- Lexicon Pharmaceuticals (NASDAQ:LXRX) announces the publication of results from the Phase 3 Tandem3 study assessing dual SGLT1 and SGLT2 inhibitor sotagliflozin in type 1 diabetics in the New England Journal of Medicine. The online publication coincides with the presentation of data at the European Association for the Study of Diabetes conference in Lisbon, Portugal.
- The study met its primary endpoint of demonstrating sotagliflozin's (400 mg) superiority to placebo as measured by the proportion of patients achieving <7.0% HbA1c at week 24 and no episode of severe hypoglycemia and no episode of diabetic ketoacidosis (DKA) after randomization.
- Patients in the treatment group experienced a mean body weight reduction from baseline of 2.2 kg compared to a mean gain of 0.8 kg in the control group. Patients receiving sotagliflozin also experienced a larger drop in systolic blood pressure and the amount of bolus insulin used.
- Sotagliflozin's safety profile was consistent with those observed in Tandem1 and Tandem2. The rate of severe hypoglycemia was 3.0% over the treatment period compared to 2.4% for placebo. The rate of DKA was also higher, 3.0% vs. 0.6%.
- Shares are down 2% premarket on light volume.
- Previously: Lexicon Pharma's sotagliflozin successful in third late-stage diabetes study (June 9)
- Now read: Lexicon Pharmaceuticals: Stock Out Of Favor But Fundamentals Improving
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