- Question
- To determine whether sotagliflozin, an SGLT1 and SGLT2 inhibitor, reduces cardiovascular events in patients with type 2 diabetes and chronic kidney disease, with or without albuminuria.
- Design
- Multicenter, randomized 1:1, double-blind, placebo-controlled trial of 10584 patients with a median follow-up of 16 months. It ended early owing to loss of funding and the primary end point was changed during the trial.
- Population
- Adults with type 2 diabetes (glycated hemoglobin ≥7%), chronic kidney disease with an estimated glomerular filtration rate of 25 to 60 ml/min/1.73 m2, and risk factors for cardiovascular disease.
- Intervention
- Sotagliflozin 200 mg once daily, with possible up-titration to 400 mg during the first 6 months.
- Control
- Matching placebo, with the same up-titration option.
- Primary outcome
- Composite of the total number of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure.
- Results
- The primary end-point rate was 5.6 events per 100 patient-years with sotagliflozin versus 7.5 with placebo (HR 0.74; 95% CI 0.63 to 0.88; P<0.001). Cardiovascular death did not differ significantly (HR 0.90; 95% CI 0.73 to 1.12; P = 0.35).
- Safety
- Diarrhea, genital mycotic infections, volume depletion, and diabetic ketoacidosis were more common with sotagliflozin than with placebo.
- Conclusion
- In patients with diabetes and chronic kidney disease, sotagliflozin lowered the risk of the composite of cardiovascular death, heart failure hospitalization, and urgent heart failure visits, at the cost of more adverse events.
- Why it matters
- It extended the evidence for SGLT inhibitors to patients with diabetes and chronic kidney disease, even without albuminuria, and reinforced their benefit on heart failure events in this high-risk population.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026