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Can a common diabetes drug stop prediabetes in its tracks? early study tests feasibility

NCT ID NCT06828731

Disease control Sponsor: Charles George VA Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether it's possible to use the diabetes drug empagliflozin in 60 veterans with prediabetes. Participants took the drug or received standard lifestyle advice for 12 weeks. The main goal was to see if people would join and stay in the study, not to prove the drug works. If successful, it could pave the way for larger trials to see if empagliflozin can prevent diabetes.

What this could mean

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

Active substance
Empagliflozin (a diabetes drug that helps the kidneys remove sugar from the body)
What this could lead to
If this pilot shows it's feasible, it could lead to larger studies testing whether empagliflozin can prevent or delay type 2 diabetes in people with prediabetes.
What could go wrong
This is a very small, early-phase feasibility study with only 60 veterans. It is not designed to prove the drug works for prediabetes, and results may not apply to the general population.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

60 people

The number who actually took part.

Started

Dec 2024

Finished

Sep 2025

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

35 to 60 years

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: Diagnosis of prediabetes defined by HbA1c \>5.7% and \<6.5% or fasting glucose 100-125 mg/dL with documentation of diagnosis (ICD-10 code) within electronic health record at time of enrollment * Age 35 to 60 years at time of enrollment * Able to read and speak English Exclusion Criteria: * Diagnosis of diabetes (type 2 or type 1) * Contraindication to SGLT2i medication per medication labeling, prior adverse reaction to SGLT2i medication, or received SGLT2i medication within the 6 months prior to enrollment * Currently prescribed an antihyperglycemic agent approved for treatment of type 2 diabetes or taking any FDA-approved weight loss agent or over-the-counter supplement promoted for weight loss * Veterans unable to complete informed consent process (Veterans with impaired decision-making ability or who require use of a legally authorized representative) * Women who are pregnant or may become pregnant * Veterans with neurogenic bladder, indwelling catheter, or urinary tract infection within the previous 12 months requiring hospitalization or emergency department visit

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Conditions

The condition(s) this trial relates to.

prediabetes syndrome type 2 diabetes mellitus prevention target

As listed by the trial registrant

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

Prediabetes

Contacts and locations

Locations

  • Charles George VA Medical Center

    Asheville, North Carolina, 28805, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.