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ID 118567
Kudo, Akihiro Fukushima Medical University
Machii, Noritaka Fukushima Medical University
Ono, Toshio Iwaki City Medical Center
Saito, Haruka Fukushima Medical University
Oshiro, Yoshito Ohama Daiichi Hospital
Takahashi, Ryu Ohama Daiichi Hospital
Oshiro, Koichi Ohama Daiichi Hospital
Taneda, Yoshinobu Taneda Clinic
Higa, Moritake Tomishiro Central Hospital
Nakachi, Ken Shonan Hospital
Masuzaki, Hiroaki University of the Ryukyus
Shimabukuro, Michio Fukushima Medical University KAKEN Search Researchers
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Journal Article
Introduction: This 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 methods: Changes 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.
Results: Among 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 (183–156mg/dL, p=0.001), maximum glucose (300–253, p<0.01), and SD glucose (57–45, p<0.05) decreased. Time in range increased (p<0.05), while time above the range decreased in the dapagliflozin add-on group but not in the no add-on group. After 12-week treatment with dapagliflozin add-on, 8-hydroxy-2’-deoxyguanosine (8OHdG), as well as hemoglobin A1c (HbA1c), decreased.
Conclusions: This 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.
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BMJ Open Diabetes Research & Care
BMJ Publishing Group
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Medical Sciences