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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

NCT05102071 — Withdrawn, Boehringer Ingelheim

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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

RegistryNCT05102071
StatusWithdrawn - Study was canceled because database sample size was inadequate.
Study typeObservational
SponsorBoehringer Ingelheim (Industry)
ConditionsDiabetes Mellitus, Type 2, Cardiovascular Diseases
Interventionsempagliflozin, metformin, sulfonylurea (Drug)
Datesstart 2021-11-01, primary completion 2022-06-15 (estimated), completion 2022-06-15 (estimated), first posted 2021-11-01, last updated 2022-06-01
Locations1 site in United States

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-Summary

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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+Arms and interventions

ArmTypeInterventionsDescription
Treatment with empagliflozinDrug: empagliflozin; Drug: metforminas add-on therapy with metformin
Treatment with a sulfonylureaDrug: metformin; Drug: sulfonylureaas add-on therapy with metformin
  • empagliflozin (Drug): empagliflozin
  • metformin (Drug): metformin
  • sulfonylurea (Drug): sulfonylurea

+Outcome measures

Primary outcomes

  • Occurrence of first hospitalization for congestive heart failure (HHF) [up to 5 years and 3 months]

Secondary outcomes

  • 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 [up to 5 years and 3 months]: 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)

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
Boehringer Ingelheim Pharmaceuticals IncRidgefield, ConnecticutUnited States

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