Atherosclerotic Cardiovascular Disease, Type 2 Diabetes Mellitus
Conditions
Brief summary
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
Interventions
DRUGRosuvamibe
Rosuvastatin 10mg/Ezetimibe 10mg
DRUGMonorova
Rosuvastatin 20mg
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 19 and above 2. Patient with type 2 diabetes taking oral diabetes medication for at least 3 months 3. Patient diagnosed with ASCVD * Myocardial Infarction (MI) * Acute coronary syndrome (ACS) * History of Coronary revascularization(Percutaneous Coronary Intervention, PCI) * History of Coronary artery bypass graft surgery (CABG) or other arterial revascularization procedures * Stroke or Transient ischemic attack (TIA) * Peripheral Arterial Disease (PAD) * Stable Angina 4. Written informed consent
Exclusion criteria
1. Type 1 diabetes 2. HbA1c \> 8.5% at screening 3. Fasting triglyceride ≥ 400 mg/dL at screening 4. History of muscular disease or rhabdomyolysis due to use of statin 5. Hypersensitive to rosuvastatin or ezetemibe 6. Contraindications stated in the SPC of rosuvastatin or rosuvastatin/ezetimibe including the following: ① Severe renal disease (CrCL \< 30mL/min: Cockcroft-gault formula or estimated GFR (MDRD) \< 30mL/min/1.73m2) ② ALT, AST \> 3x ULN or history of active liver disease ③ CPK \> 3x ULN 7. Those participating in clinical trials of other drugs 8. Other than the above who is deemed to be ineligible to participate in the trial by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to week 24 in LDL-C level | Baseline, Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to week 12 and week 24 in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG) | Baseline, Week 12, Week 24 |
| Change from baseline to week 12 and week 24 in high-sensitivity C-reactive protein (hs-CRP) | 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 | Baseline, Week 24 |
| Change from baseline to week 12 and week 24 in glycosylated hemoglobin (HbA1c) | Baseline, Week 12, Week 24 |
| Change from baseline to week 12 in LDL-C level | Baseline, Week 12 |
| Change from baseline to week 12 and week 24 in homeostasis model assessment for insulin resistance (HOMA-IR) | Baseline, Week 12, Week 24 |
| Proportion of subjects achieving LDL-C < 70mg/dL | Baseline, Week 12, Week 24 |
| Proportion of subjects achieving LDL-C < 55mg/dL | Baseline, Week 12, Week 24 |
| Occurrence of MACCE (Major Adverse Cardiovascular and Cerebrovascular Event) | Up to 24 weeks |
| Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG) | Baseline, Week 12, Week 24 |
Countries
South Korea
Outcome results
None listed