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NCT02915198PHASE4Recruiting

Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes

VA Office of Research and Development

Start Date

4/3/2023

Completion Date

9/28/2029

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.

Detailed Description

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 based on safety and tolerability) or matching placebo. All patients receive counseling on therapeutic lifestyle recommendations. CSP #2002 had a Pilot Phase trial from 2/2019 to 1/2021 and was approved for the full-scale trial, with Full-scale study launch in 04/2023.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Metformin XR

DRUG

Placebo

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Conditions

Prediabetic StateAtherosclerosisMetformin

Locations

Phoenix VA Health Care System, Phoenix, AZ

Phoenix, Arizona 85012

United States

Southern Arizona VA Health Care System, Tucson, AZ

Tucson, Arizona 85723-0001

United States

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

Little Rock, Arkansas 72205-5484

United States

VA Loma Linda Healthcare System, Loma Linda, CA

Loma Linda, California 92357-1000

United States

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California 90822

United States

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California 94304-1207

United States

VA San Diego Healthcare System, San Diego, CA

San Diego, California 92161-0002

United States

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

West Los Angeles, California 90073-1003

United States

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado 80045-7211

United States

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

West Haven, Connecticut 06516-2770

United States

Bay Pines VA Healthcare System, Pay Pines, FL

Bay Pines, Florida 33744-0000

United States

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

Gainesville, Florida 32608-1135

United States

Miami VA Healthcare System, Miami, FL

Miami, Florida 33125

United States

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia 30033-4004

United States

VA Pacific Islands Health Care System, Honolulu, HI

Honolulu, Hawaii 96819-1522

United States

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois 60612

United States

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois 60141-3030

United States

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa 52246-2292

United States

Lexington VA Medical Center, Lexington, KY

Lexington, Kentucky 40502-2235

United States

Rehabilitation R&D Service, Baltimore, MD

Baltimore, Maryland 21202

United States

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

Boston, Massachusetts 02130-4817

United States

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota 55417-2309

United States

Kansas City VA Medical Center, Kansas City, MO

Kansas City, Missouri 64128-2226

United States

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

Omaha, Nebraska 68105-1850

United States

New Mexico VA Health Care System, Albuquerque, NM

Albuquerque, New Mexico 87108-5153

United States

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

New York, New York 10010-5011

United States

Durham VA Medical Center, Durham, NC

Durham, North Carolina 27705-3875

United States

Cincinnati VA Medical Center, Cincinnati, OH

Cincinnati, Ohio 45220-2213

United States

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio 44106-1702

United States

VA Portland Health Care System, Portland, OR

Portland, Oregon 97207-2964

United States

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina 29401-5703

United States

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

Columbia, South Carolina 29209-1638

United States

Memphis VA Medical Center, Memphis, TN

Memphis, Tennessee 38104-2127

United States

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

Dallas, Texas 75216-7167

United States

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas 77030-4211

United States

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

Salt Lake City, Utah 84148-0001

United States

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia 23249

United States

Salem VA Medical Center, Salem, VA

Salem, Virginia 24153-6404

United States

Huntington VA Medical Center, Huntington, WV

Huntington, West Virginia 25704-9300

United States

Clement J. Zablocki VA Medical Center, Milwaukee, WI

Milwaukee, Wisconsin 53295-0001

United States