Actively Recruiting
Atmeg (Atorvastatin and Omega-3 Combination) and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia
Led by Seoul National University Bundang Hospital · Updated on 2026-05-05
105
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
Sponsors
S
Seoul National University Bundang Hospital
Lead Sponsor
K
Korea United Pharm. Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 asymptomatic atherosclerosis.
CONDITIONS
Official Title
Atmeg (Atorvastatin and Omega-3 Combination) and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Type 2 diabetes under treatment with HbA1c 6.0-10.0% at screening visit
- Male or female aged 20 years or older
- Mixed dyslipidemia under moderate-intensity statin with triglyceride 63200 mg/dL, HDL-cholesterol 6345 mg/dL, LDL-cholesterol 63100 mg/dL
- Moderate-intensity statins include atorvastatin 10-20mg, rosuvastatin 5mg, simvastatin 20-40mg, pravastatin 40-80mg, lovastatin 40mg, fluvastatin XL 80mg, fluvastatin 40mg twice daily, pitavastatin 2-4mg
- Identified carotid artery plaque with carotid intima-media thickness of 1.0 mm or more
- Asymptomatic patients without history of angina, myocardial infarction, or cerebral infarction
- Creatinine level of 1.8 mg/dL or less
You will not qualify if you...
- Dyslipidemia requiring other therapy with triglyceride over 500 mg/dL or LDL-cholesterol over 190 mg/dL
- Uncontrolled hypertension with systolic blood pressure over 180 mmHg or diastolic blood pressure over 110 mmHg
- Severe renal dysfunction with eGFR below 30 mL/min/1.73m2
- AST or ALT liver enzyme levels over 120 or chronic liver disease
- Pregnant or childbearing women not using adequate contraception
- Medication changes related to chronic diseases within the past 3 months
- Use of dyslipidemia therapies other than statins
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
SNUBH
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
Research Team
S
Soo Lim
CONTACT
M
Minji Sohn
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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