Ipragliflozin: Phase III data

A double-blind, Japanese Phase III trial in 151 Type II diabetics with inadequate glycemic control on pioglitazone showed that once-daily 50 mg ipragliflozin as an add-on to pioglitazone met the primary endpoint of reducing HbA1c from baseline to week 24 vs. placebo (0.64% vs. a 0.22% increase, p<0.001). Additionally, a greater proportion of patients receiving ipragliflozin achieved a target HbA1c of <7% vs. placebo (12.4% vs. 0%). On secondary endpoints, ipragliflozin led to significant reductions from baseline to week 24 in FPG (36.4 mg/dL vs. a 6.1 mg/dL increase, p<0.001) and body weight (2.29 kg vs. a 0.51 kg increase, p<0.001) vs. placebo. Astellas also said it observed reductions in both systolic and diastolic blood pressure in the ipragliflozin arm compared to placebo. Ipragliflozin was well tolerated as an add-on to pioglitazone. Data were presented at the European Association for the Study of Diabetes meeting in Berlin. Astellas could not be reached for details on potential next steps. ...