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
| Registry | NCT05102071 |
|---|---|
| Status | Withdrawn - Study was canceled because database sample size was inadequate. |
| Study type | Observational |
| Sponsor | Boehringer Ingelheim (Industry) |
| Conditions | Diabetes Mellitus, Type 2, Cardiovascular Diseases |
| Interventions | empagliflozin, metformin, sulfonylurea (Drug) |
| Dates | start 2021-11-01, primary completion 2022-06-15 (estimated), completion 2022-06-15 (estimated), first posted 2021-11-01, last updated 2022-06-01 |
| Locations | 1 site in United States |
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All trials for Diabetes Mellitus, Type 2 All trials for Cardiovascular Diseases All trials of empagliflozin All trials of metformin
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Treatment with empagliflozin | Drug: empagliflozin; Drug: metformin | as add-on therapy with metformin | |
| Treatment with a sulfonylurea | Drug: metformin; Drug: sulfonylurea | as add-on therapy with metformin |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Boehringer Ingelheim Pharmaceuticals Inc | Ridgefield, Connecticut | United States |