Status:

COMPLETED

Empa PASS on Urinary Tract Malignancies

Lead Sponsor:

Boehringer Ingelheim

Collaborating Sponsors:

Eli Lilly and Company

Conditions:

Diabetes Mellitus, Type 2

Eligibility:

All Genders

18+ years

Brief 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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

November 16 2016

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 11 2024

Estimated Enrollment :

344995 Patients enrolled

Trial Details

Trial ID

NCT03464045

Start Date

November 16 2016

End Date

March 11 2024

Last Update

April 20 2025

Active Locations (3)

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Page 1 of 1 (3 locations)

1

The National Register Data

Helsinki, Finland

2

The Swedish prescribed drug register

Stockholm, Sweden

3

United Kingdom Clinical Practice Research Datalink (CPRD)

London, United Kingdom