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OpenTrials
Completed

NCT Number: NCT03363464

Comparative Effectiveness of Empagliflozin in the US

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bringham Women Hospital

Boston, Massachusetts, 02120, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients >= 18 years old for Marketscan and Optum, and >=65 years old for Medicare only
  • Patients initiating empagliflozin or a DPP-4 inhibitor within the study period. Initiation was defined as no use of SGLT-2 inhibitors (canagliflozin, dapagliflozin, ertugliflozin) or DPP-4 inhibitors in the previous 12 months.
  • Restriction to patients with a diagnosis of T2DM (ICD-9 Dx code of 250.x0 or 250.x2; ICD-10 Dx code of E11.x) in the 12 months prior to drug initiation.

Exclusion criteria

  • Patients with missing or ambiguous age or sex information.
  • All patients who have less than 12 months of continuous registration in the database prior to initiation of empagliflozin or a DPP-4 inhibitor will be excluded.
  • Patients with type 1 diabetes mellitus (T1DM) defined as at least 1 inpatient or outpatient codes in the 12 months prior to drug initiation.
  • Secondary diabetes, and gestational diabetes in the 12 months prior to drug initiation
  • History of cancer in the 5 years prior to drug initiation
  • End-stage renal disease (ESRD) in the 12 months prior to drug initiation
  • HIV diagnosis or treatment in the 12 months prior to drug initiation
  • Organ transplant in the 12 months prior to drug initiation
  • Patients that were in nursing homes in the 12 months prior to drug initiation
  • Patients with concomitant SGLT-2 inhibitor and DPP-4 inhibitor initiation will also be excluded.
  • Patients initiating more than one DPP-4i on cohort entry date will additionally be excluded Additional exclusion criteria apply.

Treatment and study plan

Empagliflozin

Drug

Empagliflozin

Other names: JARDIANCE, JARDIANZ, GIBTULIO

DPP-4 inhibitor

Drug

dipeptidyl peptidase-4 inhibitor

GLP-1 receptor agonist

Drug

Glucagon-like peptide-1 receptor agonist

Primary outcomes

  1. 3-point major adverse cardiovascular events (MACE)

    Time frame: 60 months

    i.e., non-fatal myocardial infarction (MI), non-fatal stroke, or cardiovascular (CV) mortality; as well as each individual component:

    • Hospital admission for MI (for purposes of this individual component, fatal MI is included)
    • Hospital admission for stroke (for purposes of this individual component, fatal stroke is included)
    • CV mortality
  2. Hospitalization for heart failure (specific, based on primary inpatient diagnosis code)

    Time frame: 60 months

  3. Hospitalization for heart failure (broad, based on any inpatient diagnosis code)

    Time frame: 60 months

  4. Modified MACE

    Time frame: 60 months

    i.e., composite of MI, stroke or all-cause mortality

  5. Composite of MI or stroke hospital admission for heart failure

    Time frame: 60 months

  6. All-cause mortality

    Time frame: 60 months

Secondary outcomes

  1. Coronary revascularization procedure

    Time frame: 60 months

  2. Hospitalization for unstable angina

    Time frame: 60 months

  3. Composite of MI, stroke, unstable angina hospitalization or coronary revascularization

    Time frame: 60 months

  4. End-stage renal disease (ESRD)

    Time frame: 60 months

  5. Bone fracture

    Time frame: 60 months

  6. Diabetic ketoacidosis (Inpatient, primary position)

    Time frame: 60 months

  7. Diabetic ketoacidosis (Inpatient, any position)

    Time frame: 60 months

  8. Severe hypoglycemia

    Time frame: 60 months

  9. Urinary tract cancers

    Time frame: 60 months

  10. Lower-limb amputation

    Time frame: 60 months

  11. Acute kidney injury (Inpatient, primary)

    Time frame: 60 months

  12. Acute kidney injury (Inpatient, any position)

    Time frame: 60 months

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) Study Program

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Dec 6, 2017
Registry last updated
Jul 22, 2026

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.

Published trials that share one or more normalized conditions with this study.