THE WOODLANDS, Texas
April 14, 2014
Lexicon Pharmaceuticals, Inc.
(Nasdaq: LXRX) announced today positive, top-line results in a Phase 2 clinical trial of LX4211 in type 1 diabetes, which achieved the primary endpoint of reducing mealtime insulin use as well as several secondary endpoints, including improved glycemic control. LX4211 is an oral, first-in-class, dual inhibitor of sodium glucose transporters 1 and 2 (SGLT1 and SGLT2) that is designed to lower blood glucose levels through two insulin-independent mechanisms of action.
In the placebo-controlled, double-blind, 28-day study, LX4211 reduced the total daily mealtime bolus insulin dose by 32% compared to 6% for placebo (p=0.007), while significantly improving glycemic control with a mean HbA1c reduction of 0.55% in the LX4211-treated group compared to a reduction of only 0.06% with placebo (p=0.002). This improvement was accompanied by significant improvement in the time spent in a glucose range of 70-180 mg/dl, a significant reduction in time in hyperglycemic range, and no increase in hypoglycemia. Multiple measures indicated that LX4211 treatment resulted in reduced variability in blood glucose levels. Overall, LX4211 was well tolerated with no discontinuations of study medication due to adverse events.
"The results from this study provide a clear demonstration of proof-of-concept of LX4211 as an oral, investigational new drug for type 1 diabetes complementing insulin therapy," said
, M.D., Ph.D., Lexicon's president and chief executive officer. "The magnitude of improved glycemic control by several measures, including HbA1c in only four weeks, and lower insulin requirements are highly encouraging and support the progression of LX4211 into late-stage development for type 1 diabetes."
In this multicenter study, 33 patients with poorly controlled type 1 diabetes on either an insulin pump or multiple insulin injection therapy were randomized 1:1 to receive either placebo or a 400 mg dose of LX4211 orally once per day before breakfast for four weeks. Patients adjusted their insulin as needed, recorded their blood sugars, and then were evaluated at the end of the study for amount of insulin used and glycemic control, as measured by HbA1c, continuous glucose monitors and serum blood glucose measures. Lexicon plans to present full results of the study at a scientific congress.