NCT03363464Completed
Comparative Effectiveness of Empagliflozin in the US
EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) Study Program
Source: ClinicalTrials.gov · Last updated 22 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 230000 (actual)
- First submitted
- 5 Oct 2017
- Start date
- 16 Oct 2017
- Primary completion date
- 9 Jul 2026
- Lead sponsor
- Boehringer Ingelheim
- Diseases
- Type 2 diabetes
- NCT number
- NCT03363464
What you commit to
- Study type: Observational
- Participants enrolled: 230000
- From 16 Oct 2017 to the primary completion date, 9 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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.
Other illness
- History of cancer in the 5 years prior to drug initiation
Age
- Patients with missing or ambiguous age or sex information.
Other
- Patients initiating more than one DPP-4i on cohort entry date will additionally be excluded Additional exclusion criteria apply.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bringham Women Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.