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Post by agedhippie on Feb 20, 2020 16:16:12 GMT -5
They're all worth repeating, IMO. A 12 week A1c reduction of 1.6% in the Afrezza arm compared to the current Standard of Care per ADA, is very clinically significant. I know aged is going to argue there should have been a RAA control arm, but that is not what this clinical trial was designed for nor intended to evaluate and compare with. ππ The study group were all at the point where the SoC says treatment should be intensified and in this case they used Afrezza rather than RAA. In other words the treatment is within scope of the SoC. I already said there should be a control arm in the other thread on this topic . Seriously, why not? Do that and you could have put the two CGM graphs side by side and let people draw their own conclusion - you wouldn't need anything else on the slide!
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Post by mango on Feb 20, 2020 16:34:57 GMT -5
They're all worth repeating, IMO. A 12 week A1c reduction of 1.6% in the Afrezza arm compared to the current Standard of Care per ADA, is very clinically significant.Β I know aged is going to argue there should have been a RAA control arm, but that is not what this clinical trial was designed for nor intended to evaluate and compare with. ππ The study group were all at the point where the SoC says treatment should be intensified and in this case they used Afrezza rather than RAA. In other words the treatment is within scope of the SoC. I already said there should be a control arm in the other thread on this topic . Seriously, why not? Do that and you could have put the two CGM graphs side by side and let people draw their own conclusion - you wouldn't need anything else on the slide! Have none of the RAA manufacturers already done a similar clinical trial with their RAAs? I see no reason to have a RAA control arm if it has already been done. Just compare the two now.
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Post by sayhey24 on Feb 20, 2020 18:48:09 GMT -5
They're all worth repeating, IMO. A 12 week A1c reduction of 1.6% in the Afrezza arm compared to the current Standard of Care per ADA, is very clinically significant. I know aged is going to argue there should have been a RAA control arm, but that is not what this clinical trial was designed for nor intended to evaluate and compare with. ππ The study group were all at the point where the SoC says treatment should be intensified and in this case they used Afrezza rather than RAA. In other words the treatment is within scope of the SoC. I already said there should be a control arm in the other thread on this topic . Seriously, why not? Do that and you could have put the two CGM graphs side by side and let people draw their own conclusion - you wouldn't need anything else on the slide! Aged - Doing an arm with an RAA IMO would be totally wrong headed. MNKD needs to totally separate itself from all RAAs and other analogs and old school insulins. What would doing an RAA arm prove? Everyone knows insulin will reduce BG levels. Everyone knows all T2s should be put on insulin day 1. Everyone also knows insulin in the form of any type of injection is the last step in the current SoC for good reason. Insulin requires needles and is dangerous. Afrezza on the other hand is not an RAA. Its an ultra acting super powder which requires no injections and has minimal risk of hypos. RAA's on the other hand when used in combination therapy, is like playing Russian-roulette. Why risk adding an RAA to a PWD using TZDs? Do no harm is why insulin is currently the last step. Afrezza and RAAs should never be brought up by MNKD in the same conversation let alone the same trial. Afrezza has obsoleted the need for RAAs and now has the data to prove it, Mike better figure out a way to market this study data to blow the entire diabetes market wide-open. IMO he should be sitting outside Bezo's office everyday trying to work a deal to become a big part of the new amazon health care offering.
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Post by rfogel on Feb 20, 2020 18:58:40 GMT -5
This article from 2009 -- care.diabetesjournals.org/content/32/suppl_2/S253 -- makes it sound like the current standard of care approach to using insulin in type 2 diabetics works pretty well. It also appears to assert that hypoglycemia is not much of a risk.
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Post by akemp3000 on Feb 20, 2020 19:13:35 GMT -5
This article from 2009 -- care.diabetesjournals.org/content/32/suppl_2/S253 -- makes it sound like the current standard of care approach to using insulin in type 2 diabetics works pretty well. It also appears to assert that hypoglycemia is not much of a risk. Wow ...and pharmacists in 1900 were called snake oil salesmen.
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Post by agedhippie on Feb 20, 2020 23:30:00 GMT -5
This article from 2009 -- care.diabetesjournals.org/content/32/suppl_2/S253 -- makes it sound like the current standard of care approach to using insulin in type 2 diabetics works pretty well. It also appears to assert that hypoglycemia is not much of a risk. There are generalizing slightly, but everyone does so I will cut them some slack. Type 2 diabetics tend to have insulin resistance which is why they need bigger doses, but it also means it has less impact when you take more than you should have. You can see this very clearly in a trial Mannkind started but abandoned where they gave both Type 2 and Type 1 diabetics 50% to much insulin. All the Type 1 diabetics were hypoglycemic, that was not true of the Type 2 team. The catch is that often thin Type 2 diabetics will have normal insulin resistance and then the Type 1 problems will apply.
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Post by agedhippie on Feb 20, 2020 23:35:22 GMT -5
Aged - Doing an arm with an RAA IMO would be totally wrong headed. MNKD needs to totally separate itself from all RAAs and other analogs and old school insulins. What would doing an RAA arm prove? Everyone knows insulin will reduce BG levels. Everyone knows all T2s should be put on insulin day 1. Everyone also knows insulin in the form of any type of injection is the last step in the current SoC for good reason. Insulin requires needles and is dangerous. Afrezza on the other hand is not an RAA. Its an ultra acting super powder which requires no injections and has minimal risk of hypos. RAA's on the other hand when used in combination therapy, is like playing Russian-roulette. Why risk adding an RAA to a PWD using TZDs? Do no harm is why insulin is currently the last step. Afrezza and RAAs should never be brought up by MNKD in the same conversation let alone the same trial. Afrezza has obsoleted the need for RAAs and now has the data to prove it, Mike better figure out a way to market this study data to blow the entire diabetes market wide-open. IMO he should be sitting outside Bezo's office everyday trying to work a deal to become a big part of the new amazon health care offering. An RAA arm proves that the Afrezza results are better than the RAA results. If you don't have that comparison then the Afrezza results are floating and the response will be exactly as you say - everyone knows insulin will reduce BG. What happened? Afrezza (insulin) lowered BG. That kills the rest of the story. This is a 20 person study with no comparator arm, that's why it's a poster and not a presentation.
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Post by agedhippie on Feb 20, 2020 23:38:50 GMT -5
The study group were all at the point where the SoC says treatment should be intensified and in this case they used Afrezza rather than RAA. In other words the treatment is within scope of the SoC. I already said there should be a control arm in the other thread on this topic . Seriously, why not? Do that and you could have put the two CGM graphs side by side and let people draw their own conclusion - you wouldn't need anything else on the slide! Have none of the RAA manufacturers already done a similar clinical trial with their RAAs? I see no reason to have a RAA control arm if it has already been done. Just compare the two now. No, there has been no requirement as the current standard is HbA1c reduction. The nearest you get is the pump trials which have integrated CGMs like the 670G, but they get better results than this study, and with far larger test groups.
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Post by sayhey24 on Feb 21, 2020 19:46:30 GMT -5
Have none of the RAA manufacturers already done a similar clinical trial with their RAAs? I see no reason to have a RAA control arm if it has already been done. Just compare the two now. No, there has been no requirement as the current standard is HbA1c reduction. The nearest you get is the pump trials which have integrated CGMs like the 670G, but they get better results than this study, and with far larger test groups. Aged - all insulin will reduce A1c. In fact the more you take the lower your BG will go and over time so will your A1c. As far as A1c there would be in theory little A1c difference between afrezza and RAAs if the RAA could more taken more aggressively. The problem is they can't. We heard this discussion at the Adcom when the FDA pressed the issue and the study doctor told them if he did what they are suggesting he would have killed his patients. The days of comparing afrezza to RAAs are behind us. There is nothing an RAA provides which afrezza can't do more safely. In short afrezza has obsoleted all RAAs. Mango ask about RAA studies. Are you telling me there are NO studies which were done by RAA vendor showing A1c reduction as a T2 add on therapy? The problem is not the A1c reduction, it compliance and safety. The difference between afrezza and all other insulins is afrezza needs no needles and is safer as it reduces hypos. We already have that study with the affinity one. I don't think we need to keep beating the horse. It ain't moving. Its been beat enough. As far as a study showing pumps are better than MDI with afrezza, I have not seen that study. Can you please provide a link? I have seen studies showing how afrezza can improve pump TIR and overall A1c.
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Post by rfogel on Feb 21, 2020 22:34:45 GMT -5
Has Mannkind ever simply asked endos and insurers what kind of study would it take to convince them to use and pay for afrezza?
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Post by agedhippie on Feb 21, 2020 23:23:30 GMT -5
No, there has been no requirement as the current standard is HbA1c reduction. The nearest you get is the pump trials which have integrated CGMs like the 670G, but they get better results than this study, and with far larger test groups. Aged - all insulin will reduce A1c. In fact the more you take the lower your BG will go and over time so will your A1c. As far as A1c there would be in theory little A1c difference between afrezza and RAAs if the RAA could more taken more aggressively. The problem is they can't. We heard this discussion at the Adcom when the FDA pressed the issue and the study doctor told them if he did what they are suggesting he would have killed his patients. The days of comparing afrezza to RAAs are behind us. There is nothing an RAA provides which afrezza can't do more safely. In short afrezza has obsoleted all RAAs. Mango ask about RAA studies. Are you telling me there are NO studies which were done by RAA vendor showing A1c reduction as a T2 add on therapy? The problem is not the A1c reduction, it compliance and safety. The difference between afrezza and all other insulins is afrezza needs no needles and is safer as it reduces hypos. We already have that study with the affinity one. I don't think we need to keep beating the horse. It ain't moving. Its been beat enough. As far as a study showing pumps are better than MDI with afrezza, I have not seen that study. Can you please provide a link? I have seen studies showing how afrezza can improve pump TIR and overall A1c. THe endo who thinks you cannot take RAA aggressively is over-simplifying. Of course you can. What you cannot do is take insulin aggressively and not monitor it. The issue for Afrezza is going to be the need for follow on dosing because of the fast clearance. Quick clearance is great when I want to correct before bed time, it's more of a problem the rest of the day when my carbs, especially if I am eating complex carbs, are going to turn up as Afrezza is clearing. As to pumps vs. Afrezza. This is a link to a Diatribe article on the 670G - diatribe.org/medtronic-minimed-670g-trial-results-44-reduction-hypoglycemia-05-a1c-improvement and the new 870G which is to be released in April - diatribe.org/news-medtronic-hypoglycemia-prediction-iqcast-sugariq-and-timing-next-gen-minimed-780g-closed-loop both of which comfortably exceed the TIR from the compliant group in STAT.
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Post by mango on Feb 22, 2020 2:34:06 GMT -5
Aged - all insulin will reduce A1c. In fact the more you take the lower your BG will go and over time so will your A1c. As far as A1c there would be in theory little A1c difference between afrezza and RAAs if the RAA could more taken more aggressively. The problem is they can't. We heard this discussion at the Adcom when the FDA pressed the issue and the study doctor told them if he did what they are suggesting he would have killed his patients. The days of comparing afrezza to RAAs are behind us. There is nothing an RAA provides which afrezza can't do more safely. In short afrezza has obsoleted all RAAs. Mango ask about RAA studies. Are you telling me there are NO studies which were done by RAA vendor showing A1c reduction as a T2 add on therapy? The problem is not the A1c reduction, it compliance and safety. The difference between afrezza and all other insulins is afrezza needs no needles and is safer as it reduces hypos. We already have that study with the affinity one. I don't think we need to keep beating the horse. It ain't moving. Its been beat enough. As far as a study showing pumps are better than MDI with afrezza, I have not seen that study. Can you please provide a link? I have seen studies showing how afrezza can improve pump TIR and overall A1c. THe endo who thinks you cannot take RAA aggressively is over-simplifying. Of course you can. What you cannot do is take insulin aggressively and not monitor it. The issue for Afrezza is going to be the need for follow on dosing because of the fast clearance. Quick clearance is great when I want to correct before bed time, it's more of a problem the rest of the day when my carbs, especially if I am eating complex carbs, are going to turn up as Afrezza is clearing. As to pumps vs. Afrezza. This is a link to a Diatribe article on the 670G - diatribe.org/medtronic-minimed-670g-trial-results-44-reduction-hypoglycemia-05-a1c-improvement and the new 870G which is to be released in April - diatribe.org/news-medtronic-hypoglycemia-prediction-iqcast-sugariq-and-timing-next-gen-minimed-780g-closed-loop both of which comfortably exceed the TIR from the compliant group in STAT. You're seriously stretching it dude. I am going to go ahead and guess that NEITHER of those pump trials were REAL-WORLD clinical trials like STAT?!?...and, even if they were, who cares? STAT proved that RAAs are inferior to Afrezza. Pumps will never be superior to Afrezza+basal injection in the real-world. You need to just stop being a troll and understand the fact that Afrezza is superior to any other mealtime insulin out there. Seriously, WTF are you even doing here?!? πππ₯π₯ You truly remind me of RisingSkeptic π₯π₯ππ
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Post by sayhey24 on Feb 22, 2020 7:24:03 GMT -5
Aged - I was not 10 feet from the endo at the Adcom who was attacked by the FDA analyst. This guy was not taking the FDA question lightly nor over-simplifying his answer. He meant what he said. Did he give an emotional answer - yes. But he gave it because he knew how dangerous stacking RAAs can be.
Should RAAs be used as step 1 in the SoC? Based on the fact the T2 has lost first phase release the answer is absolutely, except they require needles and the hypo risk is high. afrezza solves both problems. The only problem afrezza has is Mike needs to figure out how to take all this great data which was just presented and put a marketing plan together which finally gets afrezza to be the greatest selling drug of all time.
Now Mango raises an interesting question - are you RisingSkeptic?
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Post by agedhippie on Feb 22, 2020 8:31:26 GMT -5
You're seriously stretching it dude. I am going to go ahead and guess that NEITHER of those pump trials were REAL-WORLD clinical trials like STAT?!?...and, even if they were, who cares? STAT proved that RAAs are inferior to Afrezza. ... [Clipped off the insults] Lol, and that is why you should read rather than just guess. The data is uploaded from the pumps to Minimed when you use their tracking system. The Diatribe post was based on results from Medtronics in September last year ( MiniMedβ’ 670G System European Real-World Data Shows 73% Time in Range, Beyond Recommended Targets) which was data collected from 4,369 users in the real world. Interestingly the real world results were better than the clinical trial results by a couple of percent. A revised data set was presented at ATTD conference the Afrezza results are being presented at. That data set confirms the results, but the number of users has almost doubled now to 7,847. For comparison STAT was 15 people in the compliant group. There is a reason STAT described itself as a pilot study...
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Post by agedhippie on Feb 22, 2020 8:43:11 GMT -5
Aged - I was not 10 feet from the endo at the Adcom who was attacked by the FDA analyst. This guy was not taking the FDA question lightly nor over-simplifying his answer. He meant what he said. Did he give an emotional answer - yes. But he gave it because he knew how dangerous stacking RAAs can be. Should RAAs be used as step 1 in the SoC? Based on the fact the T2 has lost first phase release the answer is absolutely, except they require needles and the hypo risk is high. afrezza solves both problems. The only problem afrezza has is Mike needs to figure out how to take all this great data which was just presented and put a marketing plan together which finally gets afrezza to be the greatest selling drug of all time. Now Mango raises an interesting question - are you RisingSkeptic? Stacking RAA (in fact any insulin including Afrezza or basal) can be dangerous if you do not pay attention - no argument there. If you are not paying attention then Afrezza will be better because given the fast clearance the time at risk is about half that of RAA. My objection is to the idea that any one stacking RAA is playing Russian roulette because almost every Type 1 in the world does it today so it devalues the argument for Afrezza because the immediate reaction on hearing it is "well that's wrong" and the audience switches off. I actually agree with you that insulin should be a more commonly used option than oral meds in Type 2. I think if you want to actively manage Type 2 then insulin is the only option and if I was Type 2 I would want to use it. The issue is that people want "once a day" treatment for convenience and that the medical world is heading away from insulin treatments. The problem at the moment is that the great data is from very small datasets. To flog a dead horse, large scale trails are the answer. Am I RiskingSkeptic? Do I even have to dignify that with an answer? Come on, I thought you were better than resorting to insults (and no I am not as well you know).
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