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

Sponsor

Seoul National University Bundang Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05365425

Collaborator

Daewon Pharmaceutical Co., Ltd. (Industry)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemia Atherosclerosis Diabetes Mellitus, Type 2	Drug: Choline fenofibrate Drug: Policosanol	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Choline Fenofibrate on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes and Combined Dyslipidemia

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tgfenon Choline fenofibrate (135mg as fenofibric acid) 1 tablet once daily oral administration regardless of diet	Drug: Choline fenofibrate choline fenofibrate 178.8mg (135mg as fenofibric acid) Other Names: Tgfenon
Active Comparator: Policosanol 10 Policosanol 10mg 1 tablet once daily oral administration	Drug: Policosanol policosanol 10mg Other Names: Policosanol 10

Arm

Intervention/Treatment

Experimental: Tgfenon

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

Drug: Choline fenofibrate

choline fenofibrate 178.8mg (135mg as fenofibric acid)

Other Names:

Tgfenon

Active Comparator: Policosanol 10

Policosanol 10mg 1 tablet once daily oral administration

Drug: Policosanol

policosanol 10mg

Other Names:

Policosanol 10

Outcome Measures

Primary Outcome Measures

Volume of carotid artery plaque [24 week]
measured by 3D ultrasound imaging

Secondary Outcome Measures

Carotid intima media thickness [24 week]
Maximum carotid IMT (mm)
Coronary artery stenosis [24 week]
Severity of coronary artery stenosis percent
Plaque characteristics [24 week]
changes of non-calcified plaque volume (mm3)
Coronary artery calcium score [24 week]
0: No calcification of artery [higher scores implies worsening]
Glucose homeostasis [24 week]
changes of HbA1c (%)
Lipid metabolism [24 week]
TG concentration, HDL-cholesterol concentration
Bioelectrical Impedance Analysis [24 week]
Body composition of fat mass (kg)
Proteinuria [24 week]
albumin-to-creatinine ratio (mg/g)
changes of gut microbiota [24 week]
measured by 16S rRNA or metagenome sequencing, comparing the composition or each phylum/genus/species

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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) ≥ 1.5 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)