Diabetes Mellitus, Type 2
Conditions
Brief 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. 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
Interventions
DRUGSodium/glucose cotransporter-2 inhibitors (SGLT2i)
Sodium/glucose cotransporter-2 inhibitors (SGLT2i)
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* population includes all patients initiating a treatment with SGLT2i between April 1, 2020, and December 31, 2024.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baseline characteristic: Age | up to 5 years |
| Baseline characteristic: Gender | up to 5 years |
| Baseline characteristic: Region of residence | up to 5 years |
| Baseline characteristic: History of diabetes (date of first Long Term Disease (LTD) status related to diabetes) | up to 5 years |
| Baseline characteristic: Type of diabetes | 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) | up to 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Incidence rate of acute cardiovascular atheromatous events during the exposure period following initiation of the SGLT2i | up to 5 years |
| Time from drug initiation to first event of acute cardiovascular atheromatous events | up to 5 years |
| Incidence rate of heart failure hospitalization during the exposure period following initiation of the SGLT2i | up to 5 years |
| Time from drug initiation to first event of heart failure hospitalization | up to 5 years |
| Incidence rate of deaths all cause during the exposure period following initiation of the SGLT2i | up to 5 years |
| Time from drug initiation to death all cause | up to 5 years |
Countries
France
Outcome results
None listed