Status:
RECRUITING
Atmeg (Atorvastatin and Omega-3 Combination) and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia
Lead Sponsor:
Seoul National University Bundang Hospital
Collaborating Sponsors:
Korea United Pharm. Inc.
Conditions:
Dyslipidemias
Atherosclerosis
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
Brief Summary
This is a randomized controlled study to assess the effect of atorvastatin and omega 3 combination therapy compared with atorvastatin and ezetimibe combination therapy in Korean T2DM patients with asy...
Detailed Description
In patients with type 2 diabetes with atherosclerotic combined dyslipidemia, the effect of atorvastatin and omega 3 combination on the progression of carotid intima media thickness and carotid artery ...
Eligibility Criteria
Inclusion
- Type 2 diabetes under treatment with HbA1c 6.0-10.0% at screening visit
- Male or female of 20 years or over
- Mixed dyslipidemia under moderate-intensity statin: triglyceride ≥200 mg/dL, HDL-cholesterol ≤50 mg/dL, LDL-cholesterol ≥100 mg/dL
- moderate-intensity statin: atorvastatin 10-20mg, rosuvastatin 5mg, simvastatin 20-40mg, pravastatin 40-80mg, lovastatin 40mg, fluvastatin XL 80mg, fluvastatin 40mg bid, pitavastatin 2-4mg
- Identified carotid artery plaque: carotid intima-media thickness (cIMT) ≥ 1.0 mm
- Asymptomatic patients without history of angina, myocardial infarction, or cerebral infarction
- Creatinine ≤1.8 mg/dL
Exclusion
- Dyslipidemia which requires other therapy: triglyceride ≥500 mg/dL or LDL-cholesterol ≥190 mg/dL
- Uncontrolled hypertension: SBP \>180 mmHg or DBP \>110 mmHg
- Severe renal dysfunction: eGFR \<30 mL/min/1.73m2
- AST/ALT \>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
- Usage of dyslipidemia therapy other than statin
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT05365438
Start Date
October 1 2022
End Date
December 31 2026
Last Update
May 1 2024
Active Locations (1)
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1
SNUBH
Seongnam-si, Gyeonggi-do, South Korea, 13620