Clinical perspectives from the BEGIN and EDITION programmes: Trial-level meta-analyses outcomes with either degludec or glargine 300 U/mL vs glargine 100 U/mL in T2DM

Abstract Aims To explore comparative glycaemic control and hypoglycaemia incidence with insulin degludec 100U/mL (IDeg) or insulin glargine 300U/mL (Gla-300) versus glargine 100U/mL (Gla-100) in trial-level meta-analyses of phase 3a clinical trials including people with type-2 diabetes. Methods Meta-analyses of HbA 1c , fasting plasma glucose (FPG), average 24h self-measured plasma glucose (SMPG), pre-breakfast SMPG and hypoglycaemia incidence and rate, using data from the BEGIN (IDeg) and EDITION (Gla-300) insulin development programmes, were performed. Results In BEGIN, despite greater FPG reduction with IDeg than Gla-100, HbA 1c reduction was greater with Gla-100 (mean difference [95% CI] in HbA 1c change: 0.09 [0.01–0.18] %) whereas in EDITION, there was no difference in FPG and HbA 1c reduction between Gla-300 and Gla-100. Risk of nocturnal confirmed ( Conclusions These trial-level meta-analyses suggest that despite greater reductions in FPG, IDeg was associated with less improvement in HbA 1c versus Gla-100, with a hypoglycaemia benefit only evident at night. In contrast, Gla-300 showed similar HbA 1c reduction to Gla-100, accompanied by lower risk of hypoglycaemia both at night and at any time of day. Gla-300 and IDeg appear more similar than dissimilar, but head-to-head trials are required.