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
Overview
- Phase
- Not Applicable
- Intervention
- Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Sponsor
- Korea University Anam Hospital
- Enrollment
- 3958
- Locations
- 1
- Primary Endpoint
- major adverse cardiovascular events and diabetic microvascular events for 48 months
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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
Detailed 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.
Investigators
Sin Gon Kim
professor
Korea University Anam Hospital
Eligibility Criteria
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
Arms & Interventions
Treatment group
Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin
Intervention: Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin
Control group
Dose escalation of moderate-intensity statin
Intervention: Dose escalation of moderate-intensity statin
Outcomes
Primary Outcomes
major adverse cardiovascular events and diabetic microvascular events for 48 months
Time Frame: 48month from baseline
major adverse cardiovascular events and diabetic microvascular events for 48 months
Secondary Outcomes
- proportion of patients achieving Non-HDL-C less than 100mg/dL(48month from baseline)
- proportion of patients achieving LDL less than 70mg/dL(48month from baseline)
- change in Non-HDL-C at 48month from baseline(48month from baseline)
- change in LDL at 48month from baseline(48month from baseline)
- change in HDL-C at 48month from baseline(48month from baseline)
- change in TG at 48month from baseline(48month from baseline)
- change in LDL-C/HDL-C ratio at 48month from baseline(48month from baseline)
- change in TC/HDL-C ratio at 48month from baseline(48month from baseline)