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RECRUITINGPhase 4INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

DRUG

Choline fenofibrate

choline fenofibrate 178.8mg (135mg as fenofibric acid)

DRUG

Policosanol

policosanol 10mg

Locations (1)

SNUBH
Seongnam-si, Gyeonggi-do, South Korea