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

Condition(s) targeted: Type 2 Diabetes Mellitus Without Insulin Treatment

Intervention: simvastatin/ezetimibe (Drug); atorvastatin 20mg (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Seoul National University Hospital

Overall contact:
Hyun-Jae Kang, Phone: 82-2-2072-2279, Email: nowkang@snu.ac.kr

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.

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: change of ApoB/ApoA1

Secondary outcome:

change of lipid profile

change of HbA1c

change of HOMA index

change of hsCRP

safety

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Type 2 DM

2. Hypercholesterolemia (baseline screening LDL-C > 100 mg/dL)

3. In case of medication, stable doses of oral hypoglycemic agents for at least three months

4. HbA1c <8. 5%

5. Age: 20-80

Exclusion Criteria:

1. Chronic renal failure: creatinine > 3. 0 mg/dL

2. Serious liver disease (> x3 LFT UNL)

3. Congestive heart failure

4. Stroke or MI/coronary intervention during the preceding 3 months.

5. CK > x 2. 5 UNL

6. Unstable hypo/hyperthyroidism

7. Pregnant/lactating woman, or woman intending to become pregnant

8. 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.

Hyun-Jae Kang, Phone: 82-2-2072-2279, Email: nowkang@snu.ac.kr

Seoul national university hospital, Seoul 110744, Korea, Republic of; Not yet recruiting
Hyun-Jae Kang, Principal Investigator

Starting date: September 2010
Last updated: August 18, 2010