Atmeg (Atorvastatin and Omega-3 Combination) and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia
Recruiting · NCT05365438 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Atorvastatin-EzetimibeOmega 3-Atorvastatin
What this trial is 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.
Who can take part
Age range
20 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →