Lexicon's sotagliflozin meets secondary endpoints in Phase III for Type I diabetes

Lexicon Pharmaceuticals Inc. (NASDAQ:LXRX) reported additional data from the 24-week Phase III inTandem2 trial in 782 Type I diabetics inadequately controlled with insulin showing that once-daily 200 and 400 mg doses of oral sotagliflozin (SAR439954) given prior to the first meal of the day plus optimized insulin both met all 6 secondary endpoints vs. placebo plus optimized insulin. The secondary endpoints were the proportion of patients who achieved an HbA1c of <7% with no episode of severe hypoglycemia or diabetic ketoacidosis, body weight, bolus insulin use, fasting plasma glucose (FPG), Diabetes Treatment Satisfaction Questionnaire status (DTSQ) score and 2-item Diabetes Distress Screening Scale (DDS2) questionnaire score. Lexicon previously reported that both doses of sotagliflozin met the primary endpoint of reducing mean HbA1c from baseline to week 24 vs. placebo (0.39% and 0.37%, respectively, vs. 0.03%, p<0.001 for both) (see BioCentury, Jan. 30).

The double-blind, international trial included a 28-week, double-blind extension. Lexicon said the HbA1c benefit achieved with sotagliflozin was sustained over the entire 52-week treatment period. Over that period, 5% of patients in each sotagliflozin arm had severe hypoglycemia vs. 2.3% of patients who received placebo. Diabetic ketoacidosis occurred in 0% and 2.3% of patients who received low- and high-dose sotagliflozin, respectively, vs. 3.4% of patients who received placebo...