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

Korea University Anam Hospital3,958 enrolled

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

3,958

Conditions

T2DM (Type 2 Diabetes Mellitus)Dyslipidemias

Interventions

Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statinDRUG

Treatment group

Dose escalation of moderate-intensity statinDRUG

Control group

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Korea University Anam Hospital

Seoul, South Korea

RECRUITING