Combination therapy of atorvastatin and omega-3 for atherosclerosis in type 2 diabetes patients
Effect of Atorvastatin and Omega 3 Combination Therapy on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes and Combined Dyslipidemia
This study is testing if combining atorvastatin with omega-3 can help people with type 2 diabetes and early signs of atherosclerosis more than using atorvastatin with another medication.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Seoul National University Bundang Hospital Academic / other |
| Locations | 1 site (Seongnam-si, Gyeonggi-do) |
| Trial ID | NCT05365438 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20 and over with type 2 diabetes, mixed dyslipidemia, and asymptomatic carotid artery plaque.
Not a fit: Patients with severe dyslipidemia requiring different therapies or those with uncontrolled hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for managing atherosclerosis in patients with type 2 diabetes.
How similar studies have performed: Other studies have shown promising results with similar combination therapies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seongnam-si, Gyeonggi-do
- Snubh — Seongnam-si, Gyeonggi-do, South Korea (Recruiting)
Study contacts
- Study coordinator: Soo Lim
- Email: limsoo@snu.ac.kr
- Phone: +82-31-787-7035
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.