Lyxumia lixisenatide: Additional Phase III data

Additional data from the double-blind, international Phase III GetGoal-P trial in 484 Type II diabetics inadequately controlled with pioglitazone showed that once-daily 20 µg Lyxumia as an add-on to pioglitazone with or without metformin significantly reduced FPG from baseline to week 24 vs. placebo plus pioglitazone with or without metformin (1.16 vs. 0.32 mmol/L, p<0.0001). Additionally, a significantly greater proportion of patients receiving Lyxumia achieved an HbA1c of <7% at week 24 vs. placebo (52% vs. 26%, p<0.0001). Lyxumia also led to a non-significant reduction in mean body weight of 0.21 kg vs. a gain of 0.21 kg for placebo (p=0.1864). Data were presented at the American Diabetes Association meeting in Philadelphia. Sanofi previously reported top-line data showing that Lyxumia met the primary endpoint of reducing HbA1c from baseline to week 24 vs. placebo (see BioCentury, Feb. 13). ...