ARTICLE | Clinical News

Lexicon's LX4211 meets in Phase II Type I diabetes trial

April 15, 2014 12:23 AM UTC

Lexicon Pharmaceuticals Inc. (NASDAQ:LXRX) said once-daily oral LX4211 for 28 days met the primary endpoint of reducing total daily mealtime bolus insulin dose required to maintain or improve glycemic control from baseline to day 28 vs. placebo in a 33-patient Phase II trial to treat Type I diabetes (p=0.007). LX4211 also significantly reduced mean HbA1c from baseline to day 28, a secondary endpoint, vs. placebo (0.55% vs. 0.06%, p=0.002). LX4211 was well tolerated with no discontinuations due to adverse events and no increase in hypoglycemia reported. The double-blind, U.S. trial enrolled Type I diabetics inadequately controlled on either an insulin pump or multiple insulin injection therapy.

By year end, Lexicon plans to start a Phase III trial of LX4211 to treat Type I diabetes with a primary endpoint of reduction in HbA1c. The company said it plans to partner the dual sodium-glucose cotransporter 1 (SGLT1) and SGLT2 inhibitor prior to starting Phase III testing to treat Type II diabetes, for which the product has completed a Phase IIb trial. ...