ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01185236
Recruitment Status : Unknown
Verified August 2010 by Seoul National University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 19, 2010
Last Update Posted : August 19, 2010
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Seoul National University Hospital

August 18, 2010
August 19, 2010
August 19, 2010
September 2010
August 2011   (Final data collection date for primary outcome measure)
change of ApoB/ApoA1 [ Time Frame: after 12 weeks' treatment ]
change of ApoB/ApoA1
Same as current
No Changes Posted
  • change of lipid profile [ Time Frame: 12weeks ]
    change of total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride, and APO B48
  • change of HbA1c [ Time Frame: 12weeks ]
    change of HbA1c
  • change of HOMA index [ Time Frame: 12weeks ]
    HOMA =[Fasting insulin (mIU/L) × Fasting glucose (mmol/L)] / 22.5
  • change of hsCRP [ Time Frame: 12weeks ]
    change of hsCRP
  • safety [ Time Frame: during 12weeks of treatment ]
    CK elevation, Liver funtion test abnormality, and muscle realted adverse reactions and symptoms
Same as current
Not Provided
Not Provided
 
Study to Compare the Effect of Vytorin (Simvastatin/Ezetimibe) 10/20mg Versus Atorvastatin 20mg on ApoB/ApoA1 Ratio in Subjects With Diabetes
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

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus Without Insulin Treatment
  • Drug: simvastatin/ezetimibe
    simvastatin/ezetimibe 10/20mg once daily for 12weeks
  • Drug: atorvastatin 20mg
    atorvastatin 20mg once daily for 12weeks
  • Experimental: simvastatin/ezetimibe (vytorin) group
    vytorin 10/20mg po once daily for 12weeks
    Intervention: Drug: simvastatin/ezetimibe
  • Active Comparator: atorvastatin group
    atorvastatin 20mg po once daily for 12weeks
    Intervention: Drug: atorvastatin 20mg
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
132
Same as current
August 2011
August 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01185236
H-1007-100-324
Yes
Not Provided
Not Provided
Hyun-Jae Kang, Associate professor, Seoul ntional university hospital
Seoul National University Hospital
Merck Sharp & Dohme Corp.
Not Provided
Seoul National University Hospital
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP