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

Seoul National University

Status and phase

Enrolling

Phase 4

Conditions

Dyslipidemias

Diabetes Mellitus, Type 2

Atherosclerosis

Treatments

Drug: Omega 3-Atorvastatin

Drug: Atorvastatin-Ezetimibe

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05365438

B-2111-720-004

Details and patient eligibility

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.

Full 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.

Enrollment

105 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No 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) ≥ 1.0 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

105 participants in 3 patient groups

Atmeg with Omethyl Cutielet

Experimental group

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

Treatment:

Drug: Omega 3-Atorvastatin

Atmeg

Active Comparator group

Description:

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

Treatment:

Drug: Omega 3-Atorvastatin

ezetimibe/atorvastatin 10/20

Active Comparator group

Description:

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