Study identification

EU PAS number

EUPAS27606

Study ID

50641

Official title and acronym

Multi-country non-interventional study on the effectiveness and safety of Empagliflozin in adult patients with type 2 diabetes in Europe and Asia

DARWIN EU® study

No

Study countries

Denmark
Finland
Germany
Israel
Japan
Korea, Republic of
Norway
Spain
Sweden
Taiwan
United Kingdom

Study description

The 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.

Study status

Finalised
Research institutions and networks

Institutions

Real World Solutions, IQVIA
Netherlands
United Kingdom (Northern Ireland)
First published:
22/03/2024
Institution Other ENCePP partner
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

Contact details

Fabian Hoti

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable