Introduction & Objective: Hyperfiltration, common in youth with T2D, may increase risk for early diabetic kidney disease (DKD). The DINAMO trial showed empagliflozin (empa) vs placebo (pbo) provided durable, clinically relevant improvements in glycemic control in youth aged 10-17 years with T2D. This post hoc analysis examined changes in eGFR with empa vs pbo in the DINAMO & DINAMO MONO trials (the latter were drug naïve or not on active therapy).
Methods: We estimated eGFR using the Zappitelli combined creatinine and cystatin C equation, with hyperfiltration defined as 2 SDs above the mean for healthy youth per NHANES (>126.8 mL/min per 1.73 m2). After randomization, 116 participants received once daily empa 10 or 25 mg or pbo. We compared eGFRresponses to therapy from baseline to Week 26 stratified by hyper- and normofiltration (eGFR>126.8 and ≤126.8 mL/min per 1.73 m2, respectively), with empa dosing groups pooled.
Results: At baseline, there were 55 youth (47%) with hyperfiltration; both subgroups were of similar age and pubertal status. In the hyperfiltration subgroup at Week 26, mean eGFR had decreased substantially with empa vs pbo (Figure). In the normofiltration subgroup, mean eGFR changes between groups were similar.
Conclusion: Treatment with empa was associated with attenuated hyperfiltration in youth with T2D. The potential long-term effects of such changes on DKD risk are unclear.
P. Bjornstad: Consultant; AstraZeneca, Boehringer-Ingelheim. Advisory Panel; Lilly Diabetes, Novo Nordisk, Bayer Inc., Horizon Therapeutics plc. T. Danne: Speaker's Bureau; Abbott. Research Support; AstraZeneca. Consultant; Bayer Inc. Research Support; Boehringer-Ingelheim. Advisory Panel; Dexcom, Inc. Research Support; Lilly Diabetes. Advisory Panel; Roche Diabetes Care, Medtronic. Research Support; Novo Nordisk. Advisory Panel; Sanofi. W.V. Tamborlane: Consultant; AstraZeneca, Boehringer-Ingelheim, Novo Nordisk, Medtronic. G.J. Klingensmith: None. E. Schueler: None. I. Tartakovsky: Employee; Boehringer-Ingelheim. J. Marquard: Employee; Boehringer-Ingelheim. P. Zeitler: Consultant; Boehringer-Ingelheim. Research Support; Eli Lilly and Company. Consultant; Eli Lilly and Company. Research Support; Janssen Pharmaceuticals, Inc. S.M. Willi: Advisory Panel; MannKind Corporation. Other Relationship; Medtronic. Advisory Panel; Boehringer-Ingelheim. Other Relationship; National Institute of Diabetes and Digestive and Kidney Diseases. L.M. Laffel: Consultant; Dexcom, Inc. Advisory Panel; Medscape, Medtronic, Vertex Pharmaceuticals Incorporated. Consultant; Novo Nordisk. Advisory Panel; Lilly Diabetes, Provention Bio, Inc., Sanofi-Aventis U.S., Janssen Pharmaceuticals, Inc., MannKind Corporation.
Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance
