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

Primary Purpose

Dyslipidemias, Atherosclerosis, Diabetes Mellitus, Type 2

Status

Recruiting

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Omega 3-Atorvastatin

Atorvastatin-Ezetimibe

About this trial

This is an interventional treatment trial for Dyslipidemias

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

SNUBHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Atmeg with Omethyl Cutielet

Atmeg

ezetimibe/atorvastatin 10/20

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Volume of carotid artery plaque

measured by 3D ultrasound imaging

Secondary Outcome Measures

Carotid intima media thickness

Coronary artery stenosis

Severity of coronary artery stenosis percent

Plaque characteristics Plaque characteristics Plaque characteristics Plaque characteristics

changes of non-calcified plaque volume (mm3)

Coronary artery calcium score

0: No calcification of artery [higher scores implies worsening]

Glucose homeostasis

changes of HbA1c (%)

Lipid metabolism

TG concentration, HDL-cholesterol concentration

Bioelectrical Impedance Analysis

Body composition of fat mass (kg)

Proteinuria

albumin-to-creatinine ratio (mg/g)

Changes of gut microbiota

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

Full Information

NCT ID

NCT05365438

First Posted

April 27, 2022

Last Updated

October 1, 2022

Sponsor

Seoul National University Bundang Hospital

Collaborators

Korea United Pharm. Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05365438

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2022 (Actual)

Primary Completion Date

March 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Bundang Hospital

Collaborators

Korea United Pharm. Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslipidemias, Atherosclerosis, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Atmeg with Omethyl Cutielet

Arm Type

Experimental

Arm Description

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

Arm Title

Atmeg

Arm Type

Active Comparator

Arm Description

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

Arm Title

ezetimibe/atorvastatin 10/20

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Omega 3-Atorvastatin

Other Intervention Name(s)

Atmeg-Omethyl cutielet

Intervention Description

Atmeg 2 capsules with 1 pack of Omethyl cutielet

Intervention Type

Drug

Intervention Name(s)

Omega 3-Atorvastatin

Other Intervention Name(s)

Atmeg

Intervention Description

Atmeg 2 capsules

Intervention Type

Drug

Intervention Name(s)

Atorvastatin-Ezetimibe

Intervention Description

ezetimibe/atorvastatin 10/20 mg

Primary Outcome Measure Information:

Title

Volume of carotid artery plaque

Description

measured by 3D ultrasound imaging

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Carotid intima media thickness

Time Frame

24 weeks

Title

Coronary artery stenosis

Description

Severity of coronary artery stenosis percent

Time Frame

24 weeks

Title

Plaque characteristics Plaque characteristics Plaque characteristics Plaque characteristics

Description

changes of non-calcified plaque volume (mm3)

Time Frame

24 weeks

Title

Coronary artery calcium score

Description

0: No calcification of artery [higher scores implies worsening]

Time Frame

24 weeks

Title

Glucose homeostasis

Description

changes of HbA1c (%)

Time Frame

24 weeks

Title

Lipid metabolism

Description

TG concentration, HDL-cholesterol concentration

Time Frame

24 weeks

Title

Bioelectrical Impedance Analysis

Description

Body composition of fat mass (kg)

Time Frame

24 weeks

Title

Proteinuria

Description

albumin-to-creatinine ratio (mg/g)

Time Frame

24 weeks

Title

Changes of gut microbiota

Description

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

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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) ≥ 1.5 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Soo Lim

Phone

+82-31-787-7035

limsoo@snu.ac.kr

First Name & Middle Initial & Last Name or Official Title & Degree

Minji Sohn

rainbowmjs@naver.com

Facility Information:

Facility Name

SNUBH

City

Seongnam

State/Province

Gyeonggi

ZIP/Postal Code

13620

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Soo Lim, MD, PHD

Phone

01097662706

limsoo@snu.ac.kr

12. IPD Sharing Statement

Learn more about this trial

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

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