Efficacy and safety of ipragliflozin as an add-on to pioglitazone in Japanese patients with inadequately controlled type 2 diabetes: a randomized, double-blind, placebo-controlled study (the SPOTLIGHT study)
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Ipragliflozin is a novel oral sodium–glucose cotransporter 2 (SGLT2) inhibitor under development for the treatment of type 2 diabetes. We examined its efficacy and safety as an add-on to pioglitazone in Japanese patients with inadequately controlled diabetes. Japanese type 2 diabetes patients were randomized to 24 weeks of treatment with 50 mg ipragliflozin or placebo in a double-blind manner. At week 24, patients with hemoglobin (Hb)A1c <8.4 % were permitted to continue open-label ipragliflozin in a 28-week extension period. The primary endpoint was the change in HbA1c from baseline to week 24 (with last observation carried forward). Ninety-eight and 54 patients were randomized to ipragliflozin or placebo, respectively, and were prescribed the study drug. The mean HbA1c change from baseline to week 24 was −0.64 % and 0.22 % in the ipragliflozin and placebo groups, respectively, and the adjusted mean difference between the two groups was −0.88 % (P < 0.001). Changes in fasting plasma glucose (FPG) and body weight were significantly greater in the ipragliflozin group (both P < 0.001). Among patients who continued ipragliflozin in the extension period, reductions in HbA1c, FPG, and body weight were maintained until week 52. The incidence of treatment-emergent adverse events was not significantly different between the two groups. The most common event with a higher incidence in the ipragliflozin group than in the placebo group was pollakiuria (12/97 vs. 0/54 patients). Ipragliflozin improved glycemic control, promoted weight reduction, and had a good safety profile as an add-on to pioglitazone in Japanese type 2 diabetes patients.
KeywordsIpragliflozin Japanese Pioglitazone Randomized controlled trial SGLT2 Type 2 diabetes
Ipragliflozin is under development by Astellas Pharma Inc. and Kotobuki Pharmaceutical Co., Ltd. This study was sponsored by Astellas Pharma Inc. Medical writing and editorial support was funded by Astellas Pharma Inc., and was provided by Dr. Nicholas D. Smith and ELMCOM™.
Conflict of interest
TS, NA, KK, AU, SY, and EU are employees of Astellas Pharma Inc. AK has acted as a consultant for Astellas Pharma Inc. and has received consulting fees/honoraria from Astellas Pharma Inc.
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