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

Phase 4

• Conditions: Type 2 Diabetes Mellitus Without Insulin Treatment
• Interventions: Drug: simvastatin/ezetimibe; Drug: atorvastatin 20mg

• Registration Number: NCT01185236
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-08
• Study First Submitted: 2010-08-18
• Study First Submitted QC: 2010-08-18
• Last Update Submitted: 2010-08-18
• Study First Posted: 2010-08-19
• Last Update Posted: 2010-08-19
• Study Start: 2010-09
• Primary Completion: 2011-08
• Study Completion: 2011-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
simvastatin/ezetimibe (vytorin) group	simvastatin/ezetimibe	vytorin 10/20mg po once daily for 12weeks
atorvastatin group	atorvastatin 20mg	atorvastatin 20mg po once daily for 12weeks

Primary Outcome Measures

Name	Time	Method
change of ApoB/ApoA1	after 12 weeks' treatment	change of ApoB/ApoA1

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul national university hospital; 🇰🇷 Seoul, Korea, Republic of