Rosuvamibe contre Rosuvastatine pour les patients atteints de diabète de type 2 à haut risque d'ASCVD

Date de début de l'étude : 27 mars 2018

* ≥ 40 and \< 75 years of age at the time of informed consent * Estimated 10-year ASCVD (atherosclerotic cardiovascular disease) risk ≥ 7.5% with type 2 diabetes according to the American Diabetes Association criteria in screening * HbA1c ≥ 6% and \< 10% in screening * Body mass index (BMI) ≤ 35kg/m2 in screening * Female of childbearing with a negative pregnancy test who must agree to use contraception (including those not medically pregnant) during the study period * Written consent after being informed of the purpose and contents of the clinical trial and the characteristics and risks of IPs Exclusion Criteria: * Type 1 diabetes * Chronic hepatitis B or chronic hepatitis C, severe hepatic dysfunction (AST, ALT, ALP or CPK ≥ 3 x ULN) in screening * Heavy drinking \> 210g per week in screening * Estimated GFR \< 30mL/min/1.73m2 using the CKD-EPI formula in screening * Undergoing renal replacement therapy (hemodialysis or peritoneal dialysis) in screening * Having used other statin (HMG-CoA converting enzyme inhibitors) than Rosuvastatin or fibrate drugs in the last 3 months before screening * Taking any medication (ex. Fenofibrate, Omega 3 fatty acid, etc.) that may affect LDL \* Can be enrolled after 4 week-washout * Having used thiazolidinedione drugs in the last 3 months before screening * Taking cyclosporine concomitantly * Positive HIV test in screening * Pregnant, breastfeeding, or childbearing women who are not likely to use the appropriate contraceptive methods as judged by investigator * Subjects with a medical history of myopathy and rhabdomyolysis due to use of statin * Hypersensitive to statin and ezetimibe * Having endocrine or metabolic disease known to affect serum lipids or lipoproteins * Uncontrolled diabetes (HbA1c ≥ 10%) * Uncontrolled thyroid dysfunction (TSH ≥ 3 x ULN) * Subjects with a medical history of acute arterial diseases such as unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft or percutaneous coronary intervention in the last 6 months before screening * Subjects with a surgical history of gastrointestine or drug absorption disorders due to gastrointestinal disorders * Insulin-treated * Taking other IPs in the last 30 days before screening * Subjects who cannot discontinue contraindications that may affect the treatment of all types of diabetes and/or hypercholesterolemia during the study period * Subjects with a significant or unstable medical or psychological condition that is judged by investigator to be detrimental to safety or to successful participation in the trial * Other conditions than the above who is deemed to be ineligible to participate in the trial by investigator