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Kidney Week

Abstract: TH-PO1144

Efficacy and Safety of Sotagliflozin in Patients with Type 1 Diabetes and CKD

Session Information

  • Late-Breaking Posters
    November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: Diabetic Kidney Disease

  • 702 Diabetic Kidney Disease: Clinical

Authors

  • Sridhar, Vikas, University Health Network, Toronto, Ontario, Canada
  • Odutayo, Ayodele, University Health Network, Toronto, Ontario, Canada
  • Garg, Satish K, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
  • Danne, Thomas, Medizinische Hochschule Hannover, Hannover, Niedersachsen, Germany
  • Doria, Alessandro, Joslin Diabetes Center, Boston, Massachusetts, United States
  • Mauer, Michael, University of Minnesota Twin Cities, Minneapolis, Minnesota, United States
  • Davies, Michael J., Lexicon Pharmaceuticals Inc, The Woodlands, Texas, United States
  • Banks, Phillip, Lexicon Pharmaceuticals Inc, The Woodlands, Texas, United States
  • Girard, Manon, Lexicon Pharmaceuticals Inc, The Woodlands, Texas, United States
  • Cherney, David, University Health Network, Toronto, Ontario, Canada
Background

People with T1D, chronic kidney disease (CKD) and poor glycemic control are at high risk of kidney failure and cardiovascular events. Sodium-glucose cotransporter (SGLT) inhibitors improve glycemic control in adults with T1D but with an increased risk of diabetic ketoacidosis (DKA). This post hoc analysis evaluated the efficacy and safety of sotagliflozin (SOTA), a dual SGLT1 & 2 inhibitor, in patients with T1D and CKD.

Methods

Using patient-level data from inTandem 1 & 2, the effects of SOTA (200 or 400 mg daily) added to optimized insulin therapy on A1C, body weight (BW), systolic blood pressure (SBP), eGFR, total insulin dose, adjudicated severe hypoglycemia (SH) and DKA were compared to placebo in a patient subgroup with T1D and CKD (eGFR <60 mL/min/1.73 m2 and/or UACR ≥30 mg/g).

Results

In the 1575 patients, 237 (15%) had CKD. At baseline, patients with CKD were older, had longer T1D duration, lower eGFR, lower insulin pump use, higher total daily insulin dose, SBP, and UACR compared to the overall cohort. Relative to placebo, treatment with SOTA provided similar significant reductions in A1C, SBP and BW in the CKD and overall cohorts, but numerically smaller % reduction in total insulin dose at week 24 in the CKD cohort (Table 1). SOTA vs.placebo was associated with lower SH and higher DKA risk. However, the relative risk of SH and DKA appeared to be lower in the CKD vs. overall cohort over 52 weeks (Table 1). The expected acute eGFR decline followed by stabilization with SOTA was preserved in the CKD cohort.

Conclusion

In patients with T1D and CKD, treatment with SOTA had similar A1C and SBP lowering effects, and a lower relative risk of SH and DKA vs. the overall cohort.

Table 1. Selected key efficacy and safety endpoints by study treatment and cohort.

Funding

  • Commercial Support – Lexicon Pharmaceuticals