Ipragliflozin combined with insulin reduced the incidence of SH while maintaining comparable DKA risk in adults with T1DM. The real-world evaluation, reported in Diabetes Therapy, assessed safety outcomes using data from the JMDC Claims Database between June 2018 and December 2021. Individuals newly initiated on ipragliflozin plus insulin were matched 1:10 with those receiving insulin alone using propensity score matching. Incidence rates for DKA and SH were evaluated using Kaplan–Meier curves, and adjusted hazard ratios were calculated with Cox proportional-hazards models.

The incidence rate of DKA per 1000 patient-years was similar between treatment groups (8.3 for ipragliflozin/insulin vs 8.5 for insulin; hazard ratio [HR] 0.902, 95% confidence interval [CI] 0.418–1.945; p = 0.792). In contrast, SH occurred less frequently in the ipragliflozin/insulin group (6.6 vs 21.7 per 1000 patient-years; HR 0.284, 95% CI 0.126–0.637; p = 0.002).

These results indicate that adding ipragliflozin to insulin does not increase the risk of DKA and is associated with a markedly lower risk of SH. Appropriate monitoring, patient education, and risk-mitigation strategies remain essential when prescribing ipragliflozin with insulin in T1DM.