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Article History

Received: 13 September 2024

Accepted: 5 February 2025

First Online: 5 April 2025

Acknowledgements

: Medical writing support was provided by S. Bestall of Oxford PharmaGenesis, Oxford, UK, with funding from Novo Nordisk. Some of the data included in this manuscript were presented as an abstract at the American Diabetes Association 84th Scientific Sessions in 2024 and at the 60th Annual Meeting of the European Association for the Study of Diabetes in 2024.

: Individual participant data will be shared in datasets in a de-identified or anonymised format. Shared data will include datasets from clinical research sponsored by Novo Nordisk and completed after 2001 for product indications approved in the EU and the USA. The study protocol and redacted clinical study report will be made available according to Novo Nordisk’s data-sharing commitments. These data will be available permanently after research completion and after approval of product and product use in both the EU and the USA (no end date). 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 (IRB) according to the IRB charter (see ). These data can be accessed via an access request proposal form; the access criteria can be found at . The data will be made available on a specialised SAS data platform.

: This study was funded by Novo Nordisk. Representatives of Novo Nordisk had a role in the study design; analysis and interpretation of the data; and in the preparation, review and approval of the manuscript. Novo Nordisk did not have the right to veto publication or to control the decision regarding which journal the manuscript was submitted to; these decisions were made by the authors.

: MCR reports consulting fees from Eli Lilly, the Jaeb Center for Health Research, Zealand Pharma and Zucara Therapeutics; speaker fees from Dexcom Canada, Eli Lilly, Novo Nordisk and Sanofi Diabetes; and stock options from Supersapiens and Zucara Therapeutics. SH reports consultancy fees from Zealand Pharma and Zucara Therapeutics; fees for speaker panel involvement with Novo Nordisk; data monitoring and safety board participation with Eli Lilly; and research support from Dexcom. LC, TMPR and SKW are employees and shareholders of Novo Nordisk. VCW reports speaker fees and advisory board meeting involvement for Boehringer Ingelheim, Eli Lilly and Novo Nordisk.

: All authors had full access to the data associated with this study and contributed to interpreting the data and drafting the manuscript. LC, TMPR and SKW analysed, accessed and verified the data. The authors jointly decided to submit the manuscript, approved it before submission and took full responsibility for its content. MCR is the guarantor for this work.