CDSCO Panel grants Novo Nordisk’s Protocol Amendment Proposal For Antidiabetic Drug Semaglutide study

This came after the drug maker Novo Nordisk presented protocol amendment version 5.0 dated 07 September 2023 protocol No: NN9924-4437.

This is a research study to compare a new medicine oral Semaglutide to a dummy medicine in children and teenagers with type 2 diabetes (PIONEER TEENS).

Semaglutide injection is in a class of medications called incretin mimetics. It works by helping the pancreas to release the right amount of insulin when blood sugar levels are high. Insulin helps move sugar from the blood into other body tissues where it is used for energy.

This study compares 2 medicines for type 2 diabetes: semaglutide (new medicine) and a dummy medicine (placebo). Semaglutide will be tested to see how well it works compared to the dummy medicine. The study will also test if semaglutide is safe for children and teenagers. Participants will either get semaglutide or the dummy medicine – which one is decided by chance. Participants will take 1 tablet of the study medicine every morning on an empty stomach. They have to wait 30 minutes before they eat, drink, or take any other medication by mouth. The study will last for about 1 year and 3 months (66 weeks). Participants will have 12 clinic visits and 8 phone calls with the study doctor. At all 12 clinic visits, participants will have blood samples taken. Participants will also be asked some questions.

Semaglutide improves the efficiency of incretin function by activating GLP-1 receptors. It acts by numerous mechanisms like augmented insulin secretion (glucose-dependent), inhibition of glucagon release, and suppressed hepatic gluconeogenesis; thereby reducing both fasting as well as postprandial glucose.

At the recent SEC meeting for Endocrinology and Metabolism held on 7th March 2024, the expert panel reviewed protocol amendment version 5.0 dated 07 September 2023 protocol No.: NN9924-4437.

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

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