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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05102071
Other study ID # 1245-0262
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date June 15, 2022

Study information

Verified date May 2022
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 15, 2022
Est. primary completion date June 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
empagliflozin
empagliflozin
metformin
metformin
sulfonylurea
sulfonylurea

Locations

Country Name City State
United States Boehringer Ingelheim Pharmaceuticals Inc Ridgefield Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of first hospitalization for congestive heart failure (HHF) up to 5 years and 3 months
Secondary Hospitalizations up to 5 years and 3 months
Secondary Emergency department (ED) visits up to 5 years and 3 months
Secondary Length of stay up to 5 years and 3 months
Secondary Number of filled drugs up to 5 years and 3 months
Secondary Outpatient visits up to 5 years and 3 months
Secondary All cause cost 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) up to 5 years and 3 months
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