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

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Bundang Hospital
• Collaborator: Daewon Pharmaceutical Co., Ltd.
• Treatments: Choline; Fenofibrate; Policosanol

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)