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New research offers promise for a novel form of insulin treatment. Javier Zayas Photography/Getty Images
  • Two phase 2 trials including hundreds of participants with type 2 diabetes from several countries assessed the safety and efficacy of a long-acting form of insulin called “insulin icodec.”
  • One trial found that using injectable insulin icodec once a week was as effective as using a standard injectable form of insulin once a day.
  • The other trial found that it seems to be safe and effective to transition from a standard daily insulin injectable to weekly icodec injections.
  • If these findings are confirmed by further research, they could help greatly reduce the burden and barriers associated with more frequent insulin injections.

About 34.2 million people in the United States, roughly 10.5% of the population, have diabetes.

And around 7.4 million people in the U.S. with diabetes use an insulin formula to help control their blood sugar levels.

Insulin is a hormone that the pancreas produces to help transport sugar from the blood into cells. For a person with diabetes, either their body does not produce enough insulin, or it cannot use it efficiently.

Using insulin is an effective treatment, but the injections can be difficult to administer and painful, and some find it embarrassing. These and other barriers can keep people from using the medication correctly or at all.

To reduce these obstacles, researchers around the world are looking for more patient-friendly ways of delivering insulin. Recently, a team from the U.S., Canada, Denmark, the United Kingdom, Poland, Belgium, and Italy tested the efficacy and safety of a new injectable form of insulin used only once a week.

The findings of the team’s two studies indicate that the new injectable may be a viable option for people currently injecting insulin once a day or more often.

The studies appear in the journal Diabetes Care.

In order to inject insulin, a person currently needs to gauge how much of the medication to use based on their blood sugar levels. These vary, depending on the number of carbohydrates in the diet, the amount of exercise, and levels of stress.

Overall, the injections are complicated. According to a 2016 study, for example, many participants who used insulin often made errors involving the dose or injection site.

And mistakes can lead to serious complications, including high or low blood sugar and diabetic ketoacidosis, which can be fatal.

Researchers have made advances in insulin therapy over the past few decades, and they continue to explore new options for safe and effective insulin delivery.

The two new trials assessed the safety and efficacy of a modified version of insulin called insulin icodec.

This has a long half-life, roughly 196 hours, making it ideal as a once-a-week treatment. Half-life refers to the time that it takes the body to metabolize and excrete half of the original dose of a medication.

Both of the studies were phase 2 trials. These can include 100–300 participants with the same health-related issue who receive doses and use or undergo treatment methods shown to be safe in earlier phase 1 studies.

In both of the new trials, every participant was also taking an oral glucose-reducing medication that was not insulin, such as metformin. The studies were then randomized, which means that the participants were randomly assigned to get further doses and medications.

Both were also open-label trials, which means that the researchers and participants knew what treatments they were using.

Each study was conducted slightly differently and included varying numbers of participants with type 2 diabetes who were from different countries.

One study included 205 participants, from the U.S., Germany, Hungary, Poland, Spain, Croatia, and Slovakia, who were not currently using insulin.

In this trial, the participants were screened for 2 weeks, received treatment for 16 weeks, and followed up for 5 weeks. The study tested three ways of adjusting and optimizing insulin dosage. The goal was to see which lowered blood sugar levels the most while preventing them from dipping too low.

The other study included 154 participants, from the U.S., Canada, Czechia, Italy, and Germany, who already use insulin. The researchers followed them for 23 weeks to assess how best to transition from daily to weekly insulin injections.

Both studies found that insulin icodec was just as effective as the commonly used daily insulin glargine injections.

The researchers also found that transitioning from a daily injectable form of insulin to a weekly insulin icodec injection was safe and well-tolerated.

In addition, participants who used a double dose of insulin icodec as their first injection reached optimal glucose target levels faster than those who did not.

The study authors say that their findings could be very good news, both for people currently using daily injectable insulin and those who may need to. They describe their results as a “game-changer,” particularly for people who need multiple injections throughout the day.

In email correspondence with Medical News Today, the lead author of one of the study papers and a professor of internal medicine at the University of Texas Southwestern Medical Center, Dr. Ildiko Lingvay, wrote:

“The biggest advantage of having once-weekly insulin is convenience for the patients. It is the difference between taking seven injections [and] one injection.”

“We hope that having the option of once-weekly insulin will also improve acceptance of insulin treatment, as well as compliance, which should translate into better glucose control and lower diabetes-related complications.”

– Dr. Ildiko Lingvay

The researchers also note that the weekly option would make it easier to manage the care of someone with diabetes.

As the researchers acknowledge, their trials had fairly small sample sizes and short durations. The investigation into transitioning from daily to weekly usage excluded people with other common health issues and people taking certain types of oral glucose-lowering medications.

Also, the authors of the other study paper noted that their sample population may not be representative of people taking insulin for the first time.

Furthermore, information about the racial and ethnic makeup of the study populations was lacking. This leaves unanswered questions about the generalizability of the findings.

Meanwhile, further research must confirm whether insulin icodec is as safe and effective as these results suggest.

“An extensive phase 3 program is underway, which encompasses six studies that evaluate both patients with type 1 and type 2 diabetes [and] patients new to insulin and those already experienced with insulin,” writes Dr. Lingvay.

“It will realistically be a minimum of 2 years before such therapy might be available on the market,” she cautions.

In time, and if it is widely available, insulin icodec may improve the lives of millions of people. In addition, switching to weekly injections would also reduce the amount of plastic and improperly disposed waste associated with insulin therapy.