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

Seoul National University

Status and phase: Enrolling; Phase 4

Conditions: Dyslipidemia; Diabetes Mellitus, Type 2; Atherosclerosis

Treatments: Drug: Choline fenofibrate; Drug: Policosanol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05365425

B-2111-720-003

Details and patient eligibility

About

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

Full description

In patients with type 2 diabetes with atherosclerotic combined dyslipidemia, the effect of choline fenofibrate on the progression of carotid intima media thickness and carotid artery plaque will be evaluated by 3D carotid ultrasound.

Enrollment: 56 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

Tgfenon

Experimental group

Description:

Choline fenofibrate (135mg as fenofibric acid) 1 tablet once daily oral administration regardless of diet

Treatment:

Drug: Choline fenofibrate

Policosanol 10

Active Comparator group

Description:

Policosanol 10mg 1 tablet once daily oral administration

Treatment:

Drug: Policosanol