Overview
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
Description
A prospective, randomized, open-label, parallel, multicenter, active-drug-controlled clinical trial 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.
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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