Clinical trial · Observational
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
NCT03464045CI-TRIAL-00088745completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diabetes Mellitus, Type 2 | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DPP-4 inhibitors | Drug | — | UNRESOLVED |
| empagliflozin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- Empagliflozin initiators - UK
- description
- Participants with Type 2 diabetes mellitus (T2D) initiating (first purchase/prescription) empagliflozin (study drug), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2021 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from Clinical Practice Research Datalink (CPRD) (General practitioner Online Data \[GOLD\], and Aurum) in the United Kingdom (UK).
- interventionNames
- Drug: empagliflozin
- label
- DPP4-i initiators - UK
- description
- Participants with T2D initiating (first purchase/prescription) a dipeptidyl peptidase-4 inhibitor (DPP-4i) (comparator), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2021 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from CPRD (General practitioner Online Data \[GOLD\], and Aurum) in the UK.
- interventionNames
- Drug: DPP-4 inhibitors
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.