Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (NCT02915198) | Clinical Trial Compass
RecruitingPhase 4
Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes
United States7,410 participantsStarted 2023-04-03
Plain-language summary
This research will help us to learn if the medicine called metformin reduces the risk of death, heart attacks, and/or strokes in Veterans who have pre-diabetes and heart or blood vessel problems.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Pre-diabetes: This condition is fulfilled by HbA1c of at least 5.7%, but less than 6.5%; or two measurements of fasting plasma glucose (on separate days) of 100-125 mg/dL; or a 2-hour plasma glucose level of 140-199 mg/dL following a 75 g glucose load oral glucose tolerance test.
✓. Established atherosclerotic cardiovascular disease: Qualifying participants must have evidence of atherosclerotic disease in at least one of the following vascular beds: coronary, cerebrovascular, or peripheral arterial circulation.
✓. History of myocardial infarction at least one month prior to randomization.
✓. History of percutaneous coronary intervention or coronary artery bypass surgery at least one month prior to randomization.
✓. Angiographic evidence of coronary stenosis of at least 50% in at least two major epicardial coronary arteries.
✓. Documented prior ischemic stroke (at least one month prior to randomization),
✓. Carotid artery stenosis 50% and history of transient ischemic attack or transient ischemic visual symptoms attributable to the identified lesion(s),
✓. Asymptomatic carotid stenosis of at least 70% luminal diameter,
Exclusion criteria
✕. Treatment with metformin or other anti-diabetic medication within 12 months of randomization. Note: In the absence of a diagnosis of diabetes, inpatient treatment with insulin or treatment with an SGLT2 inhibitor (e.g., for heart failure) or a GLP-1 receptor agonist (e.g., for obesity) is not exclusionary.
What they're measuring
1
Time in days to death, non-fatal myocardial infarction, stroke, hospitalization for unstable angina, or symptom-driven coronary revascularization
Timeframe: through study completion, an average of 4.5 years
. Treatment with systemic glucocorticoids within 3 months of randomization
✕. Fasting plasma glucose greater than 130 mg/dL measured between screening and randomization visits, or any plasma glucose 180 mg/dL or HbA1c 7.0% measured within 12 months of randomization.
✕. Total CO2 below the local laboratory lower limit of normal on most recent blood chemistry panel
✕. Current treatment with cimetidine, vandetanib, or a systemic treatment with a carbonic anhydrase inhibitor.
✕. Cirrhosis, active hepatitis, or jaundice at time of randomization, or total bilirubin \> 2 times upper limit of normal
✕. Binge or heavy alcohol consumption within 6 months of randomization