NCT05882071

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

SGLT2i Use in France Based on SNDS Data Claim

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 547,150 (estimated)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Sodium/glucose cotransporter-2 inhibitors (SGLT2i)	Sodium/glucose cotransporter-2 inhibitors (SGLT2i)

Timeline

• Start date: 2023-11-15
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2023-05-31
• Last updated: 2026-01-07

Locations

1 site across 1 country: France