Long-term (52-week) efficacy and safety of ipragliflozin add-on therapy to insulin in Japanese patients with type 1 diabetes mellitus: An uncontrolled, open-label extension of a phase III study
Journal of Diabetes Investigation Mar 01, 2020
Kaku K, et al. - The present report illustrates results from the 28-week open-label extension period to evaluate the long-term (52-week) effectiveness and safety of ipragliflozin, an SGLT2-selective inhibitor, in insulin-treated Japanese patients with T1DM and inadequate glycemic control. For this investigation, ipragliflozin recipients continued treatment (50 mg, once daily), and placebo recipients were switched to once-daily 50 mg ipragliflozin at the beginning of the extension period. The open-label extension (treatment period 2) was completed by a total of 53 (placebo switched to ipragliflozin) and 108 (ipragliflozin) patients, with 24 and 44 patients receiving dose increases, respectively. In this long-term, open-label extension study, the effectiveness and safety of 50 mg, once-daily ipragliflozin in insulin-treated T1DM patients have been verified. The dose increase to 100 mg was not attributed to any safety concerns. No serious adverse events or deaths related to the therapy have been reported.
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