Diabetes drug empagliflozin tested in over 200,000 patients in Real-World setting
NCT ID NCT03363464
First seen Jun 24, 2026 · Last updated Jul 23, 2026 · Updated 6 times
Summary
This study looks at how well the diabetes drug empagliflozin (Jardiance) works in everyday medical practice, outside of a controlled research setting. Researchers are comparing it to other diabetes medicines in over 230,000 adults with type 2 diabetes. The goal is to see if the heart and kidney benefits seen in earlier trials hold true for a wider range of patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Empagliflozin (also known as Jardiance)
- What this could lead to
- If successful, this study could confirm that empagliflozin's heart and kidney benefits seen in clinical trials also apply to a broader, real-world population with type 2 diabetes.
- What could go wrong
- This is an observational study, not a controlled trial, so results may be influenced by differences between patient groups. It cannot prove cause and effect.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
230,000 people
The number who actually took part.
- Started
-
Oct 2017
- Finished
-
Jul 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
T2DM eligible patients in Medicare fee for service, plans A, B, D; United Healthcare (Optum Clinformatics Data Mart); MarketScan (Truven Healthcare Analytics)
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Bringham Women Hospital
Boston, Massachusetts, 02120, United States
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Other studies related to the condition(s) this trial covers.
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