None listed
Conditions
Interventions
Drug : 1) Drugs
? Drug for Run-in: Suvast tablet 5 mg (Rosuvastatin)
? IP
- Test drug: Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)
- Control drug: Suvast tablet 10 mg (Rosuvastatin 10 m
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion 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
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) 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 of 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL-C change rate (%);Triglyceride (TG) change rate (%) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change rates (%) of LDL-C and Triglyceride (TG);Changes (mg/dL) of Total cholesterol (TC), Triglyceride (TG), HDL-C, and non-HDL-C;Percentage (%) of subjects with a 50% or more reduction in LDL-C level;Percentage (%) of subjects with LDL-C below 70 mg/dL;Changes of lipoproteins (ApoA1 (mg/dL), ApoB (mg/dL), ApoB/ApoA1 Ratio);Change of HOMA-IR;Change of HbA1C (%);Change (mg/dL) of Fasting Plasma Glucose (FPG);Change (mg/dL) of hs-CRP;Changes of plasma triglyceride (mg/dL), ApoB100 (mg/dL), and ApoB48 (mg/dL) levels at 30-minute, 1-, 2-, 3-, 4-, 5-, and 6-hour before and after FMC in subjects who perform FMC;On the graphs at 30-minute, 1-, 2-, 3-, 4-, 5-, and 6-hour before and after FMC in subjects who perform FMC, total Area Under the Curve (tAUC) of each plasma triglyceride (mg/dL), ApoB100 (mg/dL), and ApoB48 (mg/dL);Adverse event, laboratory tests, vital signs (blood pressure, pulse rate);Electrocardiogram (12-lead ECG) | — |
Countries
Korea, Republic of
Contacts
Public ContactInsuk Ha
Seoul National University Hospital
Outcome results
None listed