Type 2 Diabetes Mellitus Without Insulin Treatment
Conditions
Keywords
Diabetes mellitus
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.
Interventions
DRUGatorvastatin 20mg
atorvastatin 20mg once daily for 12weeks
simvastatin/ezetimibe 10/20mg once daily for 12weeks
Sponsors
Merck Sharp & Dohme LLC
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of ApoB/ApoA1 | after 12 weeks' treatment | change of ApoB/ApoA1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of lipid profile | 12weeks | change of total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride, and APO B48 |
| change of HbA1c | 12weeks | change of HbA1c |
| change of HOMA index | 12weeks | HOMA =\[Fasting insulin (mIU/L) × Fasting glucose (mmol/L)\] / 22.5 |
| change of hsCRP | 12weeks | change of hsCRP |
| safety | during 12weeks of treatment | CK elevation, Liver funtion test abnormality, and muscle realted adverse reactions and symptoms |
Countries
South Korea
Contacts
Primary ContactHyun-Jae Kang
Outcome results
None listed