Non-interventional Study (NIS) on Sodium-glucose Co-transporter-2 Inhibitors (SGLT2i) Use in France

Study Overview
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Brief Summary
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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

Official Title
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SGLT2i Use in France Based on SNDS Data Claim

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Sodium/glucose cotransporter-2 inhibitors (SGLT2i)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: population includes all patients initiating a treatment with SGLT2i between April 1, 2020, and December 31, 2024. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients initiating treatment with SGLT2i<br> | Drug: Sodium/glucose cotransporter-2 inhibitors (SGLT2i)<br>* Sodium/glucose cotransporter-2 inhibitors (SGLT2i)<br>|
| Type 2 diabetes mellitus patients initiating SGLT2i<br> | Drug: Sodium/glucose cotransporter-2 inhibitors (SGLT2i)<br>* Sodium/glucose cotransporter-2 inhibitors (SGLT2i)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |