Status: Ongoing First registered on: 18/01/2019
Last updated on: 17/06/2020
1. Study identification
EU PAS Register NumberEUPAS27606
Official titleMulti-country non-interventional study on the effectiveness and safety of Empagliflozin in adult patients with type 2 diabetes in Europe and Asia
Study title acronym
Study typeObservational study
Brief description of the studyThe overall objective of this study is to examine effectiveness, safety, health care resource utilization, and cost of care outcomes associated with the use of empagliflozin or any SGLT-2 inhibitors, compared with use of dipeptidyl peptidase-4 (DPP-4) inhibitors, among patients with T2DM. This study will utilize nationwide healthcare registers, regional quality registers, regional high-quality medical health records, and other health claims data available in Denmark, Finland, Germany, Israel, Japan, Norway, South Korea, Spain, Sweden, Taiwan, and United Kingdom.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
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 groupHelsinki, Finland
Organisation/affiliationEPID Research Oy
Website/Homepagewww.epidresearch.com
Details of (Primary) lead investigator
Title Dr
Last name Hoti
First name Fabian
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?9
University of Ulm, Germany
Maccabi, Israel
Syneos Health, Japan
TFS / Quantify, Denmark, Finland, Norway, Sweden
Ajou University Hospital, South Korea
Institut d'Investigació en Atenció Primària, Spain
Institute of Clinic Hospital of Valencia, Spain
TaSPOR, Taiwan
University of Leicester, UK
Countries in which this study is being conducted
International study

Denmark
Finland
Germany
Israel
Japan
Korea, Republic of
Norway
Spain
Sweden
Taiwan
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed29/08/201829/08/2018
Start date of data collection31/03/201922/04/2019
Start date of data analysis13/05/2019
Date of interim report, if expected30/09/2019
Date of final study report31/03/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBoehringer Ingelheim100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Hoti
First name Fabian
Address line 1Metsänneidonkuja 6
Address line 2 
Address line 3 
CityEspoo 
Postcode02130 
CountryFinland
Phone number (incl. country code)358-405391919 
Alternative phone number 
Fax number (incl. country code) 
Email address fabian.hoti@epidresearch.com
Public Enquiries
Title Mr 
Last name Tamminen 
First name Ilkka 
Address line 1EPID REsearch 
Address line 2Metsänneidonkuja 6 
Address line 3 
CityEspoo 
Postcode02130 
CountryFinland 
Phone number (incl. country code)358-503102848 
Alternative phone number 
Fax number (incl. country code) 
Email address ilkka.tamminen@iqvia.com 
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