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

Boehringer Ingelheim

Status

Withdrawn

Conditions

Cardiovascular Diseases

Diabetes Mellitus, Type 2

Treatments

Drug: metformin

Drug: empagliflozin

Drug: sulfonylurea

Study type

Observational

Funder types

Industry

Identifiers

NCT05102071

1245-0262

Details and patient eligibility

About

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).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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