Efficacy and Safety of EzetimiBe/Rosuvastatin in Diabetic Dislipidemia With Hypertriglyceridaemia

Prior treatment

• Those who are expected to administer contraindication drugs during clinical trial, including screening
• Those who received other IPs or investigational medical devices within 30 days at screening

Other illness

• Patients with hypersensitivity to the main ingredient (Ezetimibe or Rosuvastatin) and ingredients of IP
• Persons with the following medical history or surgical/interventional history
  • Atherosclerotic disease occurring within 24 weeks at screening
  • Myopathy including rhabdomyolysis
  • Patients who have had a history of drug or alcohol abuse, or who have met drug or alcohol abuse criteria within 1 year at screening
  • Major mental illness (depression, bipolar disorder, etc.)
  • Malignant tumor within 5 years at screening
• Those who have the following history of drug administration within 3 months at screening
  • Non-statin lipid modulators
  • Foods or drugs that affect lipid control
  • Systemic steroids
• Those who have persistent history of drinking within 1 week at clinical trial participation or who are unable to perform TLC due to continuous drinking during clinical trial

Lab values

• Persons with the following comorbidities and laboratory abnormalities
  • CK ≥ 2 X ULN
  • Patients with severe hepatopathy (AST or ALT \> 5 X ULN)
  • Patients with unexplained persistent ALT elevation opinion or active liver disease
  • TSH (Thyroid stimulating hormone) \> 1.5 X ULN or those who do not maintain stable thyroid stimulating hormone level by investigator's judgment
  • Uncontrolled hypertension (greater than sitBP 160/100 mmHg at screening)
  • Renal disorder patients with severe renal failure (creatinine clearance (CLcr)\<30 mL/min
• Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorptioin

Other

• Pregnant and lactating women, and women and men of childbearing potential who do not agree to conduct appropriate contraception during clinical trial
• Patients with Body Mass Index (BMI) \< 15 kg/ m2 or \> 35 kg/m2
• Patients judged to be ineligible to participate in clinical trial by investigator's decision

• Screening (Visit 1) Inclusion Criteria
• Korean men and women aged 40 to 75
• Patients who have been diagnosed with type 2 diabetes based on clinical judgment and satisfy diabetes diagnosis criteria
• Who have the following laboratory values on an empty stomach
  • Patients with no prior statin therapy
  • Low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL (measured directly or calculated; calculated LDL-C is applicable only when triglyceride levels are \< 400 mg/dL)
  • 200 mg/dL ≤ Triglyceride (TG) ≤ 499 mg/dL
  • Patients currently receiving low- or moderate-intensity statin therapy
  • Low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL (measured directly or calculated; calculated LDL-C is applicable only when triglyceride levels are \< 400 mg/dL)
  • 200 mg/dL ≤ Triglyceride (TG) ≤ 499 mg/dL
• Those with less than 9% HbA1C
• Those who voluntarily agreed to participate in this clinical trial and signed a written ICF
  • Randomization (Visit 2) Inclusion Criteria
  • 1\) Persons with compliance 80% or more during Suvast tablet 5 mg Run-in period and with good TLC by investigator's judgment