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A multisite collaborative research program of observational studies to monitor the utilization and safety of dulaglutide in the EU

Description

Dulaglutide (Trulicity®) is a new glucagon-like peptide 1 receptor agonist (GLP-1 RA), indicated for the treatment of type 2 diabetes mellitus that is applied once weekly. Market launch for dulaglutide in Germany was in February 2015. The use of any GLP-1 RAs is associated with an increased risk of potentially serious medical conditions. In the clinical registration trials, i.a., hypersensitivity reactions and gastrointestinal disorders, such as acute pancreatitis, were identified as side effects. Monitoring of the use of dulaglutide under real-life conditions is required. In the context of a risk-management plan, the European Medicines Agency (EMA) demands further safety studies after approval (Post-Authorization Safety Studies – PASS) from the marketing authorization holder Eli Lilly Nederland B.V., which will be conducted until 2019.

Based on data from the German Pharmacoepidemiological Research Database (GePaRD) from 2015 to 2016, this cohort study investigates the utilization of new users of dulaglutide and estimates the risk of hypersensitivity reactions, acute pancreatitis, cardiovascular and gastrointestinal disorders during the first year of therapy. Additionally, the prevalence of pancreatic and/or thyroid cancer will be estimated. Furthermore, this study aims to investigate different subgroups of dulaglutide users for whom there is missing information in the risk-management plan (such as children and adolescents, elderly or pregnant women).

The study is conducted in cooperation with the non-profit organization Drug Safety Research Unit (DSRU). Similar studies that are part of the dulaglutide PASS program will be conducted in England, Italy and the Netherlands.

Funding period

Begin:   February 2015
End:   December 2020

Sponsor

  • Pharmaceutical industry

Contact

 Jonas Reinold