Effect of dapagliflozin on 24-hour glycemic variables in Japanese patients with type 2 diabetes mellitus receiving basal insulin supported oral therapy (DBOT): a multicenter, randomized, open-label, parallel-group study

Autor: Akihiro Kudo, Noritaka Machii, Toshio Ono, Haruka Saito, Yoshito Oshiro, Ryu Takahashi, Koichi Oshiro, Yoshinobu Taneda, Moritake Higa, Ken Nakachi, Shusuke Yagi, Hiroaki Masuzaki, Masataka Sata, Michio Shimabukuro
Rok vydání: 2023
Předmět:
Zdroj: BMJ Open Diabetes Research & Care. 11:e003302
ISSN: 2052-4897
0000-1945
DOI: 10.1136/bmjdrc-2022-003302
Popis: IntroductionThis study aimed to evaluate the impacts of dapagliflozin on 24-hour glucose variability and diabetes-related biochemical variables in Japanese patients with type 2 diabetes who had received basal insulin supported oral therapy (BOT).Research design and methodsChanges in mean daily blood glucose level before and after 48–72 hours of add-on or no add-on of dapagliflozin (primary end point) and diabetes-related biochemical variables and major safety variables during the 12 weeks (secondary end point) were evaluated in the multicenter, randomized, two-arm, open-label, parallel-group comparison study.ResultsAmong 36 participants, 18 were included in the no add-on group and 18 were included in the dapagliflozin add-on group. Age, gender, and body mass index were comparable between the groups. There were no changes in continuous glucose monitoring metrics in the no add-on group. In the dapagliflozin add-on group, mean glucose (183–156 mg/dL, p=0.001), maximum glucose (300–253, pConclusionsThis study showed that the mean daily blood glucose and other daily glucose profiles were amended after 48–72 hours of dapagliflozin add-on in Japanese patients with type 2 diabetes who received BOT. The diabetes-related biochemical variables such as HbA1c and urinary 8OHdG were also obtained during the 12 weeks of dapagliflozin add-on without major adverse events. A preferable 24-hour glucose profile in ‘time in ranges’ and an improvement in reactive oxygen species by dapagliflozin warrant us to evaluate these benefits in larger clinical studies.Trial registration numberUMIN000019457.
Databáze: OpenAIRE
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