Non-interventional Study (NIS) on Sodium-glucose Co-transporter-2 Inhibitors (SGLT2i) Use in France
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients initiating treatment with SGLT2i
|
Drug: Sodium/glucose cotransporter-2 inhibitors (SGLT2i)
Sodium/glucose cotransporter-2 inhibitors (SGLT2i)
|
| Type 2 diabetes mellitus patients initiating SGLT2i
|
Drug: Sodium/glucose cotransporter-2 inhibitors (SGLT2i)
Sodium/glucose cotransporter-2 inhibitors (SGLT2i)
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
- population includes all patients initiating a treatment with SGLT2i between April 1, 2020, and December 31, 2024.
Exclusion Criteria:
- None
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1245-0287