Comparative Effectiveness of Empagliflozin in the US

Boehringer Ingelheim

Status

Active, not recruiting

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: GLP-1 receptor agonist

Drug: Empagliflozin

Drug: DPP-4 inhibitor

Study type

Observational

Funder types

Industry

Identifiers

NCT03363464

1245.92

Details and patient eligibility

About

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.

Enrollment

230,000 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.