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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

SGLT2i Use in France Based on SNDS Data Claim

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05882071
• Other study ID #: 1245-0287
• Status: Active, not recruiting
• Start date: November 15, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: February 2024
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 547150
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
France	Boehringer Ingelheim	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline characteristic: Age		up to 5 years
Primary	Baseline characteristic: Gender		up to 5 years
Primary	Baseline characteristic: Region of residence		up to 5 years
Primary	Baseline characteristic: History of diabetes (date of first Long Term Disease (LTD) status related to diabetes)		up to 5 years
Primary	Baseline characteristic: Type of diabetes		up to 5 years
Primary	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	Incidence rate of acute cardiovascular atheromatous events during the exposure period following initiation of the SGLT2i		up to 5 years
Secondary	Time from drug initiation to first event of acute cardiovascular atheromatous events		up to 5 years
Secondary	Incidence rate of heart failure hospitalization during the exposure period following initiation of the SGLT2i		up to 5 years
Secondary	Time from drug initiation to first event of heart failure hospitalization		up to 5 years
Secondary	Incidence rate of deaths all cause during the exposure period following initiation of the SGLT2i		up to 5 years
Secondary	Time from drug initiation to death all cause		up to 5 years

External Links

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