Clinical trial NCT05882071: Non-interventional Study (NIS) on Sodium-glucose Co-transporter-2 Inhibitors (SGLT2i) Use in France
Official title: SGLT2i Use in France Based on SNDS Data Claim
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-05-31
Enrollment: 547150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients in France initiating a treatment with SGLT2i between April 1, 2020, and December 31, 2024.

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Baseline characteristic: Age
timeFrame: up to 5 years
measure: Baseline characteristic: Gender
timeFrame: up to 5 years
measure: Baseline characteristic: Region of residence
timeFrame: up to 5 years
measure: Baseline characteristic: History of diabetes (date of first Long Term Disease (LTD) status related to diabetes)
timeFrame: up to 5 years
measure: Baseline characteristic: Type of diabetes
timeFrame: up to 5 years
measure: 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)
timeFrame: up to 5 years
Secondary outcomes:
measure: Incidence rate of acute cardiovascular atheromatous events during the exposure period following initiation of the SGLT2i
timeFrame: up to 5 years
measure: Time from drug initiation to first event of acute cardiovascular atheromatous events
timeFrame: up to 5 years
measure: Incidence rate of heart failure hospitalization during the exposure period following initiation of the SGLT2i
timeFrame: up to 5 years
measure: Time from drug initiation to first event of heart failure hospitalization
timeFrame: up to 5 years
measure: Incidence rate of deaths all cause during the exposure period following initiation of the SGLT2i
timeFrame: up to 5 years
measure: Time from drug initiation to death all cause
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Boehringer Ingelheim
Study officials:
References: