NCT03464045Completed
Empa PASS on Urinary Tract Malignancies
Post-authorisation Safety Study to Assess the Risk of Urinary Tract Malignancies in Relation to Empagliflozin Exposure in Patients With Type 2 Diabetes: a Multi-database European Study
Source: ClinicalTrials.gov · Last updated 20 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 344995 (actual)
- First submitted
- 7 Mar 2018
- Start date
- 16 Nov 2016
- Primary completion date
- 11 Mar 2024
- Lead sponsor
- Boehringer Ingelheim
- Diseases
- Type 2 diabetes
- NCT number
- NCT03464045
What you commit to
- Study type: Observational
- Participants enrolled: 344995
- From 16 Nov 2016 to the primary completion date, 11 Mar 2024
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- 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)
Other illness
- Diagnosis of type 1 diabetes or other specific non-type 2 diabetes
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The National Register Data Coordinator of this site? Confirm its status | Helsinki | Finland | Unknown status |
| United Kingdom Clinical Practice Research Datalink (CPRD) Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| The Swedish prescribed drug register Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.