Biocon subsidiary Clinigene completes phase-IV study on new generation insulin
Our Corporate Bureau
26 December 2006
Also known as PRIDE study, the study is India's largest documented safety study conducted on insulin vials in recent years involving 507 doctors and 6,164 patients covering the entire country. This is the biggest PMS study for insulin conducted in India.
Post-Marketing Surveillance Studies (PMS) also called Phase IV studies are done as part of regulatory requirement, to know primarily the safety of the drug in addition to its efficacy. Phase IV studies the usage of a newly developed drug just before its market launch among a large and diverse population and in natural settings unlike Phase III, where the drug is tested in a controlled environment.
The number of patients involved was in excess of the regulatory requirement of 500 patients as mandated by the Drug Controller General of India (DGCI). Clinigene, India's first College of American Pathologists-accredited lab, analysed the users' records and prepared the report for the study.
"This study involved the three formulations of Insugem i.e. Insugem R, N and 30 / 70 covering subjects with all types of diabetes mellitus and those requiring insulin, said Dr Arvind Attignal, COO, Clinigene. "The response of the subject in terms of glycemic control was monitored by routine tests such as fasting and post-prandial blood sugar and HbA1c estimation. Overall, treatment with Insugem was administered to 334 patients (5.5 per cent) with Type I diabetes mellitus, whereas 5,555 patients (92.6 per cent) receiving formulations were diagnosed with Type II diabetes mellitus".
Rakesh Bamzai, president, marketing, said, "Results of this study reaffirm the benefits of using Insugem. It is indeed an honour that we have been able to indigenously develop a quality biotechnology product that is at par with the best global brands. Insugem is a true proponent of India's biotechnology capabilities."