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Article History

Received: 18 July 2024

Accepted: 18 December 2024

First Online: 12 January 2025

Declarations

:

: HK has received lecture fees from Boehringer Ingelheim, Eli Lilly, Sanofi-Aventis, Novo Nordisk Pharma, Sumitomo Pharma Co., Daiichi Sankyo Inc., Mitsubishi Tanabe Pharma Co.; research funds from Boehringer Ingelheim, Sumitomo Pharma Co., and Taisho Pharma Co.; and scholarship donations from Boehringer Ingelheim, Eli Lilly, Sumitomo Pharma Co., Taisho Pharma Co., Daiichi Sankyo Inc., Mitsubishi Tanabe Pharma Co., Abbott. TO has received research funding from Ono Pharmaceutical Co. TS has received research funding from Novo Nordisk Pharma. TY has received lecture fees from Eli Lilly, Sumitomo Pharma Co., Novo Nordisk Pharma, and Mitsubishi Tanabe Pharma Co. MG has received lecture fees from Pfizer. IS has received lecture fees from Ono Pharmaceutical Co., Kowa Company, Ltd., Sumitomo Pharma Co., Eli Lilly Japan K.K, and Novo Nordisk Pharma,; research funds from Japan Agency for Medical Research and Development (AMED), Cancerscan Inc., Kowa Company, Ltd., Kobayashi Pharmaceutical Co. Ltd., Nissin Food Products Co. Ltd., Rohto; and subsidies or donations from Daiichi Sankyo Co., Sumitomo Pharma Co., Takeda Pharma K.K., Mitsubishi Tanabe Pharma Co., Teijin Pharma, Mochida Pharmaceutical Co., Suzuken Memorial Foundation, Manpei Suzuki Diabetes Foundation, Midori Health Care Center, Kyowakai Medical Corporation, Osaka Central Hospital, Hakuhokai Central Hospital. HW has received honoraria for lectures from Bayer Pharma Japan, MSD, Sanwa Kagaku Kenkyusho Co., Novo Nordisk, Nippon Boehringer Ingelheim, Eli Lilly, Sumitomo Pharma, Mitsubishi Tanabe Pharma, Daiichi Sankyo Company, Ltd., Roche DC and Abbott,; for research from Kyowa Lirin Co., Ltd., SBI Pharma Co. Ltd., Nippon Boehringer Ingelheim, Sumitomo Pharma, Sanwa Kagaku, and Kowa; subsidies or donation from Abbott, Teijin Pharma, Sumitomo Pharma, Mitsubishi Tanabe Pharma, Life scan, Eli Lilly, Sanwa Kagaku, Taisho and Pharmaceutical Co. Ltd.; and endowed department by commercial entities from Takeda Pharmaceuticals, Soiken, Sanwa Kagaku, Sumitomo Pharma, Taisho Pharmaceutical Co. Ltd., Ono Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma, MSD, Kowa and Nippon Boehringer Ingelheim. Other authors have no competing interests.

: The protocol was approved by the Institutional Review Board at each participating institution, and the study was conducted in compliance with the Declaration of Helsinki and current legal regulations in Japan. This study was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), which is a non-profit organization in Japan that meets the requirements of ICMJE (UMIN000014014). Written informed consent was obtained from all participants after a full explanation of the study.