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

Withdrawn

• Conditions: Diabetes Mellitus, Type 2; Cardiovascular Diseases
• Interventions: Drug: empagliflozin; Drug: sulfonylurea; Drug: metformin

• Registration Number: NCT05102071
• Lead Sponsor: Boehringer Ingelheim

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-10-28
• Study Start: 2021-11-01
• Study First Posted: 2021-11-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-30
• Last Update Posted: 2022-06-01
• Primary Completion: 2022-06-15
• Study Completion: 2022-06-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment with a sulfonylurea	sulfonylurea	as add-on therapy with metformin
Treatment with empagliflozin	empagliflozin	as add-on therapy with metformin
Treatment with empagliflozin	metformin	as add-on therapy with metformin
Treatment with a sulfonylurea	metformin	as add-on therapy with metformin

Primary Outcome Measures

Name	Time	Method
Occurrence of first hospitalization for congestive heart failure (HHF)	up to 5 years and 3 months

Secondary Outcome Measures

Name	Time	Method
Outpatient visits	up to 5 years and 3 months
Hospitalizations	up to 5 years and 3 months
Emergency department (ED) visits	up to 5 years and 3 months
Number of filled drugs	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)
Length of stay	up to 5 years and 3 months

Trial Locations

Locations (1)

Boehringer Ingelheim Pharmaceuticals Inc; 🇺🇸 Ridgefield, Connecticut, United States