NCT05365438RecruitingPhase 4
Atmeg (Atorvastatin and Omega-3 Combination) and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia
Effect of Atorvastatin and Omega 3 Combination Therapy on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes and Combined Dyslipidemia
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 105 (estimated)
- First submitted
- 27 Apr 2022
- Start date
- 1 Oct 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Seoul National University Bundang Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT05365438
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 105
- From 1 Oct 2022 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Usage of dyslipidemia therapy other than statin
Other illness
- Uncontrolled hypertension: SBP \>180 mmHg or DBP \>110 mmHg
- Changes of medication related to chronic diseases (diabetes, hypertension, dyslipidemia, etc.) within 3 months
Lab values
- Dyslipidemia which requires other therapy: triglyceride ≥500 mg/dL or LDL-cholesterol ≥190 mg/dL
- Severe renal dysfunction: eGFR \<30 mL/min/1.73m2
- AST/ALT \>120/120 or chronic liver disease
Other
- Pregnant or childbearing woman who does not have enough contraception
Who the study is looking for
- 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
Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SNUBH Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.