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.
Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes
At a glance
Conditions
Where it's being run
40 sites across 28 statesStudy leadership
- Gregory G. Schwartz, PhD MD · STUDY_CHAIR · Rocky Mountain Regional VA Medical Center, Aurora, CO
Who to contact
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What this trial measures
- 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.