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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-06-15

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).

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Cardiovascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Treatment with empagliflozin

as add-on therapy with metformin

empagliflozin

Intervention Type DRUG

empagliflozin

metformin

Intervention Type DRUG

metformin

Treatment with a sulfonylurea

as add-on therapy with metformin

metformin

Intervention Type DRUG

metformin

sulfonylurea

Intervention Type DRUG

sulfonylurea

Interventions

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empagliflozin

Intervention Type DRUG

metformin

Intervention Type DRUG

sulfonylurea

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No