Athena Philis-Tsimikas, MD, adult endocrinologist at Scripps Whittier Diabetes Institute, talks about a game changing treatment for people with Type 2 diabetes.
Interview conducted by Ivanhoe Broadcast News in September 2022.
How many people with Type 2 diabetes need to take daily insulin shots to regulate their glucose?
PHILIS-TSIMIKAS: In the United States today, there are about 134 million people with diabetes. Of those, we know that anywhere between 25 to 40% will at some time need to use insulin as part of their daily regimen.
What are some of the challenges that are involved in taking a daily shot like that?
PHILIS-TSIMIKAS: There are a number of challenges with taking a daily shot of insulin. Those can include, first of all, just remembering to take it every morning. You also have to dial up your dose. You have to inject. For people first starting insulin, there might be fear of taking that injection. But probably the biggest deal is having to take that every single day. Sometimes, it’s even multiple injections within a day that you have to take.
What’s the consequence of forgetting to take your shot or leaving your medicines behind or running out?
PHILIS-TSIMIKAS: There are times when people forget to take an injection or travel and forget to bring it with them. When someone does not take their insulin, the consequence really is an elevation of the blood sugar values. And elevation can lead to complications of diabetes. It can lead to increased thirst, urination as an immediate outcome. So, a number of consequences that are not optimal when you miss an injection.
Now, there is this weekly experimental insulin shot, can you talk about that?
PHILIS-TSIMIKAS: This new once weekly insulin is really interesting. It is taking the same molecule of insulin, a human insulin, a synthetic human insulin, but it’s been altered a little bit and allows it to last longer in the body and get taken up a little bit slower. It has a nice even release throughout the entire week and lasts the entire week without requiring another injection.
Can you tell me about the study that Scripps Whittier has been participating in?
PHILIS-TSIMIKAS: This is a multi-international site study. We are one of the sites and it takes patients that are already taking insulin once a day for their Type 2 diabetes and randomizes them to receive either once weekly insulin or continue on a once daily form of insulin and then looks at the outcome. Who was controlled for their blood sugars better between the two groups? But also, was this done safely? Could you manage the blood sugars but do it without having excess numbers of low blood sugars, which is a fear that some might have when using an injection just once a week.
Can you talk about your results and your most recent presentation?
PHILIS-TSIMIKAS: The results of the study are interesting. When we compared the once daily with the once weekly, there was not only equal lowering of the blood sugar to an equivalent amount between the two groups, but there was actually greater lowering, better blood glucose control in the once weekly group. You always want to make sure that when this is done, you don’t have any excess low blood sugar. When this was looked at across the groups, there was not a statistically greater level of low blood sugar or hypoglycemia in the group with the once weekly injection. That makes us feel confident that you can give this safely and very effectively to control blood sugars.
How did the participants feel who took the once-a-week shot? What was their experience like?
PHILIS-TSIMIKAS: This study was interesting because it included a survey called the Diabetes Treatment Satisfaction Questionnaire. Many times, we can’t find a difference between the two groups because both groups are usually so happy to be participating that they both have a positive result. But in this study in particular, the once-weekly insulin group actually had better outcomes than the once-daily insulin group, indicating that they enjoyed better the flexibility, the convenience, and they were more willing to recommend this to others with Type 2 diabetes as a future treatment for insulin.
What’s the outlook for when this might become available here in the United States and around the globe?
PHILIS-TSIMIKAS: The study that we conducted here at Scripps Whittier Diabetes Institute was one of six studies that are Phase 3A clinical studies. Those studies have, at this point, now all been completed and we have topline results for all of them. Our study was the first one that has full results presented and it looks like they will probably apply to the FDA in 2023 some time for approval of the medication. Is that good enough?
Are you able to comment at all about Europe availability or elsewhere?
PHILIS-TSIMIKAS: I probably shouldn’t. I think they’re going to apply here in the U.S. first and then Europe. But because I’m not 100% sure it might be better not to.
Can you tell me what the differences in the groups of patients that are being studied in these Phase 3 trials are?
PHILIS-TSIMIKAS: Across all six of the Phase 3A trials, there was an interesting population that was being looked at. Our study looked at Type 2 diabetes already taking insulin. There’s one other study that included this. But then there are also three studies that looked at people starting out new initiating insulin and to see how well they tolerated the new once weekly insulin. Then, there’s one study in Type 1 diabetes to see if this can be used for that type of diabetes as well.
Could this have an impact on Type 1 diabetes patients as well?
PHILIS-TSIMIKAS: This can be used in both Type 1 and Type 2 diabetes. In Type 1 diabetes, the top line results showed once again equivalent lowering of blood glucose. There was, though, higher levels of hypoglycemia in the group receiving once-weekly insulin. It was not excessive, yet is something that will need to be evaluated to see where is the best use in Type 1 diabetes.
Are there side effects to this type of insulin and what have you found so far?
PHILIS-TSIMIKAS: This new insulin would have the same types of side effects as any insulin. It’s not different in terms of its effect at the cellular level or in its ability and purpose and way of lowering blood sugar. But it’s just that we want to look at whether the prolonged effect has any excess rates of hypoglycemia. And so far it’s not looking like it does.
Can anyone with Type 2 diabetes take this injection? Once it’s approved, is that the expectation that everyone will switch over to this?
PHILIS-TSIMIKAS: This is a type of insulin that could be taken by anyone with Type 2 diabetes. It would be up to the provider, the physician, as well as the patient if they wanted to try this and use a once-a-week injection. But it absolutely could be used by all types of individuals with Type 2 diabetes.
Looking beyond this new treatment, what’s on the horizon with diabetes? Are there other important breakthroughs or expectations in the next year or two that you’re looking at?
PHILIS-TSIMIKAS: There’s lots of breakthroughs and exciting findings for diabetes. Probably one of the biggest still remains the fact that we can use continuous glucose monitoring to measure blood sugars. The nice part about this is that you can now combine this together with these new insulins in order to titrate and achieve the best glucose possible with the most amount of safety as well. Additionally, down the road a little bit further, there’s insulins that are looking like they can react to the level of blood sugar so that when you inject them, they might become more active when the blood sugar is high and less active when the blood sugar is dropping. So this would be a type of glucose sensing insulin that can in a way almost automatically raise and lower your blood sugars when needed.
Is there anything else you would want peopl to know?
PHILIS-TSIMIKAS: I was thinking of one thing. One of the nice things about this when you think about a once weekly injection for people with diabetes, they’re going from having to take 365 injections a year to only 52 times a year. And although this might not seem like a lot to you and me, to the person having to do the injection, it can be incredibly significant.
END OF INTERVIEW
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