Comparative Effectiveness of Empagliflozin in the US

Completed

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT03363464

Run by

Boehringer Ingelheim

People needed

230000

Starts

2017-10-16

Expected to finish

2026-07-09

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Bringham Women Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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