Clinical Trial

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

Active, Not Recruiting
View on ClinicalTrials.gov →
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
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-07-31 -> 2026-08-31 2026-08-12
minor Completion pushed: 2026-07-31 -> 2026-08-31 2026-08-12
Trial Details
NCT Number NCT05882071
Lead Sponsor Boehringer Ingelheim
Conditions Diabetes Mellitus, Type 2
Enrollment 547,150 participants
Start Date 2023-11-15
Primary Completion 2026-08-31 (estimated)
Study Completion 2026-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-11