According to the Centers for Disease Control and Prevention (CDC), at least 34.2 million Americans suffer from diabetes, with another 88 million having prediabetes. And while there is no cure for diabetes, there are a number of treatments patients can use to best deal with it, where injectable insulin is the most common.
Currently, there are two phase 2 trials that are ongoing that include hundreds of participants that have been diagnosed with type 2 diabetes from a number of different countries. The trials are meant to assess the efficacy and safety of a long-acting form of insulin known as “insulin icodec.”
One of the trials discovered that when using injectable insulin icodec just once a week, it has shown itself to be just as effective as the standard form of injectable insulin that is required to be injected as least once a day.
As for the other trial, the findings show that the safety and effectivity of transitioning from the standard insulin injectable daily to the once-a-week icodec injections seems to be okay as well.
What these studies hope to achieve after further research is to work towards lessening the obstacles and hurdles involved in having to do daily or frequent insulin injections.
Going back to the over 34 million people in America that have diabetes, which is around 10.5% of the entire population, at least 7.4 million of them require the use of an insulin formula to treat their diabetes and keep their blood sugar levels in check.
The CDC explains diabetes as ‘your body either doesn’t make enough insulin or can’t use the insulin it makes as well as it should. When there isn’t enough insulin or cells stop responding to insulin, too much blood sugar stays in your bloodstream.’ There are serious health risks and issues that come from uncontrolled or prolonged diabetes, including vision loss, heart disease and kidney disease, just to name a few.
Although using insulin has proven to be a highly efficient treatment for diabetes, oftentimes, the injections can be both hard and painful to deal with each and every day. Moreover, some patients even find it embarrassing to admit that they suffer from this disease. When these issues occur, they can become barriers or setbacks that stop people from either getting the proper treatment, properly using the medication, or even getting treatment in the first place.
In order to lessen these impediments, researchers from all over the world decided to search for a better and more efficient way of providing insulin to patients. In recent months, a research team from the United States, Denmark, United Kingdom, Canada, Belgium, Italy and Poland did a trial test on the safety and efficacy of a new form of injectable insulin that only needs to be used once a week.
From the team’s two studies, there was strong evidence that this new injectable could really be a feasible option for patients that are presently injecting insulin at least once a day, if not more. To learn more about their studies, they come out in the journal Diabetes Care.
What Are the Current Insulin Therapies?
For patients that are required to inject insulin, they need to know how much of the medication they need based on their blood sugar levels. These levels depend on their carbohydrate count, how much they exercise, even their stress levels, yet that’s not all.
Insulin injections are oftentimes considered quite complicated too. In a 2016 study, it was discovered that most of the study participants required to use insulin often make mistakes with either the right dosage, the injection site, or both.
When these mistakes are made, they can even lead to grave or severe complications such as low or high blood sugar, or possibly diabetic ketoacidosis, which can even be fatal in some cases.
Throughout the past few decades, research has continued to make advances in insulin therapy, allowing new ways and options for patients to receive effective and safe insulin delivery.
Heading Towards A Less Taxing Injectable
In the two new trials, the researchers assessed the efficacy and the safety of insulin icodec, which is a modified form of insulin.
Insulin icodec is described to have an incredibly long half-life, around 196 hours, which allows it to work as a once-a-week treatment. Scientists explain that half-life indicates the ‘time that it takes the body to metabolize and excrete half of the original dose of a medication.’
Notably, both the studies are considered to be phase 2 trials. What this means is that they can have 100 to 300 participants per study that have patients with the same health-related issues that also have treatment or doses that have already been proven safe in the phase 1 studies.
At the same time, all participants in both of the new trials were taking an oral glucose-reducing medicine that was not insulin, like metformin for example. From there, the studies were randomized, meaning the study participants were randomly assigned to get more medications and doses.
Meanwhile, both of the studies were considered open-label trials, meaning both researchers and participants were aware of the actual treatments being administered. Each study was also carried out with a few variations from the other, as well as using a variety of participants all with type 2 diabetes from a variety of countries.
In one study, that had 205 participants that were not currently using insulin from Germany, Spain, the United States, Hungary, Croatia, Poland and Slovakia.
For this particular trial, the study participants were screen for 2 weeks, given treatment for 16 weeks, then had follow ups for 5 weeks. In the study, the team tested three ways of optimizing and adjusting the insulin dosage. The objective was to find out which managed to lower blood sugar levels the most without causing them to dip too low.
For the other study, there were 154 participants that were already insulin users from Czechia, Germany, the United States, Italy and Canada. The research group studied them for 23 weeks in order to find out what the best way to transition from daily insulin injections to weekly insulin injections.
What both studies found was that the insulin icodec was ‘just as effective as the commonly used daily insulin glargineinjections.’ What the research group had also learned was that shifting from a daily injectable type of insulin to a weekly insulin icodec injection was indeed well-tolerated and safe.
Moreover, the participants that used a double dose of insulin icodec as their first injection managed to get to their optimal glucose target levels quicker than those that didn’t.
It Is Way More Convenient
According to the authors of the study, their findings could be promising for both those currently using injectable insulin every day, as well as those who potentially might have to in the future. The research group also described their finding to be a “game-changer,” especially for those that require multiple injections all throughout their day.
The lead author of one of the study papers, as well as a professor of internal medicine at the University of Texas Southwestern Medical Center, Dr. Ildiko Lingvay, shared in an email, “The biggest advantage of having once-weekly insulin is convenience for the patients. It is the difference between taking seven injections [and] one injection.”
She adds, “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.”
Furthermore, the research group shares that having a weekly insulin injectable will also make it much easier for people to take care of someone diagnosed with diabetes.
The Study and Research Limitations
The research group acknowledges that while their trial studies that looked into shifting patients from daily to weekly insulin injectables had relatively small sample sizes and short durations throughout their studies. Additionally, the research excluded people with other normal health issues, as well as those taking particular types of oral glucose-lowering medications.
The other study authors took note of the fact that their sample population ‘may not be representative of people taking insulin for the first time.’ Moreover, another portion that was lacking was information about the ethnic and racial backgrounds of the participants.
At the same time, more research is needed in order to fully confirm if insulin icodec is truly as effective and safe as the study results claim.
Dr. Lingvay explains, “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,”“
“It will realistically be a minimum of 2 years before such therapy might be available on the market,” she adds.
Eventually, the hope is that in the nearby future, insulin icodec, which will hopefully become easily available worldwide, can significantly improve the lives of millions of people all over the world. Along with this, by transitioning to weekly injections, it will also lessen the amount of plastic used and incorrectly disposed of in connection with insulin therapy all over the world.
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