Hirota, Yushi
Kakei, Yasumasa
Imai, Junta
Katagiri, Hideki
Ebihara, Ken
Wada, Jun
Suzuki, Junichi
Urakami, Tatsuhiko
Omori, Takashi
Ogawa, Wataru
Funding for this research was provided by:
Boehringer Ingelheim Japan
Eli Lilly Japan
Article History
Received: 8 November 2023
Accepted: 15 December 2023
First Online: 13 January 2024
Declarations
:
: Yushi Hirota received the following remuneration and financial assistance: lecture fees from Eli Lilly Japan K.K. Sanofi, Terumo Corp., Sumitomo Pharma Co., Ltd., Abbott Japan LLC.), and research support from Sumitomo Pharma Co., Ltd., Kyowa Kirin Co., Ltd. and Medtronic Japan Co., Ltd. Junta Imai received the following financial assistance: scholarship donations from Nippon Boehringer Ingelheim Co., Ltd., Sumitomo Pharma Co., Ltd. (formerly Sumitomo Dainippon Pharma Co. Ltd.) and Mitsubishi Tanabe Pharma Co., Ltd. Hideki Katagiri received the following remuneration and financial assistance: lecture fees from Sumitomo Pharma Co.; research expenses (including those for contracted research, joint research, and clinical trials) and grants from Astellas Pharma Inc. and Taisho Pharmaceutical Co., Ltd. and scholarship donations from Sumitomo Pharma Co., Ltd., Mitsubishi Tanabe Pharma Co., Ltd. and Nippon Boehringer Ingelheim Co., Ltd. Jun Wada received the following remuneration and financial assistance: lecture fees from Astra Zeneca, Bayer Yakuhin Ltd., Nippon Boehringer Ingelheim Co., Ltd., Daiichi Sankyo Co., Ltd, Kyowa Kirin Co., Ltd., Novo Nordisk Pharma Ltd. and Mitsubishi Tanabe Pharma Co., Ltd.,; research expenses (including those for contracted research, joint research, and clinical trials) and grants from Bayer Yakuhin Ltd., Chugai Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Shionogi Pharmaceutical Co., Ltd., Sumitomo Pharma Co. and Mitsubishi Tanabe Pharma Co., Ltd.. Tatsuhiko Urakami received the following remuneration: lecture fees from Novo Nordisk Pharma Ltd., Eli Lilly Japan K.K., Abbott Japan LLC., Terumo Corp. and JCR Pharmaceuticals Co., Ltd. Wataru Ogawa has received the following remuneration and financial assistance: lecture fees from Abbott Japan LLC., Nippon Boehringer Ingelheim Co., Ltd., Sumitomo Pharma Co., Ltd. and Novo Nordisk Pharma Ltd.; research expenses (including those for contracted research, joint research, and clinical trials) and grants from Abbott Diabetes Care UK Ltd., Eli Lilly Japan K.K., Nippon Boehringer Ingelheim Co., Ltd., Noster Inc., Teijin Pharma Ltd and Sumitomo Pharma Co., Ltd. and scholarship donations from Kowa Company, Ltd., Novo Nordisk Pharma Ltd., Sumitomo Pharma Co., Ltd., Teijin Pharma Ltd. and Takeda Pharmaceutical Co. Ltd. All remaining authors declare no conflict of interest.
: The trial was performed in accordance with the 2013 Declaration of Helsinki and International Conference on Harmonization Good Clinical Practice (ICHGCP) guidelines. The study protocol and amendments were approved by Kobe University Hospital Institutional Review Board and the relevant institutional review board at each study site (Tohoku University Hospital Institutional Review Board, The Institutional Review Board of Nihon University Hospital, Jichi Medical University Hospital Institutional Review Board, and IRB of Okayama University Hospital). The trial was registered with the Japan Registry of Clinical Trials (jRCTs2051190029) and with ClinicalTrials.gov (NCT04018365). All participants provided written informed consent before entry into the study.