Status: Ongoing First registered on: 25/11/2016
Last updated on: 08/06/2020
1. Study identification
EU PAS Register NumberEUPAS16424
Official titlePost-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
Study title acronymPASS DiabCancer
Study typeObservational study
Brief description of the studyJardiance (empagliflozin), a highly potent and selective inhibitor of the sodium-glucose cotransporter 2 (SGLT-2), was approved in Europe in May 2014 for the treatment of type 2 diabetes mellitus (T2D) to improve glycaemic control in adults. Synjardy (empagliflozin/metformin HCl) was approved in Europe in May 2015. As part of the risk management plan, Boehringer Ingelheim International GmbH (BI) has committed to conduct a post-authorisation safety study (PASS) to evaluate safety of empagliflozin regarding urinary tract malignancies in incident users of empagliflozin compared to incident users of dieptidyl peptidase-4 (DPP-4) inhibitors and incident users of SGLT-2 inhibitors. The inclusion of renal cancer as a potential risk was based on preclinical toxicology findings and clinical cases of bladder cancer observed with other SGLT-2 inhibitors. This PASS will be conducted using routinely collected health information from the UK, Finland, and Sweden, through an observational cohort study among adult patients with type 2 diabetes mellitus and at least 12 months of continuous enrollment in the UK CPRD, Finland or Swedish national registries. New users of empagliflozin will be compared to new users of dipeptidyl peptidase-4 (DPP-4) inhibitors and to new users of other SGLT-2 inhibitors. Estimations will be made on the crude and adjusted incidence rates and adjusted incidence rate ratios of the primary and secondary outcomes. Primary outcomes are urinary tract cancers, bladder cancer, and renal cancer. Secondary outcomes include non-renal, non-bladder urinary tract cancers.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsEPID Research
Department/Research group
Organisation/affiliationEPID Research Oy
Website/Homepagewww.epidresearch.com
Details of (Primary) lead investigator
Title Dr
Last name Fabian
First name Hoti
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

Finland
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed05/04/2016
Start date of data collection15/11/201616/11/2016
Start date of data analysis01/12/2020
Date of interim report, if expected31/03/202113/03/2017
Date of final study report30/06/2022
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBoehringer Ingelheim International GmbH100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Fabian
First name Hoti
Address line 1EPID Research Oy
Address line 2Metsänneidonkuja 6 
Address line 3 
CityEspoo 
Postcode02130 
CountryFinland
Phone number (incl. country code)358-40-5391919 
Alternative phone number 
Fax number (incl. country code) 
Email address fhoti@fi.imshealth.com
Public Enquiries
Title Dr 
Last name Fabian 
First name Hoti 
Address line 1EPID Research Oy 
Address line 2Metsänneidonkuja 6 
Address line 3 
CityEspoo 
Postcode02130 
CountryFinland 
Phone number (incl. country code)358-40-5391919 
Alternative phone number 
Fax number (incl. country code) 
Email address fhoti@fi.imshealth.com 
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