This study will evaluate the efficacy and aafety of rosuvastatin/ezetimibe combination therapy vs. rosuvastatin monotherapy in atherosclerotic cardiovascular disease patients with type 2 diabetes mellitus
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
236
Rosuvastatin 10mg/Ezetimibe 10mg
Rosuvastatin 20mg
Kangbuk Samsung Hospital
Seoul, South Korea
Change from baseline to week 24 in LDL-C level
Time frame: Baseline, Week 24
Change from baseline to week 12 in LDL-C level
Time frame: Baseline, Week 12
Change from baseline to week 12 and week 24 in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG)
Time frame: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in high-sensitivity C-reactive protein (hs-CRP)
Time frame: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in Apolipoprotein A1, Apolipoprotein B, Apolipoprotein B48, and Apolipoprotein B/Apolipoprotein A1
Time frame: Baseline, Week 24
Change from baseline to week 12 and week 24 in glycosylated hemoglobin (HbA1c)
Time frame: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG)
Time frame: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in homeostasis model assessment for insulin resistance (HOMA-IR)
Time frame: Baseline, Week 12, Week 24
Proportion of subjects achieving LDL-C < 70mg/dL
Time frame: Baseline, Week 12, Week 24
Proportion of subjects achieving LDL-C < 55mg/dL
Time frame: Baseline, Week 12, Week 24
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Occurrence of MACCE (Major Adverse Cardiovascular and Cerebrovascular Event)
Time frame: Up to 24 weeks