To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM
Not Applicable
Recruiting
- Conditions
- T2DM (Type 2 Diabetes Mellitus)Dyslipidemias
- Registration Number
- NCT06293417
- Lead Sponsor
- Korea University Anam Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 3958
Inclusion Criteria
Inclusion Criteria:<br><br> - Patients with type 2 diabetes diagnosed by American Diabetes Association criteria<br><br> - Age = 19 years<br><br> - Non-HDL-C =100 mg/dL, TG =200, <500 mg/dL on moderate-intensity statins<br><br> - with cardiovascular risk factor<br><br>Exclusion Criteria:<br><br> - Pregnant or breastfeeding women<br><br> - Uncontrolled hyperglycemia(more than 12.0% for Subject treated with anti-diabetic<br> treatment.)<br><br> - Patient with myopathy and rhabdomyolysis<br><br> - AST/ALT more than 3 ULN<br><br> - Clinical evidence of genetic disorders such as galactose intolerance, Lapp lactose<br> deficiency, and/or glucose-galactose malabsorption
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method major adverse cardiovascular events and diabetic microvascular events for 48 months
- Secondary Outcome Measures
Name Time Method proportion of patients achieving Non-HDL-C less than 100mg/dL;proportion of patients achieving LDL less than 70mg/dL;change in Non-HDL-C at 48month from baseline;change in LDL at 48month from baseline;change in HDL-C at 48month from baseline;change in TG at 48month from baseline;change in LDL-C/HDL-C ratio at 48month from baseline;change in TC/HDL-C ratio at 48month from baseline