Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study was canceled because database sample size was inadequate.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluation of clinical outcomes (specifically cardiovascular outcomes like hospitalization for heart failure), and healthcare cost, and resource utilization, among patients on empagliflozin as an add-on therapy to metformin versus patients on sulfonylureas as an add-on therapy to metformin in patients with Type 2 Diabetes (T2D) and Cardiovascular Disease (CVD).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with empagliflozin | as add-on therapy with metformin |
| |
| Treatment with a sulfonylurea | as add-on therapy with metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| empagliflozin | Drug | empagliflozin |
| |
| metformin |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of first hospitalization for congestive heart failure (HHF) | up to 5 years and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalizations | up to 5 years and 3 months | |
| Emergency department (ED) visits | up to 5 years and 3 months | |
| Length of stay |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Patients with Type 2 Diabetes (T2D) and Cardiovascular Disease (CVD).
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Pharmaceuticals Inc | Ridgefield | Connecticut | 06879 | United States |
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: https://www.mystudywindow.com/msw/datatransparency
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
metformin |
|
| sulfonylurea | Drug | sulfonylurea |
|
| up to 5 years and 3 months |
| Number of filled drugs | up to 5 years and 3 months |
| Outpatient visits | up to 5 years and 3 months |
| All cause cost | total cost of care, divided by medical (inpatient costs, outpatient costs, emergency costs) and pharmacy costs (all reported in Per Patient Per Month (PPPM) costs) | up to 5 years and 3 months |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D008687 | Metformin |
| D013453 | Sulfonylurea Compounds |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D014508 | Urea |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
Not provided
Not provided