Efficacy and safety of sotagliflozin in patients with type 2 diabetes and stage 3 chronic kidney disease
Authors' conclusion
After 26 weeks, HbA1c was significantly reduced with sotagliflozin 400 but not 200 mg compared with placebo in this CKD3 cohort. UACR in patients with at least A2 albuminuria was reduced with each of the two doses at 26 weeks, but changes were not sustained at week 52. The safety findings were consistent with previous reports
Study context
- Population
- Adults with T2D and stage 3 CKD (eGFR 30–59 ml/min/1.73m2); baseline HbA1c 8.3% ± 1.0%
- Participants
- 787 adults
- Comparison
- Sotagliflozin 200 and 400 mg vs placebo
- Primary endpoint
- Superiority of HbA1c reduction with sotagliflozin vs placebo
- Follow-up
- Week 26
Methodological detailsphase 3, placebo-controlled
- Phase 3
- Placebo-controlled
Primary result
As reported in the abstract
Placebo-adjusted mean change in HbA1c · 26 weeks
Each group vs placeboPlacebo-adjusted mean change, % (95% CI)P value
Sotagliflozin 200 mg
−0.1(−0.2% to 0.05%)
P = 0.2095Sotagliflozin 400 mg
−0.2(−0.4% to −0.09%)
P = 0.0021Secondary outcomes
FPG, body weight and systolic blood pressure
- Significant reductions in FPG and body weight, but not systolic blood pressure
Urine albumin-creatinine ratio (UACR) in patients with at least A2 albuminuria · week 26
- UACR reduced with both sotagliflozin doses vs placebo
UACR, CKD3B subgroup · week 52
- UACR reduced with sotagliflozin 200 mg in CKD3B
Safety
- Adverse events (AEs), including serious AEs, were similar between treatment groups
Original publication
Efficacy and safety of sotagliflozin in patients with type 2 diabetes and stage 3 chronic kidney disease. Diabetes Obes Metab. Published 28 February 2023. doi:10.
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