Actively Recruiting
Effect of Atorvastatin and Omega 3 Combination Therapy on Carotid Atherosclerosis Estimated by 3D Ultrasound 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
N/A
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
Researchers are evaluating the effects of combining atorvastatin and omega-3 compared to atorvastatin and ezetimibe in Korean patients with type 2 diabetes who have asymptomatic atherosclerosis and combined dyslipidemia. This phase 4 randomized controlled study aims to understand how these treatments influence the progression of carotid artery thickness and plaque, important markers of cardiovascular health. The study is sponsored by Seoul National University Bundang Hospital. Participants will be assigned to one of three treatment groups: one receiving Atmeg capsules (each containing atorvastatin 10 mg and omega-3 1000 mg) along with Omethyl Cutielet omega-3 supplement once daily; one receiving just Atmeg capsules twice daily; and one receiving a tablet of atorvastatin 20 mg combined with ezetimibe 10 mg once daily. The treatment period lasts 24 weeks, during which the effects on carotid arteries will be closely monitored using 3D carotid ultrasound. During the study, participants will undergo assessments including carotid intima media thickness, carotid plaque area and characteristics, blood glucose control, lipid levels, body composition by bioelectrical impedance, proteinuria, and changes in gut microbiota. These evaluations are conducted at the start and completion of the 24-week treatment. Safety and adherence will be monitored throughout the trial, which enrolls adults aged 20 to 80 years with specific lipid and diabetes criteria.
CONDITIONS
Brief 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...
- Adults aged 20 years or older
- Diagnosed with type 2 diabetes under treatment with HbA1c between 6.0 and 10.0% at screening visit
- Have mixed dyslipidemia while on moderate-intensity statin therapy
- Moderate-intensity statin defined as atorvastatin 10-20 mg, rosuvastatin 5 mg, simvastatin 20-40 mg, pravastatin 40-80 mg, lovastatin 40 mg, fluvastatin XL 80 mg, fluvastatin 40 mg twice daily, or pitavastatin 2-4 mg
- Identified carotid artery plaque with carotid intima-media thickness of 1.0 mm or greater
- Asymptomatic with no history of angina, heart attack, or stroke
- Creatinine level less than or equal to 1.8 mg/dL
You will not qualify if you...
- Dyslipidemia requiring therapies other than statins: triglycerides 500 mg/dL or higher or LDL-cholesterol 190 mg/dL or higher
- Uncontrolled high blood pressure: systolic over 180 mmHg or diastolic over 110 mmHg
- Severe kidney dysfunction with eGFR less than 30 mL/min/1.73m2
- Liver enzyme levels (AST/ALT) over 120 or chronic liver disease
- Pregnant or women who can become pregnant without sufficient contraception
- Changes in medications for chronic diseases like diabetes, hypertension, or dyslipidemia within the last 3 months
- Use of dyslipidemia treatments other than statins
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 24 weeks
Participants receive study medications including combinations of atorvastatin and omega-3 or atorvastatin with ezetimibe to evaluate effects on carotid atherosclerosis.
Regular visits scheduled during treatment
Trial Site Locations
Total: 1 location
1
SNUBH
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
Research Team
S
Soo Lim
M
Minji Sohn
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here