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 3 study
Journal of Diabetes Investigation Dec 13, 2019
Kaku K, et al. - In insulin-treated Japanese patients with type 1 diabetes mellitus (T1DM) and inadequate glycemic control, researchers tested the long-term (52-week) effectiveness and safety of ipragliflozin. Fifty-three (placeboipragliflozin) and 108 (ipragliflozin) individuals finished the open-label extension (treatment period 2), with 24 and 44 people, respectively, receiving dose rises. According to this 28-week, open-label extension of a multicenter, randomized, placebo-controlled, 24-week phase 3 study, among insulin-treated individuals with T1D, treatment with once-daily ipragliflozin 50 mg was safe and effective. Furthermore, no safety concerns were related to a dose increase to 100 mg. Severe hypoglycemia or diabetic ketoacidosis did not occur.
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