Early postoperative basal insulin therapy versus standard of care for the prevention of diabetes mellitus after kidney transplantation: A multicenter randomized trial

Background Post-transplantation diabetes mellitus (PTDM) might be preventable. Methods This open-label, multicenter randomized trial compared 133 kidney transplant recipients given intermediate-actinginsulin isophaneforpostoperative afternoonglucose_140mg/dlwith 130patientsgiven short-acting insulin for fasting glucose _200 mg/dl (control). The primary end point was PTDM (antidiabetic treatment or oral glucose tolerance test-derived 2 hour glucose _200 mg/dl) at month 12 post-transplant. Results In the intention-to-treat population, PTDM rates at 12 months were 12.2% and 14.7% in treatment versus control groups, respectively (odds ratio [OR], 0.82; 95% confidence interval [95% CI], 0.39 to 1.76) and 13.4%versus 17.4%, respectively, at 24months (OR, 0.71; 95%CI, 0.34 to 1.49). In the per-protocol population, treatment resulted in reduced odds for PTDM at 12 months (OR, 0.40; 95% CI, 0.16 to 1.01) and 24 months (OR, 0.54; 95%CI, 0.24 to 1.20).After adjustment for polycystic kidney disease, per-protocolORs for PTDM(treatment versuscontrols)were0.21(95%CI, 0.07 to 0.62) at12monthsand0.35(95%CI, 0.14 to 0.87) at 24months. Significantlymore hypoglycemicevents (mostly asymptomatic ormildly symptomatic) occurred in the treatment group versus the control group. Within the treatment group, nonadherence to the insulin initiation protocol was associated with significantly higher odds for PTDM at months 12 and 24. Conclusions At lowovertPTDMincidence, theprimaryendpoint intheintention-to-treatpopulationdidnotdiffer significantly between treatment and control groups. In the per-protocol analysis, early basal insulin therapy resultedin significantlyhigherhypoglycemia ratesbut reducedodds forovertPTDM-asignificant reduction after adjustment for baseline differences-suggesting the intervention merits further study.