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ARTICLE | Clinical News

Lexicon's sotagliflozin meets in third Phase III Type I diabetes trial

June 15, 2017 2:32 AM UTC

Lexicon Pharmaceuticals Inc. (NASDAQ:LXRX) reported top-line data from the Phase III inTandem3 trial in 1,402 Type I diabetics with inadequate glycemic control on insulin therapy alone showing that sotagliflozin (SAR439954) met the primary endpoint of a greater proportion of patients achieving an HbA1c of <7% at week 24 and without episodes of severe hypoglycemia or diabetic ketoacidosis vs. placebo. Severe hypoglycemia and diabetic ketoacidosis both occurred in 3% of patients receiving sotagliflozin vs. 2.4% and 0.6% of patients receiving placebo, respectively.

The double-blind, international trial evaluated once-daily 400 mg oral sotagliflozin taken prior to the first meal of the day in patients on continuous subcutaneous insulin infusion or multiple daily injection therapy who had a baseline HbA1c of between 7% and 11%. Secondary endpoints include the change from baseline to week 24 in HbA1c, body weight and systolic blood pressure (SBP)...