RecruitingPhase 4NCT02915198
Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes
CSP #2002 - Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT)
Sponsor
VA Office of Research and Development
Enrollment
7,410 participants
Start Date
Apr 3, 2023
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria16
- 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.
Exclusion Criteria18
- 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
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Interventions
DRUGMetformin XR
The study medication dose may be increased by a step-wise fashion up to a maximum of 4 tablets per day.
DRUGPlacebo
For patients \< 80 years of age at the time of a study visit, and with most recent eGFR 45 mL/min/1.73 m2, study medication dose may be increased in a stepwise fashion to a maximum of 4 tablets daily, corresponding to metformin XR 2000 mg or matching placebo. For patients 80 years of age or with most recent 30 eGFR \< 45 mL/min/1.73 m2, the maximum dose of study medication is 2 tablets daily, corresponding to metformin XR 1000 mg or matching placebo
Locations(40)
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NCT02915198
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