Clinical Outcomes and Healthcare Cost and Resource Utilization (HCRU) in Patients With Type 2 Diabetes and Cardiovascular Disease on 2nd Line Empagliflozin Versus 2nd Line Sulfonylureas
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Treatment with empagliflozin as add-on therapy with metformin |
Drug: empagliflozin
empagliflozin
Drug: metformin
metformin
|
| Treatment with a sulfonylurea as add-on therapy with metformin |
Drug: metformin
metformin
Drug: sulfonylurea
sulfonylurea
|
Outcome Measures
Primary Outcome Measures
- Occurrence of first hospitalization for congestive heart failure (HHF) [up to 5 years and 3 months]
Secondary Outcome Measures
- Hospitalizations [up to 5 years and 3 months]
- Emergency department (ED) visits [up to 5 years and 3 months]
- Length of stay [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 [up to 5 years and 3 months]
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)
Eligibility Criteria
Criteria
Inclusion criteria:
-
Prevalent metformin use + initiation of empagliflozin OR prevalent metformin use + initiation of sulfonylurea
-
≥18 years of age at index date during study observation
-
≥1 inpatient and/or ≥ 2 outpatient claims denoting T2D diagnosis (in any position) in the 12 months prior to index date
-
≥1 inpatient and/or ≥2 outpatient claims denoting CVD (in any position) diagnosis in the 12 months prior to index date
-
≥2 months post-index date
-
≥12 months of no exposure to T2D medications in the pre-index period (excluding metformin in both arms)
-
≥12 months of continuous enrolment prior to index date
Exclusion criteria:
-
Diagnosis of Type 1 Diabetes, secondary, or gestational diabetes in the 12 months prior to index date
-
Diagnosis of severe comorbidities including malignancy, end-stage renal disease, human immunodeficiency virus, Hepatitis C infection, or organ transplant in the 12 months prior to index date
-
Admission to nursing home in the 12 months prior to index date
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boehringer Ingelheim Pharmaceuticals Inc | Ridgefield | Connecticut | United States | 06879 |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1245-0262