HealthDay News — Sotagliflozin is associated with improved glycemic control in patients with type 1 diabetes receiving insulin, according to a study published online September 13 in the New England Journal of Medicine to coincide with the annual meeting of the European Association for the Study of Diabetes, held from September 11 to 15 in Lisbon, Portugal.
Satish K. Garg, MD, from the University of Colorado Denver in Aurora, and colleagues randomized 1,402 patients with type 1 diabetes who were receiving treatment with any insulin therapy to receive sotagliflozin or placebo for 24 weeks.
The researchers found that the proportion of patients achieving the primary end point (glycated hemoglobin level <7.0% at week 24, with no episodes of severe hypoglycemia or diabetic ketoacidosis) was significantly larger in the sotagliflozin versus the placebo group (28.6 versus 15.2%; P<0.001). Compared with the placebo group, the least-squares mean change from baseline was significantly greater in the sotagliflozin group for glycated hemoglobin, weight, systolic blood pressure, and mean daily bolus dose of insulin (all P≤0.002). The rate of severe hypoglycemia was similar between the groups; the rate of diabetic ketoacidosis was higher in the sotagliflozin group.
“The proportion of patients who achieved a glycated hemoglobin level lower than 7.0% with no severe hypoglycemia or diabetic ketoacidosis was larger in the group that received sotagliflozin than in the placebo group,” the authors write.
Several authors disclosed ties to pharmaceutical companies, including Lexicon Pharmaceuticals, which manufactures sotagliflozin and funded the study.