Abstract | INTRODUCTION: METHODS: Patients with T2DM who had not used antidiabetic agents or who had used antidiabetic agents other than SGLT2is and DPP-4is were enrolled in the study after written informed consent had been obtained. The enrolled patients were subsequently randomly assigned to either the luseogliflozin or DPP-4i group and followed up for 52 weeks. The primary (composite) endpoint was the proportion of patients who showed improvement in ≥ 3 endpoints among the following five endpoints from baseline to week 52: glycated hemoglobin (HbA1c), weight, estimated glomerular filtration rate (eGFR), systolic blood pressure, and pulse rate. RESULTS: A total of 623 patients were enrolled in the study and subsequently randomized to either the luseogliflozin or DPP-4i groups. The proportion of patients who showed improvement in ≥ 3 endpoints at week 52 was significantly higher in the luseogliflozin group (58.9%) than in the DPP-4i group (35.0%) (p < 0.001). When stratified by body mass index (BMI) (< 25 or ≥ 25 kg/m2) or age (< 65 or ≥ 65 years), regardless of BMI or age, the proportion of patients who achieved the composite endpoint was significantly higher in the luseogliflozin group than in the DPP-4i group. Hepatic function and high-density lipoprotein-cholesterol were also significantly improved in the luseogliflozin group compared with the DPP-4i group. The frequency of non-serious/serious adverse events did not differ between the groups. CONCLUSION: This study showed the overall efficacy of luseogliflozin compared with DPP-4is over the mid/long term, regardless of BMI or age. The results suggest the importance of assessing multiple aspects regarding the effects of diabetes management. TRIAL REGISTRATION NUMBER: jRCTs031180241.
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Authors | Masahiro Sugawara, Masahiro Fukuda, Ichiro Sakuma, Yutaka Wakasa, Hideaki Funayama, Akira Kondo, Naoki Itabashi, Yasuyuki Maruyama, Takashi Kamiyama, Yasunori Utsunomiya, Akira Yamauchi, Hidenori Yoshii, Hirokazu Yamada, Koichi Mochizuki, J-SELECT study investigators |
Journal | Diabetes therapy : research, treatment and education of diabetes and related disorders
(Diabetes Ther)
Vol. 14
Issue 9
Pg. 1517-1535
(Sep 2023)
ISSN: 1869-6953 [Print] United States |
PMID | 37410308
(Publication Type: Journal Article)
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Copyright | © 2023. The Author(s). |