Lexicon announces JASN publishes sotagliflozin data

Lexicon (LXRX) announced the peer-reviewed Journal of American Society of Nephrology, or JASN, has published a research paper analyzing the efficacy and safety of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, when added to insulin in patients with type 1 diabetes, or T1D, and chronic kidney disease, or CKD. The findings from the study, “Efficacy and Safety of Sotagliflozin in Patients with Type 1 Diabetes and CKD,” concluded that people with T1D and CKD treated with sotagliflozin and insulin had similar lowering effects on glycated hemoglobin, or HbA1c, the primary endpoint of the underlying clinical trials, as T1D patients who do not have CKD. Further, the findings show that sotagliflozin was associated with a lower to neutral risk of severe hypoglycemia and did not significantly increase the risk of diabetic ketoacidosis, or DKA, among a small number of DKA events. Researchers used data from the 52-week pooled inTandem1 and 2 trials and the 24-week inTandem3 trial to assess the effects of sotagliflozin versus placebo on HbA1c, body weight, systolic blood pressure, insulin dose, and safety endpoints including adjudicated severe hypoglycemia and DKA, in each case stratified by CKD. Of the 1,575 patients in the inTandem1 and 2 trials, 237 patients were identified who had CKD. Of the 1,402 patients in the inTandem3 trial, 228 patients were identified who had CKD. At week 24, significant, placebo-adjusted reductions in HbA1c were observed in inTandem1 and 2: Non-CKD subgroup and CKD subgroup. For systolic BP, there was a significant placebo-adjusted reduction at week 24 with sotagliflozin in the non-CKD subgroup but no effect in the CKD subgroup in inTandem1 and 2. At week 52, the incidence of severe hypoglycemia was lower with sotagliflozin compared to placebo in the CKD subgroup of inTandem1 and 2, whereas the incidence of severe hypoglycemia was 5-6% across both sotagliflozin and placebo non-CKD subgroups. The incidence of adjudicated DKA at week 52 in inTandem 1 and 2 was 1%, 5%, and 3%, respectively, for the placebo, 200 mg, and 400 mg doses in the CKD subgroup, compared to 0%, 3%, and 4% in the non-CKD subgroup. Results were generally similar in inTandem3 except systolic BP was significantly reduced with sotagliflozin versus placebo in CKD and non-CKD subgroups.