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

The purpose of this study is to compare and evaluate the effects of LDL-C and Triglyceride (TG) control on the first dose Ezetimibe/Statin (Rosuvastatin 5 mg/Ezetimibe 10 mg) combination therapy compared to the average dose Statin (Rosuvastatin 10 mg) monotherapy in patients with Type 2 diabetes with hypertriglyceridemia (TG > 200 mg/dL).

Inclusion criteria

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

• Persons with compliance 80% or more during Suvast tablet 5 mg Run-in period and with good TLC by investigator's judgment

Exclusion criteria

• Patients with hypersensitivity to the main ingredient (Ezetimibe or Rosuvastatin) and ingredients of IP
• 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
• 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
• 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
• 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 are expected to administer contraindication drugs during clinical trial, including screening
• 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
• Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorptioin
• Those who received other IPs or investigational medical devices within 30 days at screening
• Patients judged to be ineligible to participate in clinical trial by investigator's decision