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Clinical Trials in South Korea / NCT05365425
Recruiting Phase 4

Choline Fenofibrate and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia

NCT05365425 · tracked via the Priya Life Science South Korea tracker
Sponsor
Seoul National University Bundang Hospital
Phase
Phase 4
Started
2023-06-01
Last updated
2026-05-05

Condition(s) studied

DyslipidemiaAtherosclerosisDiabetes Mellitus, Type 2

Investigational drug(s) / intervention(s)

Choline fenofibratePolicosanol

Choline fenofibrate: choline fenofibrate 178.8mg (135mg as fenofibric acid)

Policosanol: policosanol 10mg

Study summary

This is a randomized controlled study to assess the effect of choline fenofibrate compared with policosanol in Korean T2DM patients with asymptomatic atherosclerosis.

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Type 2 diabetes under treatment with HbA1c 6.0-10.0% at screening visit * Male or female of 20 years or over * Mixed dyslipidemia: triglyceride 200\~499 mg/dL, HDL-cholesterol male ≤45 mg/dL or female ≤50 mg/dL * Identified carotid artery plaque: carotid intima-media thickness (cIMT) ≥ 1.0 mm * Creatinine ≤1.8 mg/dL Exclusion Criteria: * Dyslipidemia which requires other therapy: triglyceride ≥500 mg/dL or LDL-cholesterol ≥190 mg/dL * Uncontrolled hypertension * Severe renal dysfunction * GOT/GPT \>120/120 or chronic liver disease * Pregnant or childbearing woman who does not have enough contraception * Changes of medication related to chronic diseases (diabetes, hypertension, dyslipidemia, etc.) within 3 months * Other antiplatlet medication such as cilostazol, clopidogrel (except aspirin)

Primary outcome measure(s)

  • Carotid intima media thickness — 24 week
    Maximum carotid IMT (mm)

Trial sites (1)

FacilityCityRegionStatus
SNUBH Seongnam-si Gyeonggi-do Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05365425 on ClinicalTrials.gov ↗ ← All trials in South Korea