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NCT03464045 Clinical Trial

Empa PASS on Urinary Tract Malignancies

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03464045
Other study ID # 1245-0097
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 16, 2016
Est. completion date March 11, 2024

Study information
Verified date April 2024
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 and to patients initiating other Sodium glucose co-transporter-2 (SGLT-2) inhibitors (i.e. two comparator groups)

Recruitment information / eligibility
Status Completed
Enrollment 98000
Est. completion date March 11, 2024
Est. primary completion date March 11, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• empagliflozin
drug
• DPP-4 inhibitors
drug
• SGLT-2 inhibitors
drug

Locations
Country Name City State
Finland The National Register Data Helsinki
Sweden The Swedish prescribed drug register Stockholm
United Kingdom United Kingdom Clinical Practice Research Datalink (CPRD) London

Sponsors (2)
Lead Sponsor Collaborator
Boehringer Ingelheim Eli Lilly and Company

Countries where clinical trial is conducted

Finland,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary occurence of urinary tract cancer first incidence of urinary cancer up to 60 months
Primary occurence of bladder cancer up to 60 months
Primary occurence of renal cancer up to 60 months
Secondary occurence of other urinary tract cancers non-renal, non- urinary bladder, urinary tract cancers up to 60 months
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