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Abstract: TH-OR54

Renal Effects of Empagliflozin Alone or in Combination with Semaglutide in Albuminuric Type 2 Diabetes: A Randomized, Placebo-Controlled Trial

Session Information

Category: Diabetic Kidney Disease

  • 702 Diabetic Kidney Disease: Clinical

Authors

  • Persson, Frederik, Steno Diabetes Center Copenhagen, Herlev, Capital Region, Denmark
  • Sivalingam, Suvanjaa, Steno Diabetes Center Copenhagen, Herlev, Capital Region, Denmark
  • Wasehuus, Victor, Steno Diabetes Center Copenhagen, Herlev, Capital Region, Denmark
  • Rotbain Curovic, Viktor, Steno Diabetes Center Copenhagen, Herlev, Capital Region, Denmark
  • Hansen, Tine, Steno Diabetes Center Copenhagen, Herlev, Capital Region, Denmark
  • Rossing, Peter, Steno Diabetes Center Copenhagen, Herlev, Denmark
Background

Different mechanisms of sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor (GLP-1) agonists indicate that combination therapy may have additive or synergistic effects. We investigated if combined treatment with empagliflozin (SGLT2) and semaglutide (GLP-1RA) can reduce urinary albumin creatinine ratio (UACR) compared to treatment with empagliflozin alone in individuals with type 2 diabetes and albuminuria.

Methods

Randomized, placebo-controlled, double-blind, parallel study including individuals with type 2 diabetes and albuminuria. All initiated open label empagliflozin in a run-in period of 26 weeks. Subsequently, they were randomized to subcutaneous injections of semaglutide or placebo for 26 weeks. Primary endpoint was change in UACR. Secondary endpoints were change in (1) HbA1c; (2) body weight; (3) measured glomerular filtration rate (GFR); and (4) 24-hour systolic blood pressure.

Results

A total of 60 participants on empagliflozin were randomly assigned to additional semaglutide (n=30) or placebo (n=30). Mean age was 70.1 (SD 8.0) years, 22 % were female and median UACR was 128.2 [IQR 78.5-285.3] mg/g.
Mean UACR change from randomization to week 52 was -15.5 ((95 % CI -34.0 to 8.0) %, p=0.17) in the semaglutide group and 14.8 ((-11.8 to 49.4) %, p=0.29) in the placebo group with a mean difference of -26.4 ((-48.2 to 4.6) %; p=0.086). The mean change in HbA1c was -9.4 ((-13.5 to -5.2) mmol/mol, p<0.001) in the semaglutide group and -0.6 (-4.4 to 3.3) mmol/mol, p=0.77) in the placebo group with a significant difference between groups (mean difference: -8.8 (-14.3 to -3.3) mmol/mol, p=0.002). No difference between treatment groups in body weight (p=0.28), measured GFR (p=0.33) or 24-hour systolic blood pressure (p=0.26) was observed.

Conclusion

This randomized clinical trial could not demonstrate a significant effect of combined treatment with empagliflozin and semaglutide compared to empagliflozin alone on UACR, measured GFR, 24-hour systolic blood pressure or body weight in participants with type 2 diabetes and albuminuria. The combined treatment significantly improved glycemic control compared to treatment with empagliflozin alone.

Funding

  • Private Foundation Support