Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients initiating treatment with SGLT2i |
| ||
| Type 2 diabetes mellitus patients initiating SGLT2i |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium/glucose cotransporter-2 inhibitors (SGLT2i) | Drug | Sodium/glucose cotransporter-2 inhibitors (SGLT2i) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
All patients in France initiating a treatment with SGLT2i between April 1, 2020, and December 31, 2024.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim | Paris | 75013 | France |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D012964 | Sodium |
| ID | Term |
|---|---|
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D004700 | Endocrine System Diseases |
| D008670 |
| Metals |