Actively Recruiting

Phase 4
Age: 20Years +
All Genders
NCT05365425

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

Led by Seoul National University Bundang Hospital · Updated on 2026-05-05

56

Participants Needed

1

Research Sites

239 weeks

Total Duration

On this page

Sponsors

S

Seoul National University Bundang Hospital

Lead Sponsor

D

Daewon Pharmaceutical Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 20 years or older
  • Diagnosed with type 2 diabetes under treatment with HbA1c between 6.0% and 10.0% at screening
  • Mixed dyslipidemia with triglycerides between 200 and 499 mg/dL
  • HDL-cholesterol 45 mg/dL or less for males, or 50 mg/dL or less for females
  • Presence of carotid artery plaque with carotid intima-media thickness of 1.0 mm or more
  • Creatinine level 1.8 mg/dL or less
Not Eligible

You will not qualify if you...

  • Dyslipidemia requiring other therapy: triglycerides 500 mg/dL or higher or LDL-cholesterol 190 mg/dL or higher
  • Uncontrolled high blood pressure
  • Severe kidney dysfunction
  • Liver enzymes GOT or GPT above 120 or presence of chronic liver disease
  • Pregnant or childbearing women without adequate contraception
  • Medication changes related to chronic diseases within the last 3 months
  • Use of other antiplatelet drugs such as cilostazol or clopidogrel (except aspirin)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

SNUBH

Seongnam-si, Gyeonggi-do, South Korea, 13620

Actively Recruiting

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Research Team

S

Soo Lim

CONTACT

M

Minji Sohn

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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