Pieber, Thomas R. http://orcid.org/0000-0003-3554-0405
Arfelt, Kristine N.
Cailleteau, Roman http://orcid.org/0000-0002-8938-7912
Hart, Marlies
Kar, Soumitra http://orcid.org/0000-0003-1701-0347
Mursic, Ines http://orcid.org/0000-0003-3836-6529
Svehlikova, Eva http://orcid.org/0000-0002-9743-2031
Urschitz, Martina http://orcid.org/0000-0002-3729-8977
Haahr, Hanne http://orcid.org/0000-0002-6980-8230
Funding for this research was provided by:
Novo Nordisk A/S
Medical University of Graz
Article History
Received: 28 November 2022
Accepted: 7 March 2023
First Online: 13 June 2023
Acknowledgements
: The authors are grateful to N. R. Kristensen (Novo Nordisk A/S, Søborg, Denmark) for performing the pharmacokinetic modelling. Medical writing support was provided by C. Roepstorff (CR Pharma Consult, Copenhagen, Denmark), funded by Novo Nordisk. Some of the data were presented as an abstract at the American Diabetes Association 82nd Scientific Sessions in 2022 and at the 58th EASD Annual Meeting of the European Association for the Study of Diabetes in 2022.
: Data will be shared with bona fide researchers submitting a research proposal requesting access to data for use as approved by the Independent Review Board according to the Independent Review Board Charter (see novonordisk-trials.com). The data will be made available on a specialised SAS data platform. Individual participant data will be shared in data sets in a de-identified/anonymised format. Data sets from Novo Nordisk sponsored clinical research completed after 2001 for product indications approved in both the EU and USA will be shared. Study protocol and redacted Clinical Study Report will be available according to Novo Nordisk data sharing commitments. The data will be available permanently after research completion and approval of product and product use in both the EU and USA. There is no end date.
: Open access funding provided by Medical University of Graz. This study was funded by Novo Nordisk A/S. The sponsor was involved in the study design, analysis and interpretation of data, and preparation of the report.
: TRP has received research support (directed to Medical University of Graz, Graz, Austria) from AstraZeneca, Novo Nordisk and Sanofi, has served as speaker, board member and in advisory panels for Arecor and Novo Nordisk and is an employee of CBmed – Center for Biomarker Research in Medicine. KNA, RC, SK and HH are employees and shareholders of Novo Nordisk. ES has received travel grants from Mylan. All other authors declare that there are no relationships or activities that might bias, or be perceived to bias, their work.
: HH contributed to the study conception. TRP, ES, HH and KNA contributed to the study design. TRP, ES, MH, IM and MU contributed to data acquisition. KNA, RC and SK contributed to data analysis. All authors contributed to drafting and critical revision of the manuscript and approval of the final manuscript. TRP is the guarantor and takes responsibility for the content of the article.