Sotagliflozin: Phase III data
Top-line data from the double-blind, North American Phase III inTandem1 trial in 793 Type I diabetics inadequately controlled with insulin showed that once-daily 200 and 400 mg sotagliflozin given prior to the first meal of the day each met the primary endpoint of reducing mean HbA1c from baseline to week 24 vs. placebo (0.43% and 0.49%, respectively, vs. 0.08%, p<0.001 for both). Severe hypoglycemic events occurred in 4.2% and 4.6% of patients receiving low- and high-dose sotagliflozin, respectively, vs. 6.7% of patients receiving placebo. Diabetic ketoacidosis occurred in 1.1% and 3.1% of patients receiving low- and high-dose sotagliflozin, respectively, vs. 0% of patients receiving placebo. Sotagliflozin was generally well tolerated. ...