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ACTIVE NOT RECRUITING
NCT03363464

Comparative Effectiveness of Empagliflozin in the US

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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

Interventions

DRUG

Empagliflozin

Empagliflozin

DRUG

DPP-4 inhibitor

dipeptidyl peptidase-4 inhibitor

DRUG

GLP-1 receptor agonist

Glucagon-like peptide-1 receptor agonist

Locations (1)

Bringham Women Hospital

Boston, Massachusetts, United States