Fukuda, Masahiro http://orcid.org/0000-0003-0172-8661
Sakuma, Ichiro
Wakasa, Yutaka
Funayama, Hideaki
Kondo, Akira
Itabashi, Naoki
Maruyama, Yasuyuki
Kamiyama, Takashi
Utsunomiya, Yasunori
Yamauchi, Akira
Yoshii, Hidenori
Yamada, Hirokazu
Mochizuki, Koichi
Sugawara, Masahiro
,
Clinical trials referenced in this document:
Documents that mention this clinical trial
Effect of Luseogliflozin, a Sodium-Glucose Cotransporter 2 Inhibitor, and Dipeptidyl-Peptidase 4 Inhibitors on the Quality-of-Life and Treatment Satisfaction of Patients With Type 2 Diabetes Mellitus: A Subanalysis of a Multicenter, Open-Label, Randomized-Controlled Trial (J-SELECT Study)
https://doi.org/10.1007/s13300-024-01575-w
Funding for this research was provided by:
Taisho Pharmaceutical Co., Ltd.
Article History
Received: 30 January 2024
Accepted: 22 March 2024
First Online: 24 April 2024
Declarations
:
: Masahiro Fukuda received personal profit from Ono Pharmaceutical Co., Ltd. Ichiro Sakuma received grants from the National Cerebral and Cardiovascular Center and personal profits from Kowa Company, Ltd., Novo Nordisk Pharma, Ltd., Japan Boehringer Ingelheim, Sumitomo Pharma Co., Ltd., Kyowa Kirin Co., Ltd., and Sanwa Kagaku Kenkyusho Co., Ltd. The other authors (Yutaka Wakasa, Hideaki Funayama, Akira Kondo, Naoki Itabashi, Yasuyuki Maruyama, Takashi Kamiyama, Yasunori Utsunomiya, Akira Yamauchi, Hidenori Yoshii, Hirokazu Yamada, Koichi Mochizuki and Masahiro Sugawara) declare no conflict of interest.
: The trial protocol was first approved by the Japan Physicians Association Institutional Review Board (reference no. 007-1710) according to the Ethical Guidelines for Medical and Health Research Involving Human Subjects issued by the Ministry of Health, Labour, and Welfare in Japan. Participation of each medical institution for study implementation was inspected and approved collectively by the Japan Physicians Association Institutional Review Board or by the ethics review board in each institution. The list of ethics review boards which first approved the participation of each medical institution is shown in Supplementary Materials Table 1. Before enrolling the first patient, this study was registered at the University Hospital Medical Information Network Clinical Trial Registry (UMIN-CTR) (UMIN000030128) on November 27, 2017. Subsequently, following the enforcement of a new law, ‘the Clinical Trials Act,’ in April 2018 in Japan, this study and its protocols were again inspected and approved by the Certified Clinical Research Review Board of Toho University (reference no. THC18008), which obtained certification from the Minister of Health, Labour, and Welfare in Japan. After approval from the certified review board, this study was registered in the Japan Registry of Clinical Trials (jRCT) (jRCTs031180241) on March 15, 2019, which is the clinical trial registration developed by the Ministry of Health, Labour, and Welfare in Japan, according to the requirements of the Clinical Trials Act. The study was conducted in accordance with the Declaration of Helsinki, the Clinical Trials Act, and other current legal regulations in Japan. Written informed consent was obtained prior to treatment from all enrolled patients who met the eligibility criteria.