To assess the efficacy and safety of rosuvastatin/ezetimibe combination therapy compared to rosuvastatin monotherapy in Korean patients with type 2 diabetes mellitus and hypercholesterolemia
This study is to assess the efficacy and safety of Rosuvamibe® (rosuvastatin 5mg/ezetimibe 10mg) vs Monorova® (rosuvastatin 10mg) treated for 8 weeks in Korean patients with type 2 diabetes mellitus and hypercholesterolemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Rosuvastatin 5mg/ezetimibe 10mg qd for 8 weeks
Rosuvastatin 10mg qd for 8 weeks
Asan Medical Center
Kora-ri, South Korea
Asan Medical Center
Seoul, South Korea
Change from baseline to week 8 in ApoB/ApoA1 ratio
Time frame: Baseline, Week 8
Proportion of over 50% reduction in LDL-C
Time frame: Baseline, Week 8
Proportion of subjects achieving the comprehensive lipid target (LDL-C<70mg/dL, Non-HDL-C<100mg/dL, and ApoB<80mg/dL)
Time frame: Baseline, Week 8
Change from baseline to week 8 in total, non-HDL, LDL and HDL cholesterol, triglyceride, ApoB, ApoA1 and ApoB48
Time frame: Baseline, Week 8
Change from baseline to week 8 in HOMA-IR
Time frame: Baseline, Week 8
Change from baseline to week 8 in hs-CRP
Time frame: Baseline, Week 8
Change from baseline to week 8 in HbA1C
Time frame: Baseline, Week 8
Change from baseline to week 8 in FPG
Time frame: Baseline, Week 8
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