Clinigene International Private Limited, a wholly owned subsidiary of Biocon Ltd, has concluded a post marketing surveillance study results of Insugen evaluation (PRIDE).
The PRIDE study is India's largest documented safety study conducted on Insulin vials in recent years involving 507 doctors and 6164 patients across the country. This is the biggest post marketing surveillance (PMS) study for Insulin conducted in India. The numbers of patients involved were in excess of the regulatory requirement of 500 patients as stipulated by the Drug Controller General of India (DGCI). Clinigene, India's first CAP (College of American Pathologists) accredited lab analyzed targeted patient records and prepared the report of the study.
Post Marketing Surveillance Studies also called phase IV studies are done as part of regulatory requirement, to know primarily the safety of the drug in addition to the efficacy of the drug. Phase IV studies are based on the usage of drug by large populations and in natural settings unlike phase III, where the drug is tested in a controlled environment.
Dr Arvind Attignal, chief operating officer, Clinigene said, "This study involved the three formulations of Insugen which is Insugen R, N & 30/70 covering subjects with all types of diabetes mellitus and those requiring insulin. The response of the subject in terms of glycaemia control was monitored by routine tests such as Fasting and Post Prandial blood sugar and HbA1c estimation. Overall, treatment with Insugen was administered to 334 patients (5.5 per cent) with type I diabetes mellitus, whereas 5555 patients (92.6 per cent) receiving formulations were diagnosed with type II diabetes mellitus".
According to Rakesh Bamzai, president, marketing, Biocon, "Results of this study reaffirm the benefits of using Insugen. This indigenously developed quality biotechnology product is on par with the best global brands. "
The six-year-old Clinigene is one of India's leading Clinical Research Organizations offering comprehensive clinical services from phase 1-phase 4. The company maintains disease focused patient registries and clinical database in various therapeutic areas like diabetes, lipidemia, oncology, cardiovascular and neurology that enable faster study start-up and more efficient data collection.
Biocon launched the world's first recombinant human insulin, Insugen in November 2004 using Pichia expression. It also introduced India's first indigenously produced monoclonal antibody BIOMAb-EGFR early this year.