Appraisal of Sotagliflozin as Adjunctive Therapy for Type 1 Diabetes
Author(s): Nasser Mikhail
Background: Sotagliflozin is a dual inhibitor of sodium-glucose cotransporters 1 and 2 (SGLT1 and SGLT2) approved in Europe as adjunctive treatment to insulin in patients with type 1 diabetes.
Objective: To review the efficacy and safety of sotagliflozin in type 1 diabetes.
Methods: Literature search (English, Spanish, French) of clinical trials, meta-analysis and expert opinions until March 2, 2020. Search terms included sotagliflozin, SGLT1 and SGLT2 inhibitors, glycated hemoglobin (HbA1c), efficacy, safety, diabetic ketoacidosis (DKA), hypoglycemia.
Results: When added to insulin, sotagliflozin is associated with modest reduction in mean levels by 0.34% compared with placebo. Incidence of overall hypoglycemia and severe hypoglycemia are significantly decreased by 22-31% with sotagliflozin versus placebo. Patients randomized to sotagliflozin had significant decrease in mean total daily insulin doses by approximately 9%, weight by 3.5%, systolic blood pressure (SBP) by 3.8 mmHg, and diastolic blood pressure (DBP) by 1.4 mmHg compared with placebo. Diabetic ketoacidosis was the most frequent and serious adverse effect of sotagliflozin, and the commonest cause of drug discontinuation. Following DKA, other adverse effects of sotagliflozin were genital mycotic infections, diarrhea, and volume depletion.
Conclusion: Sotagliflozin may be a useful addition to insulin in a limited number of patients with type 1 diabetes with body mass index ≥ 27 kg/m2, and those who are at high risk for severe hypoglycemia. These patients should be willing to monitor ketones and follow recommendations for DKA prevention, and using insulin doses of ≥ 0.5 units/kg/day as per guidelines.