None listed
Conditions
Interventions
Drug : Atobamib® tablet: once daily, orally (PO), Atorva® tablet: once daily, orally (PO)
The total study period is approximately 8 weeks from the date of enrollment, during which the planned examinat
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Individuals aged 20 to 80 years at the time of obtaining informed consent. 2)Patients with Type 2 diabetes mellitus. 3)Patients who are starting statin treatment for the first time or those who have previously used statins but have not taken any lipid-lowering drugs within the last 4 weeks. 4)Individuals with an HbA1c = 8.5% at screening. 5)Individuals with an LDL-C = 100 mg/dl and TG < 400 mg/dl at screening. 6)Individuals who have understood the purpose, content, characteristics, and risks of the clinical trial and have provided written informed consent after receiving sufficient explanation.
Exclusion criteria
Exclusion criteria: 1)Individuals with a history of muscle disease or rhabdomyolysis caused by statin use. 2)Individuals who have shown hypersensitivity to Atorvastatin or Ezetimibe. 3)Individuals with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. 4)Individuals with a history of cardiovascular disease prior to screening (unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass surgery, or coronary artery intervention). 5)Individuals who have experienced heart failure (NYHA class III or IV) or uncontrolled arrhythmia within the past 6 months prior to screening. 6)Individuals with AST or ALT levels greater than three times the upper limit of normal at screening. 7)Individuals with end-stage renal disease (those on renal replacement therapy) at screening. 8)Individuals receiving treatment for thyroid dysfunction at screening (however, patients on thyroid hormone replacement therapy who have maintained a stable dose for at least 6 weeks prior to screening are eligible). 9)Individuals with a history of gastrointestinal surgery or gastrointestinal disorders leading to impaired drug absorption. 10)Women receiving hormone replacement therapy. 11)Individuals currently receiving insulin therapy. 12)Individuals who are positive for HBV, HCV, or HIV and are undergoing treatment at screening. 13)Individuals who have been treated with or are currently using, or are expected to use, the following medications within 4 weeks prior to screening: ?Drugs that affect the metabolism of statins through cytochrome P450 CYP3A4 isoenzyme: Amiodarone, verapamil, azole antifungals, cyclosporine, macrolide antibiotics, nefazodone, protease inhibitors. ?Drugs that affect lipid metabolism: Fibrates, bile acid sequestrants, niacin, probucol. Oral corticosteroids. ?Glecaprevir and pibrentasvir. 14)Individuals with a history of malignant tumors (except for those with no disease for 5 years or those whose only past malignancy was basal or squamous cell carcinoma of the skin). 15)Individuals who have taken any investigational drug within 30 days prior to screening. 16)Pregnant or breastfeeding women: Women of childbearing potential must have a negative pregnancy test at screening, and during the clinical trial, must use an effective method of contraception (including those medically unable to become pregnant). 17)Individuals unable to read the informed consent (e.g., illiterate, non-Korean nationals): Illiterate individuals may enroll if accompanied by a witness, and foreign nationals who understand Korean and can read Hangul are eligible. 18)Individuals with significant or unstable medical or psychological conditions that, in the investigator's judgment, may compromise safety or successful participation in the trial. 19)Any other individuals deemed by the investigator to be unsuitable for participation in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A percentage change in LDL cholesterol level from baseline to an 8-week follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of LDL cholesterol reduced by 30% or 50% (respectively) at Week 8 of investigational drug administration compared to before administration;The proportion reaching the target values suggested in domestic and international lipid-related clinical guidelines in lipid test results at Week 8 of investigational drug administration compared to before administration;Change from before investigational drug administration to Week 8 in the following indicators: Lipid variables (TC, Non-HDL cholesterol, triglyceride, HDL cholesterol, Apo B, Apo A1, Apo B/A1 ratio) | — |
Countries
Korea, Republic of
Contacts
Public ContactWooJe Lee
Asan Medical Center
Outcome results
None listed