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Post by hellodolly on Nov 6, 2023 6:19:07 GMT -5
Rapidly enrolled 141 patients in less than four months
Large study will compare A1c from baseline to 17 weeks for adults when switching from injectable insulin or pumps to inhaled insulin (Afrezza® (insulin human) Inhalation Powder)
Initial standardized meal data from INHALE-3 on target for presenting in 1Q 2024 followed by primary endpoint analysis in 2Q 2024
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Nov. 06, 2023 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that it has fully enrolled patients in INHALE-3, a Phase 4 clinical trial evaluating inhaled insulin (combined with basal insulin) versus usual care in adults living with type 1 diabetes.
“We are excited to see the high level of engagement by INHALE-3 investigators, study staff, and subjects across 19 sites nationwide,” said Dr. Kevin Kaiserman, Senior Vice President, Clinical Development and Medical Affairs for MannKind Corporation. “This was a rapid enrollment process, and we are looking forward to sharing results in 2024.”
INHALE-3 is a 17-week randomized controlled trial with a 13-week extension. The study will randomly assign participants over 18 years of age with T1D who are using Multiple Daily Injections (MDI), an automated insulin delivery (AID) system, or a pump without automation to either continue their usual care or adopt an insulin regimen of a daily basal injection plus Afrezza at mealtimes. Both arms will utilize continuous glucose monitoring to assess mealtime control and A1c levels. More information on the study is available at: ClinicalTrials.gov(NCT05904743).
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Post by agedhippie on Nov 6, 2023 8:31:33 GMT -5
I think this trial is Afrezza's best chance of changing the story. The design is interesting and I thought having the dumb pump arm was a mistake, but I suspect it's about saying you don't have to move to an AID pump and that Afrezza is an option. Those dumb pumps are aging out and their users are going to have to switch to something else.
Some of the endpoints are not going to matter - the standardized meal test being the poster child. That purely comes down to the type of insulin used and was has been shown before Afrezza will win by a mile. The issue is that it's not going to change anything since that behavior has already been shown with zero impact (but it will let them write a PR early in the trial.) The 13 week extension when everyone is switched to Afrezza will be interesting as it should show change nicely.
Which outcomes matter? Only two; HbA1c and TIR. Keep focused on outcomes and not features because the endos will.
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Post by letitride on Nov 6, 2023 8:48:06 GMT -5
I think this trial is Afrezza's best chance of changing the story. The design is interesting and I thought having the dumb pump arm was a mistake, but I suspect it's about saying you don't have to move to an AID pump and that Afrezza is an option. Those dumb pumps are aging out and their users are going to have to switch to something else. Some of the endpoints are not going to matter - the standardized meal test being the poster child. That purely comes down to the type of insulin used and was has been shown before Afrezza will win by a mile. The issue is that it's not going to change anything since that behavior has already been shown with zero impact (but it will let them write a PR early in the trial.) The 13 week extension when everyone is switched to Afrezza will be interesting as it should show change nicely. Which outcomes matter? Only two; HbA1c and TIR. Keep focused on outcomes and not features because the endos will. Did this trial preclude an AID pump or are they not available yet? |
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Post by peppy on Nov 6, 2023 8:49:46 GMT -5
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Post by peppy on Nov 6, 2023 9:00:48 GMT -5
On twitter/X
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Post by sayhey24 on Nov 6, 2023 9:07:42 GMT -5
I think this trial is Afrezza's best chance of changing the story. The design is interesting and I thought having the dumb pump arm was a mistake, but I suspect it's about saying you don't have to move to an AID pump and that Afrezza is an option. Those dumb pumps are aging out and their users are going to have to switch to something else. Some of the endpoints are not going to matter - the standardized meal test being the poster child. That purely comes down to the type of insulin used and was has been shown before Afrezza will win by a mile. The issue is that it's not going to change anything since that behavior has already been shown with zero impact (but it will let them write a PR early in the trial.) The 13 week extension when everyone is switched to Afrezza will be interesting as it should show change nicely. Which outcomes matter? Only two; HbA1c and TIR. Keep focused on outcomes and not features because the endos will. Did this trial preclude an AID pump or are they not available yet? The AID is part of the study but the AID can not beat afrezza for post prandial glucose control. That is why Aged wants to down play this and wants to point at TIR. With TIR you are no longer looking just at post prandial control but you are adding in the basal's fasting so you can "blur" just how good afrezza is. If you are just looking at afrezza you would only be looking at 2 hour control after eating. Nothing beats afrezza and thats why the industry wants to ignore this. Afrezza plus the AID will beat the AID alone but not by much because afrezza is only providing better control for 6 hours of the 24 hour day. That other 75% is what Aged needs to "blur" the value of afrezza which is stopping the spike real time. |
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Post by agedhippie on Nov 6, 2023 17:18:30 GMT -5
Did this trial preclude an AID pump or are they not available yet? The trial is made up of 1/3 Afrezza + Tresiba, 1/3 dumb pumps, 1/3 AID pumps. At the end of the 17 week trial everyone gets switched to Afrezza + Tresiba for a 13 week extension to the trial. The AID pumps have been out for three years or so now. |
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Post by agedhippie on Nov 6, 2023 17:51:01 GMT -5
The AID is part of the study but the AID can not beat afrezza for post prandial glucose control. That is why Aged wants to down play this and wants to point at TIR. With TIR you are no longer looking just at post prandial control but you are adding in the basal's fasting so you can "blur" just how good afrezza is. ... There has been a ton of data over the years showing that Afrezza has a faster onset and where exactly has that got us? Nobody cares, why do you think it will be different this time? Treating diabetes is about the outcome and that's where Afrezza needs to show it can work as a component in the treatment hence the primary outcome in this trial is the HbA1c, and everything else is (literally and figuratively) a secondary outcome. Say what you like, but HbA1c and TIR are the two metrics the endos will be looking at. Blur is a nice way of saying you want to avoid an inconvenient truth - outcomes matter, not features. |
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Post by runner on Nov 6, 2023 18:00:16 GMT -5
It seems somewhat unusual to issue a press release the day before earnings. Would it not have been more advantageous to announce this trial update during the conference call tomorrow?
It certainly didn't do us any favours today.
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Post by liane on Nov 6, 2023 18:13:51 GMT -5
It seems somewhat unusual to issue a press release the day before earnings. Would it not have been more advantageous to announce this trial update during the conference call tomorrow? It certainly didn't do us any favours today. They cannot release a material event during the cc - that would not be widely disseminated enough. It has to be a PR - though it could have been done tomorrow. |
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Post by sayhey24 on Nov 6, 2023 18:47:18 GMT -5
The AID is part of the study but the AID can not beat afrezza for post prandial glucose control. That is why Aged wants to down play this and wants to point at TIR. With TIR you are no longer looking just at post prandial control but you are adding in the basal's fasting so you can "blur" just how good afrezza is. ... There has been a ton of data over the years showing that Afrezza has a faster onset and where exactly has that got us? Nobody cares, why do you think it will be different this time? Treating diabetes is about the outcome and that's where Afrezza needs to show it can work as a component in the treatment hence the primary outcome in this trial is the HbA1c, and everything else is (literally and figuratively) a secondary outcome. Say what you like, but HbA1c and TIR are the two metrics the endos will be looking at. Blur is a nice way of saying you want to avoid an inconvenient truth - outcomes matter, not features. The going in hype is nothing can beat the AID. How much does BP have invested in it? I would say a lot. I think the take away from the very fast enrollment is there are a lot of PWDs who are looking for an alternative to the pump, be it an AID or not. To 'WIN" does afrezza need to win the A1c and TIR races? Maybe not based on the enrollment interest. Its actually a bit shocking. Maybe it just needs to be a tie or maybe just close is good enough. Assuming Mike finally understands how to dose afrezza, it will win the post prandial time period but then afrezza passes the baton to the basal and that will need to be aggressively dosed. Will 1 shot of basal beat the AID, fat chance. Can afrezza make up the difference? Afrezza will have to be damn good since its only working 6 hrs of the 24 hour day. We will see. There are a few things they can do so afrezza/Tresiba wins but they will need to be a bit proactive using the CGM and aggressive with Tresiba while side-stepping the hypos. |
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Post by letitride on Nov 6, 2023 20:00:09 GMT -5
A win to me is if everyone that switched says it changed their lives. At that point its on Mike to prove how and why.
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Post by agedhippie on Nov 7, 2023 8:29:52 GMT -5
... Will 1 shot of basal beat the AID, fat chance. Can afrezza make up the difference? Afrezza will have to be damn good since its only working 6 hrs of the 24 hour day. We will see. There are a few things they can do so afrezza/Tresiba wins but they will need to be a bit proactive using the CGM and aggressive with Tresiba while side-stepping the hypos. Being aggressive with basal and side stepping hypos are mutually exclusive. It's a rookie mistake because part of your mealtime glucose is now covered by basal and not meal time insulin. That will screw you because if you have gaps without eating (a late lunch for example) there is a significant risk that you will go low because the basal is steadily chewing through your blood glucose at a constant rate. This is why you do basal testing to get that right. |
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Post by sayhey24 on Nov 7, 2023 15:09:42 GMT -5
... Will 1 shot of basal beat the AID, fat chance. Can afrezza make up the difference? Afrezza will have to be damn good since its only working 6 hrs of the 24 hour day. We will see. There are a few things they can do so afrezza/Tresiba wins but they will need to be a bit proactive using the CGM and aggressive with Tresiba while side-stepping the hypos. Being aggressive with basal and side stepping hypos are mutually exclusive. It's a rookie mistake because part of your mealtime glucose is now covered by basal and not meal time insulin. That will screw you because if you have gaps without eating (a late lunch for example) there is a significant risk that you will go low because the basal is steadily chewing through your blood glucose at a constant rate. This is why you do basal testing to get that right. When I am talking about aggressive I mean aggressive. Since all the PWDs will be wearing a CGM I doubt any will go low during fasting. I would also be surprised if we have a lot of "rookies" in this trial. Assuming the average AID user has a A1c of 7.3 based on this study - www.medscape.com/viewarticle/995738?form=fpf#vp_1With afrezza its well within doable to target fasting BG at 140 or even 126. Then its a question of how aggressive they are with the afrezza to stop the spike and not go low. Assuming they have the PWD back under 140 in 2 hours, afrezza will win but we will see. |
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Post by agedhippie on Nov 7, 2023 17:27:04 GMT -5
When I am talking about aggressive I mean aggressive. Since all the PWDs will be wearing a CGM I doubt any will go low during fasting. I would also be surprised if we have a lot of "rookies" in this trial. ... I wouldn't expect many rookies either which is why you are not going to get aggressive basal dosing. People tend to get irritable when their CGM wakes them up in the middle of the night to eat glucose tablets because they dosed basal "aggressively". You dose the correct dose, this is really 101 stuff. You also need newer trial data. That article looked at 2014 to 2021, pumps have come a long way in the last couple of years and that's what endos will be comparing with. |
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