Onishi, Yukiko http://orcid.org/0000-0003-1180-5982
Shirabe, Shinichiro
Eguchi, Kosei
Nishijima, Keiji
Sato, Toshihiro
Seino, Hiroaki
Funding for this research was provided by:
Novo Nordisk A/S
Article History
Received: 25 November 2022
Accepted: 9 May 2023
First Online: 15 June 2023
Declarations
:
: YO has received honoraria/lecture fees from Novo Nordisk Pharma Ltd. and Sumitomo Pharma. SS has received honoraria/lecture fees from Eli Lilly Japan K.K., Novo Nordisk Pharma Ltd. and Sumitomo Pharma. KE and TS are employees of Novo Nordisk. KN holds shares in and is an employee of Novo Nordisk. HS has received research funding from Astellas Pharma Inc., Taisho Toyama Pharmaceutical, Takeda Pharmaceutical, Novo Nordisk Pharma, Sanofi, Mitsubishi Tanabe Pharma Co., Novartis Pharma K.K., Shionogi Pharma Co. Ltd., Boehringer Ingelheim, AstraZeneca K.K., and MSD; and honoraria from Shionogi Pharma Co., Mitsubishi Tanabe Pharma Co., Astellas Pharma Inc., Novartis Pharma K.K., Eli Lilly, Ono Pharmaceutical Co., MSD, and Sanofi.
: The protocol was approved by the IEC or other appropriate body and was provided by each investigator prior to undertaking any study-related activities. Specifically, the protocol was approved by: Institute for Adult Diseases, Asahi Life Foundation Institutional Review Board (approval date: 03 Dec 2018; approval number: 11000766); Medical Corporation Ichi YouKai Institutional Review Board Makato Honda Board (approval date: 13 Feb 2019; approval number: 14000077); Seino Naika Clinic Chairman, Ethical Review Board (approval date: 15 Dec 2018; approval number: 18000150); Shinagawa East One Medical Clinic Ethical Review Board Shinagawa East One Medical Clinic (approval date: 26 Nov 2018; approval number: 11000993); Nihonbashi Sakura Clinic Institutional Review Board (approval date: 05 Dec 2018; approval number: 11001007); Heiwadai Hospital Institutional Review Board (approval date: 21 Nov 2018; approval number: 11000861); Jinnouchi Hospital Ethical Review Board (approval date: 10 Dec 2018; approval number: 16000034); Kouhoukai Ethical Committee (approval date: 03 Dec 2018; approval number: 18000145); Hospital Joint Institutional Review Board (approval date: 21 Dec 2018; approval number: 14000050); and Institutional Review Board for Considering the Ethics of Special Non-Profit Entity Clinical Trials (approval date: 28 Jan 2019; approval number: 12000065).
: All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and/or with the Helsinki Declaration of 1964 and later versions. Informed consent was provided by each participant prior to undertaking any study-related activities (during the first and only study visit).
: Informed consent was provided by each participant prior to undertaking any study-related activities (during the first and only study visit).
: NCT03786406, 26 December 2018 and NCT03811288, 22 January 2019.
: All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be submitted.
: Some of the results from this study were previously presented at the 64<sup>th</sup> Annual Meeting of the Japanese Diabetes Society, virtual meeting, 2021.