Introduction: We examined differences in hypoglycaemia risk between insulin glargine 300 U/mL (Gla-300) and insulin glargine 100 U/mL (Gla-100) in individuals with type 2 diabetes (T2DM) using the low blood glucose index (LBGI).
Methods: Daily profiles of self-monitored plasma glucose (SMPG) from the EDITION 2, EDITION 3 and SENIOR treat-to-target trials of Gla-300 versus Gla-100 were used to compute the LBGI, which is an established metric of hypoglycaemia risk. The analysis also examined documented (blood glucose readings < 3.0 mmol/L [54 mg/dL]) symptomatic hypoglycaemia (DSH).
Results: Overall LBGI in EDITION 2 and SENIOR and night-time LBGI in all three trials were significantly (p < 0.05) lower with Gla-300 versus Gla-100. The largest differences between Gla-300 and Gla-100 were observed during the night. In all three trials, individual LBGI results correlated with the observed number of DSH episodes per participant (EDITION 2 [r = 0.35, p < 0.001]; EDITION 3 [r = 0.26, p < 0.001]; SENIOR [r = 0.30, p < 0.001]). Participants at moderate risk of experiencing hypoglycaemia (defined as LBGI > 1.1) reported 4- to 8-fold more frequent DSH events than those at minimal risk (LBGI ≤ 1.1) (p ≤ 0.009).
Conclusions: The LBGI identified individuals with T2DM at risk for hypoglycaemia using SMPG data and correlated with the number of DSH events. Using the LBGI metric, a lower risk of hypoglycaemia with Gla-300 than Gla-100 was observed in all three trials. The finding that differences in LBGI are greater at night is consistent with previously published differences in the pharmacokinetic profiles of Gla-300 and Gla-100, which provides the physiological foundation for the presented results.
Keywords: Basal insulin; Glycaemic variability; Hypoglycaemia; Insulin glargine; Type 2 diabetes.