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NCT05365425 | Recruiting | Dyslipidemia

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

Seoul National University Bundang Hospital

Information provided by (Responsible Party):

Soo Lim

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

Dyslipidemia

Atherosclerosis

Diabetes Mellitus, Type 2

Intervention/treatment

Choline fenofibrate

Policosanol

Phase

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 Type : Interventional
Estimated Enrollment : 56 participants
Masking : Single
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
Actual Study Start Date : June 1, 2023
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : December 31, 2024
Arm Intervention/treatment

Experimental: Tgfenon

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

Drug: Choline fenofibrate

Active Comparator: Policosanol 10

Policosanol 10mg 1 tablet once daily oral administration

Drug: Policosanol
Ages Eligible for Study: 20 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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) ≥ 1.5 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)
Choline Fenofibrate and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia

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

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Locations

Recruiting

Korea, Republic of, Gyeonggi

SNUBH

Seongnam, Gyeonggi, Korea, Republic of, 13620