Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05365438

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

SNUBH

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

Location status: Recruiting

Location contact

Soo Lim, MD, PHD

CONTACT

[email protected]

01097662706

About this study

In patients with type 2 diabetes with atherosclerotic combined dyslipidemia, the effect of atorvastatin and omega 3 combination on the progression of carotid intima media thickness and carotid artery plaque will be evaluated by 3D carotid ultrasound.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega 3-Atorvastatin

Drug

Atmeg 2 capsules with 1 pack of Omethyl cutielet

Other names: Atmeg-Omethyl cutielet

Atorvastatin-Ezetimibe

Drug

ezetimibe/atorvastatin 10/20 mg

Primary outcomes

  1. Carotid intima media thickness

    Time frame: 24 weeks

    maximum carotid IMT (mm)

Secondary outcomes

  1. Area of carotid artery plaque

    Time frame: 24 weeks

    measured by ultrasound

  2. Plaque characteristics Plaque characteristics Plaque characteristics Plaque characteristics

    Time frame: 24 weeks

    changes of non-calcified plaque volume (mm3)

  3. Glucose homeostasis

    Time frame: 24 weeks

    changes of HbA1c (%)

  4. Lipid metabolism

    Time frame: 24 weeks

    TG concentration, HDL-cholesterol concentration

  5. Bioelectrical Impedance Analysis

    Time frame: 24 weeks

    Body composition of fat mass (kg)

  6. Proteinuria

    Time frame: 24 weeks

    albumin-to-creatinine ratio (mg/g)

  7. Changes of gut microbiota

    Time frame: 24 weeks

    measured by 16S rRNA or metagenome sequencing, comparing the composition or each phylum/genus/species

Study contacts

Contact information is provided by the study sponsor or research team.

Minji Sohn

CONTACT

[email protected]

Soo Lim

CONTACT

[email protected]

+82-31-787-7035

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Collaborators

  • Korea United Pharm. Inc.

Registry information

Official study title

Effect of Atorvastatin and Omega 3 Combination Therapy on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes and Combined Dyslipidemia

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 9, 2022
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.