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

Phase 4

Recruiting

• Conditions: Dyslipidemias; Atherosclerosis; Diabetes Mellitus, Type 2
• Interventions: Drug: Omega 3-Atorvastatin; Drug: Atorvastatin-Ezetimibe

• Registration Number: NCT05365438
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Study Timeline

• Study First Submitted: 2022-04-27
• Study First Submitted QC: 2022-05-03
• Study First Posted: 2022-05-09
• Study Start: 2022-10-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atmeg with Omethyl Cutielet	Omega 3-Atorvastatin	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	Omega 3-Atorvastatin	Atmeg: 2 capsules daily (1 capsule containes atorvastatin 10 mg and Omega-3 1000 mg)
ezetimibe/atorvastatin 10/20	Atorvastatin-Ezetimibe	1 tablet once daily (atorvastatin 20mg with ezetimibe 10mg)

Primary Outcome Measures

Name	Time	Method
Carotid intima media thickness	24 weeks	maximum carotid IMT (mm)

Secondary Outcome Measures

Name	Time	Method
Area of carotid artery plaque	24 weeks	measured by ultrasound
Plaque characteristics Plaque characteristics Plaque characteristics Plaque characteristics	24 weeks	changes of non-calcified plaque volume (mm3)
Glucose homeostasis	24 weeks	changes of HbA1c (%)
Lipid metabolism	24 weeks	TG concentration, HDL-cholesterol concentration
Bioelectrical Impedance Analysis	24 weeks	Body composition of fat mass (kg)
Proteinuria	24 weeks	albumin-to-creatinine ratio (mg/g)
Changes of gut microbiota	24 weeks	measured by 16S rRNA or metagenome sequencing, comparing the composition or each phylum/genus/species

Trial Locations

Locations (1)

SNUBH; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of