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Randomized Controlled Trial
. 2021 Dec;23(12):2632-2642.
doi: 10.1111/dom.14513. Epub 2021 Aug 20.

Efficacy and safety of sotagliflozin in patients with type 2 diabetes and severe renal impairment

David Z I Cherney  1 , Ele Ferrannini  2 , Guillermo E Umpierrez  3 , Anne L Peters  4 , Julio Rosenstock  5 , Amy K Carroll  6 , Pablo Lapuerta  6 , Phillip Banks  6 , Rajiv Agarwal  7
Affiliations
Randomized Controlled Trial

Efficacy and safety of sotagliflozin in patients with type 2 diabetes and severe renal impairment

David Z I Cherney et al. Diabetes Obes Metab. 2021 Dec.

Abstract

Aims: To assess the efficacy and safety of sotagliflozin, a dual inhibitor of sodium-glucose cotransporter-1 and -2, in adults with type 2 diabetes (T2D) and stage 4 chronic kidney disease (CKD4).

Materials and methods: This 52-week, phase 3, randomized (1:1:1), placebo-controlled trial evaluated sotagliflozin 200 mg and sotagliflozin 400 mg once daily in 277 patients with T2D and estimated glomerular filtration rate (eGFR) 15 to 30 mL/min/1.73 m2 . The primary endpoint was glycated haemoglobin (HbA1c) reduction with sotagliflozin 400 mg versus placebo at 26 weeks. A hierarchical statistical testing approach was used.

Results: The baseline mean HbA1c was 65 ± 12 mmol/mol (8.1% ± 1.1%), systolic blood pressure (SBP) was 144 ± 15 mmHg, and eGFR was 24 ± 4 mL/min/1.73m2 . Placebo-adjusted changes with sotagliflozin 400 mg were -3 mmol/mol (-0.3%; 95% confidence interval -7 to 0.6 [-0.6 to 0.05]; P = 0.096) and -8 mmol/mol (-0.7%; -13 to -3 [-1.2 to -0.2]; P = 0.003) in HbA1c at Weeks 26 and 52, respectively, -1.5 kg (-3.0 to -0.1) in body weight at Week 26, -5.4 mmHg (-9.4 to -1.3) in SBP at Week 12, and -0.3 mL/min/1.73 m2 (-2.1 to 1.6; P = 0.776) in eGFR at Week 52. Over 52 weeks, 11.8%, 5.4% and 3.3% of patients receiving placebo and sotagliflozin 200 and 400 mg, respectively, required rescue therapy for hyperglycaemia. Adverse events (AEs) occurred in 82.8%, 86.2% and 81.1% of patients and serious cardiovascular AEs occurred in 12.9%, 3.2% and 4.4% of patients in the placebo and sotagliflozin 200 and 400 mg groups, respectively.

Conclusions: After 26 weeks, HbA1c reductions with sotagliflozin were not statistically significant versus placebo in adults with T2D and CKD4. The 52-week safety profile was consistent with results of the SCORED outcomes trial (NCT03242018).

Keywords: SGLT2 inhibitors; antihyperglycaemic therapy; severe renal impairment; sotagliflozin; stage 4 chronic kidney disease; type 2 diabetes.

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References

REFERENCES

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