Drug OverdoseNCT07193069
Clinical and Biological Signs of Dapagliflozin Overdose in ICU Patients With Metformin Poisoning
An observational study of Drug Overdose and Metformin, run by Centre Hospitalier de Saint-Denis at 1 site in France.
Trial summary
This study looks at patients admitted to intensive care for drug poisoning involving metformin, a common diabetes medication. Researchers will compare two groups: patients who overdosed on metformin alone and those who took both metformin and dapagliflozin, another diabetes drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Overdose, Metformin, Dapagliflozin
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 11 Apr 2025to 11 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Patients under 18 years of age
- No exposure to metformin
- Exposure to dapagliflozin without metformin
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Saint-Denis
Saint-Denis, France
Nolan HASSOLD, 0142356140, coordination.rechercheclinique@ghtpdfr.fr
About this study
This study looks at patients admitted to intensive care for drug poisoning involving metformin, a common diabetes medication. Researchers will compare two groups: patients who overdosed on metformin alone and those who took both metformin and dapagliflozin, another diabetes drug. The goal is to find clinical or laboratory signs that could help doctors quickly recognize a dapagliflozin overdose in this context, which could improve treatment and patient outcomes.
- Conditions
- Drug Overdose, Metformin, Dapagliflozin, Lactic Acidosis, Diabetic Ketoacidosis, Intensive Care Units
- Medical subject headings
- Drug Overdose, Acidosis, Lactic, Diabetic Ketoacidosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of clinical and biological differences between patients admitted to intensive care for metformin overdose alone versus those with combined metformin and dapagliflozin overdose.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start11 Apr 2025
- Primary completion11 Apr 2026 (estimated)
- Study completion11 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug OverdoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193069
- Sponsor's protocol ID
- 0109_REANIMATION_INTEND
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biological Signs of Dapagliflozin Overdose in ICU Patients With Metformin Poisoning
- ClinicalTrials.gov ID
- NCT07193069
- Acronym / sponsor ID
- 0109_REANIMATION_INTEND
- Conditions
- Drug Overdose, Metformin, Dapagliflozin, Lactic Acidosis, Diabetic Ketoacidosis, Intensive Care Units
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 11 Apr 2026 (estimated)
- Study completion
- 11 Apr 2026 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study looks at patients admitted to intensive care for drug poisoning involving metformin, a common diabetes medication. Researchers will compare two groups: patients who overdosed on metformin alone and those who took both metformin and dapagliflozin, another diabetes drug. The goal is to find clinical or laboratory signs that could help doctors quickly recognize a dapagliflozin overdose in this context, which could improve treatment and patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Patients under 18 years of age
- No exposure to metformin
- Exposure to dapagliflozin without metformin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of clinical and biological differences between patients admitted to intensive care for metformin overdose alone versus those with combined metformin and dapagliflozin overdose.
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Centre Hospitalier de Saint-Denis
Saint-Denis, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Overdose and Metformin, run by Centre Hospitalier de Saint-Denis at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of clinical and biological differences between patients admitted to intensive care for metformin overdose alone versus those with combined metformin and dapagliflozin overdose. (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.