Sotagliflozin effective and safe in reducing HbA1c among diabetes patients with CKD
USA: Sotagliflozin 400 but not 200 mg significantly reduced HbA1c compared with placebo after 26 weeks in adults with type 2 diabetes (T2D) and stage 3 chronic kidney disease (CKD3), findings from a phase 3 trial have shown. Sotagliflozin is a dual inhibitor of sodium-glucose cotransporters 1 and 2 (SGLT1/2).
The researchers also noted a reduction of urine albumin creatinine ratio (UACR) at 26 weeks in patients with at least A2 albuminuria with each of the two doses; the changes did not sustain at week 52. The study appeared in Diabetes, Obesity and Metabolism on 13 February 2023.
Sotagliflozin is a dual sodium–glucose co-transporter-2 and 1 inhibitor for treating both type 2 (T2D) and type 1 (T1D) diabetes. Sotagliflozin inhibits renal sodium-glucose cotransporter 2 and intestinal SGLT-1, delaying glucose absorption and lowering post-prandial glucose.
David Z.I. Cherney from the University of Toronto in Toronto, Canada, and colleagues conducted the phase 3, randomized, placebo-controlled trial to assess the safety and efficacy of sotagliflozin in adults with type 2 diabetes and stage 3 CKD.
The study evaluated sotagliflozin 200 and 400 mg in 787 patients with type 2 diabetes and eGFR (estimated glomerular filtration rate) 30-59 mL/min/1.73 m2. The primary objective was the superiority of HbA1c reductions at week 26 with sotagliflozin vs placebo. Secondary endpoints were changes in other glycemic and renal endpoints overall and in CKD3 subgroups.
The authors reported the following findings:
- At 26 weeks, the placebo-adjusted mean change in HbA1c (from a baseline of 8.3% ± 1.0) was -0.1% and -0.2% in the sotagliflozin 200 and 400 mg groups, respectively.
- The authors observed significant reductions in fasting plasma glucose and body weight but not systolic blood pressure.
- Among patients with ≥A2 albuminuria at Week 26, the urine albumin creatinine ratio was reduced with both sotagliflozin doses relative to placebo.
- At Week 52, UACR was reduced with sotagliflozin 200 mg in the CKD3B group.
- Adverse events (AEs), including serious AEs, were comparable between treatment groups.
"HbA1c was significantly reduced after 26 weeks, with sotagliflozin 400 but not 200 mg compared with placebo in this CKD3 cohort," the researchers wrote.
At 26 weeks, UACR in patients with at least A2 albuminuria was reduced with each of the two doses, but changes were not sustained at Week 52. Safety findings were consistent with previous reports.
Reference:
Cherney, David Z I., et al. "Efficacy and Safety of Sotagliflozin in Patients With Type 2 Diabetes and Stage 3 Chronic Kidney Disease." Diabetes, Obesity & Metabolism, 2023.
