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

Exclusion Criteria

• •1. Patients with hypersensitivity to the main ingredient (Ezetimibe or Rosuvastatin) and ingredients of IP
• •2. Pregnant and lactating women, and women and men of childbearing potential who do not agree to conduct appropriate contraception during clinical trial
• •3. Patients with Body Mass Index (BMI) \< 15 kg/ m2 or \> 35 kg/m2
• •4. 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
• •5. 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
• •6. 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
• •7. Those who are expected to administer contraindication drugs during clinical trial, including screening
• •8. 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
• •9. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorptioin
• •10. Those who received other IPs or investigational medical devices within 30 days at screening
• •11. Patients judged to be ineligible to participate in clinical trial by investigator's decision