Study identification

EU PAS number

EUPAS16424

Study ID

48643

Official title and acronym

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 (PASS DiabCancer)

DARWIN EU® study

No

Study countries

Finland
Sweden
United Kingdom

Study description

Jardiance (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.

Study status

Finalised
Research institutions and networks

Institutions

IQVIA
United Kingdom
First published:
22/04/2024
Institution Non-Pharmaceutical company ENCePP partner

Contact details

Hoti Fabian

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
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Date of interim report, if expected

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Date of final study report

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Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim International GmbH
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)