Novo Nordisk gets approval to carry out clinical trials on weekly insulin
Novo Nordisk is gearing up to test the efficacy and safety of its new weekly insulin injection, IcoSema, in India. The company has got a go-ahead from the Drug Controller General of India (DCGI) to conduct phase-III studies for the new drug which is meant to control blood sugar levels in people with type-two diabetes.
IcoSema is a combination of insulin and Semaglutide.
The company had presented its proposal to conduct clinical trials in April this year.
After detailed deliberation, the subject expert committee (SEC) under the DGCI recommended allowing the company to conduct the trial, said the minutes of the meeting held on September 29. ET has seen the minutes.
The proposed weekly insulin shot could prove to be a game changer as at present patients need to take insulin daily, according to doctors.
«Patients always come to me requesting to decrease or stop insulin injections.
Once a week insulin will decrease discomfort of daily injections and is likely to be as effective as regular insulin,» said Anoop Misra, chairman, Fortis-C-DOC Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology.
Novo Nordisk has been conducting trials for insulin Icodec in several countries and has seen successful outcomes, increasing the likelihood of getting approval from the US Food and Drug Administration.
Novo Nordisk's proposed study is expected to compare the efficacy and safety of once-weekly IcoSema and once-weekly Semaglutide. Both treatment arms with or without oral anti-diabetic drugs, in participants with type-2 diabetes.
Participants of the study will either get IcoSema or Semaglutide, which they will have to inject once a week.
IcoSema is a new medicine that doctors cannot prescribe.
