Increased Risk of Diabetic Ketoacidosis with Sotagliflozin in Type 1 Diabetes Patients

The study aimed to evaluate the incidence and risk factors for diabetic ketoacidosis (DKA) and related adverse events in adults with type 1 diabetes treated with sotagliflozin as an adjunct to insulin. Data from two identically designed, 52-week, randomized studies were pooled and analyzed. Patients were administered placebo, sotagliflozin 200 mg, or sotagliflozin 400 mg once daily.

Results showed a total of 191 ketosis-related adverse events, with 37 events adjudicated as DKA. The exposure-adjusted incidence rate of DKA was higher in the sotagliflozin groups compared to placebo. No patient died from a DKA event. Sotagliflozin treatment led to a small median increase in β-hydroxybutyrate (BHB) levels over 52 weeks. The implementation of a risk mitigation plan was associated with a lower incidence of DKA.

In conclusion, the addition of sotagliflozin to insulin therapy in patients with type 1 diabetes increases the risk of DKA compared to insulin alone. However, this risk can be managed with patient education and an enhanced risk mitigation plan. The study underscores the importance of monitoring and patient education in managing the risk of DKA with sotagliflozin treatment.