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

Active, not recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Sodium/glucose cotransporter-2 inhibitors (SGLT2i)

• Registration Number: NCT05882071
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-22
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-05-31
• Study Start: 2023-11-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-27
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 547150

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients initiating treatment with SGLT2i	Sodium/glucose cotransporter-2 inhibitors (SGLT2i)	-
Type 2 diabetes mellitus patients initiating SGLT2i	Sodium/glucose cotransporter-2 inhibitors (SGLT2i)	-

Primary Outcome Measures

Name	Time	Method
Baseline characteristic: Gender	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
Baseline characteristic: Region of residence	up to 5 years
Baseline characteristic: Age	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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Boehringer Ingelheim; 🇫🇷 Paris, France