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

Dyslipidemias Clinical Trial

— ENSEMBLE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06293417
• Other study ID #: HT-EF-01
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: February 1, 2027

Study information

• Verified date: March 2024
• Source: Korea University Anam Hospital
• Contact: SIN-GON KIM
• Phone: 8229205890
• Email: k50367[@]korea.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The goal of this observational study 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3958
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2027
• Gender: All
• Age group: 19 Years and older

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Dyslipidemias
• T2DM (Type 2 Diabetes Mellitus)

Intervention

Drug:
• Statin and Ezefeno
Treatment group
• Statin doubling
Control group

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major adverse cardiovascular events and diabetic microvascular events for 48 months	major adverse cardiovascular events and diabetic microvascular events for 48 months	48month from baseline
Secondary	proportion of patients achieving Non-HDL-C less than 100mg/dL	proportion of patients achieving Non-HDL-C less than 100mg/dL	48month from baseline
Secondary	proportion of patients achieving LDL less than 70mg/dL	proportion of patients achieving LDL less than 70mg/dL	48month from baseline
Secondary	change in Non-HDL-C at 48month from baseline	change in Non-HDL-C at 48month from baseline	48month from baseline
Secondary	change in LDL at 48month from baseline	change in LDL at 48month from baseline	48month from baseline
Secondary	change in HDL-C at 48month from baseline	change in HDL-C at 48month from baseline	48month from baseline
Secondary	change in TG at 48month from baseline	change in TG at 48month from baseline	48month from baseline
Secondary	change in LDL-C/HDL-C ratio at 48month from baseline	change in LDL-C/HDL-C ratio at 48month from baseline	48month from baseline
Secondary	change in TC/HDL-C ratio at 48month from baseline	change in TC/HDL-C ratio at 48month from baseline	48month from baseline