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

October 1, 2022 updated by: Soo Lim, Seoul National University Bundang Hospital

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

105

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Seongnam, Gyeonggi, Korea, Republic of, 13620
        • Recruiting
        • SNUBH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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) ≥ 1.5 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Atmeg with Omethyl Cutielet
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 2 capsules with 1 pack of Omethyl cutielet
Other Names:
  • Atmeg-Omethyl cutielet
Drug: Omega 3-Atorvastatin
Atmeg 2 capsules
Other Names:
  • Atmeg
ACTIVE_COMPARATOR: Atmeg
Atmeg: 2 capsules daily (1 capsule containes atorvastatin 10 mg and Omega-3 1000 mg)
Drug: Omega 3-Atorvastatin
Atmeg 2 capsules with 1 pack of Omethyl cutielet
Other Names:
  • Atmeg-Omethyl cutielet
Drug: Omega 3-Atorvastatin
Atmeg 2 capsules
Other Names:
  • Atmeg
ACTIVE_COMPARATOR: ezetimibe/atorvastatin 10/20
1 tablet once daily (atorvastatin 20mg with ezetimibe 10mg)
Drug: Atorvastatin-Ezetimibe
ezetimibe/atorvastatin 10/20 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of carotid artery plaque
Time Frame: 24 weeks
measured by 3D ultrasound imaging
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Carotid intima media thickness
Time Frame: 24 weeks
24 weeks
Coronary artery stenosis
Time Frame: 24 weeks
Severity of coronary artery stenosis percent
24 weeks
Plaque characteristics Plaque characteristics Plaque characteristics Plaque characteristics
Time Frame: 24 weeks
changes of non-calcified plaque volume (mm3)
24 weeks
Coronary artery calcium score
Time Frame: 24 weeks
0: No calcification of artery [higher scores implies worsening]
24 weeks
Glucose homeostasis
Time Frame: 24 weeks
changes of HbA1c (%)
24 weeks
Lipid metabolism
Time Frame: 24 weeks
TG concentration, HDL-cholesterol concentration
24 weeks
Bioelectrical Impedance Analysis
Time Frame: 24 weeks
Body composition of fat mass (kg)
24 weeks
Proteinuria
Time Frame: 24 weeks
albumin-to-creatinine ratio (mg/g)
24 weeks
Changes of gut microbiota
Time Frame: 24 weeks
measured by 16S rRNA or metagenome sequencing, comparing the composition or each phylum/genus/species
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

Korea United Pharm. Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2022

Primary Completion (ANTICIPATED)

March 31, 2024

Study Completion (ANTICIPATED)

December 31, 2024

Study Registration Dates

First Submitted

April 27, 2022

First Submitted That Met QC Criteria

May 3, 2022

First Posted (ACTUAL)

May 9, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 4, 2022

Last Update Submitted That Met QC Criteria

October 1, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-2111-720-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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