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- Title
Overall Efficacy and Safety of Sodium-Glucose Cotransporter 2 Inhibitor Luseogliflozin Versus Dipeptidyl-Peptidase 4 Inhibitors: Multicenter, Open-Label, Randomized-Controlled Trial (J-SELECT study).
- Authors
Sugawara, Masahiro; Fukuda, Masahiro; Sakuma, Ichiro; Wakasa, Yutaka; Funayama, Hideaki; Kondo, Akira; Itabashi, Naoki; Maruyama, Yasuyuki; Kamiyama, Takashi; Utsunomiya, Yasunori; Yamauchi, Akira; Yoshii, Hidenori; Yamada, Hirokazu; Mochizuki, Koichi; Seino, Hiroaki; Murata, Kaori; Yatagai, Shigeo; Koyama, Hiroshi; Yamamoto, Hareaki; Shimizu, Miho
- Abstract
Introduction: Evidence of a direct comparison between dipeptidyl-peptidase 4 inhibitors (DPP-4is) and sodium-glucose cotransporter 2 inhibitors (SGLT2is) remains lacking, and no clear treatment strategy or rationale has been established using these drugs. This study aimed to compare the overall efficacy and safety of DPP-4is and the SGLT2i luseogliflozin in patients with type 2 diabetes mellitus (T2DM). 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.
- Subjects
SODIUM-glucose cotransporter 2 inhibitors; CD26 antigen; TYPE 2 diabetes; SYSTOLIC blood pressure; GLYCOSYLATED hemoglobin; GLUCOSE transporters
- Publication
Diabetes Therapy, 2023, Vol 14, Issue 9, p1517
- ISSN
1869-6953
- Publication type
Article
- DOI
10.1007/s13300-023-01438-w