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Abstract: SA-PO263

Sotagliflozin, a Dual SGLT1 and SGLT2 Inhibitor, Reduces the Risk of Cardiovascular and Renal Disease as Assessed by Steno Risk Engines in Adults With Type 1 Diabetes

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical

Authors

  • Stougaard, Elisabeth B., Steno Diabetes Center Copenhagen, Herlev, Capital Region, Denmark
  • Rossing, Peter, Steno Diabetes Center Copenhagen, Herlev, Denmark
  • Vistisen, Dorte, Steno Diabetes Center Copenhagen, Herlev, Denmark
  • Banks, Phillip, Lexicon Pharmaceuticals, Inc., The Woodlands, Texas, United States
  • Girard, Manon, Lexicon Pharmaceuticals, Inc., The Woodlands, Texas, United States
  • Davies, Michael J., Lexicon Pharmaceuticals, Inc., The Woodlands, Texas, United States
  • Persson, Frederik, Steno Diabetes Center Copenhagen, Herlev, Capital Region, Denmark
Background

Sotagliflozin (SOTA) demonstrated cardiovascular and renal benefits in high-risk adults with type 2 diabetes. No studies have shown whether this can be demonstrated in type 1 diabetes (T1D). Treatment with SOTA is associated with increased risk of diabetic ketoacidosis (DKA). The potential cardiorenal benefits may outweigh the risk of DKA when evaluating SOTA for T1D. This analysis estimated the risk of cardiovascular disease (CVD) and end-stage kidney disease (ESKD) in adults with T1D treated with SOTA.

Methods

Participant-level data were used from the inTandem trials evaluating 2977 adults with T1D randomized to once-daily placebo, SOTA 200 mg or SOTA 400 mg for 24 weeks. For each participant, the cumulative risks of developing CVD and ESKD were estimated using the Steno T1 Risk Engines, which are prediction models for the 5- and 10-year risk of CVD and 5-year risk of ESKD. The estimated risk was calculated at baseline and week 24. The difference in least-square mean percent change in estimated risk from baseline (95% CI and p-value) was compared between groups using a mixed model with percent change from baseline as dependent and including the treatment group as fixed effect, and the baseline value as covariate.

Results

SOTA significantly reduced 5- and 10-year CVD risk scores by approximately 4 to 7% compared to placebo (Table). ESKD risk score was numerically reduced with SOTA 200 mg and significantly reduced with SOTA 400 mg relative to placebo. Similar results were observed with SOTA pooled.

Conclusion

Using the Steno T1 Risk Engines, the estimated risk of CVD and ESKD was significantly reduced with SOTA compared to placebo. This provides additional results that may positively enhance the benefit/risk assessment of SOTA use in T1D.

Funding

  • Commercial Support