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

Primary Purpose

Type 2 Diabetes Mellitus Without Insulin Treatment

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

simvastatin/ezetimibe

atorvastatin 20mg

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus Without Insulin Treatment focused on measuring Diabetes mellitus

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Seoul national university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

simvastatin/ezetimibe (vytorin) group

atorvastatin group

Arm Description

vytorin 10/20mg po once daily for 12weeks

atorvastatin 20mg po once daily for 12weeks

Outcomes

Primary Outcome Measures

change of ApoB/ApoA1

Secondary Outcome Measures

change of lipid profile

change of total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride, and APO B48

change of HbA1c

change of HOMA index

HOMA =[Fasting insulin (mIU/L) × Fasting glucose (mmol/L)] / 22.5

change of hsCRP

safety

CK elevation, Liver funtion test abnormality, and muscle realted adverse reactions and symptoms

Full Information

NCT ID

NCT01185236

First Posted

August 18, 2010

Last Updated

August 18, 2010

Sponsor

Seoul National University Hospital

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT01185236

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Unknown status

Study Start Date

September 2010 (undefined)

Primary Completion Date

August 2011 (Anticipated)

Study Completion Date

August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Seoul National University Hospital

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus Without Insulin Treatment

Keywords

Diabetes mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

simvastatin/ezetimibe (vytorin) group

Arm Type

Experimental

Arm Description

vytorin 10/20mg po once daily for 12weeks

Arm Title

atorvastatin group

Arm Type

Active Comparator

Arm Description

atorvastatin 20mg po once daily for 12weeks

Intervention Type

Drug

Intervention Name(s)

simvastatin/ezetimibe

Intervention Description

simvastatin/ezetimibe 10/20mg once daily for 12weeks

Intervention Type

Drug

Intervention Name(s)

atorvastatin 20mg

Intervention Description

atorvastatin 20mg once daily for 12weeks

Primary Outcome Measure Information:

Title

change of ApoB/ApoA1

Description

change of ApoB/ApoA1

Time Frame

after 12 weeks' treatment

Secondary Outcome Measure Information:

Title

change of lipid profile

Description

change of total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride, and APO B48

Time Frame

12weeks

Title

change of HbA1c

Description

change of HbA1c

Time Frame

12weeks

Title

change of HOMA index

Description

HOMA =[Fasting insulin (mIU/L) × Fasting glucose (mmol/L)] / 22.5

Time Frame

12weeks

Title

change of hsCRP

Description

change of hsCRP

Time Frame

12weeks

Title

safety

Description

CK elevation, Liver funtion test abnormality, and muscle realted adverse reactions and symptoms

Time Frame

during 12weeks of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hyun-Jae Kang

Phone

82-2-2072-2279

nowkang@snu.ac.kr

Facility Information:

Facility Name

Seoul national university hospital

City

Seoul

ZIP/Postal Code

110744

Country

Korea, Republic of

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hyun-Jae Kang

12. IPD Sharing Statement

Citations:

PubMed Identifier

23728830

Citation

Lee JH, Kang HJ, Kim HS, Sohn DW, Oh BH, Park YB. Effects of ezetimibe/simvastatin 10/20 mg vs. atorvastatin 20 mg on apolipoprotein B/apolipoprotein A1 in Korean patients with type 2 diabetes mellitus: results of a randomized controlled trial. Am J Cardiovasc Drugs. 2013 Oct;13(5):343-51. doi: 10.1007/s40256-013-0031-6.

Results Reference

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

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