Actively Recruiting

Phase 4
Age: 20Years - 80Years
All Genders
NCT05365438

Atmeg (Atorvastatin and Omega-3 Combination) and Carotid Atherosclerosis 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

221 weeks

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

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.

CONDITIONS

Official Title

Atmeg (Atorvastatin and Omega-3 Combination) and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia

Who Can Participate

Age: 20Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Type 2 diabetes under treatment with HbA1c 6.0-10.0% at screening visit
  • Male or female aged 20 years or older
  • Mixed dyslipidemia under moderate-intensity statin with triglyceride 63200 mg/dL, HDL-cholesterol 6345 mg/dL, LDL-cholesterol 63100 mg/dL
  • Moderate-intensity statins include atorvastatin 10-20mg, rosuvastatin 5mg, simvastatin 20-40mg, pravastatin 40-80mg, lovastatin 40mg, fluvastatin XL 80mg, fluvastatin 40mg twice daily, pitavastatin 2-4mg
  • Identified carotid artery plaque with carotid intima-media thickness of 1.0 mm or more
  • Asymptomatic patients without history of angina, myocardial infarction, or cerebral infarction
  • Creatinine level of 1.8 mg/dL or less
Not Eligible

You will not qualify if you...

  • Dyslipidemia requiring other therapy with triglyceride over 500 mg/dL or LDL-cholesterol over 190 mg/dL
  • Uncontrolled hypertension with systolic blood pressure over 180 mmHg or diastolic blood pressure over 110 mmHg
  • Severe renal dysfunction with eGFR below 30 mL/min/1.73m2
  • AST or ALT liver enzyme levels over 120 or chronic liver disease
  • Pregnant or childbearing women not using adequate contraception
  • Medication changes related to chronic diseases within the past 3 months
  • Use of dyslipidemia therapies other than statins

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

SNUBH

Seongnam-si, Gyeonggi-do, South Korea, 13620

Actively Recruiting

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Research Team

S

Soo Lim

CONTACT

M

Minji Sohn

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Atmeg (Atorvastatin and Omega-3 Combination) and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia | DecenTrialz