Atherosclerotic Cardiovascular Disease, Type 2 Diabetes
Conditions
Keywords
High ASCVD risk patients with type 2 diabetes
Brief 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
Detailed description
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
Interventions
DRUGRosuvamibe
Rosuvastatin 10mg/Ezetimibe10mg qd for 24 weeks
DRUGMonorova
Rosuvastatin 20mg qd for 24 weeks
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 74 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percent change from baseline to week 24 in low-density lipoprotein cholesterol (LDL-C) | Up to 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline to week 12 and to week 24 in 10-year ASCVD risk | Up to 12 weeks, Up to 24 weeks | — |
| Proportion of subjects achieving the comprehensive lipid target (LDL-C < 70mg/dL, Non-HDL-C < 100mg/dL, and Apolipoprotein B < 80mg/dL) without withdrawn due to adverse events | Up to 24 weeks | — |
| Mean change from baseline to week 24 in calculated LDL cholesterol(mg/dL), HDL cholesterol(mg/dL), Triglyceride(mg/dL), non-HDL cholesterol(mg/dL), Apolipoprotein B(mg/dL), Apolipoprotein A1(mg/dL) | Up to 24 weeks | — |
| Mean change from baseline to week 24 in Hepatic Steatosis Index (HSI) | Up to 24 weeks | hepatic steatosis index (HSI)= 8x(ALT/AST ratio)+BMI (+2, if female; +2, if diabetes mellitus) |
| Mean change from baseline to week 24 in Fatty Liver Index (FLI) | Up to 24 weeks | FLI scores will be calculated based on triglycerides, BMI, r-GT and Waist circumference. BMI(kg/m\^2) will be calculated based on height(m) and weight(kg). |
| Proportion of subjects achieving < 7.5% 10-year ASCVD risk without withdrawn due to adverse events | Up to 24 weeks | — |
| Mean change from baseline to week 24 in HbA1c | Up to 24 weeks | — |
| Mean change from baseline to week 24 in fasting plasma glucose (FPG) | Up to 24 weeks | — |
| Mean change from baseline to week 24 in sCD36 | Up to 24 weeks | — |
| Mean change from baseline to week 24 in HOMA-IR | Up to 24 weeks | — |
| Mean change from baseline to week 24 in HOMA-B | Up to 24 weeks | — |
| Mean change from baseline to week 24 in non-alcoholic fatty liver disease liver fat score (NAFLD-LFS) | Up to 24 weeks | — |
Countries
South Korea
Outcome results
None listed