Randomized Controlled Trial of Dapagliflozin for Post-Transplant Diabetes Mellitus in Renal Transplant Recipients.
Prospective randomized data on sodium-glucose cotransporter-2 inhibitors in kidney transplant recipients with post-transplant diabetes mellitus (PTDM) remain limited.
In this randomized controlled trial, adult kidney transplant recipients with PTDM were assigned to dapagliflozin 10 mg daily plus standard care or standard care alone for 38 weeks. Prespecified primary outcomes were changes in hemoglobin A1c (HbA1c) and estimated glomerular filtration rate (eGFR). Secondary outcomes included fasting plasma glucose (FPG), serum uric acid (UA), urinary albumin-to-creatinine ratio (UACR), renal resistive index (RRI), and safety.
At week 38, between-group differences in HbA1c and eGFR were not statistically significant. Longitudinal analyses across all visits likewise showed no significant between-group differences in HbA1c (P = 0.635) or eGFR trajectories (P = 0.457). Compared with standard care, dapagliflozin was associated with greater reductions in FPG and greater improvement in UA, UACR, and RRI. Exploratory analysis within the dapagliflozin group showed no significant correlation between changes in UACR and HbA1c. Dapagliflozin was generally well tolerated, with no significant between-group differences in adverse events, and tacrolimus trough concentrations remained stable.
In kidney transplant recipients with PTDM, dapagliflozin was generally well tolerated over 38 weeks. Although HbA1c and eGFR did not differ significantly between groups, favorable changes were observed in several secondary and exploratory surrogate measures. These findings are hypothesis-generating and require confirmation in larger blinded trials powered for clinical outcomes.
In this randomized controlled trial, adult kidney transplant recipients with PTDM were assigned to dapagliflozin 10 mg daily plus standard care or standard care alone for 38 weeks. Prespecified primary outcomes were changes in hemoglobin A1c (HbA1c) and estimated glomerular filtration rate (eGFR). Secondary outcomes included fasting plasma glucose (FPG), serum uric acid (UA), urinary albumin-to-creatinine ratio (UACR), renal resistive index (RRI), and safety.
At week 38, between-group differences in HbA1c and eGFR were not statistically significant. Longitudinal analyses across all visits likewise showed no significant between-group differences in HbA1c (P = 0.635) or eGFR trajectories (P = 0.457). Compared with standard care, dapagliflozin was associated with greater reductions in FPG and greater improvement in UA, UACR, and RRI. Exploratory analysis within the dapagliflozin group showed no significant correlation between changes in UACR and HbA1c. Dapagliflozin was generally well tolerated, with no significant between-group differences in adverse events, and tacrolimus trough concentrations remained stable.
In kidney transplant recipients with PTDM, dapagliflozin was generally well tolerated over 38 weeks. Although HbA1c and eGFR did not differ significantly between groups, favorable changes were observed in several secondary and exploratory surrogate measures. These findings are hypothesis-generating and require confirmation in larger blinded trials powered for clinical outcomes.