Lingvay, Ildiko https://orcid.org/0000-0001-7006-7401
Benamar, Malik https://orcid.org/0009-0001-1820-1527
Chen, Liming https://orcid.org/0000-0002-5682-2340
Fu, Ariel https://orcid.org/0009-0007-0220-5877
Jódar, Esteban https://orcid.org/0000-0002-1234-8560
Nishida, Tomoyuki https://orcid.org/0009-0004-5812-7167
Riveline, Jean-Pierre https://orcid.org/0000-0001-7991-0741
Yabe, Daisuke https://orcid.org/0000-0002-5334-7687
Zueger, Thomas https://orcid.org/0000-0001-6190-7405
Réa, Rosângela https://orcid.org/0000-0002-2102-0495
Funding for this research was provided by:
Novo Nordisk A/S
Article History
Received: 16 August 2024
Accepted: 8 November 2024
First Online: 17 January 2025
Change Date: 5 May 2025
Change Type: Correction
Change Details: A Correction to this paper has been published:
Change Details: https://doi.org/10.1007/s00125-025-06435-1
Acknowledgements
: The authors thank all trial participants and staff. Medical writing support was provided by G. Rogers and J. Geatrell of Oxford PharmaGenesis, Oxford, UK, funded by Novo Nordisk A/S.
: Individual participant data will be shared in data sets in a de-identified/anonymised format. Shared data will include data sets from Novo Nordisk-sponsored clinical research completed after 2001 for product indications approved in both the EU and the USA. The trial protocol and redacted clinical trial report will be made available according to Novo Nordisk data sharing commitments. These data will be available after research completion and 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 novonordisk-trials.com). These data can be accessed via an access request proposal form; the access criteria can be found at novonordisk-trials.com. The data will be made available on a specialised SAS data platform. The results tables will be made available according to US and EU law, via Clinicaltrials.gov and EU Clinical Trials Register. Clinical trials synopsis will be uploaded to novonordisk-trials.com for clinical projects that have been discontinued.
: This trial was funded by Novo Nordisk A/S. Representatives of Novo Nordisk A/S were involved in the design and conduct of the trial; collection, management, analysis and interpretation of the data; and preparation, review and approval of the manuscript. Investigators were responsible for trial-related medical decisions and data collection; Novo Nordisk undertook site monitoring, data collation and analysis. Medical writers (G. Rogers and J. Geatrell from Oxford PharmaGenesis, Oxford, UK), funded by Novo Nordisk, assisted with drafting the manuscript under direction of the authors. Novo Nordisk did not have the right to veto publication or to control the decision regarding the journal to which the manuscript was submitted; these decisions were made by the authors.
: IL has received research funding (paid to the institution they are affiliated with) from Boehringer Ingelheim, Merck, Mylan, Novo Nordisk, Pfizer and Sanofi, and has received advisory/consulting fees and/or other support from AstraZeneca, Bayer, Boehringer Ingelheim, Carmot Therapeutics, Eli Lilly, GI Dynamics, Intarcia Therapeutics, Intercept Pharmaceuticals, Johnson & Johnson, MannKind, Merck, Mylan, Novartis, Novo Nordisk, Pfizer, Sanofi, Shionogi, Structure Therapeutics, Target Pharma, Valeritas and Zealand Pharma. MB and AF are employees of Novo Nordisk A/S. LC has received research funding (paid to the institution they are affiliated with) from AstraZeneca and Eli Lilly. EJ has received research funding (paid to the institution they are affiliated with) from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Faes Farma, MSD, Novartis and Novo Nordisk, and has received advisory/consulting fees and/or other support from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, MSD, Novo Nordisk, Technofarma, UCB and Viatris. TN is an employee of Novo Nordisk Pharma Ltd. J-PR is an advisory panel member for Abbott, Air Liquide International, Alphadiab, AstraZeneca, Dexcom, Eli Lilly, Medtronic, MSD, Novo Nordisk and Sanofi, and has received research funding from and provided research support to Abbott, Air Liquide International, Medtronic, Novo Nordisk and Sanofi. DY has received consulting or speaker fees from Eli Lilly Japan K.K., Mitsubishi Tanabe Pharma, MSD K.K., Nippon Boehringer Ingelheim, Novo Nordisk Pharma Ltd and Sumitomo Pharma, and clinically commissioned/received joint research grants from Arklay, Nippon Boehringer Ingelheim, Novo Nordisk Pharma Ltd and Taisho Pharmaceutical. TZ has received research funding (paid to the institution they are affiliated with) from Akero Therapeutics, Novartis and Novo Nordisk, and has received advisory/consulting fees and/or other support (paid to the institution they are affiliated with) from AstraZeneca, Eli Lilly, Novo Nordisk, and Sanofi. RR is an advisory panel member for AstraZeneca, Boehringer Ingelheim, Eli Lilly and Novo Nordisk, has participated in speakers’ bureaus for AstraZeneca, Boehringer Ingelheim, Eli Lilly, MSD and Novo Nordisk, and has received research grants from Boehringer Ingelheim, Eli Lilly and Novo Nordisk.
: All authors had full access to the data associated with this trial and contributed to interpreting the data and drafting the manuscript. The authors jointly decided to submit the manuscript, approved it before submission and take full responsibility for its content. IL is the guarantor of this work.