It’s human nature to hope for better things and for some to focus on improving things. Historically, diabetes has been difficult, and many people have been unable to achieve their glucose management goals. The tools and technologies that we have today help a lot, but it’s not a perfect system. Researchers are still working hard to find ways to reduce the burden of living with diabetes and improve outcomes. One of the areas of focus has been reducing the amount of injections.
Developments in Insulins
Compared to when insulin was first discovered and developed, many different types of insulin are available now. Animal insulin was still being used until 1984, when scientists were able to create synthetic human insulin.1 Once they were able to develop synthetic insulins, more research went into creating both longer-acting and shorter-acting options, and insulins that did not have significant peaks. This was one of the key challenges with the earlier insulins—you had to eat to feed the insulin versus give insulin for the food.
Developing a new drug/medication is a challenging feat. Millions of dollars and countless hours are spent working to get something to market in the United States. Here’s a quick rundown on the process2 –
- Discovery and Development – also often called Research and development (R&D), is where many compounds are tested to see if they have the potential to be helpful, but most do not make it past this stage.
- Preclinical Research – the phase in research where the lab tests the compound’s safety to ensure it is not toxic. This is also typically where animal testing is utilized.
- Clinical Research – refers to studies conducted in people. There are four phases of clinical research:
- Phase 1: identifies safety in humans and dosages
- Phase 2: looks at how well it works and what side effects are common
- Phase 3: continues to monitor the drug over a more extended period and in a more significant number of people
- Phase 4: further safety and effectiveness of the drug in several thousand people – usually done after approval
- FDA Drug Review – thorough review by the FDA of all the data about the proposed drug.
- Post-Market Safety and Monitoring – Continued monitoring of how the medication works, whether it interacts with other drugs, and any developments over time.
Weekly insulins – where are we now?
There are currently two weekly insulins that have completed phase 3 clinical trials: insulin icodec (Awiqli) made by Novo Nordisk and insulin efsitora alfa (efsitora) made by Eli Lilly. Both insulins were studied in adults with type 2 diabetes who were not previously on insulin, and both have been shown to be comparable to daily basal insulins. These were both large randomized controlled trials in which participants were monitored to look at changes in HbA1C with the weekly insulins versus daily basal insulins.
The results were very favorable to the weekly insulins:
- HbA1C was lowered more by the weekly insulins – by 1.34% in Efsitora compared to 1.26% with Tresiba,3, and 1.57% with Awiqli compared to 1.32% with Lantus.4
- Time in Range was higher on weekly insulins than daily – Efsitora provided 45 more minutes in range and Awiqli 71.9% time in range versus 66.9%.
- Time Below Range was comparable for weekly vs. daily insulins—Awiqli had 0.3% time below range compared to 0.2% in Lantus. Specific results on Efsitora have not yet been published.
Who will benefit from weekly insulin?
Anyone with insulin-requiring diabetes who wants to use them. This is a potential game changer for people who struggle to take insulin consistently but could also reduce the burden for those who do take it consistently and want a little less work related to their diabetes. For those who are very sensitive to getting ketones and are at higher risk for ketosis or DKA, having a weekly insulin in the background while still using an insulin pump could be a literal lifesaver.
We don’t know yet who will benefit from weekly insulin, but it’s very exciting to see it on the horizon. Anything that makes diabetes a little bit easier is a win in my book.
Resources:
Written and clinically reviewed by Marissa Town, RN, BSN, CDCES
