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

Withdrawn before enrolling

Conditions studied: Diabetes Mellitus, Type 2, Cardiovascular Diseases

In brief

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).

Key facts

Study ID

NCT05102071

Run by

Boehringer Ingelheim

People needed

0

Starts

2021-11-01

Expected to finish

2022-06-15

Last updated by the study team

2022-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Boehringer Ingelheim Pharmaceuticals Inc — Ridgefield, Connecticut, United States

Full record on ClinicalTrials.gov

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