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Efficacy and safety of sotagliflozin in patients with type 2 diabetes and stage 3 chronic kidney disease

Aim: To assess the efficacy and safety of sotagliflozin, a dual inhibitor of sodium-glucose co-transporters 1 and 2, in adults with type 2 diabetes (T2D) and stage 3 chronic kidney disease (CKD3).

Materials and methods: This phase 3, randomized, placebo-controlled trial evaluated sotagliflozin 200 and 400 mg in 787 patients with T2D and an estimated glomerular filtration rate of 30-59 ml/min/1.73m2 . The primary objective was superiority of week 26 HbA1c reductions with sotagliflozin versus placebo. Secondary endpoints included changes in other glycaemic and renal endpoints overall and in CKD3 subgroups.

Results: At 26 weeks, the placebo-adjusted mean change in HbA1c (from a baseline of 8.3% ± 1.0%) was -0.1% (95% CI: -0.2% to 0.05%; P = .2095) and -0.2% (-0.4% to -0.09%; P = .0021) in the sotagliflozin 200 and 400 mg groups, respectively. Significant reductions in fasting plasma glucose and body weight, but not systolic blood pressure, were observed. Among patients with at least A2 albuminuria at week 26, the urine albumin-creatinine ratio (UACR) 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 similar between the treatment groups.

Conclusions: 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 (NCT03242252).

 

Comments:

The aim of the study was to evaluate the efficacy and safety of sotagliflozin, a dual inhibitor of sodium-glucose co-transporters 1 and 2, in adults with type 2 diabetes (T2D) and stage 3 chronic kidney disease (CKD3).

The study was a phase 3, randomized, placebo-controlled trial that included 787 patients with T2D and an estimated glomerular filtration rate (eGFR) of 30-59 ml/min/1.73m2. The primary objective of the study was to determine whether sotagliflozin was superior to placebo in reducing HbA1c levels at week 26. Secondary endpoints included changes in other glycemic and renal endpoints both overall and in CKD3 subgroups.

The results of the study showed that after 26 weeks, the mean change in HbA1c levels from baseline was -0.1% in the placebo group, -0.2% in the sotagliflozin 200 mg group, and -0.2% in the sotagliflozin 400 mg group. However, the difference in HbA1c reduction between the sotagliflozin groups and placebo was only statistically significant for the sotagliflozin 400 mg group.

The study also found significant reductions in fasting plasma glucose and body weight with both sotagliflozin doses compared to placebo. However, there was no significant difference in systolic blood pressure between the treatment groups.

Among patients with at least A2 albuminuria at week 26, both sotagliflozin doses showed a reduction in urine albumin-creatinine ratio (UACR) compared to placebo. However, these changes in UACR were not sustained at week 52, except for the sotagliflozin 200 mg group in the CKD3B subgroup.

The safety findings of the study were consistent with previous reports, and there were no significant differences in adverse events (AEs) between the treatment groups.

In conclusion, sotagliflozin 400 mg was found to significantly reduce HbA1c levels compared to placebo after 26 weeks in patients with T2D and CKD3. Both sotagliflozin doses showed a reduction in UACR at week 26, but these changes were not sustained at week 52, except for the sotagliflozin 200 mg group in the CKD3B subgroup. The safety profile of sotagliflozin was consistent with previous studies.

Related Products

Cat.No. Product Name Information
S8103 Sotagliflozin Sotagliflozin is an oral dual SGLT1/SGLT2 inhibitor with IC50 of 36 nM and 1.8 nM, respectively. Phase 3.

Related Targets

SGLT