SGLT2i Use in France Based on SNDS Data Claim
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 547,150
- Locations
- 1
- Primary Endpoint
- Baseline characteristic: Age
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •population includes all patients initiating a treatment with SGLT2i between April 1, 2020, and December 31, 2024.
Exclusion Criteria
- Not provided
Arms & Interventions
Type 2 diabetes mellitus patients initiating SGLT2i
Intervention: Sodium/glucose cotransporter-2 inhibitors (SGLT2i) (Drug)
Patients initiating treatment with SGLT2i
Intervention: Sodium/glucose cotransporter-2 inhibitors (SGLT2i) (Drug)
Outcomes
Primary Outcomes
Baseline characteristic: Age
Time Frame: up to 5 years
Baseline characteristic: Type of diabetes
Time Frame: up to 5 years
Baseline characteristic: Gender
Time Frame: 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)
Time Frame: up to 5 years
Baseline characteristic: Region of residence
Time Frame: up to 5 years
Baseline characteristic: History of diabetes (date of first Long Term Disease (LTD) status related to diabetes)
Time Frame: up to 5 years
Secondary Outcomes
- 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)