Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
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
Trial design
Treatments tested in this trial
- Metformin XR
- Placebo
Treatment groups
7,410 Participants
are divided into 2 treatment groupsLocations
40Arizona
Phoenix VA Health Care System, Phoenix, AZ85012, Phoenix United States
Southern Arizona VA Health Care System, Tucson, AZ85723-0001, Tucson United States
Arkansas
Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR72205-5484, Little Rock United States
California
VA Loma Linda Healthcare System, Loma Linda, CA92357-1000, Loma Linda United States
Sponsors and collaborators
VA Office of Research and Development
Lead sponsor
Source ClinicalTrials.gov