Bringham Women Hospital
Boston, Massachusetts, 02120, United States
NCT Number: NCT03363464
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.
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Notify Me18 year and older
All sexes
Observational
Boston, Massachusetts, 02120, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Empagliflozin
Other names: JARDIANCE, JARDIANZ, GIBTULIO
dipeptidyl peptidase-4 inhibitor
Glucagon-like peptide-1 receptor agonist
Time frame: 60 months
i.e., non-fatal myocardial infarction (MI), non-fatal stroke, or cardiovascular (CV) mortality; as well as each individual component:
Time frame: 60 months
Time frame: 60 months
Time frame: 60 months
i.e., composite of MI, stroke or all-cause mortality
Time frame: 60 months
Time frame: 60 months
Time frame: 60 months
Time frame: 60 months
Time frame: 60 months
Time frame: 60 months
Time frame: 60 months
Time frame: 60 months
Time frame: 60 months
Time frame: 60 months
Time frame: 60 months
Time frame: 60 months
Time frame: 60 months
Time frame: 60 months
Boehringer Ingelheim
Industry
EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) Study Program
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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