Abstract | INTRODUCTION: METHODS: This open-label, randomized, parallel-group study commenced in June 2021, will conclude recruitment in May 2023, and will end by March 2025. Sixty patients with NASH complicated by T2DM are enrolled at the Ehime University Hospital in Toon, Japan. Participants will be randomized into: (1) an intervention group receiving combination therapy with the SGLT2i luseogliflozin 2.5 mg, once daily (Taisho Pharmaceutical, Tokyo, Japan) and the GLP-1 RA semaglutide 0.5 mg, once per week (Novonordisk, Copenhagen, Denmark); and (2) a control group receiving monotherapy with the GLP-1 analog semaglutide. The primary endpoints, which will be ascertained by liver biopsy, are: (1) NASH resolution rate from baseline without worsening of liver fibrosis after 52 weeks of intervention; (2) rate of improvement from baseline of at least 1 point in the NAFLD activity score without worsening of liver fibrosis after 52 weeks of intervention; and (3) rate of improvement from baseline of at least one fibrosis stage without worsening of NASH after 52 weeks of intervention. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trial Registry (UMIN-CTR) number: UMIN000045003. Japan Registry of Clinical Trials registration number: jRCTs061210009.
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Authors | Teruki Miyake, Osamu Yoshida, Bunzo Matsuura, Shinya Furukawa, Masashi Hirooka, Masanori Abe, Yoshio Tokumoto, Yohei Koizumi, Takao Watanabe, Eiji Takeshita, Kotaro Sunago, Atsushi Yukimoto, Kyoko Watanabe, Masumi Miyazaki, Sayaka Kanzaki, Hironobu Nakaguchi, Mitsuhito Koizumu, Yasunori Yamamoto, Teru Kumagi, Yoichi Hiasa |
Journal | Diabetes therapy : research, treatment and education of diabetes and related disorders
(Diabetes Ther)
Vol. 13
Issue 5
Pg. 1083-1096
(May 2022)
ISSN: 1869-6953 [Print] United States |
PMID | 35312970
(Publication Type: Journal Article)
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Copyright | © 2022. The Author(s). |
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