CCDRD AG completed two independent biosimilar insulin developments with pivotal immunogenicity, CLAMP, therapeutic equivalence and safety trials. The insulin types were rapid insulin, NPH insulin as well as a mix of both types.
Two clinical developments – 6 phase III trials
Therapeutic equivalence of recombinant human insulin, multicentric
250 type I diabetes patients
Therapeutic equivalence of recombinant human insulin, multicentric
300 type II diabetes patients
Open follow-up safety study, monocentric
200 type I diabetes patients
Open follow-up safety study, multicentric
210 type II diabetes patients
Immunogenicity study comparing two insulins, multicentric
500 patients
Comparison of PD and PK parameters using CLAMP technique, monocentric
24 diabetes patients
Immunogenicity study of two recombinant insulins, multicentric
500 patients