Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Prediabetic State, Atherosclerosis, Metformin

In brief

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.

Key facts

Study ID

NCT02915198

Run by

VA Office of Research and Development

People needed

7410

Starts

2023-04-03

Expected to finish

2029-09-28

Last updated by the study team

2025-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Coronary artery disease is fulfilled by at least one of (1), (2), or (3):
• 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.
• Cerebrovascular disease is fulfilled by at least one of criteria (1) through (4):
• 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,
• History of carotid revascularization (surgical or catheter-based).
• Peripheral arterial disease: Fulfilled by at least one of the following:
• History of aorto-iliac or peripheral artery intervention (surgical or catheter based) for limb ischemia, or amputation for limb ischemia,
• Symptoms of intermittent claudication with ankle:brachial index less than or equal to 0.85.
• Renal function: Estimated glomerular filtration rate at least 45 mL/min/1.73 m2.
• Informed consent has been fully executed, and participant agrees to study procedures.

You may not qualify if…

• 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
• 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
• Severe anemia (hemoglobin < 10 g/dL)
• Prior history of intolerance to metformin
• Myocardial infarction, coronary revascularization procedure, or stroke within 1 month of randomization
• Uncontrolled hypertension at screening assessment (systolic blood pressure 180 mm Hg or diastolic blood pressure 110 mm Hg
• Acute or decompensated congestive heart failure
• Expected survival less than study duration
• Participants considered to be unable, unwilling, or unreliable to meet protocol requirements
• Impaired decision-making capacity, defined by any history of dementia or cognitive impairment
• Concurrent participation in another research study involving a randomized comparison of drug or device treatments, unless specifically excepted.
• Pregnant, intent to become pregnant during the trial, or lactating
• Women of childbearing potential who are not using a highly effective method of contraception

Where it is running

• Clement J. Zablocki VA Medical Center, Milwaukee, WI — Milwaukee, Wisconsin, United States (enrolling)
• Southern Arizona VA Health Care System, Tucson, AZ — Tucson, Arizona, United States (enrolling)
• Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR — Little Rock, Arkansas, United States (enrolling)
• VA Loma Linda Healthcare System, Loma Linda, CA — Loma Linda, California, United States (enrolling)
• VA Long Beach Healthcare System, Long Beach, CA — Long Beach, California, United States (enrolling)
• VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States (enrolling)
• VA San Diego Healthcare System, San Diego, CA — San Diego, California, United States (enrolling)
• VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles, California, United States (enrolling)
• Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora, Colorado, United States (enrolling)
• VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven, Connecticut, United States (enrolling)
• Bay Pines VA Healthcare System, Pay Pines, FL — Bay Pines, Florida, United States (enrolling)
• North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States (enrolling)
• Miami VA Healthcare System, Miami, FL — Miami, Florida, United States (enrolling)
• Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States (enrolling)
• VA Pacific Islands Health Care System, Honolulu, HI — Honolulu, Hawaii, United States (enrolling)
• Salem VA Medical Center, Salem, VA — Salem, Virginia, United States (enrolling)
• Huntington VA Medical Center, Huntington, WV — Huntington, West Virginia, United States (enrolling)
• Phoenix VA Health Care System, Phoenix, AZ — Phoenix, Arizona, United States (enrolling)
• Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States (enrolling)
• Iowa City VA Health Care System, Iowa City, IA — Iowa City, Iowa, United States (enrolling)
• Rehabilitation R&D Service, Baltimore, MD — Baltimore, Maryland, United States (enrolling)
• VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston, Massachusetts, United States (enrolling)
• Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States (enrolling)
• Kansas City VA Medical Center, Kansas City, MO — Kansas City, Missouri, United States (enrolling)
• Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE — Omaha, Nebraska, United States (enrolling)

Full record on ClinicalTrials.gov

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