Type 2 DiabetesMALANCT07300293
Lactic Acidosis and Prior Metformin Treatment
An observational study of Type 2 Diabetes, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Metformin is a drug frequently prescribed to patients with type 2 diabetes. Furthermore, diabetes can lead to micro- and macrovascular complications that may cause chronic organ failure. The presence of diabetes also increases the risk of infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2024to May 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: Adult patient (≥18 years) having experienced lactic acidosis (pH <7.35 and lactate level ≥5 mmol/L) within the first 24 hours of hospitalization.
Who may be able to join
- Adult patient (≥18 years)
- Admitted to the intensive care unit of Hautepierre Hospital - Strasbourg University Hospital between January 1, 2014, and December 31, 2023
- Having experienced lactic acidosis (pH <7.35 and lactate level ≥5 mmol/L) within the first 24 hours of hospitalization.
Who cannot join
- Patient without arterial blood gas measurements during the first 24 hours of admission
- whose background treatment is unknown and could not be determined
- for whom a limitation of active therapies was implemented before or during the first 24 hours of hospitalization
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
Service de Médecine Intensive - Réanimation - CHU de Strasbourg - France
Strasbourg, 67091
Vincent CASTELAIN, MD, PhD, 33 3.88.12.79.15, vincent.castelain@chru-strasbourg.fr
Vincent CASTELAIN, MD, PhD
About this study
Official title: Prognosis of Lactic Acidosis Upon Admission to Intensive Care According to the Existence of Prior Treatment With Metformin
Metformin is a drug frequently prescribed to patients with type 2 diabetes. Furthermore, diabetes can lead to micro- and macrovascular complications that may cause chronic organ failure. The presence of diabetes also increases the risk of infections. All of these factors contribute to the frequent admission of patients to the ICU who have been receiving metformin treatment in the preceding days. Acute renal failure, which is also frequently observed upon admission to the ICU, increases the risk of metformin overdose. In cases of overdose, metformin acts on several metabolic pathways that can lead to or even accelerate metabolic acidosis, sometimes severe. However, the impact on prognosis is controversial.
The role of metformin in lactic acidosis in patients treated for acute illness may be underestimated in routine practice.
This study aims to investigate the impact of prior metformin treatment on ICU survival in patients admitted to the ICU with severe lactic acidosis.
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, Metformin Treatment, Lactic acidosis, Metabolic acidosis
- Medical subject headings
- Diabetes Mellitus, Type 2, Acidosis, Lactic, Acidosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rates of patients with severe lactic acidosis admitted to the ICU after prior metformin treatment
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start6 Nov 2024
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300293
- Sponsor's protocol ID
- 9381
- Acronym
- MALA
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis of Lactic Acidosis Upon Admission to Intensive Care According to the Existence of Prior Treatment With Metformin
- ClinicalTrials.gov ID
- NCT07300293
- Acronym / sponsor ID
- MALA / 9381
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, Metformin Treatment, Lactic acidosis, Metabolic acidosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 23 Dec 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.
Metformin is a drug frequently prescribed to patients with type 2 diabetes. Furthermore, diabetes can lead to micro- and macrovascular complications that may cause chronic organ failure. The presence of diabetes also increases the risk of infections. All of these factors contribute to the frequent admission of patients to the ICU who have been receiving metformin treatment in the preceding days. Acute renal failure, which is also frequently observed upon admission to the ICU, increases the risk of metformin overdose. In cases of overdose, metformin acts on several metabolic pathways that can lead to or even accelerate metabolic acidosis, sometimes severe. However, the impact on prognosis is controversial.
The role of metformin in lactic acidosis in patients treated for acute illness may be underestimated in routine practice.
This study aims to investigate the impact of prior metformin treatment on ICU survival in patients admitted to the ICU with severe lactic acidosis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patient (≥18 years) having experienced lactic acidosis (pH <7.35 and lactate level ≥5 mmol/L) within the first 24 hours of hospitalization.
Key inclusion criteria (3 listed)
- Adult patient (≥18 years)
- Admitted to the intensive care unit of Hautepierre Hospital - Strasbourg University Hospital between January 1, 2014, and December 31, 2023
- Having experienced lactic acidosis (pH <7.35 and lactate level ≥5 mmol/L) within the first 24 hours of hospitalization.
Key exclusion criteria (3 listed)
- Patient without arterial blood gas measurements during the first 24 hours of admission
- whose background treatment is unknown and could not be determined
- for whom a limitation of active therapies was implemented before or during the first 24 hours of hospitalization
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
Survival rates of patients with severe lactic acidosis admitted to the ICU after prior metformin treatment
Time frame: Up to 18 months
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 23 Dec 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.
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 Type 2 Diabetes, run by University Hospital, Strasbourg, France 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 3 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 23 Dec 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?
Contact Vincent CASTELAIN, MD, PhD (33 3.88.12.79.15, vincent.castelain@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rates of patients with severe lactic acidosis admitted to the ICU after prior metformin treatment (time frame: Up to 18 months). 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 23 Dec 2025.