This is a randomized controlled study to assess the effect of atorvastatin and omega 3 combination therapy compared with atorvastatin and ezetimibe combination therapy in Korean T2DM patients with asymptomatic atherosclerosis.
Type 2 diabetes under treatment with HbA1c 6.0-10.0% at screening visit
Male or female of 20 years or over
Mixed dyslipidemia under moderate-intensity statin: triglyceride ≥200 mg/dL, HDL-cholesterol ≤50 mg/dL, LDL-cholesterol ≥100 mg/dL
moderate-intensity statin: atorvastatin 10-20mg, rosuvastatin 5mg, simvastatin 20-40mg, pravastatin 40-80mg, lovastatin 40mg, fluvastatin XL 80mg, fluvastatin 40mg bid, pitavastatin 2-4mg
Dyslipidemia which requires other therapy: triglyceride ≥500 mg/dL or LDL-cholesterol ≥190 mg/dL
Uncontrolled hypertension: SBP >180 mmHg or DBP >110 mmHg
Severe renal dysfunction: eGFR <30 mL/min/1.73m2
AST/ALT >120/120 or chronic liver disease
Seoul National University Bundang Hospital
Lead sponsor
Korea United Pharm. Inc.
Collaborator