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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Choline fenofibrate
Drugcholine fenofibrate 178.8mg (135mg as fenofibric acid)
Policosanol
Drugpolicosanol 10mg
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: TgfenonExperimental treatment 1 intervention
Group B: Policosanol 10Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Carotid intima media thickness
Maximum carotid IMT (mm)
Time frame
24 weekSecondary outcomes
1
Area of carotid artery plaque
measured by ultrasound
Time frame
24 week2
Plaque characteristics
changes of non-calcified plaque volume (mm3)
Time frame
24 week3
Glucose homeostasis
changes of HbA1c (%)
Time frame
24 week4
Lipid metabolism
TG concentration, HDL-cholesterol concentration
Time frame
24 weekSponsors and contacts
Click on the lead sponsor to view all of their trials.
Seoul National University Bundang Hospital
Lead sponsor
Daewon Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov