Choline Fenofibrate and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia
Effect of Choline Fenofibrate on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes and Combined Dyslipidemia
1 other identifier
interventional
56
1 country
1
Brief Summary
This is a randomized controlled study to assess the effect of choline fenofibrate compared with policosanol in Korean T2DM patients with asymptomatic atherosclerosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2023
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2022
CompletedFirst Posted
Study publicly available on registry
May 9, 2022
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
May 5, 2026
May 1, 2026
3.6 years
March 16, 2022
May 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Carotid intima media thickness
Maximum carotid IMT (mm)
24 week
Secondary Outcomes (7)
Area of carotid artery plaque
24 week
Plaque characteristics
24 week
Glucose homeostasis
24 week
Lipid metabolism
24 week
Bioelectrical Impedance Analysis
24 week
- +2 more secondary outcomes
Study Arms (2)
Tgfenon
EXPERIMENTALCholine fenofibrate (135mg as fenofibric acid) 1 tablet once daily oral administration regardless of diet
Policosanol 10
ACTIVE COMPARATORPolicosanol 10mg 1 tablet once daily oral administration
Interventions
choline fenofibrate 178.8mg (135mg as fenofibric acid)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SNUBH
Seongnam-si, Gyeonggi-do, 13620, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 16, 2022
First Posted
May 9, 2022
Study Start
June 1, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
May 5, 2026
Record last verified: 2026-05