Comparative Effectiveness of Empagliflozin in the US

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boehringer Ingelheim
Study ID
NCT03363464
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    Empagliflozin
  • DPP-4 inhibitor — DRUG
    dipeptidyl peptidase-4 inhibitor
  • GLP-1 receptor agonist — DRUG
    Glucagon-like peptide-1 receptor agonist

Study Details

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.

Key Dates

Start date
Oct 16, 2017
Status verified
Apr 2026
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
230,000 participants (actual)

Arms

  • Arm: patients with T2DM initiating empagliflozin
    Type 2 diabetes mellitus
  • Arm: patients with T2DM initiating a DPP-4 inhibitor
    dipeptidyl peptidase-4 inhibitor treated patients
  • Arm: patients with T2DM initiating a GLP-1 receptor agonist
    Glucagon-like peptide-1 receptor agonist treated patients

Primary Outcome Measure

3-point major adverse cardiovascular events (MACE) [ Time Frame: 60 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Bringham Women HospitalBostonMassachusetts02120-

Find similar trials in Boston, MA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Bringham Women Hospital· Boston, MA

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