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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Combination therapy
Drug* pitavastatin 4mg * ezetimibe 10mg
High intensity statin monotherapy
Drugrosuvastatin 20mg
Treatment groups
Trial outcomes
Primary outcomes
new-onset diabetes mellitus meeting diagnostic criteria for conventional diabetes during the treatment period
Secondary outcomes
1. Composite of major clinical events of cardiovascular disease (death from cardiovascular disease, nonfatal myocardial infarction or nonfatal stroke)
Other outcomes
Reperfusion procedure for any type of artery
3. Individual components of the composite of major clinical events of cardiovascular disease
Death from any cause
An element of the criteria met at diagnosis of diabetes mellitus
Sponsors and contacts
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Korea University Anam Hospital
Lead sponsor
Daewon Pharmaceutical Co., Ltd.
Collaborator
Samjin Pharmaceutical Co., Ltd.
Collaborator