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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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