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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05102071
• Other study ID #: 1245-0262
• Status: Withdrawn
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

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

External Links

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