Submit safety data of initial 30 subjects : CDSCO Tells Novo-Nordisk On IcoSema and insulin icodec study

Written by Dr. Divya Colin Published On 2022-09-28T18:00:20+05:30 | Updated On 28 Sept 2022 6:00 PM IST

Submit safety data of initial 30 subjects : CDSCO Tells Novo-Nordisk On IcoSema and insulin icodec study

New Delhi: Citing to remove the 'interim analysis' from the said condition, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has directed drug major Novo Nordisk regarding the antidiabetic fixed dose combination drug IcoSema and insulin icodec that the firm should submit the safety data of initial 30 subjects for review by committee and further continuation of the study in the country.

This came after the firm presented justification for the waiver of the condition no. (1) vide the permission dated 02-JUN-2022 for the COMBINE-1 trial protocol no. NN1535-4591, version 3.0 dated 10Aug2021,before the committee.

Insulin icodec is a long-acting basal insulin analogue, intended for once-weekly treatment, being developed by Novo Nordisk, for the treatment of type 1 and type 2 diabetes mellitus. The product has a terminal half-life of approximately 196 hours. Clinical development is underway in several countries.

Icosema is a combination of GLP-1 analogue semaglutide and insulin icodec intended for once-weekly treatment, which controls Blood Sugar Level in People With Type 2 Diabetes. Semaglutide is a glucagon-like peptide 1 (GLP-1) analog used to manage type 2 diabetes along with lifestyle changes, such as dietary restrictions and increased physical activity. Semaglutide was developed by Novo Nordisk and approved by the FDA for subcutaneous injection in December 2017.

GLP-1 is a physiological hormone that promotes glycemic control via several different mechanisms, including insulin secretion, slowing gastric emptying, and reducing postprandial glucagon secretion. The homeostasis of glucose is dependent on hormones such as insulin and amylin, which are secreted by the beta cells of the pancreas. Semaglutide is 94% similar to human GLP-1. Analogs of this hormone such as semaglutide stimulate the synthesis of insulin by stimulating pancreatic islet cells and reducing glucagon secretion.

At the recent SEC meeting for Endocrinology and Metabolism held on September 9th 2022,the expert panel reviewed the justification of the drug IcoSema and insulin icodec for the the waiver of the condition no.(1) video the permission dated 02-JUN-2022 for the COMBINE-1 trial protocol no.NN1535-4591, version 3.0 dated 10Aug2022.

After detailed deliberation, the committee recommended the removal of the 'interim analysis' from the said condition and further added that the firm should submit the safety data of initial 30 subjects for review by committee and further continuation of the study in the country.

Also Read:DoP should be under Ministry of Health not Chemicals and Fertilizers: Parliamentary Panel

NovoNordiskcdscoantidiabeticclinical trailsIntermin AnalysisIcoSemainsulin icodecsemaglutide

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.