Efficacy, safety, and immunogenicity of recombinant insulin aspart in adults with type 2 diabetes mellitus: a randomized, open-label, multicenter, phase-3 study

Background and purpose: To compare the efficacy, safety, and immunogenicity of recombinant insulin aspart 100 U/mL manufactured by BioGenomics Limited (BGL-ASP) with innovator NovoRapid[sup.®] in type 2 diabetes mellitus patients (T2 DM). Experimental approach: This was a multicenter, open-label, randomized, parallel-group study in T2 DM patients, on premix human insulin therapy ± oral anti-diabetics. Besides self-monitored plasma glucose, fasting and post-prandial plasma glucose (FPG and PPG) were tested at baseline, week 12, and week 24. Anti-insulin aspart antibodies measured immunogenicity at 12 and 24 weeks. Findings/Results: 160 patients out of 320 patients randomly received BGL-ASP and the remaining patients received NovoRapid[sup.®]. The changes in glycated hemoglobin (HbA1c) from baseline to weeks 12 and 24 for the BGL-ASP group were -0.8 ± 0.83 and -0.8 ± 0.81, respectively, while for the NovoRapid[sup.®]group was -0.8 ± 1.01 and -0.9 ± 0.89, respectively. Changes in FPG and PPG were comparable between the treatment groups after 12 weeks and 24 weeks. The incidence of detectable antibodies at baseline, weeks 12, and 24 were comparable between treatment groups. Eighteen (11.3%) patients in the BGL-ASP group and 23 (14.4%) in the NovoRapid®group reported adverse events. Conclusion and implications: BGL-ASP and NovoRapid[sup.®]were comparable and equally effective in lowering HbA1c, FPG, and PPG levels, with similar immunogenicity and safety profiles. Keywords: Biosimilar, Immunogenicity, Insulin aspart, NovoRapid.sup.®, Type 2 diabetes mellitus