Current partner codePEPTIDESDE
NCT03363464·Not applicable·OBSERVATIONAL

Comparative Effectiveness of Empagliflozin in the US

Status

Completed

Phase

Not applicable

Enrollment

230,000

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Empagliflozin

Empagliflozin

DRUG

DPP-4 inhibitor

dipeptidyl peptidase-4 inhibitor

DRUG

GLP-1 receptor agonist

Glucagon-like peptide-1 receptor agonist

Timeline

From registration to results.

  1. First posted

    Dec 6, 2017

  2. Study start

    Oct 16, 2017

  3. Primary completion

    Jul 9, 2026

  4. Study completion

    Jul 9, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jul 22, 2026

Outcomes

What the study measures.

Primary 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

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Bringham Women Hospital

Boston, Massachusetts, United States

Related trials

More studies on Glucagon.

Related PeptideStat pages

Put the record in context.

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