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Could a diabetes pill save lives in septic shock?

NCT ID NCT07488689

Disease control Sponsor: University Hospital, Strasbourg, France 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether dapagliflozin, a drug used for diabetes, can help people with septic shock—a severe infection that causes organ failure. The drug aims to protect blood vessels and reduce inflammation. About 568 ICU patients will receive either dapagliflozin or a placebo, and researchers will track survival and recovery over 28 days.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 568 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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. Patient aged ≥ 18 years 2. Hospitalized in ICU for septic shock according to Sepsis-3 definition (PMID: 26903338). Septic shock should be the primary reason for admission. 3. Septic shock diagnosed for less than 12 hours prior to randomization 4. Skin mottling (mottling score ≥ 2) according to Ait-Oufella and/or prolonged capillary refill time \> 3 seconds 5. Patient benefiting from social health insurance (or having a close relative who is a beneficiary) 6. Patient or legal representative having signed an informed consent to participate in the study. In case immediate consent is not possible, an emergency procedure will be applied in accordance with current regulations Exclusion Criteria: 1. Patient in whom oral administration is not possible at the initial stage (e.g., emergency digestive surgery, acute mesenteric ischemia, etc.). 2. Patient treated with SGLT2 inhibitor before ICU admission 3. Hypoglycemia \< 0.5 g/L (2.75 mmol/L) 4. End-stage kidney disease undergoing maintenance dialysis 5. Medical history of type 1 diabetes (gliflozins are not authorized for treatment of this type of diabetes) 6. Medical history of diabetic ketoacidosis 7. Ongoing Fournier's gangrene 8. Current treatment with lithium 9. Cirrhose child C 10. Do not resuscitate order at inclusion in the study 11. Concomitant participation in another interventional therapeutic trial 12. Patient deprived of liberty or under legal protection (guardianship, conservatorship, or legal protection) 13. Pregnancy or breastfeeding 14. Contraindications to dapagliflozin

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Conditions

The condition(s) this trial relates to.

toxic shock syndrome

As listed by the trial registrant

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

Septic shock

How to take part

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

  1. The places running it

    1 site. 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

  • Hôpital Civil, Service de médecine intensive et réanimation, Hôpitaux Universitaires de Strasbourg

    Strasbourg, France

More trials for these conditions

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