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

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Bundang Hospital
• Collaborator: Korea United Pharm. Inc.
• Treatments: Atorvastatin; Ezetimibe

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