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April 14, 2014
06:10 EDTLXRXLexicon achieves positive results in Type 1 diabetes clinical trial
Lexicon Pharmaceuticals announced 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 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, 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. 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.
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March 25, 2015
08:03 EDTLXRXLexicon announces first patient screened in Phase 3 trial of sotagliflozin
Lexicon announced that it has commenced screening in its first pivotal Phase 3 clinical trial of sotagliflozin for type 1 diabetes. Lexicon will be conducting two pivotal Phase 3 clinical trials of sotagliflozin, one in North America and another primarily in Europe. Each pivotal trial is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy, safety and tolerability of sotagliflozin in adult patients with type 1 diabetes. Two dose levels of sotagliflozin, 200mg and 400mg once daily, will be tested along with placebo. The primary efficacy endpoint under evaluation will be reduction of A1C versus placebo on optimized insulin treatment at 24 weeks, with secondary endpoints including percentage of patients achieving A1C levels of less than 7%, reduction in meal-time, or bolus, insulin use and weight loss.
March 18, 2015
08:34 EDTLXRXLexicon and Ipsen expand agreement for telotristat etiprate commercialization
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