NCT05365438

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for phase_4

Timeline
8mo left

Started Oct 2022

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Oct 2022Dec 2026

First Submitted

Initial submission to the registry

April 27, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 5, 2026

Status Verified

May 1, 2026

Enrollment Period

4.3 years

First QC Date

April 27, 2022

Last Update Submit

May 2, 2026

Conditions

DyslipidemiasAtherosclerosisDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Carotid intima media thickness

    maximum carotid IMT (mm)

    24 weeks

Secondary Outcomes (7)

  • Area of carotid artery plaque

    24 weeks

  • Plaque characteristics Plaque characteristics Plaque characteristics Plaque characteristics

    24 weeks

  • Glucose homeostasis

    24 weeks

  • Lipid metabolism

    24 weeks

  • Bioelectrical Impedance Analysis

    24 weeks

  • +2 more secondary outcomes

Study Arms (3)

Atmeg with Omethyl Cutielet

EXPERIMENTAL

Atmeg: 2 capsules daily (1 capsule containes atorvastatin 10 mg and Omega-3 1000 mg) Omethyl Cutielet: Omega-3 2000mg (920mg as EPA ethyl ester, 760mg as DHA ethyl ester) once daily

Drug: Omega 3-Atorvastatin

Atmeg

ACTIVE COMPARATOR

Atmeg: 2 capsules daily (1 capsule containes atorvastatin 10 mg and Omega-3 1000 mg)

Drug: Omega 3-Atorvastatin

ezetimibe/atorvastatin 10/20

ACTIVE COMPARATOR

1 tablet once daily (atorvastatin 20mg with ezetimibe 10mg)

Drug: Atorvastatin-Ezetimibe

Interventions

Omega 3-AtorvastatinDRUG

Atmeg 2 capsules with 1 pack of Omethyl cutielet

Also known as: Atmeg-Omethyl cutielet
Atmeg with Omethyl Cutielet
Atorvastatin-EzetimibeDRUG

ezetimibe/atorvastatin 10/20 mg

ezetimibe/atorvastatin 10/20

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SNUBH

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

RECRUITING

MeSH Terms

Conditions

DyslipidemiasAtherosclerosisDiabetes Mellitus, Type 2

Interventions

liptruzet

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersEndocrine System Diseases

Central Study Contacts

Soo Lim

CONTACT

+82-31-787-7035limsoo@snu.ac.kr

Minji Sohn

CONTACT

rainbowmjs@naver.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 27, 2022

First Posted

May 9, 2022

Study Start

October 1, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 5, 2026

Record last verified: 2026-05

Locations

KR(1)