high-intensity rosuvastatin vs. moderate-intensity rosuvastatin/ezetimibe in high atherosclerotic cardiovascular disease risk patients with type 2 diabetes

Conditions: Atherosclerotic Cardiovascular Disease; Type 2 Diabetes

Summary: to assess the efficacy and safety of moderate-intensity rosuvastatin/ezetimibe compared to high-intensity rosuvastatin in high atherosclerotic cardiovascular disease risk patients with type 2 diabetes

this study is to assess the efficacy and safety of rosuvamibe® (rosuvastatin 10mg/ezetimibe 10mg) vs. rosuvastatin 20mg treated for 24 weeks in atherosclerotic cardiovascular disease risk (≥ 7.5%) patients with type 2 diabetes

Eligibility criteria:
* ≥ 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

Keywords: high ascvd risk patients with type 2 diabetes