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Authors
Bensignor, Megan O. https://orcid.org/0000-0002-9341-1858
Freese, Rebecca L.
Rudser, Kyle D.
Kelly, Aaron S.
Kunin-Batson, Alicia
Gross, Amy C. https://orcid.org/0000-0003-2809-8460
Bramante, Carolyn https://orcid.org/0000-0001-5858-2080
Shih, Winnie
Peterson, Craig
Fox, Claudia K. https://orcid.org/0000-0001-5732-0062
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Article History
Received: 12 November 2024
Revised: 14 May 2025
Accepted: 29 May 2025
First Online: 15 June 2025
Competing interests
: MOB receives research support as donated study drug (VIVUS LLC) and continuous glucose monitoring devices (Abbott Inc). CKF serves as a site PI for Novo Nordisk and Eli Lilly clinical trials. Compensation is paid directly to her institution. ASK engages in unpaid consulting and educational activities, as well as serves as an unpaid investigator for Novo Nordisk; engages in unpaid consulting activities and serves as an unpaid investigator for Boehringer Ingelheim, Eli Lilly, and VIVUS; receives donated drug/placebo from Novo Nordisk and Vivus for National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)-funded clinical trials. WS and CP are both employees of VIVUS LLC.
: The University of Minnesota Institutional Review Board approved this analysis and informed consent was not required for this secondary analysis. The original trial, including all methods, was conducted in accordance with International Council for Harmonisation (ICH) E6 (R2) Good Clinical Practices (GCP) guidelines and the principles of the Declaration of Helsinki. An independent central Institutional Review Board (IRB) in addition to individual site IRBs approved the parent trial protocol.
