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

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: Type 2 Diabetes Mellitus Without Insulin Treatment

Treatments: Drug: simvastatin/ezetimibe; Drug: atorvastatin 20mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01185236

H-1007-100-324

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

simvastatin/ezetimibe (vytorin) group

Experimental group

Description:

vytorin 10/20mg po once daily for 12weeks

Treatment:

Drug: simvastatin/ezetimibe

atorvastatin group

Active Comparator group

Description:

atorvastatin 20mg po once daily for 12weeks

Treatment:

Drug: atorvastatin 20mg