Status: Ongoing First registered on: 10/05/2016
Last updated on: 03/06/2020
1. Study identification
EU PAS Register NumberEUPAS13413
Official titlePost-authorisation safety study in patients with type 2 diabetes mellitus to assess the risk of acute liver injury, acute kidney injury and chronic kidney disease, severe complications of urinary tract infection, genital infections, and diabetic ketoacidosis among patients treated with empagliflozin compared to patients treated with DPP-4 inhibitors
Study title acronymPASS renal, liver injury, infection, ketoacidosis
Study typeObservational study
Brief description of the studyEmpagliflozin (Jardiance), a highly potent and selective inhibitor of the sodium-glucose cotransporter 2 (SGLT2), was approved in Europe in May 2014 for the treatment of type 2 diabetes mellitus (T2DM) to improve glycaemic control in adults. As part of the risk management plan, Boehringer Ingelheim International GmbH (BI) has committed to conduct a post-authorisation safety study (PASS) to evaluate the liver and renal safety of empagliflozin. The study will also evaluate the risks of severe complications of urinary tract infections (UTIs), genital infections and diabetic ketoacidosis. To evaluate the association between empagliflozin use and mentioned outcomes routinely collected health information from the Clinical Practice Research Datalink (CPRD), in the United Kingdom. For the evaluation of the rarest outcomes, the Danish Population Registries in Denmark and the HealthCore Integrated Research Database (HIRD) in the United States. This PASS will be conducted through an observational cohort study among adult patients with T2DM and at least 12 months of continuous enrolment in the data source where new users of empagliflozin will be compared to new users of dipeptidyl peptidase-4 (DPP4) inhibitors. Estimations will be made on the crude and adjusted incidence rates and adjusted incidence rate ratios of the primary and secondary outcomes. The primary outcomes will be: acute liver injury (ALI) in patients without predisposing conditions, acute kidney injury, severe complications of urinary tract infection, genital infections, and diabetic ketoacidosis. The secondary outcomes will be: ALI in patients with or without predisposing conditions, chronic kidney disease, and severe genital infections.
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 belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Details of (Primary) lead investigator
Title Dr
Last name Rebordosa
First name Cristina
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?3

HealthCore, United States
Aarhus University, Denmark
Countries in which this study is being conducted
International study

Denmark
United Kingdom
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed31/12/201509/03/2016
Start date of data collection30/03/201615/03/2016
Start date of data analysis31/01/2020
Date of interim report, if expected15/06/201620/06/2016
Date of final study report30/09/2021
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 Rebordosa
First name Cristina
Address line 1Avenida Diagonal 605, 9-1
Address line 2 
Address line 3 
CityBarcelona 
Postcode08028 
CountrySpain
Phone number (incl. country code)34933622807 
Alternative phone number 
Fax number (incl. country code)34937608507 
Email address crebordosa@rti.org
Public Enquiries
Title Dr 
Last name Rebordosa 
First name Cristina 
Address line 1Avenida Diagonal 605, 9-1 
Address line 2 
Address line 3 
CityBarcelona 
Postcode08028 
CountrySpain 
Phone number (incl. country code)34933622807 
Alternative phone number 
Fax number (incl. country code)34937608507 
Email address crebordosa@rti.org 
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