Comparative Effectiveness of Empagliflozin in the US

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

230000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-16

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Observe the Effectiveness of Empagliflozin, Other SGLT-2 Inhibitors, or DPP-4 Inhibitors in Patients With Type 2 Diabetes

NCT03817463

Diabetes Mellitus, Type 2

COMPLETED

Efficacy and Safety of Empagliflozin Versus Sitagliptin in Patients With Type 2 Diabetes

NCT01984606

Diabetes Mellitus, Type 2

WITHDRAWN PHASE3

Characteristics of Empagliflozin Initiators

NCT03050619

Type 2 Diabetes

COMPLETED

Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin

NCT03351478

Type 2 Diabetes Mellitus

COMPLETED PHASE3

To Assess the Risk of Acute Pancreatitis in Patients With Type 2 Diabetes Mellitus Treated With Empagliflozin

NCT05162014

Diabetes Mellitus, Type 2

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patients with T2DM initiating empagliflozin

Type 2 diabetes mellitus

Empagliflozin

Intervention Type DRUG

Empagliflozin

patients with T2DM initiating a DPP-4 inhibitor

dipeptidyl peptidase-4 inhibitor treated patients

DPP-4 inhibitor

Intervention Type DRUG

dipeptidyl peptidase-4 inhibitor

patients with T2DM initiating a GLP-1 receptor agonist

Glucagon-like peptide-1 receptor agonist treated patients

GLP-1 receptor agonist

Intervention Type DRUG

Glucagon-like peptide-1 receptor agonist

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Empagliflozin

Intervention Type DRUG

DPP-4 inhibitor

dipeptidyl peptidase-4 inhibitor

Intervention Type DRUG

GLP-1 receptor agonist

Glucagon-like peptide-1 receptor agonist

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

JARDIANCE, JARDIANZ, GIBTULIO

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No