Bangalore, Dec 26 (UNI) Clinigene International Private Limited, a wholly owned subsidiary of biopharma major Biocon has concluded a landmark post marketing results of Insugen evaluation (pride) study covering 6164 patients and 507 doctors.
The Company in a release here said today that the study was the largest documented safety study on insulin vials with 99 per cent of the doctors opined that safety with Insugen was at par with the leading marketed brands of insulin in the country.
The efficacy of Insugen in treating diabetes mellitus was as expected by the investigators the released said that the number of patients involved was in excess of the regulatory requirement of 500 patients as stipulated by the Drug Controller General of India.
Dr Arvind Attignal, Chief Operating Officer of Clinigene said in the release the study involved three fomulations of Insugen covering subjects with all types of diabetes mellitus and those requiring insulin. The response in terms of glycemic control was monitored by routine tests such as fasting and post prandial blood sugar.
Overall treatment with Insugen was administered to 334 patients with Type I diabetes and 5555 with type II diabetes.
The study also called Phase Iv studies were done as part of regulatory requirement to ascertain primarily the safety of the drug in addition to its efficacy.
UNI VK RM TS1536
The Company in a release here said today that the study was the largest documented safety study on insulin vials with 99 per cent of the doctors opined that safety with Insugen was at par with the leading marketed brands of insulin in the country.
The efficacy of Insugen in treating diabetes mellitus was as expected by the investigators the released said that the number of patients involved was in excess of the regulatory requirement of 500 patients as stipulated by the Drug Controller General of India.
Dr Arvind Attignal, Chief Operating Officer of Clinigene said in the release the study involved three fomulations of Insugen covering subjects with all types of diabetes mellitus and those requiring insulin. The response in terms of glycemic control was monitored by routine tests such as fasting and post prandial blood sugar.
Overall treatment with Insugen was administered to 334 patients with Type I diabetes and 5555 with type II diabetes.
The study also called Phase Iv studies were done as part of regulatory requirement to ascertain primarily the safety of the drug in addition to its efficacy.
UNI VK RM TS1536
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