Novo Nordisk Bags Nod To Peform Clinical Trials On Weekly Insulin

India Pharma Outlook Team | Friday, 20 October 2023

 India Pharma Outlook Team

Novo Nordisk, a Danish pharmaceutical company, is preparing to test the efficacy and safety of their new weekly insulin injection, IcoSema, in India. The medicine Controller General of India (DCGI) has given the business permission to conduct phase-III tests for the new medicine, which is intended to manage blood sugar levels in persons with type 2 diabetes. IcoSema is a medication that combines insulin with Semaglutide In April of this year, the business announced their proposal to conduct clinical studies.

According to the minutes of the September 29 meeting, the subject expert committee (SEC) under the DGCI approved allowing the corporation to conduct the trial after extensive consideration. ET has reviewed the minutes. According to physicians,the planned weekly insulin shot might be a game changer because patients currently need to take insulin every day. "Patients frequently want me to reduce or discontinue insulin shots. Once-weekly insulin injections would alleviate the agony of daily injections and are anticipated to be as beneficial as regular insulin," said Anoop Misra, chairman of the Fortis-C-DOC Centre of Excellence for Diabetes, Metabolic Diseases, and Endocrinology.

Novo Nordisk has been performing insulin Icodec trials in numerous countries with positive results, boosting the chances of clearance by the US Food and Drug Administration . The proposed trial by Novo Nordisk will compare the efficacy and safety of once-weekly IcoSema and once-weekly Semaglutide. In patients with type 2 diabetes, both treatment arms with or without oral anti-diabetic medications were used. Participants in the trial will be given either IcoSema or Semaglutide to inject once a week.

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