BGL-IAM-CTP301-V2 Clinion ePRO

The proposed study is designed to compare efficacy, safety and immunogenicity of recombinant Insulin Aspart Mix 30 100 U/mL, manufactured by BioGenomics Limited (which will be referred as BGL-ASP Mix-30 in this document)] with NovoMix® 30, manufactured by Novo Nordisk, in patients with diabetes mellitus.
According to The Global Report on Diabetes published by WHO in 2016, globally an estimated 422 million adults were living with diabetes in 2014, compared to 108 million in 1980. Diabetes is a chronic illness that requires continuing medical care and patient self-management education to prevent risks of short-term and long-term complications.1 The global prevalence (age-standardized) of diabetes has nearly doubled since 1980, rising from 4.7% to 8.5% in the adult population.