Study of Metformin to Lower Heart and Blood Vessel Risks in Adults with Pre-Diabetes and Atherosclerosis

What this Trial Is About

Researchers are studying whether the medicine metformin can reduce the risk of death, heart attacks, and strokes in Veterans who have pre-diabetes along with problems related to heart or blood vessels. This is a multicenter, prospective, randomized, double-blind trial focused on secondary prevention to compare metformin with placebo in reducing mortality and cardiovascular complications. Eligible participants have pre-diabetes based on blood sugar levels and established atherosclerotic cardiovascular disease, with adequate kidney function. Participants are randomly assigned to receive either metformin extended-release XR or a matching placebo. The treatment starts with 500 mg of metformin XR or placebo once daily, with doses gradually increased up to 2000 mg daily as tolerated. All participants also receive counseling on lifestyle changes to support their health. The study began its full-scale phase in April 2023 following a pilot phase and will continue with treatment and monitoring over several years. During the study, participants will have regular assessments including monitoring for death, heart attacks, strokes, hospitalizations for unstable angina, and coronary procedures, tracked over an average of 4.5 years. Researchers will measure time to these events as the main outcome. Secondary outcomes include cardiovascular, cancer-related, and diabetes-related events. Participants will be followed closely to ensure safety and adherence to the study medication and procedures throughout the trial period.

Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes