Patients with type 1 diabetes receiving sotagliflozin had a higher incidence of glycated hemoglobin level below 7.0% without hypoglycemia or diabetic ketoacidosis compared with those receiving placebo, according to a study by the New England Journal of Medicine.
Researchers identified 1402 individuals with type 1 diabetes currently receiving treatment with insulin therapy, and randomly assigned participants to receive either sotagliflozin (400 mg/d) or placebo for a total of 24 weeks in a phase 3, double-blinded trial (ClinicalTrials.gov identifier: NCT02531035) at 133 centers in 19 countries worldwide. The primary endpoint of the study was a glycated hemoglobin level below 7.0% after 24 weeks of treatment without any episodes of severe hypoglycemia or diabetic ketoacidosis.
Study results showed that a larger number of patients assigned to the sotagliflozin treatment group (200 of 699 participants [28.6%]) achieved the primary endpoint of a glycated hemoglobin level below 7.0% compared with those assigned to the placebo group (107 of 703 participants [15.2%]), with an estimated between-group difference of 13.4 percentage points (95% CI, 9.0-17.8; P <.001). However, it was noted that the rate of diabetic ketoacidosis was higher overall in patients in the sotagliflozin group compared with those in the placebo group (3.0% [21 patients] and 0.6% [4 patients], respectively).
Researchers concluded that a larger proportion of patients receiving sotagliflozin reached a glycated hemoglobin level below 7.0% when compared with those receiving placebo. However, a higher rate of diabetic ketoacidosis was observed in those assigned to the sotagliflozin treatment group.
Clinicians should consider the use of sotagliflozin in patients with type 1 diabetes currently on an insulin treatment regime without adequate glycemic control in an effort to lower glycated hemoglobin levels below 7.0%, but should closely monitor patients for any signs and symptoms of diabetic ketoacidosis.
This study was funded by Lexicon Pharmaceuticals (The Woodlands, TX).
Garg SK, Henry RR, Banks P, et al. Effects of sotagliflozin added to insulin in patients with type 1 diabetes [published online September 13, 2017]. N Engl J Med. doi: 10.1056/NEJMoa1708337