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Diabetes Mellitus, Type 2NCT03363464

Comparative Effectiveness of Empagliflozin in the US

An observational study of Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Empagliflozin, DPP-4 inhibitor and GLP-1 receptor agonist
How many people
230,000 participants
Where
1 siteUnited States
Study dates
16 Oct 2017to 9 Jul 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: T2DM eligible patients in Medicare fee for service, plans A, B, D; United Healthcare (Optum Clinformatics Data Mart); MarketScan (Truven Healthcare Analytics)

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Bringham Women Hospital

    Boston, Massachusetts, 02120

Other trials in United States

About this study

Official title: EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) Study Program

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.

Being tested
Empagliflozin, DPP-4 inhibitor, GLP-1 receptor agonist
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EmpagliflozinDrug

    Also called JARDIANCE, JARDIANZ, GIBTULIO

    Empagliflozin

  • DPP-4 inhibitorDrug

    dipeptidyl peptidase-4 inhibitor

  • GLP-1 receptor agonistDrug

    Glucagon-like peptide-1 receptor agonist

Study groups in NCT03363464
Study groupRoleWhat they receive
patients with T2DM initiating empagliflozinType 2 diabetes mellitus
Receives: Drug: Empagliflozin
patients with T2DM initiating a DPP-4 inhibitordipeptidyl peptidase-4 inhibitor treated patients
Receives: Drug: DPP-4 inhibitor
patients with T2DM initiating a GLP-1 receptor agonistGlucagon-like peptide-1 receptor agonist treated patients
Receives: Drug: GLP-1 receptor agonist

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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

    Measured: 60 months

  2. Hospitalization for heart failure (specific, based on primary inpatient diagnosis code)

    Measured: 60 months

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

    Measured: 60 months

  4. Modified MACE

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

    Measured: 60 months

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

    Measured: 60 months

  6. All-cause mortality

    Measured: 60 months

Secondary outcomes (12)

  1. Coronary revascularization procedure

    Measured: 60 months

  2. Hospitalization for unstable angina

    Measured: 60 months

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

    Measured: 60 months

  4. End-stage renal disease (ESRD)

    Measured: 60 months

  5. Bone fracture

    Measured: 60 months

  6. Diabetic ketoacidosis (Inpatient, primary position)

    Measured: 60 months

  7. Diabetic ketoacidosis (Inpatient, any position)

    Measured: 60 months

  8. Severe hypoglycemia

    Measured: 60 months

  9. Urinary tract cancers

    Measured: 60 months

  10. Lower-limb amputation

    Measured: 60 months

  11. Acute kidney injury (Inpatient, primary)

    Measured: 60 months

  12. Acute kidney injury (Inpatient, any position)

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2017
  2. Study start16 Oct 2017
  3. Primary completion9 Jul 2026
  4. Study completion9 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
230,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03363464
Sponsor's protocol ID
1245.92
Status last verified
Jul 2026
First submitted
5 Oct 2017
Last updated
22 Jul 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Publications

  • Patorno E, Pawar A, Franklin JM, Najafzadeh M, Deruaz-Luyet A, Brodovicz KG, Sambevski S, Bessette LG, Santiago Ortiz AJ, Kulldorff M, Schneeweiss S. Empagliflozin and the Risk of Heart Failure Hospitalization in Routine Clinical Care. Circulation. 2019 Jun 18;139(25):2822-2830. doi: 10.1161/CIRCULATIONAHA.118.039177. Epub 2019 Apr 8.

    PubMed 30955357

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-point major adverse cardiovascular events (MACE) (time frame: 60 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03363464, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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