Choline Fenofibrate and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20+
SponsorSeoul National University Bundang Hospital
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Choline fenofibrate
- Policosanol
Treatment groups
56 Participants
are divided into 2 treatment groupsLocations
1SNUBH13620, Seongnam-siGyeonggi-do, South Korea
Sponsors and collaborators
Seoul National University Bundang Hospital
Lead sponsor
Daewon Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov