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

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Jan 6, 2021

Keywords

ClinConnect Summary

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).

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Screening (Visit 1) Inclusion Criteria
• • 1. Korean men and women aged 40 to 75
• • 2. Patients who have been diagnosed with type 2 diabetes based on clinical judgment and satisfy diabetes diagnosis criteria
• • 3. 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
• • 4. Those with less than 9% HbA1C
• • 5. 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
• 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