Efficacy and Safety of Degludec U100 Versus Glargine U300 for the Hospital Management of Patients with Type 2 Diabetes: A Prospective, Open-Label, Non-Inferiority Randomized Trial

Abstract Aims No head-to-head comparisons of two ultra-long acting insulins, degludec-100 and glargine-300, have been reported in the inpatient setting. We compared the efficacy and safety of these two insulins for the hospital management of patients with type 2 diabetes (T2D). Methods This target-to-treat, randomized controlled trial enrolled patients with T2D admitted for coronary artery bypass graft surgery (CABG). On the day of transition (day 2 of surgery) from intravenous insulin infusion to multiple subcutaneous insulin injections, patients were randomly assigned (1: 1) to receive a basal-bolus regimen using either degludec-100 or glargine-300 as basal and glulisine as bolus before meals. Insulin was adjusted daily to maintain a fasting blood glucose (BG) <140 mg/dL and pre-meal BG <180, while avoiding hypoglycemia <70 mg/dL. The primary endpoint was non-inferiority in mean differences between groups in their daily BG concentrations measured during the duration of the hospital stay and a week post-discharge, up to 12 days (point-of-care measurements, pre-breakfast, pre-lunch, pre-dinner and nighttime [0300 hours]: non-inferiority was deemed a difference <18 mg/dL). The major safety outcome was the occurrence of hypoglycemia. Secondary outcome measures included mean differences between groups in their daily BG concentrations, time in range (TIR, %), time below range (TBR, %), and time above range(TAR, %), as assessed by continuous glucose monitoring system (CGMS, n = 142). Results Between October 12, 2021, and February 10, 2022, 324 consecutive patients with T2D undergoing CABG were screened, 239 patients were randomly assigned to treatment; 122 to degludec-100 group and 117 to glargine-300 group. The mean daily BG concentration in the degludec-100 group (157 mg/dL [SD 25]) was not inferior to that in the glargine-300 group (162 mg/dL [SD 24]), with a mean BG difference of -5 mg/dL (95% CI, -11 to 2, p = 0.18). There were no differences between degludec-100 group and glargine-300 group in mean percentage of readings within target BG of 70-180 mg/dL (74% ± 29% vs. 73% ± 30%, p = 0.19), daily basal insulin dose (19 ± 8 vs. 21 ± 9 units/day, p = 0.13), length of stay in hospital (median [IQR]: 9 [8-11] vs. 9 [8-11] days, p = 0.51), or hospital complications (21.3% vs. 21.4%, p = 0.99). There were no differences in the proportion of patients with BG <70 mg/dL (15.6% vs. 23.1%, p = 0.14) or <54 mg/dL (1.6% vs. 4.3%, p = 0.226) between degludec-100 and glargine-300 groups. There was no difference between groups in mean daily BG concentrations (141 ± 26 vs. 142 ± 28 mg/dL, p = 0.88), TIR (72. 0% vs. 72.9%, p = 0.71), TBR (5.9% vs. 5.2%, p = 0.50) and TAR (22. 0% vs. 21.8%, 0.93) as assessed by CGMS. Conclusions Treatment with degludec-100 as a basal insulin is as effective and safe as glargine-300 for the hospital management of patients with T2D admitted to cardiac surgery service in the non-intensive care unit setting. Presentation: Sunday, June 12, 2022 12:30 p.m. - 2:30 p.m.