Recruiting
Atmeg (Atorvastatin and Omega-3 Combination) and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia
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.
ClinicalTrials.gov IDNCT05365438
PhasePHASE4
Enrollment105
SponsorSeoul National University Bundang Hospital
Age20 Years
SexALL
Conditions studied
Dyslipidemias, Atherosclerosis, Diabetes Mellitus, Type 2
About this study
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.
Interventions
- Drug: Omega 3-Atorvastatin — Atmeg 2 capsules with 1 pack of Omethyl cutielet
- Drug: Omega 3-Atorvastatin — Atmeg 2 capsules
- Drug: Atorvastatin-Ezetimibe — ezetimibe/atorvastatin 10/20 mg
Primary outcomes
- Carotid intima media thickness (24 weeks)
Eligibility information
Inclusion Criteria:
* 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 Criteria:
* 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
Study locations
- SNUBH, Seongnam-si, Gyeonggi-do 13620 South Korea
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.