Clinical trial
Effect of Choline Fenofibrate on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes and Combined Dyslipidemia
Name
B-2111-720-003
Description
This is a randomized controlled study to assess the effect of choline fenofibrate compared with policosanol in Korean T2DM patients with asymptomatic atherosclerosis.
Trial arms
Trial start
2023-06-01
Estimated PCD
2025-12-31
Trial end
2026-12-31
Status
Recruiting
Phase
Early phase I
Treatment
Choline fenofibrate
choline fenofibrate 178.8mg (135mg as fenofibric acid)
Arms:
Tgfenon
Other names:
Tgfenon
Policosanol
policosanol 10mg
Arms:
Policosanol 10
Other names:
Policosanol 10
Size
56
Primary endpoint
Carotid intima media thickness
24 week
Eligibility criteria
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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 56, 'type': 'ESTIMATED'}}
Updated at
2024-05-01
1 organization
2 products
4 indications
Organization
Seoul National University Bundang HospitalProduct
Choline fenofibrateIndication
lipid metabolism disorderIndication
AtherosclerosisIndication
Diabetes MellitusIndication
Type 2Product
Policosanol