To confirm non-inferiority of insulin degludec/insulin aspart (IDegAsp) once-daily (OD) versus insulin glargine (IGlar) U100 OD + insulin aspart (IAsp) OD for HbA 1c after 26 weeks, and compare efficacy and safety between groups at W26 + W38. Methods: A 38-week, randomised, open-label, treat-to-target (HbA 1c < 7.0%) trial in adults with type 2 diabetes mellitus (on basal insulin ± oral antidiabetic drugs; HbA 1c 7.0-10.0%). Randomisation (1:1): IDegAsp or IGlar U100 + IAsp. Intensification to IDegAsp twice daily (BID) was permitted at W26 + W32, or with additional IAsp injections at W26 (maximum IAsp BID) or W32 (maximum IAsp three-times daily). Results: For W0-W26, mean percentage-change (standard deviation) HbA 1c was: IDegAsp, À1.1 (0.9); IGlar U100 + IAsp, À1.1 (0.8); estimated treatment difference: 0.07% (95% confidence interval [CI]: À0.06; 0.21) confirmed non-inferiority. At W26 and W38, target HbA 1c achievement, and mean fasting and postprandial glucose were similar across groups. At W38, more subjects achieved target HbA 1c without hypoglycaemia with IDegAsp (22.5%) than with IGlar U100 + IAsp (21.1%), with significantly fewer nocturnal episodes (W0-W38, estimated rate ratio: 0.61 [95% CI: 0.40; 0.93]). Safety profiles were similar across treatment groups throughout. Conclusions: IDegAsp OD/BID are effective treatment intensification options versus multiple injection basal-bolus therapies, achieving similar glycaemic control, with significantly less nocturnal hypoglycaemia.

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