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Comparative Effectiveness of Empagliflozin in the US
Sponsor: Boehringer Ingelheim
Summary
Empagliflozin, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, was launched as a treatment for type 2 diabetes mellitus (T2DM) in the U.S. in August 2014. In contrast with several previous cardiovascular outcomes trials, which failed to demonstrate an association with a higher or a lower risk of cardiovascular outcomes associated with members of other recently marketed antidiabetic classes, the EMPA-REG OUTCOME trial has shown that patients at high cardiovascular risk randomized to empagliflozin vs. placebo, were associated with a reduced risk of hospitalization for heart failure, cardiovascular mortality, and all-cause mortality. However, these and other findings arising from an extensive clinical trial program aimed at evaluating the efficacy and safety profile for empagliflozin have yet to be demonstrated in a non-trial environment. This study aims to investigate the transferability of the effects demonstrated in dedicated randomized clinical studies to a broader population under real world conditions.
Official title: EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) Study Program
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
230000
Start Date
2017-10-16
Completion Date
2026-04-30
Last Updated
2026-02-18
Healthy Volunteers
No
Conditions
Interventions
Empagliflozin
Empagliflozin
DPP-4 inhibitor
dipeptidyl peptidase-4 inhibitor
GLP-1 receptor agonist
Glucagon-like peptide-1 receptor agonist
Locations (1)
Bringham Women Hospital
Boston, Massachusetts, United States