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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05102071
Collaborator
(none)
265
Enrollment
1
Location
24
Anticipated Duration (Days)
336.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Study Design

Study Type:
Observational
Anticipated Enrollment :
265 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
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
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Nov 25, 2021
Anticipated Study Completion Date :
Nov 25, 2021

Arms and Interventions

ArmIntervention/Treatment
Treatment with empagliflozin

as add-on therapy with metformin

Drug: empagliflozin
empagliflozin

Drug: metformin
metformin

Treatment with a sulfonylurea

as add-on therapy with metformin

Drug: metformin
metformin

Drug: sulfonylurea
sulfonylurea

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Hospitalizations [up to 5 years and 3 months]

  2. Emergency department (ED) visits [up to 5 years and 3 months]

  3. Length of stay [up to 5 years and 3 months]

  4. Number of filled drugs [up to 5 years and 3 months]

  5. Outpatient visits [up to 5 years and 3 months]

  6. 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 Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Boehringer Ingelheim Pharmaceuticals IncRidgefieldConnecticutUnited States06879

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT05102071
Other Study ID Numbers:
  • 1245-0262
First Posted:
Nov 1, 2021
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2021