Combination therapy of atorvastatin and omega-3 for atherosclerosis in type 2 diabetes patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effects of a combination therapy of atorvastatin and omega-3 compared to atorvastatin and ezetimibe in patients with type 2 diabetes and asymptomatic atherosclerosis. The study involves a randomized controlled design and utilizes 3D carotid ultrasound to assess changes in carotid intima-media thickness and plaque progression. The participants will be Korean adults with mixed dyslipidemia and specific inclusion criteria related to their diabetes and lipid levels.

Why it matters

Who can join: the full rules

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

Where it's running

• Snubh
  Seongnam-si, Gyeonggi-do, South Korea Recruiting

Study contacts

• Study coordinator: Soo Lim
• Email: limsoo@snu.ac.kr
• Phone: +82-31-787-7035

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.