The QWINT Program: Once-Weekly Insulin Efsitora
Akshay Jain, MD: Greetings from Chicago. I'm Akshay Jain, endocrinologist from Vancouver, Canada. Joining us at the ADA 85th Scientific Sessions today, we've got a very special guest, Dr Athena Philis-Tsimikas, who is the corporate vice president at Scripps in San Diego. Welcome.
Athena Philis-Tsimikas, MD: Thank you so much. Happy to be here.
Jain: Dr Philis-Tsimikas is one of the lead investigators of the QWINT trial, looking at new basal insulin efsitora alfa. What do you think is the need to have another new insulin?
Philis-Tsimikas: It's a good question, because we have so many amazing new drugs that have come out and that we're seeing here at the ADA this year. Despite that, we know that there are over 800 million people with diabetes across the world, just recently published, and that means that there's still going to be many people that require insulin.
We know that about 50%-25% of people will still, at some point, require insulin. I do think that insulin remains relevant, and we need to have new ways to deliver and really make it easier for people to take insulin.
Jain: That makes sense. Despite all the new medications, insulin's not going anywhere. It's still going to be the backbone for many people requiring optimal diabetes management. Tell us about the QWINT program. What are the studies talking about, and what are they evaluating?
Philis-Tsimikas: The QWINT programs are interesting and exciting. You said it's a basal insulin, but it's actually a once-weekly basal insulin. As opposed to the once daily that we've had for a long time and newer once dailies that were longer, this now takes us even longer.
Insulin efsitora was tested in the QWINT trials. It was tested in people naive to insulin, people already on insulin, and in type 1 diabetes— so both type 2 and type 1 diabetes — and looking to see if it was noninferior to daily basal insulin and even if it was superior.
Jain: That's great. What did the study show?
Philis-Tsimikas: I was the lead author on QWINT-3, which was a basal insulin switch trial. For people already coming in on basal insulin, we switched them to go to either efsitora or degludec. At the end of 26 weeks, we showed that it was noninferior. They had a lowering of their A1c from about 7.8% down to about 7%. It was noninferior. They did not show superiority, but what an amazing finding to know that you could take insulin just once a week and still get your A1c down to just below 7%.
Jain: Remarkable ability to drop the injection burden, going from 365 shots a year to just 52 shots a year. That's really uplifting. Where I work in Canada, we've got access to insulin icodec, which is a once-weekly insulin, and that is also helping improve patient outcomes. We are moving forward with our ability to give basal insulin with fewer shots.
In your studies, were there any patient reported outcomes that were evaluated?
Philis-Tsimikas: There were. We did look at satisfaction questionnaires. Satisfaction questionnaires came out better for those who were on once-weekly insulin efsitora. In addition, we also looked at patient safety, so we wanted to make sure that, while you're getting to those better A1cs, do you really have no difference in hypoglycemia? It did show that — for combined nocturnal, both level 2 and level 3 outcomes — there was no difference in terms of the hypoglycemia rates.
Jain: That's a really important thing. One very interesting thing that I saw at the presentation yesterday on the QWINT-1 study is that they looked at level 1 hypoglycemia. Do you want to share some of the results with our audience about that?
Philis-Tsimikas: Sure. QWINT-1 was a very interesting study because it gave a fixed dose of this basal once-weekly insulin at intervals of every 4 weeks. If you needed an incremental increase, it increased from 100 to 150, to 250, up to 400.
Despite having this fixed-dose adjustment, there was no increase in the level 1 or the level 2/level 3 combined hypoglycemia episodes. It's interesting because in all the other trials of once-weekly insulin, level 1 with icodec and efsitora, both were slightly more elevated in those groups. It's very interesting that in the fixed-dose implementation we did not see that difference.
Jain: I think that's remarkable. The safety is very important. It's paramount. Also, it gives more confidence to primary care, especially those who are a little shy of starting insulin.
Now, one thing that I'd love to talk to you about is the loading dose concept. This is not something that one is aware of when you are using daily basil insulin. Can you tell us about the need for doing this loading and what exactly the loading entails?
Philis-Tsimikas: Right, absolutely. This was found in both the icodec and the efsitora studies that we did. Because this has a very long half-life and it takes a while to get up to a steady state, we do need to give a one-time only starting dose.
With efsitora, it was three times what the calculated weekly dose was. You take your daily dose, multiply it by seven to get your weekly dose, and then by three for that one-time starting dose. Icodec was similar in that you had to take it times seven, but then one and a half times, so you gave a 50% extra dose.
That starting dose allows you to get up a little bit faster so that you don't run higher blood sugars during that first 2-3-week time period.
Jain: That's excellent. The other very interesting thing that I saw about the QWINT-1 study was that 76% of individuals were able to get to a dose with this fixed-dose regimen without requiring more than 400 units a week. It doesn't require too much for that flexible dosing aspect. Do you want to share a little bit more about that?
Philis-Tsimikas: I think that was absolutely an interesting part. The fact that you can manage the majority of patients with just this one insulin injection once a week without having to then further titrate in a very detailed way that can be difficult for the patient and the provider, right? So, 76% of the time is remarkable.
Jain: I think one thing to also note is that, as clinicians, we are always aware that it's a marathon, not a sprint, right? Sooner or later, as long as you're up-titrating, you'll get to the target range.
With the QWINT-1 protocol, for the first month, you're continuing to stay on 100 units. I think it's important to reassure the patients that we will be going up in a gradual manner, so that they're not too worried that the sugar's not coming down that quickly.
Philis-Tsimikas: Absolutely. If you think about it, for someone who's insulin naive, that's where they've been running. It might not even make a difference for them.
Jain: Exactly.
Philis-Tsimikas: For someone who's been on insulin that we're switching over, that might make a little bit of a difference but certainly not for that insulin-naive population.
Jain: Any final pearls of wisdom that you want to give to our audience?
Philis-Tsimikas: Maybe just that for our patients who were on the study, they were all incredibly happy to be able to convert over to this once-weekly dose. Many did not want to stop, and they're all looking forward to seeing when once-weekly insulin will be available — in the United States, at least. I know you are lucky to have it in Canada and other places in Europe. We're looking forward to it in the United States as well.
Jain: Thank you so much for joining us, Dr Philis-Tsimikas.
Philis-Tsimikas: Thank you so much.
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