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Common diabetes drug tested to save hearts in Pre-Diabetes

NCT ID NCT02915198

Disease control Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether metformin, a common diabetes medicine, can reduce the risk of death, heart attacks, and strokes in veterans who have pre-diabetes and already have heart or blood vessel disease. About 7,410 participants will receive either metformin or a placebo. The goal is to see if metformin can help control the disease and prevent serious cardiovascular events.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Metformin (extended-release)
What this could lead to
If it works, this could show that metformin helps prevent major heart problems in people with pre-diabetes and existing heart disease.
What could go wrong
This is a large Phase 4 trial, but metformin is already widely used for diabetes. It may not provide additional heart benefits for pre-diabetes, and some people may experience digestive side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 7,410 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

atherosclerosis atherosclerotic cardiovascular disease cerebrovascular disorder coronary artery disorder peripheral arterial disease prediabetes syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atherosclerosis Metformin Prediabetic state

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    38 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atlanta VA Medical and Rehab Center, Decatur, GA

    RECRUITING

    Decatur, Georgia, 30033-4004, United States

  • Bay Pines VA Healthcare System, Pay Pines, FL

    RECRUITING

    Bay Pines, Florida, 33744-0000, United States

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

    RECRUITING

    Little Rock, Arkansas, 72205-5484, United States

  • Cincinnati VA Medical Center, Cincinnati, OH

    ACTIVE_NOT_RECRUITING

    Cincinnati, Ohio, 45220-2213, United States

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

    RECRUITING

    Milwaukee, Wisconsin, 53295-0001, United States

  • Durham VA Medical Center, Durham, NC

    RECRUITING

    Durham, North Carolina, 27705-3875, United States

  • Edward Hines Jr. VA Hospital, Hines, IL

    RECRUITING

    Hines, Illinois, 60141-3030, United States

  • Hunter Holmes McGuire VA Medical Center, Richmond, VA

    RECRUITING

    Richmond, Virginia, 23249, United States

  • Huntington VA Medical Center, Huntington, WV

    RECRUITING

    Huntington, West Virginia, 25704-9300, United States

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

    RECRUITING

    Iowa City, Iowa, 52246-2292, United States

  • Jesse Brown VA Medical Center, Chicago, IL

    TERMINATED

    Chicago, Illinois, 60612, United States

  • Kansas City VA Medical Center, Kansas City, MO

    RECRUITING

    Kansas City, Missouri, 64128-2226, United States

  • Lexington VA Medical Center, Lexington, KY

    NOT_YET_RECRUITING

    Lexington, Kentucky, 40502-2235, United States

  • Louis Stokes VA Medical Center, Cleveland, OH

    RECRUITING

    Cleveland, Ohio, 44106-1702, United States

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

    RECRUITING

    New York, New York, 10010-5011, United States

  • Memphis VA Medical Center, Memphis, TN

    RECRUITING

    Memphis, Tennessee, 38104-2127, United States

  • Miami VA Healthcare System, Miami, FL

    RECRUITING

    Miami, Florida, 33125, United States

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

    RECRUITING

    Houston, Texas, 77030-4211, United States

  • Minneapolis VA Health Care System, Minneapolis, MN

    RECRUITING

    Minneapolis, Minnesota, 55417-2309, United States

  • New Mexico VA Health Care System, Albuquerque, NM

    RECRUITING

    Albuquerque, New Mexico, 87108-5153, United States

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

    RECRUITING

    Gainesville, Florida, 32608-1135, United States

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

    RECRUITING

    Omaha, Nebraska, 68105-1850, United States

  • Phoenix VA Health Care System, Phoenix, AZ

    RECRUITING

    Phoenix, Arizona, 85012, United States

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

    RECRUITING

    Charleston, South Carolina, 29401-5703, United States

  • Rehabilitation R&D Service, Baltimore, MD

    RECRUITING

    Baltimore, Maryland, 21202, United States

  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    RECRUITING

    Aurora, Colorado, 80045-7211, United States

  • Salem VA Medical Center, Salem, VA

    RECRUITING

    Salem, Virginia, 24153-6404, United States

  • Southern Arizona VA Health Care System, Tucson, AZ

    RECRUITING

    Tucson, Arizona, 85723-0001, United States

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

    RECRUITING

    Boston, Massachusetts, 02130-4817, United States

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

    RECRUITING

    West Haven, Connecticut, 06516-2770, United States

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

    RECRUITING

    West Los Angeles, California, 90073-1003, United States

  • VA Loma Linda Healthcare System, Loma Linda, CA

    RECRUITING

    Loma Linda, California, 92357-1000, United States

  • VA Long Beach Healthcare System, Long Beach, CA

    RECRUITING

    Long Beach, California, 90822, United States

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

    RECRUITING

    Dallas, Texas, 75216-7167, United States

  • VA Pacific Islands Health Care System, Honolulu, HI

    RECRUITING

    Honolulu, Hawaii, 96819-1522, United States

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

    RECRUITING

    Palo Alto, California, 94304-1207, United States

  • VA Portland Health Care System, Portland, OR

    RECRUITING

    Portland, Oregon, 97207-2964, United States

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

    RECRUITING

    Salt Lake City, Utah, 84148-0001, United States

  • VA San Diego Healthcare System, San Diego, CA

    RECRUITING

    San Diego, California, 92161-0002, United States

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

    RECRUITING

    Columbia, South Carolina, 29209-1638, United States

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