Trial record 2 of 6 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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Seoul National University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01185236
First received: August 18, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • change of ApoB/ApoA1 [ Time Frame: after 12 weeks' treatment ] [ Designated as safety issue: No ]
    change of ApoB/ApoA1


Secondary Outcome Measures:
  • change of lipid profile [ Time Frame: 12weeks ] [ Designated as safety issue: No ]
    change of total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride, and APO B48

  • change of HbA1c [ Time Frame: 12weeks ] [ Designated as safety issue: No ]
    change of HbA1c

  • change of HOMA index [ Time Frame: 12weeks ] [ Designated as safety issue: No ]
    HOMA =[Fasting insulin (mIU/L) × Fasting glucose (mmol/L)] / 22.5

  • change of hsCRP [ Time Frame: 12weeks ] [ Designated as safety issue: No ]
    change of hsCRP

  • safety [ Time Frame: during 12weeks of treatment ] [ Designated as safety issue: Yes ]
    CK elevation, Liver funtion test abnormality, and muscle realted adverse reactions and symptoms


Estimated Enrollment: 132
Study Start Date: September 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01185236

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

Locations
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.
  More Information

No publications provided by Seoul National University Hospital

Additional 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
Study First Received: August 18, 2010
Last Updated: August 18, 2010
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Diabetes mellitus

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

ClinicalTrials.gov processed this record on October 30, 2014