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.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Medscape
2 days ago
- Medscape
PHQ-3: A Quick, Yet Still Effective Depression Screen
A shortened version of the commonly used nine-item Patient Health Questionnaire (PHQ-9) may offer clinicians a quicker yet still effective way to screen for depressive symptoms, new research suggested. The PHQ-3 only includes items 1 (about interest), 2 (about depressed mood), and 6 (about self-esteem or failure) from the PHQ-9. In a survey study of more than 96,000 US adult participants, the PHQ-3 had 98% sensitivity and 76% specificity for predicting at least moderate or greater depressive symptoms. Additionally, it was 'highly correlated' with the full PHQ-9 and noninferior to a recently validated four-item version for effectiveness — and it yielded a sensitivity of more than 90% across all ages, races, and ethnicities. Lead study author Roy H. Perlis, MD, vice chair of research in the Department of Psychiatry at Mass General Brigham, Boston, said the investigators wanted to determine the shortest version of the PHQ-9 that could still be effective — and found that the PHQ-3 hit the 'sweet spot' they were looking for. 'We let the data tell us what the constellation of symptoms are that best predict overall severity and how well they do at identifying depression. It's a way we might be able to get the maximum amount of information in the shortest amount of time,' Perlis told Medscape Medical News. However, he noted that he's not yet ready to recommend the PHQ-3 for widespread use in clinical practice. 'I want to see further studies in clinical settings. But I think we made a good start towards showing it did well in a big, general sample of US adults,' Perlis said. The findings were published online on July 21 in JAMA Network Open . Shorter Attention Spans 'The PHQ-9 was not intended as a tool to diagnose depression. It's just a way to start the conversation; and although it's not perfect, it is useful,' Perlis noted. The original patient-reported PHQ was a screen for depression as well as for anxiety, eating disorders, alcohol misuse, and somatization. The version with a nine-item depression scale (PHQ-9) became widely used to screen for depression plus related symptoms, such as fatigue and troubled sleep. However, the length has become burdensome to some patients, especially those who prefer to use phone apps rather than printed out forms. 'Faced with a long list of survey questions, some individuals may be tempted to speed through or to not respond at all,' the investigators wrote. At the recent American Psychiatric Association annual meeting, clinicians in the audience at several sessions mentioned their patients have been complaining that the PHQ-9 is too long and that they prefer data to be delivered in smaller 'chunks.' Perlis said that attitude was a big motivator for their study. 'We're in an era where we have shorter attention spans and people want things very quickly,' he said. 'Personally, I would always rather have the PHQ-9. The question we were trying to answer was: Can we ask fewer questions if we don't have the time or the space to ask about nine [items] and do almost as well?' Perlis reported. The research assessed data from four waves of an online survey conducted from November 2023 to July 2024. In the first wave, they identified the optimal questionnaire items to be included. The four waves had a total of 96,234 participants (57% women; mean age, 47.3 years). Of these, 68% were White individuals, 13% were Black individuals, 10% were Hispanic or Latino individuals, 5% were Asian, and 4% were classified as 'other.' In the full patient population, 26% had moderate or greater depressive symptoms, as measured by a PHQ-9 score ≥ 10. Follow-Up Is Key After examining shortened versions of the PHQ-9 that ranged from including just one item up to eight items, the PHQ-3 with items 1 (interest), 2 (depressed mood), and 6 (self-esteem or failure) was deemed to be the 'optimal' version. It had a sensitivity of 0.98 (95% CI, 0.97-0.98) and a specificity of 0.76 (95% CI, 0.75-0.76) for moderate or greater depressive symptoms. Across all subgroups except participants aged 65 or older, the sensitivity for the PHQ-3 was > 0.94. For that subgroup, it was 0.93. The PHQ-3 was also noninferior to previously reported sensitivity and specificity of the PHQ-Depression-4 in the whole study group and in all subgroups. The area under the receiver operating characteristic curve (AUROC) for predicting moderate or greater depressive symptoms was 0.83 for the PHQ-3. The AUROC for the PHQ-9 was 0.84. 'While a shortened scale cannot capture the full range of the PHQ-9, it may facilitate more widespread and efficient investigation of psychiatric symptoms in general population samples when participant burden and/or data collection expense must be minimized,' the investigators wrote. Overall, Perlis said the PHQ-3 could be a possible first-step screening tool, with more questions added as needed. 'What's most important is that people are screening for depression and, if someone screens positive, that they're following up with a more comprehensive evaluation and offering treatment if it's indicated,' he said. 'It's really about figuring out who needs follow-up.' Menu of Options? In an accompanying editorial, Kurt Kroenke, MD, Regenstrief Institute Indianapolis, noted that the study had 'numerous strengths,' including its large and diverse study population but also several limitations. First, criteria for calculating sensitivity and specificity was not a structured psychiatric interview, which is what was used in the past to evaluate two- and nine-item PHQs. Also, because the researchers pulled from a general population sample, future studies should focus on actual patients from both primary care and psychiatric settings, Kroenke suggested. He noted that in addition to the various shortened PHQs, the two-item and four-item versions of the Patient-Reported Outcomes Measurement Information System have shown benefit. 'Clinicians and researchers looking for ultrashort depression measures now have a menu from which to choose, which is good since one size may not fit all purposes,' Kroenke wrote. 'Expanded use of brief screeners to increase detection of depression has the potential to decrease the burden of the most prevalent mental disorder worldwide,' he added.
Business Wire
2 days ago
- Business Wire
Planet Ships Two More Pelicans to Launch Site; Announces Production Line Now Fully Ramped
SAN FRANCISCO--(BUSINESS WIRE)--Planet Labs PBC (NYSE: PL), a leading provider of daily data and insights about change on Earth, today announced it has shipped its Pelican-3 and Pelican-4 satellites to Vandenberg Space Force Base ahead of their launch aboard SpaceX's Falcon 9 rocket. Planet's satellite production line is now fully ramped and operational, with multiple Pelican and Tanager satellites currently in production – demonstrating a proven ability to rapidly manufacture large fleets of Earth-imaging satellites at scale. Planet has launched and deployed over 650 Earth observation satellites to date. 'Building on our recently-announced satellite service partnerships in Asia and Europe, we've ramped up production of our Pelican fleet,' said Will Marshall, Co-Founder and CEO of Planet. 'Launching these additional satellites enables us to more rapidly respond to market needs. With high resolution, low latency, and NVIDIA's lightning-fast GPU onboard, Pelicans are the optimal satellites to meet the demands of the AI transformation.' This is one of several upcoming Pelican launches scheduled for this year. These Gen 1 Pelican satellites are built to provide up to 40 cm class resolution imagery across 6 multispectral bands optimized for cross-sensor analysis. They are also equipped with NVIDIA Jetson AI chips to facilitate on-orbit computing at the edge, helping accelerate the delivery of valuable insights to customers. The second generation Pelican satellites, launching beginning next year, are expected to reach 30 cm. 'It's incredible to see the progress the team has made with the Pelican program. Each launch marks a significant milestone in building a constellation that allows rapid, intraday global revisits and helps our customers solve the problems that challenge them,' said Brian Lewis, Mission Director, Pelican. 'Whether it's more urgently responding to natural disasters or providing critical defense and intelligence awareness, Pelicans are foundational to Planet's mission to use space to improve life on Earth. The continued expansion of this fleet will help us achieve a more secure, stable, and sustainable future.' This pod of Pelican spacecraft will supplement Planet's fleet of tasking satellites, providing significant additional capacity for on-demand, high-resolution tasking for customers in sectors including defense and intelligence, civil government, and commercial enterprise. Planet plans to launch additional Pelican satellites over the next year. Designed and built to interoperate with other Planet spacecraft, Pelican aims to continue seamlessly enabling and empowering customer access to rapid, crisp, and dynamic imagery and data solutions. Learn more about Pelican capabilities here. About Planet Labs PBC Planet is a leading provider of global, daily satellite imagery and geospatial solutions. Planet is driven by a mission to image the world every day, and make change visible, accessible and actionable. Founded in 2010 by three NASA scientists, Planet designs, builds, and operates the largest Earth observation fleet of imaging satellites. Planet provides mission-critical data, advanced insights, and software solutions to customers comprising the world's leading agriculture, forestry, intelligence, education and finance companies and government agencies, enabling users to simply and effectively derive unique value from satellite imagery. Planet is a public benefit corporation listed on the New York Stock Exchange as PL. To learn more visit and follow us on X (formerly Twitter) or tune in to HBO's 'Wild Wild Space'. Forward-looking Statements Certain statements contained in this press release are 'forward-looking statements' about Planet within the meaning of the securities laws, including statements about the expansion of the high resolution capacity of Planet's fleet, the delivery of such capacity to Planet customers, and the Company's ability to realize any of the potential benefits from product and satellite launches, either as designed, within the expected time frame, in a cost-effective manner, or at all. Such statements, which are not of historical fact, involve estimates, assumptions, judgments and uncertainties. There are a number of factors that could cause actual results or outcomes to differ materially from those addressed in the forward-looking statements. Such factors are detailed in Planet's filings with the Securities and Exchange Commission. Planet does not undertake an obligation to update its forward-looking statements to reflect future events, except as required by applicable law.
Medscape
2 days ago
- Medscape
The QWINT Program: Once-Weekly Insulin Efsitora
This transcript has been edited for clarity. 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.
