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Kidney Week

Abstract: PO1008

Kidney Effects of Empagliflozin in People with Type 1 Diabetes

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical

Authors

  • Cherney, David, University Health Network, University of Toronto, Toronto, Ontario, Canada
  • Bjornstad, Petter, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
  • Perkins, Bruce A., Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada
  • Rosenstock, Julio, Dallas Diabetes Research Center at Medical City, Dallas, Texas, United States
  • Neubacher, Dietmar, Boehringer Ingelheim International GmbH, Ingelheim, Germany
  • George, Jyothis T., Boehringer Ingelheim International GmbH, Ingelheim, Germany
  • Marquard, Jan, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut, United States
  • Soleymanlou, Nima, Boehringer Ingelheim Canada Ltd/Ltée, Burlington, Ontario, Canada
Background

Empagliflozin lowers the risk of cardiovascular and kidney events in type 2 diabetes (T2D). In the empagliflozin in type 1 diabetes (T1D) clinical program (EASE), glycemic control, weight and blood pressure improved with empagliflozin as adjunct to insulin treatment, though diabetic ketoacidosis risk was higher with use of the 10 and 25mg doses vs the 2.5mg dose. The kidney effects of empagliflozin in T1D remain incompletely understood.

Methods

Here we report changes in kidney parameters in phase 3 placebo-controlled trials EASE-2 (empagliflozin 10/25mg; 52-week; n=730) and EASE-3 (empagliflozin 2.5/10/25mg; 26-week; n=975).

Results

Mean±SD baseline estimated glomerular filtration rate (eGFR in mL/min/1.73 m2) in EASE-2/EASE-3 was 97.3±18.2 and 98.5±18.2 and median (interquartile range) baseline urinary albumin-to-creatinine ratio (UACR in mg/g of creatinine) was 6.2 (2.7,14.1) in both studies. After 26 weeks of treatment in EASE-3, mean placebo-corrected eGFR changes with empagliflozin 2.5mg (n=230), 10mg (n=228) and 25mg (n=234) were -0.14 (p=0.87), -2.57 (p=0.004) and −3.56 (p<0.0001), respectively. Mean placebo-corrected eGFR changes with empagliflozin 10mg and 25mg were −2.09 (p=0.02; n=226) and −2.60 (p=0.002; n=228) after 52 weeks in EASE-2, respectively. Changes in eGFR 3 weeks after end of therapy (FU) returned to above baseline levels. In participants with UACR <30mg/g, no significant changes in urinary albumin-to-creatinine ratio (UACR) were observed. In a pooled analysis (EASE-2 + EASE-3), in participants with baseline UACR ≥30 mg/g, UACR decreased by 16% (p=0.27) and 30% (p=0.02) with empagliflozin 10mg (n=71) and 25mg (n=77) vs placebo (n=65), respectively, at 26 weeks. In EASE-3, in people with baseline UACR ≥30 mg/g, treatment with empagliflozin 2.5mg (n=36) for 26 weeks did not significantly attenuate UACR vs placebo (n=34). Hematocrit and serum albumin increased in EASE-2 and EASE-3 with empagliflozin treatment while serum uric acid decreased; changes in these parameters returned to near baseline values at the FU visit after 26 and 52 weeks of treatment.

Conclusion

In conclusion, empagliflozin doses >2.5 mg/day as adjunct therapy to insulin in T1D resulted in short-term changes in kidney markers comparable to changes observed with SGLT2 inhibitor use in T2D.

Funding

  • Commercial Support