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New study aims to spot hidden danger in diabetes drug overdoses

NCT ID NCT07193069

Knowledge-focused Sponsor: Centre Hospitalier de Saint-Denis Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study examines patients in intensive care who have overdosed on metformin, a common diabetes drug. Researchers will compare those who took only metformin with those who also took dapagliflozin, another diabetes medication. The goal is to find specific signs that could help doctors quickly recognize a dapagliflozin overdose and improve treatment.

What this could mean

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

Active substance
dapagliflozin
What this could lead to
If successful, this study could help doctors quickly identify a dapagliflozin overdose in patients with metformin poisoning, leading to better care in the ICU.
What could go wrong
This is a small observational study with only 50 participants, so results may not apply to all patients. It is not testing a new treatment, only looking for patterns.

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.

Participants

About 50 people

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

Started

Apr 2025

Expected to finish

Apr 2026

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.

Who is studied

The study population will consist of adult patients (aged 18 years and older) who were admitted to intensive care units across multiple centers for acute drug poisoning involving metformin, with or without dapagliflozin. Participants will be identified retrospectively through case collection from the SRLF (Société de Réanimation de Langue Française) and existing hospital records over the past 10 years. The study will include both cases of isolated metformin overdose and cases of combined metformin and dapagliflozin overdose.

Ages

18 years and older

Sex

Anyone

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: * Adults aged 18 years or older * Admission to an intensive care unit (ICU) due to acute drug poisoning * Documented exposure to either: * Metformin alone * Metformin in combination with dapagliflozin Exclusion Criteria: * Patients under 18 years of age * No exposure to metformin * Exposure to dapagliflozin without metformin

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Conditions

The condition(s) this trial relates to.

diabetic ketoacidosis Drug Overdose lactic acidosis poisoning

As listed by the trial registrant

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

Dapagliflozin Diabetic ketoacidosis Drug overdose Intensive care units Lactic acidosis Metformin

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

  • Centre Hospitalier de Saint-Denis

    RECRUITING

    Saint-Denis, France, France

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