Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes
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
Interventions
Metformin XR
Placebo
Conditions
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