Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000223

EU PAS number

EUPAS1000000223

Study ID

1000000223

Official title and acronym

DARWIN EU® - Drug Utilisation Study on GLP-1 Receptor Agonists

DARWIN EU® study

Yes

Study countries

Belgium
Germany
Netherlands
Spain
United Kingdom

Study description

A shortage of medicines containing GLP-1 Receptor Agonists is affecting EU Member States since 2022 and will continue throughout 2024. The shortage involves the medicinal products Ozempic (semaglutide), Victoza (liraglutide), Trulicity (dulaglutide) and Saxenda (liraglutide).
The shortage is based on an increased demand for these medicines in addition to other causes, e.g. capacity constraints.
Medicinal products belonging to the class of Glucagon-Like Peptide-1 receptor agonists (GLP-1 RA) are either authorised for the treatment of diabetes (Ozempic, Victoza, Trulicity, Bydureon, Rybelsus) or authorised for weight management (Saxenda, Wegovy); with the exception of Mounjaro (tirzepatide), a glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 RA that is authorised for both indications. Of concern has been the off-label use of GLP-1 RAs for weight management which has been mentioned frequently in the news and social media and is exacerbating existing shortages with serious consequences for public health.
This study aims to provide an overview of the characteristics of patients prescribed with a GLP-1 RA medicinal product and how these have changed over the past ten years. This will help contextualise what determinants might be driving the demand for GLP-1 RA vis-à-vis the observed shortage of medicines, including exploring comparative trends of prescription of other medicinal products used in diabetes and for weight management as well as patterns of off-label use.

Study status

Finalised
Research institutions and networks

Institutions

Networks

Contact details

Marta Pineda Moncusi

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol

DARWIN EU_D2.2.3_Protocol_P3-C1-008_GLP1_agonists shortages_V3.pdf

English (778.06 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable