Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease

This multicenter, double-blind randomized trial (SCORED) evaluated the efficacy of sotagliflozin, a dual SGLT1/SGLT2 inhibitor in 10,584 adults with type 2 diabetes and chronic kidney disease (eGFR 25–60 ml/min/1.73 m²), with or without albuminuria. Participants were assigned to sotagliflozin or placebo and followed for a median of 16 months. The revised primary outcome was the total number of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent heart failure visits. Sotagliflozin significantly lowered event rates (5.6 vs. 7.5 per 100 patient-years; HR: 0.74; 95% CI: 0.63–0.88; P<0.001). Rates of death from cardiovascular causes alone were not significantly different (HR: 0.90; P=0.35). Original coprimary endpoints also showed benefit for heart failure outcomes but less clarity for ischemic endpoints. Sotagliflozin was associated with increased rates of diarrhea, genital mycotic infections, volume depletion, and diabetic ketoacidosis. The trial was terminated early due to funding loss, and endpoint adjudication remained incomplete, relying on investigator-reported events. Nonetheless, findings support sotagliflozin’s role in reducing heart failure-related events in a high-risk diabetic population.

This multicenter, double-blind randomized trial (SCORED) evaluated the efficacy of sotagliflozin, a dual SGLT1/SGLT2 inhibitor in 10,584 adults with type 2 diabetes and chronic kidney disease (eGFR 25–60 ml/min/1.73 m²), with or without albuminuria. Participants were assigned to sotagliflozin or placebo and followed for a median of 16 months. The revised primary outcome was the total number of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent heart failure visits. Sotagliflozin significantly lowered event rates (5.6 vs. 7.5 per 100 patient-years; HR: 0.74; 95% CI: 0.63–0.88; P<0.001). Rates of death from cardiovascular causes alone were not significantly different (HR: 0.90; P=0.35). Original coprimary endpoints also showed benefit for heart failure outcomes but less clarity for ischemic endpoints. Sotagliflozin was associated with increased rates of diarrhea, genital mycotic infections, volume depletion, and diabetic ketoacidosis. The trial was terminated early due to funding loss, and endpoint adjudication remained incomplete, relying on investigator-reported events. Nonetheless, findings support sotagliflozin’s role in reducing heart failure-related events in a high-risk diabetic population.