Efficacy and Safety of Luseogliflozin (TS-071) in Japanese Children and Adolescents with Type 2 Diabetes Mellitus: A Multicenter, Randomized, Double-masked, Placebo-controlled Phase 3 Study.

INTRODUCTION This study evaluated the efficacy and safety of luseogliflozin (TS-071), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, in Japanese children and adolescents with type 2 diabetes (T2D).

Methods

In this multicenter, randomized, double-masked, placebo-controlled phase 3 trial, patients aged 10-17 years with hemoglobin A1c (HbA1c) levels of 7.0%-12.0%, with or without prior metformin use, were enrolled. Participants were randomized (2:1) to receive luseogliflozin 2.5 mg or placebo for 12 weeks (period I), followed by a 40-week open-label extension (period II), allowing dose escalation to 5 mg.

Results

Forty-eight participants were randomized and received luseogliflozin (n = 31) or placebo (n = 17). The primary endpoint-change in HbA1c from baseline at the end of period I-was -1.45% (95% CI, -1.78% to -1.11%) in the luseogliflozin group. The between-group difference in HbA1c change was -1.76% (95% CI, -2.49% to -1.02%). Luseogliflozin maintained efficacy through 52 weeks, with a mean HbA1c change of -0.92% ± 1.74% at the end of period II. Adverse events (AEs) and adverse drug reactions (ADRs) occurred in 85.4% and 29.2% of patients, respectively. No deaths occurred; three serious AEs and one mild hypoglycemic event were reported. Urinary and genital infections were the most frequent ADRs.

Conclusion

Luseogliflozin significantly improved glycemic control and was well tolerated, supporting its potential as an effective and safe treatment option for children and adolescents with T2D.