Actively Recruiting
Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes
Led by VA Office of Research and Development · Updated on 2025-12-17
7410
Participants Needed
40
Research Sites
338 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Pre-diabetes defined by HbA1c between 5.7% and less than 6.5%, or two fasting plasma glucose measurements of 100-125 mg/dL on separate days, or 2-hour plasma glucose 140-199 mg/dL after a 75 g oral glucose tolerance test
- Established atherosclerotic cardiovascular disease in coronary, cerebrovascular, or peripheral arterial circulation
- Coronary artery disease defined by history of myocardial infarction at least 1 month before randomization, or history of coronary intervention or surgery at least 1 month before randomization, or angiographic evidence of at least 50% stenosis in at least two major coronary arteries
- Cerebrovascular disease defined by prior ischemic stroke at least 1 month before randomization, or carotid artery stenosis 50% with history of transient ischemic attack or visual symptoms, or asymptomatic carotid stenosis 70% or more, or history of carotid revascularization
- Peripheral arterial disease defined by history of arterial intervention or amputation for limb ischemia, or symptoms of intermittent claudication with ankle-brachial index 0.85 or less
- Estimated glomerular filtration rate (kidney function) of at least 45 mL/min/1.73 m2
- Ability and willingness to provide informed consent and agree to study procedures
You will not qualify if you...
- Use of metformin or other anti-diabetic medication within 12 months before randomization
- Treatment with systemic glucocorticoids within 3 months before randomization
- Fasting plasma glucose over 130 mg/dL between screening and randomization, or any plasma glucose over 180 mg/dL or HbA1c 7.0% or higher within 12 months before randomization
- Total CO2 below local lab lower limit on recent blood chemistry
- Current treatment with cimetidine, vandetanib, or systemic carbonic anhydrase inhibitors
- Liver disease including cirrhosis, active hepatitis, jaundice, or total bilirubin over twice the upper limit of normal
- Binge or heavy alcohol use within 6 months before randomization
- Severe anemia with hemoglobin less than 10 g/dL
- Prior intolerance to metformin
- Heart attack, coronary procedure, or stroke within 1 month before randomization
- Uncontrolled high blood pressure (systolic ≥180 mm Hg or diastolic ≥110 mm Hg)
- Acute or decompensated congestive heart failure
- Life expectancy less than study duration
- Unable, unwilling, or unreliable to comply with study
- History of dementia or cognitive impairment
- Participation in another drug or device randomized study unless excepted
- Pregnant, intending pregnancy, or breastfeeding
- Women of childbearing potential not using highly effective contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 40 locations
1
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, United States, 85012
Actively Recruiting
2
Southern Arizona VA Health Care System, Tucson, AZ
Tucson, Arizona, United States, 85723-0001
Actively Recruiting
3
Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR
Little Rock, Arkansas, United States, 72205-5484
Actively Recruiting
4
VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, United States, 92357-1000
Actively Recruiting
5
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States, 90822
Actively Recruiting
6
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1207
Actively Recruiting
7
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161-0002
Actively Recruiting
8
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073-1003
Actively Recruiting
9
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States, 80045-7211
Actively Recruiting
10
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States, 06516-2770
Actively Recruiting
11
Bay Pines VA Healthcare System, Pay Pines, FL
Bay Pines, Florida, United States, 33744-0000
Actively Recruiting
12
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States, 32608-1135
Actively Recruiting
13
Miami VA Healthcare System, Miami, FL
Miami, Florida, United States, 33125
Actively Recruiting
14
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033-4004
Actively Recruiting
15
VA Pacific Islands Health Care System, Honolulu, HI
Honolulu, Hawaii, United States, 96819-1522
Actively Recruiting
16
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, United States, 60612
Terminated
17
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-3030
Actively Recruiting
18
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, United States, 52246-2292
Actively Recruiting
19
Lexington VA Medical Center, Lexington, KY
Lexington, Kentucky, United States, 40502-2235
Not Yet Recruiting
20
Rehabilitation R&D Service, Baltimore, MD
Baltimore, Maryland, United States, 21202
Actively Recruiting
21
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130-4817
Actively Recruiting
22
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417-2309
Actively Recruiting
23
Kansas City VA Medical Center, Kansas City, MO
Kansas City, Missouri, United States, 64128-2226
Actively Recruiting
24
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, United States, 68105-1850
Actively Recruiting
25
New Mexico VA Health Care System, Albuquerque, NM
Albuquerque, New Mexico, United States, 87108-5153
Actively Recruiting
26
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, United States, 10010-5011
Actively Recruiting
27
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705-3875
Actively Recruiting
28
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, United States, 45220-2213
Active, Not Recruiting
29
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106-1702
Actively Recruiting
30
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States, 97207-2964
Actively Recruiting
31
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States, 29401-5703
Actively Recruiting
32
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
Columbia, South Carolina, United States, 29209-1638
Actively Recruiting
33
Memphis VA Medical Center, Memphis, TN
Memphis, Tennessee, United States, 38104-2127
Actively Recruiting
34
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States, 75216-7167
Actively Recruiting
35
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030-4211
Actively Recruiting
36
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States, 84148-0001
Actively Recruiting
37
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, United States, 23249
Actively Recruiting
38
Salem VA Medical Center, Salem, VA
Salem, Virginia, United States, 24153-6404
Actively Recruiting
39
Huntington VA Medical Center, Huntington, WV
Huntington, West Virginia, United States, 25704-9300
Actively Recruiting
40
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, United States, 53295-0001
Actively Recruiting
Research Team
G
Gregory G Schwartz, PhD MD
CONTACT
K
Kevin Gropp
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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