N/A N=344,995

Empa PASS on Urinary Tract Malignancies

Diabetes Mellitus, Type 2

Bottom Line

View on ClinicalTrials.gov: NCT03464045 ↗

Enrolled (actual)

344,995

Serious AEs

—

Results posted

Mar 2025

Primary outcome: Primary: Occurrence of Urinary Tract Cancer — 0.73; 1.07; 1.34; 1.52 Events per 1000 patient years — p=0.122

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: empagliflozin (Drug); DPP-4 inhibitors (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Mar 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Occurrence of Urinary Tract Cancer	0.73; 1.07; 1.34; 1.52; 1.27; 1.49	0.122
PRIMARY Occurrence of Bladder Cancer	0.45; 0.67; 0.92; 1.03; 0.51; 0.64	0.220
PRIMARY Occurrence of Renal Cancer	0.24; 0.34; 0.42; 0.50; 0.76; 0.82	0.420

Summary

The aim of the study is to assess the risk of urinary tract malignancies in patients initiating empagliflozin (free or fixed dose combination) compared to patients initiating a dipeptidyl peptidase-4 (DPP-4) inhibitor.

Eligibility Criteria

Inclusion Criteria

Diagnosis of type 2 diabetes
Age over 18 years at index date
At least 1 year of membership in the medication database prior to index date

Exclusion Criteria

Patients with any cancer (excluding non-melanoma skin cancer) recorded at any time prior to the index date (i.e. during the available look-back time)
Diagnosis of type 1 diabetes or other specific non-type 2 diabetes
Use of any SGLT-2 inhibitor or any DPP-4 inhibitor (including free and fixed-dose combinations) recorded at any time prior to index date (i.e. during the available look-back time).
Use of fixed-dose combinations of SGLT-2 inhibitors with DPP-4 inhibitors
Diagnosis of end stage renal disease or receipt of renal dialysis recorded at any time prior to index date (i.e. during the available look-back time)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03464045). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.