About this trial
The AVOID-DM trial is a multicenter, prospective, randomized study comparing the risk of new-onset diabetes mellitus (DM) between two cholesterol-lowering strategies in patients with prediabetes and established atherosclerotic cardiovascular disease (ASCVD). The study evaluates pitavastatin plus ezetimibe combination therapy versus high-intensity statin monotherapy (rosuvastatin 20 mg). Enrolling 2,000 non-diabetic participants with ASCVD, subjects are randomized 1:1 into the two treatment arms. The primary outcome is the incidence of new-onset DM over a follow-up period of up to 36 months. Secondary outcomes include cardiovascular events, changes in LDL cholesterol, fasting glucose, HbA1c, and insulin resistance. This trial hypothesizes that the combination therapy will achieve LDL targets with a lower risk of new-onset DM compared to high-intensity statin monotherapy.
Eligibility criteria
Qualifiers
Patients aged 18 years or older.
Fasting glucose less than 126 mg/dL.*
HbA1c less than 6.5%.
Plasma glucose less than 200 mg/dL after 2 hours during a 75 g oral glucose tolerance test (OGTT).*Note: For fasting glucose, two measurements of 126 mg/dL or greater within 3 months are required for a diagnosis of diabetes.
Disqualifiers
Patient is pregnant or breastfeeding or of childbearing potential.
Requires concomitant administration of strong inhibitors of CYP3A4 (itraconazole, ketoconazole, protease inhibitors, erythromycin, clarithromycin, telithromycin, and nefazodone) or CYP2C9 (relative contraindication not dependent on CYP450 statins).
Chronic kidney disease (eGFR < 30 ml/min/1.73m²) or dialysis-dependent renal failure.
Uncontrolled hypothyroidism.
Trial design
Treatments tested in this trial
- Combination therapy
- High intensity statin monotherapy
Treatment groups
Sponsors and collaborators
Korea University Anam Hospital
Lead sponsor
Daewon Pharmaceutical Co., Ltd.
Collaborator
Samjin Pharmaceutical Co., Ltd.
Collaborator