Clinical trial NCT01185236: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus Without Insulin Treatment
Keywords: Diabetes mellitus
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2010-08-19
Enrollment: 132
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: change of ApoB/ApoA1
timeFrame: after 12 weeks' treatment
Secondary outcomes:
measure: change of lipid profile
timeFrame: 12weeks
measure: change of HbA1c
timeFrame: 12weeks
measure: change of HOMA index
timeFrame: 12weeks
measure: change of hsCRP
timeFrame: 12weeks
measure: safety
timeFrame: during 12weeks of treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
References:
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.