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Post by dreamboatcruise on Apr 11, 2017 13:13:47 GMT -5
You know what the most ridiculous thing about this is? You think I'm bashing Afrezza. I have been consistent in my view: 1. Afrezza is a slightly milder insulin than SC and costs around the same. Proven in clinical trials. 2. Management has been arrogant, self-enriching, foot-dragging, and may well deny me the chance to try Afrezza. 3. Related to #2: Al Mann was a salesman, to the point of sometimes going to far in his claims. 4. I take about 50 IU of SC at meals and 70IU of basal at supper time. It can burn like a bitch. Of course I'd give it a try, but I suspect that given my dose, it wouldn't be sufficient, but who knows? I may be one of the folks it works great for. 5. There's nothing magical about Afrezza, and I push back on those who ignore 6000 people in clinical trials and instead cherry pick from about a dozen people active on social media, ignoring the thousands that have discontinued for various reasons. Kind of like going through Google results until you find the one that agrees with you at result #36. *Of course, if somebody thinks that Afrezza has no side effects, when I talk about side effects, they think I'm bashing, even though their view is what's distorted. *If somebody thinks that retail short sellers inflate the share count by 20M shares (post split), when I talk about dilution increasing the share count by 60M shares, they think I'm bashing. *If somebody thinks that Afrezza is the most effective diabetes treatment ever, when I talk about Mike C stating that efficacy is one of the top 2 reasons for lack of Rx renewals, some how I'm bashing. *When I state that Google, Dexcom, Novo, Microsoft, are not about to buy out MNKD somehow I'm wrong, and yet no apologies to the board by self-purported insiders when they are again and again shown to be spouting self-serving folderol. *When I show that MNKD has not only not tested on children (other than inhaler handling - no insulin)but asked (and received permission) to put pediatric testing off by a decade (2021 completion instead of the 2011 NDA), somehow it's me that's against children. MNKD would be just as happy for those with poor reading skills to think that the FDA begged _them_ to test on children as opposed to MNKD asking not to have to test on (nor sell to) children. To reiterate: 1. Afrezza is an approved treatment option for diabetics. Some people find that it works well. 37% did in the trials, and it looks like about the same number do in the commercial market. Yay for them.2. Of course I'd try a titration pack to see if it worked. I've hung around this long! 3. For me, it's not Afrezza, but it _is_ magical thinking about Afrezza that I'm against. 4. And yeah, it _is_ management. Unfortunately people around here are really losing track of this statement. Afrezza is an OPTION and hopefully an option that helps PWDs in their day to day struggle. It is not the standard care and it doesn't work for everybody. It's along the same lines as when someone used to post on a social media outlet that it doesn't work for them and next thing you know numerous people were all over them for bashing, bizarre. And now to be a "real" Mannkind supporter here you need to not only say Afrezza can't possibly ever disappoint a patient, you need to spread FUD that Metformin and squbq insulin is toxic. I think the situation at this point is a bit more intentional than people "losing track" of reality.
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Post by lojothehus on Apr 11, 2017 13:24:16 GMT -5
Unfortunately people around here are really losing track of this statement. Afrezza is an OPTION and hopefully an option that helps PWDs in their day to day struggle. It is not the standard care and it doesn't work for everybody. It's along the same lines as when someone used to post on a social media outlet that it doesn't work for them and next thing you know numerous people were all over them for bashing, bizarre. And now to be a "real" Mannkind supporter here you need to not only say Afrezza can't possibly ever disappoint a patient, you need to spread FUD that Metformin and squbq insulin is toxic. I think the situation at this point is a bit more intentional than people "losing track" of reality. I dunno, but sounds like bashing to me?
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Post by peppy on Apr 11, 2017 16:06:43 GMT -5
let's cut through all the carp. You are a type two diabetic on medications. Be honest. With all you know,- if you are a non smoker, -if Afrezza was covered by Canadian medical insurance Would you choose, (your choice) to use afrezza to treat the type two you are now treating with other medication? I really would like to know.
You know what the most ridiculous thing about this is? You think I'm bashing Afrezza. I have been consistent in my view: 1. Afrezza is a slightly milder insulin than SC and costs around the same. Proven in clinical trials. 2. Management has been arrogant, self-enriching, foot-dragging, and may well deny me the chance to try Afrezza. 3. Related to #2: Al Mann was a salesman, to the point of sometimes going to far in his claims. 4. I take about 50 IU of SC at meals and 70IU of basal at supper time. It can burn like a bitch. Of course I'd give it a try, but I suspect that given my dose, it wouldn't be sufficient, but who knows? I may be one of the folks it works great for. 5. There's nothing magical about Afrezza, and I push back on those who ignore 6000 people in clinical trials and instead cherry pick from about a dozen people active on social media, ignoring the thousands that have discontinued for various reasons. Kind of like going through Google results until you find the one that agrees with you at result #36. *Of course, if somebody thinks that Afrezza has no side effects, when I talk about side effects, they think I'm bashing, even though their view is what's distorted. *If somebody thinks that retail short sellers inflate the share count by 20M shares (post split), when I talk about dilution increasing the share count by 60M shares, they think I'm bashing. *If somebody thinks that Afrezza is the most effective diabetes treatment ever, when I talk about Mike C stating that efficacy is one of the top 2 reasons for lack of Rx renewals, some how I'm bashing. *When I state that Google, Dexcom, Novo, Microsoft, are not about to buy out MNKD somehow I'm wrong, and yet no apologies to the board by self-purported insiders when they are again and again shown to be spouting self-serving folderol. *When I show that MNKD has not only not tested on children (other than inhaler handling - no insulin)but asked (and received permission) to put pediatric testing off by a decade (2021 completion instead of the 2011 NDA), somehow it's me that's against children. MNKD would be just as happy for those with poor reading skills to think that the FDA begged _them_ to test on children as opposed to MNKD asking not to have to test on (nor sell to) children. To reiterate: 1. Afrezza is an approved treatment option for diabetics. Some people find that it works well. 37% did in the trials, and it looks like about the same number do in the commercial market. Yay for them. 2. Of course I'd try a titration pack to see if it worked. I've hung around this long! 3. For me, it's not Afrezza, but it _is_ magical thinking about Afrezza that I'm against. 4. And yeah, it _is_ management. I think you know the label forwards and back wards, and if I didn't know better you could be a bot. I really wanted to know if you secretly had afrezza lust in your heart.
If I look deep, why isn't it working for some? All I can think of is those individuals, their liver? Insulin resistance? Or they were dosing like subq, under dosing for afrezza.
Al Mann seems like a brain. He knew this drug. Unbelievable he knew.
I would really like a digital noninvasive glucose monitor watch.
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Post by dreamboatcruise on Apr 11, 2017 16:52:21 GMT -5
I think you know the label forwards and back wards, and if I didn't know better you could be a bot. I really wanted to know if you secretly had afrezza lust in your heart.
If I look deep, why isn't it working for some? All I can think of is those individuals, their liver? Insulin resistance? Or they were dosing like subq, under dosing for afrezza.
Al Mann seems like a brain. He knew this drug. Unbelievable he knew.
I would really like a digital noninvasive glucose monitor watch.
Perhaps... Education that was lacking from their healthcare provider combined with lack of interest or ability to figure it out on their own. If everyone were really motivated and had basic analytical inclination, it probably wouldn't matter that many healthcare providers have not really understand Afrezza... but in the real world a lot of people are at best going to do what their doctors tell them to do.
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Post by sayhey24 on Apr 11, 2017 19:06:58 GMT -5
You know what the most ridiculous thing about this is? You think I'm bashing Afrezza. I have been consistent in my view: 1. Afrezza is a slightly milder insulin than SC and costs around the same. Proven in clinical trials. 2. Management has been arrogant, self-enriching, foot-dragging, and may well deny me the chance to try Afrezza. 3. Related to #2: Al Mann was a salesman, to the point of sometimes going to far in his claims. 4. I take about 50 IU of SC at meals and 70IU of basal at supper time. It can burn like a bitch. Of course I'd give it a try, but I suspect that given my dose, it wouldn't be sufficient, but who knows? I may be one of the folks it works great for. 5. There's nothing magical about Afrezza, and I push back on those who ignore 6000 people in clinical trials and instead cherry pick from about a dozen people active on social media, ignoring the thousands that have discontinued for various reasons. Kind of like going through Google results until you find the one that agrees with you at result #36. *Of course, if somebody thinks that Afrezza has no side effects, when I talk about side effects, they think I'm bashing, even though their view is what's distorted. *If somebody thinks that retail short sellers inflate the share count by 20M shares (post split), when I talk about dilution increasing the share count by 60M shares, they think I'm bashing. *If somebody thinks that Afrezza is the most effective diabetes treatment ever, when I talk about Mike C stating that efficacy is one of the top 2 reasons for lack of Rx renewals, some how I'm bashing. *When I state that Google, Dexcom, Novo, Microsoft, are not about to buy out MNKD somehow I'm wrong, and yet no apologies to the board by self-purported insiders when they are again and again shown to be spouting self-serving folderol. *When I show that MNKD has not only not tested on children (other than inhaler handling - no insulin)but asked (and received permission) to put pediatric testing off by a decade (2021 completion instead of the 2011 NDA), somehow it's me that's against children. MNKD would be just as happy for those with poor reading skills to think that the FDA begged _them_ to test on children as opposed to MNKD asking not to have to test on (nor sell to) children. To reiterate: 1. Afrezza is an approved treatment option for diabetics. Some people find that it works well. 37% did in the trials, and it looks like about the same number do in the commercial market. Yay for them.2. Of course I'd try a titration pack to see if it worked. I've hung around this long! 3. For me, it's not Afrezza, but it _is_ magical thinking about Afrezza that I'm against. 4. And yeah, it _is_ management. Unfortunately people around here are really losing track of this statement. Afrezza is an OPTION and hopefully an option that helps PWDs in their day to day struggle. It is not the standard care and it doesn't work for everybody. It's along the same lines as when someone used to post on a social media outlet that it doesn't work for them and next thing you know numerous people were all over them for bashing, bizarre. I thought what afrezza is and is not was settled a long time ago. I have no idea what slightly milder insulin than SC means. Afrezza is monomer human insulin stabilized with FDKP. The FDKP separates as soon as it hits the lung lining. The monomer insulin goes directly into the blood and the FDKP gets excreted in human waste. Afrezza is the exact same, identical insulin which is released by the pancreas. It is not an Analog. If someone thinks afrezza does not work what they are saying is if their pancreas was healthy the insulin released by it would not work for them. In other words, they are wrong. The biggest problem afrezza has is its too Damn expensive. The good news is this a problem management could address if they wanted. If they think it is not working it is because they are not properly dosing. They are either taking too little or taking it too soon for the meal or whatever they ate is digesting slowly - usually from high fat content and the initial dose is already leaving their system and they need a second dose to mimic phase 2 insulin release. Afrezza is not magic. It is monomer human insulin. Just like with the pancreas if it does not release enough insulin your BG will stay high. Its pretty simple though - a little puff will do it. As far as management being arrogant, I have ZERO explanation based on publicly known information why they have done what they have and are doing. If they have other information that a long-standing deal has already been done, then everything they have been doing makes perfect sense. Short of that I would say Matt is delusional. No international deals, no clinicals for the kids, not going after the PCP market, not even doing a deal with a monitoring company like a One Drop which seems to show up everywhere MNKD is. On the surface - it make little sense. I don't think Matt is delusional. I could be wrong. You say you take about 50 IU of SC at meals and 70IU Whats your FBG? I bet if you start using afrezza and get you FBG under 100 (better yet 90) and do that for 3 months you will not be using that much. Get yourself a Dexcom or Libre or take a lot of finger pokes and give it a try. To titrate your basal properly take Edelman's advise "basal insulin Type 1" - tcoyd.org/videos/the-edelman-report.html BTW - don't follow his example when his BG is 180 and he did not immediately correct with afrezza - he should know better. Someone was talking about afrezza and refrigeration. I would be one guilty of saying it does not need refrigeration. However, I did not make that up. I got that from the gal who did the QA studies. They made her available during one of the factory tours so this was said in public. FDKP prevents the insulin molecule from decaying. She said 2 years at room temperature and it would be fine. I asked why the recommendation for refrigeration and she said MNKD wanted to be conservative. I don't know if she was telling me the truth but I had and still have no reason not to believe her.
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Post by dreamboatcruise on Apr 11, 2017 19:46:57 GMT -5
I thought what afrezza is and is not was settled a long time ago. I have no idea what slightly milder insulin than SC means. Afrezza is monomer human insulin stabilized with FDKP. The FDKP separates as soon as it hits the lung lining. The monomer insulin goes directly into the blood and the FDKP gets excreted in human waste. Afrezza is the exact same, identical insulin which is released by the pancreas. It is not an Analog. If someone thinks afrezza does not work what they are saying is if their pancreas was healthy the insulin released by it would not work for them. In other words, they are wrong. The biggest problem afrezza has is its too Damn expensive. The good news is this a problem management could address if they wanted. If they think it is not working it is because they are not properly dosing. They are either taking too little or taking it too soon for the meal or whatever they ate is digesting slowly - usually from high fat content and the initial dose is already leaving their system and they need a second dose to mimic phase 2 insulin release. Afrezza is not magic. It is monomer human insulin. Just like with the pancreas if it does not release enough insulin your BG will stay high. Its pretty simple though - a little puff will do it. As far as management being arrogant, I have ZERO explanation based on publicly known information why they have done what they have and are doing. If they have other information that a long-standing deal has already been done, then everything they have been doing makes perfect sense. Short of that I would say Matt is delusional. No international deals, no clinicals for the kids, not going after the PCP market, not even doing a deal with a monitoring company like a One Drop which seems to show up everywhere MNKD is. On the surface - it make little sense. I don't think Matt is delusional. I could be wrong. You say you take about 50 IU of SC at meals and 70IU Whats your FBG? I bet if you start using afrezza and get you FBG under 100 (better yet 90) and do that for 3 months you will not be using that much. Get yourself a Dexcom or Libre or take a lot of finger pokes and give it a try. To titrate your basal properly take Edelman's advise "basal insulin Type 1" - tcoyd.org/videos/the-edelman-report.html BTW - don't follow his example when his BG is 180 and he did not immediately correct with afrezza - he should know better. Someone was talking about afrezza and refrigeration. I would be one guilty of saying it does not need refrigeration. However, I did not make that up. I got that from the gal who did the QA studies. They made her available during one of the factory tours so this was said in public. FDKP prevents the insulin molecule from decaying. She said 2 years at room temperature and it would be fine. I asked why the recommendation for refrigeration and she said MNKD wanted to be conservative. I don't know if she was telling me the truth but I had and still have no reason not to believe her. Just to be accurate, the pancreas stores insulin in it's hexamer form. It does not disassociate into the active monomer form until after it is released into the bloodstream. Here is a reference that describes production, storage and release of insulin in the pancreas. www.ebi.ac.uk/pdbe/widgets/QuipStories/insulin/insulin.pdf
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Post by sportsrancho on Apr 11, 2017 20:02:19 GMT -5
Someone was talking about afrezza and refrigeration. I would be one guilty of saying it does not need refrigeration. However, I did not make that up. I got that from the gal who did the QA studies. They made her available during one of the factory tours so this was said in public. FDKP prevents the insulin molecule from decaying. She said 2 years at room temperature and it would be fine. I asked why the recommendation for refrigeration and she said MNKD wanted to be conservative. I don't know if she was telling me the truth but I had and still have no reason not to believe her.
This is exactly what I heard. And at some point they will do tests to prove it.
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Post by derek2 on Apr 11, 2017 20:03:55 GMT -5
Hi sayhey24 Your posts are always thoughtful. To avoid the post getting huge, I'll just reply with a fresh post. Paragraph 1 - I agree. Simple facts on your part. My "mild" characterization is due to the upper limit on its dosing due to non-linearity above 20 - 25 units. If you don't need a huge dose, then it's not an issue. The 0.4% change in HbA1c in the affinity trial vs. placebo also points to it being milder than SC. Again, mild is not necessarily a bad thing, especially for T1s and children. Paragraph 2 - mostly agree, but the fact that Afrezza does not have dosing linearity above 20 units due to its mode of administration (as per FDA briefing notes) somewhat limits its 1:1 comparison to insulin released from the pancreas, at least for edge cases. Paragraph 3 - Agree 100% Paragraph 4 - Agree, but I don't know how easily that's addressed in a patient population in which many people have trouble taking one pill a day. Note: when I say I don't know I mean I don't know. I'm not implying people can't be trained and motivated. Obviously, some can - just look at Sam and Eric. Paragraph 5 - Hopefully management will surprise us. Paragraph 6 - my FBG runs 94 to 110, and BG is never over 170 2 hrs after meals. 9 months ago I started with a new endo and that's helped a lot. My peak insulin use was 60 per meal and 80 basal while not in great control, so this is an improvement. I've done this cycle of good control for abt 4 years followed by a year or 2 of frustration and then locking back in for another 4 or 5 several times since I was diagnosed in 2000. I've used Dr Berenstein's approach in the past to good effect. The whole refrigeration thing is kind of weird.
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Post by saxcmann on Apr 11, 2017 20:36:28 GMT -5
I think you know the label forwards and back wards, and if I didn't know better you could be a bot. I really wanted to know if you secretly had afrezza lust in your heart.
If I look deep, why isn't it working for some? All I can think of is those individuals, their liver? Insulin resistance? Or they were dosing like subq, under dosing for afrezza.
Al Mann seems like a brain. He knew this drug. Unbelievable he knew.
I would really like a digital noninvasive glucose monitor watch.
Perhaps... Education that was lacking from their healthcare provider combined with lack of interest or ability to figure it out on their own. If everyone were really motivated and had basic analytical inclination, it probably wouldn't matter that many healthcare providers have not really understand Afrezza... but in the real world a lot of people are at best going to do what their doctors tell them to do. Amen! Exactly!
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Post by sayhey24 on Apr 11, 2017 20:47:19 GMT -5
Hi sayhey24 Your posts are always thoughtful. To avoid the post getting huge, I'll just reply with a fresh post. Paragraph 1 - I agree. Simple facts on your part. My "mild" characterization is due to the upper limit on its dosing due to non-linearity above 20 - 25 units. If you don't need a huge dose, then it's not an issue. The 0.4% change in HbA1c in the affinity trial vs. placebo also points to it being milder than SC. Again, mild is not necessarily a bad thing, especially for T1s and children. Paragraph 2 - mostly agree, but the fact that Afrezza does not have dosing linearity above 20 units due to its mode of administration (as per FDA briefing notes) somewhat limits its 1:1 comparison to insulin released from the pancreas, at least for edge cases. Paragraph 3 - Agree 100% Paragraph 4 - Agree, but I don't know how easily that's addressed in a patient population in which many people have trouble taking one pill a day. Note: when I say I don't know I mean I don't know. I'm not implying people can't be trained and motivated. Obviously, some can - just look at Sam and Eric. Paragraph 5 - Hopefully management will surprise us. Paragraph 6 - my FBG runs 94 to 110, and BG is never over 170 2 hrs after meals. 9 months ago I started with a new endo and that's helped a lot. My peak insulin use was 60 per meal and 80 basal while not in great control, so this is an improvement. I've done this cycle of good control for abt 4 years followed by a year or 2 of frustration and then locking back in for another 4 or 5 several times since I was diagnosed in 2000. I've used Dr Berenstein's approach in the past to good effect. The whole refrigeration thing is kind of weird. Derek - thanks for the thoughtful post unlike the nonsense reply about pancreas storing insulin in hexamer. Where are you getting the nonsense about not linear dosing? There is 10 units of insulin in the 4u, 20 in the 8u and 30units in the 12u. Thats all they could fit in the cartridge without going to "Al's" new process he blurted out on a conference call. You get a little less than 40% of the insulin from the device due to waste which never gets into the lung. If you need 24u take two Bigs(12u). It doses linear unlike Exubera. The FDA is wrong if thats what they said. but I don't know how easily that's addressed in a patient population in which many people have trouble taking one pill a day - I don't know the answer to this but we will find out soon enough if Stefan Schwarz is successful. What their exact protocal is which Edelman has helped to define is intended to turn the current standards on their head. Schwarz wanted the T2 market which should be on insulin sooner - 40% of the market. Its a huge market. But I say why wait they should start day 1 when the new T2 is diagnosed. Give them the CGM, hook them to the cloud and give them insulin. Provide tele-coaching and in 3 to 6 months many will be in remission and just need further monitoring and occasional maintenance. Onduo still gets their service fee for monitoring. With CGMs there is NO hiding. Metformin as been obsoleted by technology just like the pump. The big problem for Big Pharma is so has most of the other diabetic treatments and research. So, why is MNKD not currently addressing this PCP/T2 market???
never over 170 - you never really want it over 140. Thats why Finta and others have set their CGM lines at 130. Once it goes over 140 for any extended period you start building muscle insulin resistance. You get into the 170-180 range and you really need more insulin. Now, the big thing with afrezza is the "First Phase" insulin release which mimics the pancreas. This shuts off liver glucose production. You want to blunt the rise by about 100 to keep it in "normal" 120-130 range. Give it a try. Go big on the initial afrezza dosing, this is the biggest dosing mistake. The pancreas will always dump what it needed for the last meal and the liver will always save you with monomer human insulin. You want to think like a pancreas. You have to really really try to get a severe hypo. High fat foods will require a second dose and you really want to get it under 90 before your meal, ideally during fasting with Edelmans basal protocol.
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Post by sayhey24 on Apr 11, 2017 20:57:01 GMT -5
Also - Nothing wrong with Dr Berenstein's approach before afrezza but afrezza also obsoletes this. With afrezza you want to eat in moderation and some carbs are OK. You really want more of a low fat diet just like they are going to have on that TV show.
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Post by dreamboatcruise on Apr 11, 2017 21:15:39 GMT -5
seyhay... if you didn't like the scientific reference, perhaps a layman's version will be easier to read... www.dummies.com/food-drink/special-diets/diabetes-diets/insulin-and-zinc-two-peas-in-a-pancreas/The insulin stored in the pancreas that makes up the first phase release is indeed hexamer. The difference between hexamer and monomer isn't relevant when it goes directly into the blood, as the former rapidly disassociates into the latter. Novalin-R and Humulin-R (regular human insulin) create hexamers in the solution just as occurs in the pancreas. They have rapid action when injected IV just as when hexamers are released from the pancreas. The delayed reaction of these when injected subq is because the hexamer is too large to readily transfuse into the capillaries. It must first disassociate and that does not happen quickly in the subcutaneous environment.
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Post by lennymnkd on Apr 12, 2017 4:15:13 GMT -5
What are you trying to say ! Derek
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Post by boytroy88 on Apr 12, 2017 4:54:16 GMT -5
Someone was talking about afrezza and refrigeration. I would be one guilty of saying it does not need refrigeration. However, I did not make that up. I got that from the gal who did the QA studies. They made her available during one of the factory tours so this was said in public. FDKP prevents the insulin molecule from decaying. She said 2 years at room temperature and it would be fine. I asked why the recommendation for refrigeration and she said MNKD wanted to be conservative. I don't know if she was telling me the truth but I had and still have no reason not to believe her. This is exactly what I heard. And at some point they will do tests to prove it. Here's a video of Matt Bendall showing Afrezza out of refrigeration of 105 days and it still being effective - vimeo.com/153597580
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Post by sayhey24 on Apr 12, 2017 5:22:26 GMT -5
seyhay... if you didn't like the scientific reference, perhaps a layman's version will be easier to read... www.dummies.com/food-drink/special-diets/diabetes-diets/insulin-and-zinc-two-peas-in-a-pancreas/The insulin stored in the pancreas that makes up the first phase release is indeed hexamer. The difference between hexamer and monomer isn't relevant when it goes directly into the blood, as the former rapidly disassociates into the latter. Novalin-R and Humulin-R (regular human insulin) create hexamers in the solution just as occurs in the pancreas. They have rapid action when injected IV just as when hexamers are released from the pancreas. The delayed reaction of these when injected subq is because the hexamer is too large to readily transfuse into the capillaries. It must first disassociate and that does not happen quickly in the subcutaneous environment. Great - no one is talking about what is STORED. We are talking about what is USED. When it is excreted into the blood it passes through the cell membrane as a MONOMER. No one is taking insulin IV unless they are in the emergency room. I will read BOTH your papers later. Regular human insulin is stabilized with zinc which makes the 6 molecules get all balled up. They are not usable in that form. Analogs are a whole other story - first they have different GMO molecules much different than human insulin. They are not what is natural to the body and in the solution you have a mix of hexamers, dimmers and monomers. That is why Al Mann created the holy grail of insulin. He figured out with Sol Steiners help how to create the exact same insulin used NATURALLY by the body. Thats the greatness behind afrezza and all we hear about is its inhaled. This is also why the afrezza users are seeing two important things; no severe hypos - because it works in harmony with the liver; its very predictable because its natural to body function.
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