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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Rosuvastatin 10mg/Ezetimibe10mg qd for 24 weeks
Rosuvastatin 20mg qd for 24 weeks
Daegu Catholic University Medical Center
Daegu, South Korea
NOT_YET_RECRUITINGKeimyung University Dongsan Medical Center
Daegu, South Korea
NOT_YET_RECRUITINGKyungpook National University Hospital
Daegu, South Korea
Mean percent change from baseline to week 24 in low-density lipoprotein cholesterol (LDL-C)
Time frame: Up to 24 weeks
Proportion of subjects achieving < 7.5% 10-year ASCVD risk without withdrawn due to adverse events
Time frame: Up to 24 weeks
Mean change from baseline to week 12 and to week 24 in 10-year ASCVD risk
Time frame: 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 80mg/dL) without withdrawn due to adverse events
Time frame: 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)
Time frame: Up to 24 weeks
Mean change from baseline to week 24 in Hepatic Steatosis Index (HSI)
hepatic steatosis index (HSI)= 8x(ALT/AST ratio)+BMI (+2, if female; +2, if diabetes mellitus)
Time frame: Up to 24 weeks
Mean change from baseline to week 24 in Fatty Liver Index (FLI)
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).
Time frame: Up to 24 weeks
Mean change from baseline to week 24 in non-alcoholic fatty liver disease liver fat score (NAFLD-LFS)
Time frame: Up to 24 weeks
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Yeungnam University Medical Center
Daegu, South Korea
RECRUITINGThe Catholic University of Korea, St. Vincent's Hospital
Gyeonggi-do, South Korea
NOT_YET_RECRUITINGKorea University Anam Hospital
Seoul, South Korea
NOT_YET_RECRUITINGMean change from baseline to week 24 in HbA1c
Time frame: Up to 24 weeks
Mean change from baseline to week 24 in fasting plasma glucose (FPG)
Time frame: Up to 24 weeks
Mean change from baseline to week 24 in sCD36
Time frame: Up to 24 weeks
Mean change from baseline to week 24 in HOMA-IR
Time frame: Up to 24 weeks
Mean change from baseline to week 24 in HOMA-B
Time frame: Up to 24 weeks