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 Overview
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Brief Summary
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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).

Official Title
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Clinical and Economic Impact of 2nd Line Initiation of Empagliflozin After Metformin, as Compared to 2nd Line Initiation of Sulfonylurea After Metformin in Patients With Type 2 Diabetes and Cardiovascular Disease

Conditions
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Diabetes Mellitus, Type 2, Cardiovascular Diseases

Intervention / Treatment
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* Drug: empagliflozin
* Drug: metformin
* Drug: sulfonylurea


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment with empagliflozin<br>as add-on therapy with metformin | Drug: empagliflozin<br>* empagliflozin<br>Drug: metformin<br>* metformin<br>|
| Treatment with a sulfonylurea<br>as add-on therapy with metformin | Drug: metformin<br>* metformin<br>Drug: sulfonylurea<br>* sulfonylurea<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of first hospitalization for congestive heart failure (HHF) |  | up to 5 years and 3 months | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |