Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes

PHASE4RecruitingINTERVENTIONAL
Enrollment

7,410

Participants

Timeline

Start Date

April 3, 2023

Primary Completion Date

March 31, 2029

Study Completion Date

March 31, 2029

Conditions
Prediabetic StateAtherosclerosisMetformin
Interventions
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"

Trial Locations (40)

21202

RECRUITING

Rehabilitation R&D Service, Baltimore, MD, Baltimore

23249

RECRUITING

Hunter Holmes McGuire VA Medical Center, Richmond, VA, Richmond

33125

RECRUITING

Miami VA Healthcare System, Miami, FL, Miami

60612

TERMINATED

Jesse Brown VA Medical Center, Chicago, IL, Chicago

85012

ACTIVE_NOT_RECRUITING

Phoenix VA Health Care System, Phoenix, AZ, Phoenix

90822

RECRUITING

VA Long Beach Healthcare System, Long Beach, CA, Long Beach

85723-0001

RECRUITING

Southern Arizona VA Health Care System, Tucson, AZ, Tucson

72205-5484

RECRUITING

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

92357-1000

RECRUITING

VA Loma Linda Healthcare System, Loma Linda, CA, Loma Linda

94304-1207

RECRUITING

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

92161-0002

RECRUITING

VA San Diego Healthcare System, San Diego, CA, San Diego

90073-1003

RECRUITING

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

80045-7211

RECRUITING

Rocky Mountain Regional VA Medical Center, Aurora, CO, Aurora

06516-2770

RECRUITING

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

33744-0000

RECRUITING

Bay Pines VA Healthcare System, Pay Pines, FL, Bay Pines

32608-1135

RECRUITING

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

30033-4004

RECRUITING

Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur

96819-1522

RECRUITING

VA Pacific Islands Health Care System, Honolulu, HI, Honolulu

60141-3030

RECRUITING

Edward Hines Jr. VA Hospital, Hines, IL, Hines

52246-2292

RECRUITING

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

40502-2235

NOT_YET_RECRUITING

Lexington VA Medical Center, Lexington, KY, Lexington

02130-4817

RECRUITING

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

55417-2309

RECRUITING

Minneapolis VA Health Care System, Minneapolis, MN, Minneapolis

64128-2226

RECRUITING

Kansas City VA Medical Center, Kansas City, MO, Kansas City

68105-1850

RECRUITING

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

87108-5153

RECRUITING

New Mexico VA Health Care System, Albuquerque, NM, Albuquerque

10010-5011

RECRUITING

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

27705-3875

RECRUITING

Durham VA Medical Center, Durham, NC, Durham

45220-2213

RECRUITING

Cincinnati VA Medical Center, Cincinnati, OH, Cincinnati

44106-1702

RECRUITING

Louis Stokes VA Medical Center, Cleveland, OH, Cleveland

97207-2964

RECRUITING

VA Portland Health Care System, Portland, OR, Portland

29401-5703

RECRUITING

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

29209-1638

RECRUITING

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

38104-2127

RECRUITING

Memphis VA Medical Center, Memphis, TN, Memphis

75216-7167

RECRUITING

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

77030-4211

RECRUITING

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

84148-0001

RECRUITING

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

24153-6404

RECRUITING

Salem VA Medical Center, Salem, VA, Salem

25704-9300

RECRUITING

Huntington VA Medical Center, Huntington, WV, Huntington

53295-0001

RECRUITING

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

All Listed Sponsors
lead

VA Office of Research and Development

FED