Diabetes Mellitus, Type 2NCT05882071
Non-interventional Study (NIS) on Sodium-glucose Co-transporter-2 Inhibitors (SGLT2i) Use in France
An observational study of Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 1 site in France.
Trial summary
The primary objective of this study are: Describe the characteristics of all patients initiating sodium-glucose co-transporter-2 inhibitors (SGLT2i) and the modalities of prescriptions of these two drugs and the concomitant treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Sodium/glucose cotransporter-2 inhibitors (SGLT2i)
- How many people
- 547,150 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2023to 30 Nov 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients in France initiating a treatment with SGLT2i between April 1, 2020, and December 31, 2024.
Who may be able to join
- population includes all patients initiating a treatment with SGLT2i between April 1, 2020, and December 31, 2024.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SGLT2i Use in France Based on SNDS Data Claim
The primary objective of this study are:
- Describe the characteristics of all patients initiating sodium-glucose co-transporter-2 inhibitors (SGLT2i) and the modalities of prescriptions of these two drugs and the concomitant treatments.
Read more
The secondary objectives are:
- Assess the occurrence of atheromatous cardiovascular events (unstable angina, fatal and non-fatal Myocardial infarction (MI), Transient ischemic attack (TIA), fatal and non-fatal stroke), deaths from all causes, hospitalization for heart failure and hospitalization for end-stage renal disease as main and related diagnoses during the exposure to the studied treatment
- Assess the occurrence of the main safety events (ketoacidosis, lower limb amputation and Fournier's gangrene) during the exposure to the studied treatment
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Sodium/glucose cotransporter-2 inhibitors (SGLT2i)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium/glucose cotransporter-2 inhibitors (SGLT2i)Drug
Sodium/glucose cotransporter-2 inhibitors (SGLT2i)
| Study group | Role | What they receive |
|---|---|---|
| Patients initiating treatment with SGLT2i | Not described Receives: Drug: Sodium/glucose cotransporter-2 inhibitors (SGLT2i) | |
| Type 2 diabetes mellitus patients initiating SGLT2i | Not described Receives: Drug: Sodium/glucose cotransporter-2 inhibitors (SGLT2i) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline characteristic: Age
Measured: up to 5 years
Baseline characteristic: Gender
Measured: up to 5 years
Baseline characteristic: Region of residence
Measured: up to 5 years
Baseline characteristic: History of diabetes (date of first Long Term Disease (LTD) status related to diabetes)
Measured: up to 5 years
Baseline characteristic: Type of diabetes
Measured: up to 5 years
Proportion of patients with a history of cardio-vascular events including heart failure hospitalizations and lower limb amputation, renal events, ketoacidosis, Fournier's gangrene over the two years before the index date (initiation of SGLT2i)
Measured: up to 5 years
Secondary outcomes (6)
Incidence rate of acute cardiovascular atheromatous events during the exposure period following initiation of the SGLT2i
Measured: up to 5 years
Time from drug initiation to first event of acute cardiovascular atheromatous events
Measured: up to 5 years
Incidence rate of heart failure hospitalization during the exposure period following initiation of the SGLT2i
Measured: up to 5 years
Time from drug initiation to first event of heart failure hospitalization
Measured: up to 5 years
Incidence rate of deaths all cause during the exposure period following initiation of the SGLT2i
Measured: up to 5 years
Time from drug initiation to death all cause
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start15 Nov 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 547,150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882071
- Sponsor's protocol ID
- 1245-0287
- Status last verified
- Oct 2026
- First submitted
- 22 May 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SGLT2i Use in France Based on SNDS Data Claim
- ClinicalTrials.gov ID
- NCT05882071
- Acronym / sponsor ID
- 1245-0287
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 547,150 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 31 May 2023 (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.
The primary objective of this study are:
- Describe the characteristics of all patients initiating sodium-glucose co-transporter-2 inhibitors (SGLT2i) and the modalities of prescriptions of these two drugs and the concomitant treatments.
The secondary objectives are:
- Assess the occurrence of atheromatous cardiovascular events (unstable angina, fatal and non-fatal Myocardial infarction (MI), Transient ischemic attack (TIA), fatal and non-fatal stroke), deaths from all causes, hospitalization for heart failure and hospitalization for end-stage renal disease as main and related diagnoses during the exposure to the studied treatment
- Assess the occurrence of the main safety events (ketoacidosis, lower limb amputation and Fournier's gangrene) during the exposure to the studied treatment
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients initiating treatment with SGLT2i | – | Drug: Sodium/glucose cotransporter-2 inhibitors (SGLT2i) |
| Type 2 diabetes mellitus patients initiating SGLT2i | – | Drug: Sodium/glucose cotransporter-2 inhibitors (SGLT2i) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients in France initiating a treatment with SGLT2i between April 1, 2020, and December 31, 2024.
Key inclusion criteria (1 listed)
- population includes all patients initiating a treatment with SGLT2i between April 1, 2020, and December 31, 2024.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium/glucose cotransporter-2 inhibitors (SGLT2i)Sodium/glucose cotransporter-2 inhibitors (SGLT2i) | Drug | Patients initiating treatment with SGLT2i, Type 2 diabetes mellitus patients initiating SGLT2i |
Primary outcome
Baseline characteristic: Age
Time frame: up to 5 years
Baseline characteristic: Gender
Time frame: up to 5 years
Baseline characteristic: Region of residence
Time frame: up to 5 years
Baseline characteristic: History of diabetes (date of first Long Term Disease (LTD) status related to diabetes)
Time frame: up to 5 years
Baseline characteristic: Type of diabetes
Time frame: up to 5 years
Proportion of patients with a history of cardio-vascular events including heart failure hospitalizations and lower limb amputation, renal events, ketoacidosis, Fournier's gangrene over the two years before the index date (initiation of SGLT2i)
Time frame: up to 5 years
6 secondary outcomes
Incidence rate of acute cardiovascular atheromatous events during the exposure period following initiation of the SGLT2i
Time frame: up to 5 years
Time from drug initiation to first event of acute cardiovascular atheromatous events
Time frame: up to 5 years
Incidence rate of heart failure hospitalization during the exposure period following initiation of the SGLT2i
Time frame: up to 5 years
Time from drug initiation to first event of heart failure hospitalization
Time frame: up to 5 years
Incidence rate of deaths all cause during the exposure period following initiation of the SGLT2i
Time frame: up to 5 years
Time from drug initiation to death all cause
Time frame: up to 5 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 13 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Diabetes Mellitus, Type 2, run by Boehringer Ingelheim 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline characteristic: Age (time frame: up to 5 years). The study lists 6 primary outcomes in all. 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 13 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.