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2022-09-22| Trials & Approvals

Novo Nordisk’s Once-Weekly Insulin Snags Another Victory

by Max Heirich
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Novo Nordisk presented data from their Phase 3a ONWARDS 2 trial at the 58th European Association for the Study of Diabetes (EASD) Annual Meeting 2022. The trial, testing once-weekly insulin icodec demonstrated positive results. This trial is part of the larger ONWARDS program, all of which share similar results. 

Related Article: FDA Finds Carcinogen In Merck’s Diabetes Drug, Allows Continued Sales To Avoid Shortage

A Once-weekly Alternative to Insulin

Basal insulin is the long-acting version of insulin, as opposed to bosul, which is administered before meals. Because the body requires less insulin outside of meals, basal insulin releases slowly over a longer period of time. An example of basal insulin is Sanofi’s Lantus insulin, released over the course of twenty-four hours, the average for basal insulin. 

However, Novo Nordisk is developing a kind of basal insulin that releases over the span of a week. Similar to other basal insulins, patients inject insulin icodec in the layer of fat just beneath the skin. Currently, insulin icodec is undergoing clinical development in multiple Phase 3 Clinical Trials.

The Fifth Success of the Onwards Clinical Program

The ONWARDS Clinical program consists of six Phase 3a trials evaluating insulin icodec. Included in the trials are both diabetes Type 1 & Type 2 patients. The most recent trial concluded in the program is ONWARDS 2, a trial evaluating the efficacy and safety of once-weekly insulin iodec injections versus once-daily insulin degludec injections.

The trial’s primary endpoint was the demonstration of a reducing HbA1c at week 26. 37% of adults in the study treated with once-weekly insulin icodec achieved an HbA1c <7.0% without experiencing significant hypoglycemia. In comparison, only 27% of daily insulin degludec patients saw the same results. 

On the trial achieving its primary endpoint, Martin Holst Lange, Executive Vice President of Development of Novo Nordisk, said, “We are very pleased to see the promising results from the ONWARDS programme so far. The patient-reported outcomes data we see in ONWARDS 2 further strengthen our belief that insulin icodec has the potential to become the ideal insulin for people living with type 2 diabetes initiating insulin treatment.”

The results from the ONWARDS 2 trial match the other results from the larger program. Aside from this trial, ONWARDS 1, 3, 4, and 6 demonstrated similar positive results. Though ONWARDS 5 hasn’t concluded, the results of its sister trials already form a robust basis for further clinical testing or even submissions to regulatory agencies. 

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