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
Authors' 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.
Study context
- Population
- Japanese patients aged 10–17 years with T2D and hemoglobin A1c (HbA1c) 7.0%-12.0%, with or without prior metformin userandomized 2:1
- Participants
- 48 patients
- Comparison
- Luseogliflozin 2.5 mg vs placebo
- Luseogliflozinn = 31
- Placebon = 17reference
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- End of period I (12 weeks)
Methodological detailsmulticenter, double-masked, placebo-controlled, phase 3, 40-week open-label extension
- Multicenter
- Double-masked
- Placebo-controlled
- Phase 3
- 40-week open-label extension
Primary result
As reported in the abstract
Luseogliflozin
−1.45
CI −1.78%–-1.11% · %
Further findings
- Change in HbA1c from baseline (luseogliflozin) · end of period II (52 weeks)
- −0.92 · mean · ± 1.74% · %
Safety
- Adverse events (AEs)
- 85.4%
- Adverse drug reactions
- 29.2%
- Deaths
- 0
- Serious AEs
- 3
- Mild hypoglycemic event
- 1
- Urinary and genital infections were the most frequent adverse drug reactions
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
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. Horm Res Paediatr. Published 5 September 2026. doi:10.
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