| Trial ID: | L6587 |
| Source ID: | NCT05882071
|
| Associated Drug: |
Sodium/Glucose Cotransporter-2 Inhibitors (Sglt2i)
|
| Title: |
Non-interventional Study (NIS) on Sodium-glucose Co-transporter-2 Inhibitors (SGLT2i) Use in France
|
| Acronym: |
|
| Status: |
ACTIVE_NOT_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Sodium/glucose cotransporter-2 inhibitors (SGLT2i)
|
| Outcome Measures: |
Primary: Baseline characteristic: Age, up to 5 years|Baseline characteristic: Gender, up to 5 years|Baseline characteristic: Region of residence, 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|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|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
|
| Sponsor/Collaborators: |
Sponsor: Boehringer Ingelheim
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
547150
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2023-11-15
|
| Completion Date: |
2026-07-31
|
| Results First Posted: |
|
| Last Update Posted: |
2024-11-27
|
| Locations: |
Boehringer Ingelheim, Paris, 75013, France
|
| URL: |
https://clinicaltrials.gov/show/NCT05882071
|
