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Phase 4Recruiting

Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes

Sponsored by VA Office of Research and Development

About this study

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.

CSP #2002 is a multicenter, prospective, randomized, double blind, secondary prevention trial to test the hypothesis that treatment with metformin, compared with placebo, reduces mortality and cardiovascular morbidity in Veterans with pre-diabetes and established atherosclerotic cardiovascular disease. Qualifying patients have pre-diabetes defined by HbA1c, fasting blood glucose, or oral glucose tolerance test criteria; clinically evident coronary, cerebrovascular, or peripheral arterial atherosclerotic cardiovascular disease; and estimated glomerular filtration rate of at least 45 mL/min/1.73 m2; and do not fulfill any exclusion criteria. Patients who are eligible and agree to participate are randomly assigned to treatment with metformin XR (titrated to a maximum dose of 2000 mg daily bas…

Where this study is enrolling (38)

  • Southern Arizona VA Health Care System, Tucson, AZ

    Tucson, Arizona

    I'm interested

  • Phoenix VA Health Care System, Phoenix, AZ

    Phoenix, Arizona

    I'm interested

  • Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR

    Little Rock, Arkansas

    I'm interested

  • VA Loma Linda Healthcare System, Loma Linda, CA

    Loma Linda, California

    I'm interested

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

    West Los Angeles, California

    I'm interested
Show all 38 locations

  • VA Long Beach Healthcare System, Long Beach, CA

    Long Beach, California

    I'm interested

  • VA San Diego Healthcare System, San Diego, CA

    San Diego, California

    I'm interested

  • VA Palo Alto Health Care System, Palo Alto, CA

    Palo Alto, California

    I'm interested

  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    Aurora, Colorado

    I'm interested

  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT

    West Haven, Connecticut

    I'm interested

  • North Florida/South Georgia Veterans Health System, Gainesville, FL

    Gainesville, Florida

    I'm interested

  • Bay Pines VA Healthcare System, Pay Pines, FL

    Bay Pines, Florida

    I'm interested

  • Miami VA Healthcare System, Miami, FL

    Miami, Florida

    I'm interested

  • Atlanta VA Medical and Rehab Center, Decatur, GA

    Decatur, Georgia

    I'm interested

  • VA Pacific Islands Health Care System, Honolulu, HI

    Honolulu, Hawaii

    I'm interested

  • Edward Hines Jr. VA Hospital, Hines, IL

    Hines, Illinois

    I'm interested

  • Iowa City VA Health Care System, Iowa City, IA

    Iowa City, Iowa

    I'm interested

  • Lexington VA Medical Center, Lexington, KY

    Lexington, Kentucky

    I'm interested

  • Rehabilitation R&D Service, Baltimore, MD

    Baltimore, Maryland

    I'm interested

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    Boston, Massachusetts

    I'm interested

  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis, Minnesota

    I'm interested

  • Kansas City VA Medical Center, Kansas City, MO

    Kansas City, Missouri

    I'm interested

  • Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

    Omaha, Nebraska

    I'm interested

  • New Mexico VA Health Care System, Albuquerque, NM

    Albuquerque, New Mexico

    I'm interested

  • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

    New York, New York

    I'm interested

  • Durham VA Medical Center, Durham, NC

    Durham, North Carolina

    I'm interested

  • Louis Stokes VA Medical Center, Cleveland, OH

    Cleveland, Ohio

    I'm interested

  • VA Portland Health Care System, Portland, OR

    Portland, Oregon

    I'm interested

  • Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC

    Columbia, South Carolina

    I'm interested

  • Ralph H. Johnson VA Medical Center, Charleston, SC

    Charleston, South Carolina

    I'm interested

  • Memphis VA Medical Center, Memphis, TN

    Memphis, Tennessee

    I'm interested

  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

    Dallas, Texas

    I'm interested

  • Michael E. DeBakey VA Medical Center, Houston, TX

    Houston, Texas

    I'm interested

  • VA Salt Lake City Health Care System, Salt Lake City, UT

    Salt Lake City, Utah

    I'm interested

  • Salem VA Medical Center, Salem, VA

    Salem, Virginia

    I'm interested

  • Hunter Holmes McGuire VA Medical Center, Richmond, VA

    Richmond, Virginia

    I'm interested

  • Huntington VA Medical Center, Huntington, WV

    Huntington, West Virginia

    I'm interested

  • Clement J. Zablocki VA Medical Center, Milwaukee, WI

    Milwaukee, Wisconsin

    I'm interested
Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.