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

RECRUITINGN/ASponsored by Korea University Anam Hospital
Actively Recruiting
PhaseN/A
SponsorKorea University Anam Hospital
Started2024-03-01
Est. completion2027-02-01
Eligibility
Age19 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06293417

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

Eligibility

Age: 19 Years+Healthy volunteers accepted
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

Conditions3

DiabetesDyslipidemiasT2DM (Type 2 Diabetes Mellitus)

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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