Efficacy and Safety of Insulin Glargine 300 U/mL versus Insulin Degludec in Patients with Type 2 Diabetes: A Randomized, Open-Label, Crossover Study Using Continuous Glucose Monitoring Profiles.

Aims/Introduction Compared with glargine 100 U/mL (Gla100), glargine 300 U/mL (Gla300) and degludec (Deg) - the ultralong-acting insulins - reportedly have more stable effects and reduce the risk of hypoglycemia. Currently, they are considered to be the most useful basal insulins. The present study aimed to compare the efficacy and safety of Gla300 and Deg on glycemic control using continuous glucose monitoring. Materials and Methods In this single-center, open-label, parallel-group, two-period, cross-over study, 30 patients with type 2 diabetes were randomized to once-daily Gla300 followed by Deg with the same units (n = 15) or vice versa (n = 15). The primary end-points of this study were the mean percentage of time within the target glucose range of 70-180 mg/dL as efficacy and hypoglycemia of dL as safety indicators, as measured using continuous glucose monitoring during each treatment period. Results The mean percentage of time within the target glucose range was not different between Gla300 and Deg (77.8 +/- 19.2 vs 76.9 +/- 18.3%, P = 0.848). However, the mean percentage of time of hypoglycemia with Gla300 was significantly lower than that of Deg (1.3 +/- 2.7 vs 5.5 +/- 6.4%, P = 0.002). In the secondary safety end-points, the mean percentage of time of severe hypoglycemia (dL) or nocturnal hypoglycemia with Gla300 was also significantly lower than that of Deg. Conclusions The present study showed the comparable efficacy of Gla300 and Deg on glycemic control; however, the risk of hypoglycemia was markedly lower for Gla300 than for Deg.