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RECRUITINGPhase 4INTERVENTIONAL

Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes

CSP #2002 - Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. 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. 2. 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): 1. History of myocardial infarction at least one month prior to randomization. 2. History of percutaneous coronary intervention or coronary artery bypass surgery at least one month prior to randomization. 3. 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): 1. Documented prior ischemic stroke (at least one month prior to randomization), 2. Carotid artery stenosis 50% and history of transient ischemic attack or transient ischemic visual symptoms attributable to the identified lesion(s), 3. Asymptomatic carotid stenosis of at least 70% luminal diameter, 4. History of carotid revascularization (surgical or catheter-based). Peripheral arterial disease: Fulfilled by at least one of the following: 1. History of aorto-iliac or peripheral artery intervention (surgical or catheter based) for limb ischemia, or amputation for limb ischemia, 2. Symptoms of intermittent claudication with ankle:brachial index less than or equal to 0.85. 3\. Renal function: Estimated glomerular filtration rate at least 45 mL/min/1.73 m2. 4\. willing to sign a consent form has been fully executed, and participant agrees to study procedures. Who Should NOT Join This Trial: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. 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. 2. 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): 1. History of myocardial infarction at least one month prior to randomization. 2. History of percutaneous coronary intervention or coronary artery bypass surgery at least one month prior to randomization. 3. 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): 1. Documented prior ischemic stroke (at least one month prior to randomization), 2. Carotid artery stenosis 50% and history of transient ischemic attack or transient ischemic visual symptoms attributable to the identified lesion(s), 3. Asymptomatic carotid stenosis of at least 70% luminal diameter, 4. History of carotid revascularization (surgical or catheter-based). Peripheral arterial disease: Fulfilled by at least one of the following: 1. History of aorto-iliac or peripheral artery intervention (surgical or catheter based) for limb ischemia, or amputation for limb ischemia, 2. Symptoms of intermittent claudication with ankle:brachial index less than or equal to 0.85. 3\. Renal function: Estimated glomerular filtration rate at least 45 mL/min/1.73 m2. 4\. Informed consent has been fully executed, and participant agrees to study procedures. Exclusion Criteria: 1. 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. 2. Treatment with systemic glucocorticoids within 3 months of randomization 3. 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. 4. Total CO2 below the local laboratory lower limit of normal on most recent blood chemistry panel 5. Current treatment with cimetidine, vandetanib, or a systemic treatment with a carbonic anhydrase inhibitor. 6. Cirrhosis, active hepatitis, or jaundice at time of randomization, or total bilirubin \> 2 times upper limit of normal 7. Binge or heavy alcohol consumption within 6 months of randomization 8. Severe anemia (hemoglobin \< 10 g/dL) 9. Prior history of intolerance to metformin 10. Myocardial infarction, coronary revascularization procedure, or stroke within 1 month of randomization 11. Uncontrolled hypertension at screening assessment (systolic blood pressure 180 mm Hg or diastolic blood pressure 110 mm Hg 12. Acute or decompensated congestive heart failure 13. Expected survival less than study duration 14. Participants considered to be unable, unwilling, or unreliable to meet protocol requirements 15. Impaired decision-making capacity, defined by any history of dementia or cognitive impairment 16. Concurrent participation in another research study involving a randomized comparison of drug or device treatments, unless specifically excepted. 17. Pregnant, intent to become pregnant during the trial, or lactating 18. Women of childbearing potential who are not using a highly effective method of contraception

Treatments Being Tested

DRUG

Metformin XR

The study medication dose may be increased by a step-wise fashion up to a maximum of 4 tablets per day.

DRUG

Placebo

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 (20)

Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, United States
Southern Arizona VA Health Care System, Tucson, AZ
Tucson, Arizona, United States
Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR
Little Rock, Arkansas, United States
VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, United States
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States
Bay Pines VA Healthcare System, Pay Pines, FL
Bay Pines, Florida, United States
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States
Miami VA Healthcare System, Miami, FL
Miami, Florida, United States
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States
VA Pacific Islands Health Care System, Honolulu, HI
Honolulu, Hawaii, United States
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, United States
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, United States
Lexington VA Medical Center, Lexington, KY
Lexington, Kentucky, United States
Rehabilitation R&D Service, Baltimore, MD
Baltimore, Maryland, United States