ARTICLE | Clinical News

Sotagliflozin: Ph II data

November 4, 2016 7:54 PM UTC

Top-line data from the double-blind, U.S. Phase II inTandem4 trial in 141 Type I diabetics inadequately controlled with insulin showed that once-daily 200 and 400 mg oral sotagliflozin given prior to the first meal of the day each met the primary endpoint of reducing mean HbA1c from baseline to week 12 vs. placebo (0.84% and 0.73%, respectively, vs. 0.35%, p<0.001 and p=0.006). The once-daily 75 mg dose of sotagliflozin reduced the endpoint by 0.6%. On secondary endpoints, low-, mid- and high-dose sotagliflozin reduced mean 2-hour PPG by 20.51, 27.6 and 49.67 mg/dL, respectively, vs. 0.21 mg/dL for placebo; improved mean 24-hour UGE by 42.02, 57.99 and 70.71 g, respectively, vs. an increase of 0.26 mg for placebo; and reduced mean body weight by 0.16, 1.24 and 1.48 kg, respectively, vs. an increase of 1.13 kg for placebo. Additionally, low- and high-dose sotagliflozin reduced systolic blood pressure (SBP) from baseline to week 12 by 1.5 and 4.4 mmHg, respectively. Sotagliflozin was generally well tolerated. There was 1 case of severe hypoglycemia in each of the sotagliflozin arms and 1 case of diabetic ketoacidosis in the 400 mg sotagliflozin arm...