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Comparative Effectiveness of Empagliflozin in the US

NCT03363464 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 230000

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Empagliflozin

Empagliflozin

DRUG

DPP-4 inhibitor

dipeptidyl peptidase-4 inhibitor

DRUG

GLP-1 receptor agonist

Glucagon-like peptide-1 receptor agonist

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-16
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03363464 on ClinicalTrials.gov