Comparison of Pitavastatin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus

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.

NCT Number	NCT06767774
Lead Sponsor	Korea University Anam Hospital Collaborators: Daewon Pharmaceutical Co., Ltd., Samjin Pharmaceutical Co., Ltd.
Conditions	ASCVD, Diabetes, Statin
Enrollment	2,000 participants
Start Date	2025-04-25
Primary Completion	2029-08-31 (estimated)
Study Completion	2030-01-31 (estimated)
Updated on ClinicalTrials.gov	2025-04-27