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Trial record 2 of 2 for:    vytorin and type 1 diabetes

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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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
Merck Sharp & Dohme Corp.
Information provided by:
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


  • 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Without Insulin Treatment Drug: simvastatin/ezetimibe Drug: atorvastatin 20mg Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2010
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : August 2011

Arm Intervention/treatment
Experimental: simvastatin/ezetimibe (vytorin) group
vytorin 10/20mg po once daily for 12weeks
Drug: simvastatin/ezetimibe
simvastatin/ezetimibe 10/20mg once daily for 12weeks
Active Comparator: atorvastatin group
atorvastatin 20mg po once daily for 12weeks
Drug: atorvastatin 20mg
atorvastatin 20mg once daily for 12weeks

Primary Outcome Measures :
  1. change of ApoB/ApoA1 [ Time Frame: after 12 weeks' treatment ]
    change of ApoB/ApoA1

Secondary Outcome Measures :
  1. change of lipid profile [ Time Frame: 12weeks ]
    change of total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride, and APO B48

  2. change of HbA1c [ Time Frame: 12weeks ]
    change of HbA1c

  3. change of HOMA index [ Time Frame: 12weeks ]
    HOMA =[Fasting insulin (mIU/L) × Fasting glucose (mmol/L)] / 22.5

  4. change of hsCRP [ Time Frame: 12weeks ]
    change of hsCRP

  5. safety [ Time Frame: during 12weeks of treatment ]
    CK elevation, Liver funtion test abnormality, and muscle realted adverse reactions and symptoms

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01185236

Contact: Hyun-Jae Kang 82-2-2072-2279 nowkang@snu.ac.kr

Korea, Republic of
Seoul national university hospital Not yet recruiting
Seoul, Korea, Republic of, 110744
Principal Investigator: Hyun-Jae Kang         
Sponsors and Collaborators
Seoul National University Hospital
Merck Sharp & Dohme Corp.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hyun-Jae Kang, Associate professor, Seoul ntional university hospital
ClinicalTrials.gov Identifier: NCT01185236     History of Changes
Other Study ID Numbers: H-1007-100-324
First Posted: August 19, 2010    Key Record Dates
Last Update Posted: August 19, 2010
Last Verified: August 2010

Keywords provided by Seoul National University Hospital:
Diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Atorvastatin Calcium
Ezetimibe, Simvastatin Drug Combination
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors