Asian biotechnology leader Biocon today said that the global phase 3 study for its recombinant human insulin (Insugen), in Type 1 diabetes mellitus patients, demonstrates comparable safety and efficacy with the innovator product.
This multi-centre, randomised study was conducted in nearly 300, Type 1 diabetes mellitus patients, to compare efficacy, safety and immunogenicity of Biocon's regular human insulin (Insugen R) and Isophane human Insulin (Insugen N) against the innovator products (Actrapid and Insulatard) sourced from Europe.
"The trial met its efficacy end-point by demonstrating non-inferiority in HbA1c endpoint at 6 months. Immunogenicity and safety as evaluated by hypoglycemic events at the 6 month time point were also similar," Biocon said in a statement.
Kiran Mazumdar-Shaw, chairman and managing director, Biocon, said, "The positive outcome of this global phase 3 study is a significant milestone in our global insulins development programme and will enable regulatory approvals of our recombinant human insulin products across developed and emerging markets.
"Human insulin is a widely accepted component of insulin therapy for diabetes patients and Biocon's human insulin, will present an affordable alternative to the patients worldwide. These data along with the recent PK-PD data for our insulin glargine (Basalog) demonstrate our commitment to pursue our global insulins strategy and deliver affordable therapy to the patients."
The Part 2 of the study to demonstrate additional safety and immunogenicity over one year is ongoing and is expected to be completed by next year with the final results expected in H1, FY14, Bangalore-based Biocon said.