Ipragliflozin: Phase III data

A double-blind, Japanese Phase III trial in 242 Type II diabetics with inadequate glycemic control on a sulfonylurea showed that once-daily 50 mg ipragliflozin an add-on to a sulfonylurea met the primary endpoint of reducing HbA1c from baseline to week 24 vs. placebo (0.83% vs. a 0.32% increase, p<0.001). Additionally, a greater proportion of patients receiving ipragliflozin achieved a target HbA1c of <7% vs. placebo (19.4% vs. 5.3%). On secondary endpoints, ipragliflozin led to significant reductions from baseline to week 24 in FPG (41.4 vs. 1 mg/dL, p<0.001) and body weight (2.33 vs. 0.88 kg, 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 a sulfonylurea. 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. ...