Lyxumia lixisenatide: Phase III data

Top-line data from the double-blind, international Phase III GetGoal-P trial in 484 Type II diabetics inadequately controlled with pioglitazone showed that Lyxumia as an add-on to pioglitazone with or without metformin met the primary endpoint of significantly reducing HbA1c from baseline to week 24 vs. placebo plus pioglitazone with or without metformin. Specifically, Lyxumia reduced mean HbA1c from 8.08% at baseline to 7.06% at week 24, while placebo reduced the endpoint from 8.05% at baseline to 7.59% at week 24 (p<0.0001). The most common adverse event was nausea. Additionally, 3.4% and 1.2% of patients who received Lyxumia and placebo, respectively, reported symptomatic hypoglycemia at week 24. ...