Metformin for Prediabetes and Heart Disease

This study is investigating if metformin XR, a common diabetes medication, can reduce the risk of serious heart problems like heart attacks, strokes, or death in Veterans. You may be able to join if you have pre-diabetes (blood sugar levels higher than normal but not yet diabetes) and existing heart or blood vessel disease. Researchers will compare metformin XR to a placebo (an inactive pill that looks like the study drug). The main goal is to see if metformin XR can lower the number of these events over an average of 4.5 years. The study is currently recruiting a large number of participants.

Study design
This is a randomized, double-blind study, meaning participants are randomly assigned to receive either metformin XR or a placebo, and neither you nor your doctors will know which you are receiving. The study plans to enroll 7410 participants.
What's involved
You would take study medication, either metformin XR or placebo, which may be increased in a step-wise fashion up to a maximum of 4 tablets per day. You will also receive counseling on healthy lifestyle recommendations.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through study completion, which is an average of 4.5 years, to track events like death, heart attack, or stroke.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02915198

Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes

Recruiting
PHASE4Ages 18+InterventionalTreatment
VA Office of Research and Development
~7,410 participants
Updated 2025-12-17 on ClinicalTrials.gov
What's tested:Metformin XRPlacebo

At a glance

Recruiting sites
37 of 40 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time in days to death, non-fatal myocardial infarction, stroke, hospitalization for unstable angina, or symptom-driven coronary revascularization
Measured over through study completion, an average of 4.5 years
Prediabetic State
Atherosclerosis
Metformin
40 sites across 28 states
California5
Florida3
Arizona2
Illinois2
Ohio2
South Carolina2
Texas2
Virginia2
  • Gregory G. Schwartz, PhD MD · STUDY_CHAIR · Rocky Mountain Regional VA Medical Center, Aurora, CO

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  • Time in days to death, non-fatal myocardial infarction, stroke, hospitalization for unstable angina, or symptom-driven coronary revascularizationthrough study completion, an average of 4.5 years

    The primary outcome measure is the time to first occurrence of death, non-fatal myocardial infarction or stroke, hospitalization for unstable angina with objective evidence of acute myocardial ischemia, or coronary revascularization driven by acute or progressive symptoms.