Liver funtion test abnormality, and muscle realted adverse reactions and symptoms | during 12weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes mellitus