NCT06767774

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

Comparison of Pitavastatin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus in Prediabetic Patients With Atherosclerotic Cardiovascular Disease

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Korea University Anam Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• ASCVD
• Diabetes
• Statin

Interventions

Type	Name	Description
DRUG	Combination therapy	* pitavastatin 4mg * ezetimibe 10mg
DRUG	High intensity statin monotherapy	rosuvastatin 20mg

Timeline

• Start date: 2025-04-25
• Primary completion: 2029-08-31
• Completion: 2030-01-31
• First posted: 2025-01-10
• Last updated: 2025-04-27

Locations

1 site across 1 country: South Korea