Comparative Effectiveness of Empagliflozin in the US

Boehringer Ingelheim logo

Boehringer Ingelheim

Status

Active, not recruiting

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: DPP-4 inhibitor
Drug: Empagliflozin
Drug: GLP-1 receptor agonist

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.

Trial design

230,000 participants in 3 patient groups

patients with T2DM initiating empagliflozin
Description:
Type 2 diabetes mellitus
Treatment:
Drug: Empagliflozin
patients with T2DM initiating a DPP-4 inhibitor
Description:
dipeptidyl peptidase-4 inhibitor treated patients
Treatment:
Drug: DPP-4 inhibitor
patients with T2DM initiating a GLP-1 receptor agonist
Description:
Glucagon-like peptide-1 receptor agonist treated patients
Treatment:
Drug: GLP-1 receptor agonist

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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