Gal, Peter
Feldmajer, Gyorgyi
Augusto, Margarida http://orcid.org/0000-0002-2010-8284
Gani, Ray
Hook, Emma
Bullement, Ash
Philips, Zoe
Smith, Inger
Funding for this research was provided by:
Novo Nordisk A/S, Søborg, Denmark
Article History
Accepted: 18 June 2023
First Online: 28 July 2023
Declarations
:
: MA is an employee of Novo Nordisk A/S and shareholder of Novo Nordisk A/S. IS is a health economics contractor commissioned by Novo Nordisk A/S. Development of the model was commissioned to Evidera by Novo Nordisk and GF, PG, and RG are employees of Evidera. Validation of the model was commissioned to Delta Hat by Novo Nordisk and AB, EH, and ZP are employees of Delta Hat.
: This study was funded by Novo Nordisk A/S, Søborg, Denmark. Novo Nordisk A/S and Evidera were responsible for the study concept and design, data collection, and the decision to submit this article for publication. With the input of all authors, Novo Nordisk A/S were involved in analysis and interpretation of data and writing of this report.
: Protocols for both study NN9931-4296 (NCT02970942) and REGENERATE (NCT02548351) from which the current study used patient-level data, were both approved by the respective Ethics Committees.
: All patients in the NN9931-4296 (NCT02970942) and REGENERATE (NCT02548351) studies gave written informed consent for research participation.
: Not applicable.
: All data generated or analyzed during this study are included in this published article (and its supplementary information files).
: Not applicable.
: PG provided the study concept and design. All authors contributed to the analysis and interpretation of the data. GF, PG, and RG developed the cost-effectiveness model, and AB, EH, and ZP performed the validations. All authors contributed to the drafting of the paper, critically revised the paper for intellectual content, were involved in the final approval of the version to be published, and agreed to be accountable for ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. MA is the overall guarantor.