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

Not Applicable

Recruiting

• Conditions: T2DM (Type 2 Diabetes Mellitus); Dyslipidemias
• Interventions: Drug: Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin; Drug: Dose escalation of moderate-intensity statin

• Registration Number: NCT06293417
• Lead Sponsor: Korea University Anam Hospital

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.

Study Timeline

• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-02-27
• Study Start: 2024-03-01
• Study First Posted: 2024-03-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-25
• Last Update Posted: 2024-08-27
• Primary Completion: 2027-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3958

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin	Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin
Control group	Dose escalation of moderate-intensity statin	Dose escalation of moderate-intensity statin

Primary Outcome Measures

Name	Time	Method
major adverse cardiovascular events and diabetic microvascular events for 48 months	48month from baseline	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	48month from baseline	proportion of patients achieving Non-HDL-C less than 100mg/dL
proportion of patients achieving LDL less than 70mg/dL	48month from baseline	proportion of patients achieving LDL less than 70mg/dL
change in Non-HDL-C at 48month from baseline	48month from baseline	change in Non-HDL-C at 48month from baseline
change in LDL at 48month from baseline	48month from baseline	change in LDL at 48month from baseline
change in HDL-C at 48month from baseline	48month from baseline	change in HDL-C at 48month from baseline
change in TG at 48month from baseline	48month from baseline	change in TG at 48month from baseline
change in LDL-C/HDL-C ratio at 48month from baseline	48month from baseline	change in LDL-C/HDL-C ratio at 48month from baseline
change in TC/HDL-C ratio at 48month from baseline	48month from baseline	change in TC/HDL-C ratio at 48month from baseline

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of