An observational study in Diabetes Mellitus, Type 2, sponsored by Boehringer Ingelheim. Active, not recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Boehringer Ingelheim · Observational
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:
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 547,150 is above the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients in France initiating a treatment with SGLT2i between April 1, 2020, and December 31, 2024.
Exclusion Criteria:
Drug: Sodium/glucose cotransporter-2 inhibitors (SGLT2i)
Drug: Sodium/glucose cotransporter-2 inhibitors (SGLT2i)
Sodium/glucose cotransporter-2 inhibitors (SGLT2i)
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
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
Plan to share: 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
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim