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Post by brentie on Nov 5, 2021 6:18:32 GMT -5
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Post by joeypotsandpans on Nov 5, 2021 6:19:05 GMT -5
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Post by MnkdWASmyRtrmntPlan on Nov 5, 2021 7:03:16 GMT -5
Yeah!
Finally!!!
Is it ABOUT TIME for this, or what?
A Technosphere® Insulin (TI) dose – approximately double the estimated mealtime subcutaneously (SC) injection dose – reduced postprandial glucose excursions (PPGE) without any severe hypoglycemia in the first two hours
Higher dose of TI resulted in approximately 50 mg/dL improvement in PPGE at 120 minutes
Twenty adult participants (≥ 18 years) with T1D or T2D who were on a stable regimen of basal-bolus insulin therapy were enrolled in this feasibility study. Each subject received an initial dose of TI based on the conversion chart in the current U.S. package insert. At the next visit, subjects were dosed based on doubling the estimated SC injection dose of mealtime insulin and rounding down to the nearest TI cartridge. The protocol specified administering TI doses immediately prior to consuming an identical standardized meal.
only 20 participants though!!!
I assume this was one of the golden nuggets from the veins of gold that was never released until now. All this time good dosage guidelines have been sorely needed.
Is it just me or should this have been released directly after the study was completed?
Shouldn't this at least have been released at the Annual ADA event?
How big of a deal is this 21st Annual Diabetes Technology Meeting? Do Endos care about it?
So, what does a study with only 20 participants get us?
Will this make a splash at all?
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Post by peppy on Nov 5, 2021 7:09:09 GMT -5
Is this the result of the, "The dose optimization study is the Afrezza dynamic dosing study, which we're calling [AED-1] study. This protocol is very close to finalization and we're aiming for a July/August start with the possible Q4 completion, date available soon after." ? Posted in the MNKD resource center, MNKD studies, Mar 14, 2018 by me.  |
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Post by mango on Nov 5, 2021 7:22:23 GMT -5
Absolutely fantastic results.
Once again, we find Afrezza is superior to RAAs.
• A Technosphere® Insulin (TI) dose – approximately double the estimated mealtime subcutaneously (SC) injection dose – reduced postprandial glucose excursions (PPGE) without any severe hypoglycemia in the first two hours
• Higher dose of TI resulted in approximately 50 mg/dL improvement in PPGE at 120 minutes
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What ADA said in their 2021 Consensus Report:
”2. Inhaled human insulin, available only in the U.S., has a very rapid onset of action and short duration compared with subcutaneous rapid-acting analogs (3). Inhaled insulin ameliorates early postprandial hyperglycemia well, but its short duration of action results in less control of later postprandial hyperglycemia. Additionally, inhaled insulin can cause cough or sore throat, and therapy must be monitored with periodic spirometry because of possible effects on lung function (97).”
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Post by peppy on Nov 5, 2021 7:28:44 GMT -5
Absolutely fantastic results. Once again, we find Afrezza is superior to RAAs. Quick, someone alert ADA 😆 A Technosphere® Insulin (TI) dose – approximately double the estimated mealtime subcutaneously (SC) injection dose – reduced postprandial glucose excursions (PPGE) without any severe hypoglycemia in the first two hours Higher dose of TI resulted in approximately 50 mg/dL improvement in PPGE at 120 minutes I remember the CC years ago when Mike C talked about this. Mike C said, paraphrasing, " Regarding, add on dosing, we are going to do a study to see if increasing the initial dose will change the need for add on doses" something like that was the gist. sportsrancho or all do you remember? |
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Post by sportsrancho on Nov 5, 2021 7:33:18 GMT -5
Absolutely fantastic results. Once again, we find Afrezza is superior to RAAs. Quick, someone alert ADA 😆 A Technosphere® Insulin (TI) dose – approximately double the estimated mealtime subcutaneously (SC) injection dose – reduced postprandial glucose excursions (PPGE) without any severe hypoglycemia in the first two hours Higher dose of TI resulted in approximately 50 mg/dL improvement in PPGE at 120 minutes I remember the CC years ago when Mike C talked about this. Mike C said, paraphrasing, " Regarding, add on dosing, we are going to do a study to see if increasing the initial dose will change the need for add on doses" something like that was the gist. sportsrancho or all do you remember? Yes😎 |
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Post by MnkdWASmyRtrmntPlan on Nov 5, 2021 7:53:44 GMT -5
oK then.
my mistake.
this is new.
well, in that case, this is truly great!!!
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Post by MnkdWASmyRtrmntPlan on Nov 5, 2021 8:00:03 GMT -5
Any thoughts on what MNKD will be able to accomplish with this only being 20 participants?
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Post by sayhey24 on Nov 5, 2021 8:26:18 GMT -5
Any thoughts on what MNKD will be able to accomplish with this only being 20 participants? The key phrase is "reduced postprandial glucose excursions (PPGE) without any severe hypoglycemia in the first two hours" After 2 hours afrezza is gone. Any hypoglycemia after the 2 hours is not coming from afrezza. So, the greatest fear in using insulin as a front line treatment for T2s is severe hypoglycemia. A T2 not taking some other T2 med which is either messing up the liver or the pancreas should be able to take afrezza with no severe hypoglycemia concerns. Also, if you are taking afrezza you should not need any other T2 med. In Bill's VDex paper he demonstrated the same PPG results as this study. As the T2 starts going low, the liver kicks in and releases sugar. While few believed Bill back in the day, in fact I got laughed at from a Merck M&A analyst, now MNKD has their own peer viewed study. This study starts the conversation with someone who wants to own the health/diabetes market. Amazon sure seems like they want to get into medical care, just saying. Now that all the things we have been talking about for years like CGMs, telemedicine, real-time AGPs have matured and companies like Amazon seem to be in a great place to facilitate this, afrezza seems like the perfect fit since its the only thing besides a healthy pancreas which can stop the post meal sugar spike without fear of severe hypos. For years we have been saying on this board to "Go Big" when dosing afrezza and now we have the official study to back up this claim. If I were Mike, I would be making a few phone calls to some CEOs to see if they want to be his new best friend. If you control PPG excursions and get the T2 back under 140 in 2 hours there will be significant health cost reductions in heart disease, neuropathy, etc. Al Mann said afrezza would be the greatest selling drug of all time and he may just have been right, again. |
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Post by peppy on Nov 5, 2021 8:34:59 GMT -5
I think this is the not really a problem, problem, this Could be meant to solve.... add on doses at 1 hour. I copy and save this chit.   |
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Post by peppy on Nov 5, 2021 8:43:15 GMT -5
I remember the CC years ago when Mike C talked about this. Mike C said, paraphrasing, " Regarding, add on dosing, we are going to do a study to see if increasing the initial dose will change the need for add on doses" something like that was the gist. sportsrancho or all do you remember? Yes😎 I remember you talking about the kids taking 16 units before a pizza or a sandwich. You said they eat fast. Some things I remember... |
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Post by cjm18 on Nov 5, 2021 9:36:43 GMT -5
That’s a lot of insulin. Expensive.
Will mannkind try to change the dosing package insert?
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Post by sayhey24 on Nov 5, 2021 10:10:06 GMT -5
That’s a lot of insulin. Expensive. Will mannkind try to change the dosing package insert? I would think if Tyvaso does not contain the black box, which it seems it won't, I think Mike will go for a whole new label to redo the dosing and eliminate the black box. |
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Post by MnkdWASmyRtrmntPlan on Nov 5, 2021 10:37:49 GMT -5
That’s a lot of insulin. Expensive. Will mannkind try to change the dosing package insert? I would think if Tyvaso does not contain the black box, which it seems it won't, I think Mike will go for a whole new label to redo the dosing and eliminate the black box. Hey Sayhey, are you saying that MNKD may request a new label with no black-box and justify it with this study? Do you think that a 20-patient study is enough to compel the FDA? If so, that would be sweet. |
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