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

Boehringer Ingelheim

Status: Active, not recruiting

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Sodium/glucose cotransporter-2 inhibitors (SGLT2i)

Study type: Observational

Funder types: Industry

Identifiers

NCT05882071

1245-0287

Details and patient eligibility

About

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

Enrollment: 547,150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• population includes all patients initiating a treatment with SGLT2i between April 1, 2020, and December 31, 2024.

Exclusion criteria

• None

Trial design

547,150 participants in 2 patient groups

Patients initiating treatment with SGLT2i

Treatment:

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

Type 2 diabetes mellitus patients initiating SGLT2i

Treatment:

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