DRUG
Empagliflozin
Empagliflozin
Status
Completed
Phase
Not applicable
Enrollment
230,000
Locations
1
Results
Not posted
Publications
1
Study 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 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.
Interventions
DRUG
Empagliflozin
DRUG
dipeptidyl peptidase-4 inhibitor
DRUG
Glucagon-like peptide-1 receptor agonist
Timeline
First posted
Dec 6, 2017
Study start
Oct 16, 2017
Primary completion
Jul 9, 2026
Study completion
Jul 9, 2026
Results posted
Not reported
Registry updated
Jul 22, 2026
Outcomes
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
Hospitalization for heart failure (specific, based on primary inpatient diagnosis code)
Time frame · 60 months
Hospitalization for heart failure (broad, based on any inpatient diagnosis code)
Time frame · 60 months
Modified MACE
Time frame · 60 months
i.e., composite of MI, stroke or all-cause mortality
Composite of MI or stroke hospital admission for heart failure
Time frame · 60 months
All-cause mortality
Time frame · 60 months
Coronary revascularization procedure
Time frame · 60 months
Hospitalization for unstable angina
Time frame · 60 months
Composite of MI, stroke, unstable angina hospitalization or coronary revascularization
Time frame · 60 months
End-stage renal disease (ESRD)
Time frame · 60 months
Bone fracture
Time frame · 60 months
Diabetic ketoacidosis (Inpatient, primary position)
Time frame · 60 months
Diabetic ketoacidosis (Inpatient, any position)
Time frame · 60 months
Severe hypoglycemia
Time frame · 60 months
Urinary tract cancers
Time frame · 60 months
Lower-limb amputation
Time frame · 60 months
Eligibility
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.
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Bringham Women Hospital
Boston, Massachusetts, United States
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