Massey, Robert J.
Chen, Yu
Panova-Noeva, Marina
Mattheus, Michaela
Siddiqui, Moneeza K.
Schloot, Nanette C.
Ceriello, Antonio
Pearson, Ewan R.
Dawed, Adem Y.
Funding for this research was provided by:
Innovative Medicines Initiative 2 Joint Undertaking (875534)
Article History
Received: 15 March 2024
Accepted: 10 June 2024
First Online: 16 July 2024
Declarations
:
: Harmony outcome trial: The protocol for this study was approved by an independent committee who manage access to clinical trials (). All study participants have provided informed consent. Tayside Bioresource: The study was approved by the Tayside Regional Ethics Committee and informed consent was obtained from all subjects. REWIND: Ethics review boards gave ethical approval for the analysis of REWIND placebo cohort. EMPA-REG OUTCOME: The EMPA-REG OUTCOME trial was designed and overseen by a steering committee that included academic investigators and employees of Boehringer Ingelheim. The trial was conducted in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines and was approved by local authorities. An independent ethics committee or institutional review board approved the clinical protocol at each participating centre. A full list of participating sites and ethics committees can be found at https://www.nejm.org/doi/suppl/. All the patients provided written informed consent before study entry.
: All authors have reviewed and consent to the publication of this manuscript.
: Y.C. is employed by Eli Lilly and Company and owns stock. N.C.S. is employed by Lilly Deutschland GmbH and owns stock. A.Y.D. is employed by Novo Nordisk. M.M. and M.P.N. are employed by Boehringer Ingelheim Pharma GmbH & Co.KG.