RecruitingNot ApplicableNCT06293417

To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM

To Assess the Long-term Efficacy and Safety of Combined Therapy With Ezefeno Tab. in Patients With Dyslipidemia Who do Not Achieve Adequate Control of Non-HDL-C Levels Even With Moderate-intensity Monotherapy

Sponsor

Korea University Anam Hospital

Enrollment

3,958 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Dyslipidemias T2DM (Type 2 Diabetes Mellitus)

Summary

The goal of this Randomized controlled trials is to assess in the long term efficacy and safety of ezefeno. The primary endpoint are: * major adverse cardiovascular events within 48 months of the trial duration * microvascular events within 48 months of the trial duration

Eligibility

Min Age: 19 Years

Inclusion Criteria4

Patients with type 2 diabetes diagnosed by American Diabetes Association criteria
Age ≥ 19 years
Non-HDL-C ≥100 mg/dL, TG ≥200, \<500 mg/dL on moderate-intensity statins
with cardiovascular risk factor

Exclusion Criteria5

Pregnant or breastfeeding women
Uncontrolled hyperglycemia(more than 12.0% for Subject treated with anti-diabetic treatment.)
Patient with myopathy and rhabdomyolysis
AST/ALT more than 3 ULN
Clinical evidence of genetic disorders such as galactose intolerance, Lapp lactose deficiency, and/or glucose-galactose malabsorption