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Post by mango on Nov 10, 2022 12:17:29 GMT -5
Damn right, this is a great study that has just demonstrated that Afrezza + basal can achieve similar control as a Continuous Subcutaneous Insulin Infusion pump with Automatic Insulin Delivery.
We also achieved significant reduction in postprandial glucose excursions which the medical community understands is a significant factor in all sorts of health complications when it is chronically exaggerated. A tight PPG will prevent cognitive decline as well.
We should not even be using A1C anymore since it’s just a proxy and not an accurate measure of glucose homeostasis. The secondary outcome measure of TIR is the best measurement for glucose homeostasis we have today.
Overall, this is an outstanding achievement for Afrezza to go head to head against a pump and not only achieve similar control, but demonstrate superior results in PPGE which has historically been an issue.
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Post by sayhey24 on Nov 10, 2022 13:30:31 GMT -5
Mango - well said and to add to it -
This was the reason why Al Mann started looking for a faster insulin. He knew his pumps and algorithms could only do so much and no matter how good they got the root problem was - the insulin in the pump was too damn slow.
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Post by agedhippie on Nov 10, 2022 16:26:02 GMT -5
... We should not even be using A1C anymore since it’s just a proxy and not an accurate measure of glucose homeostasis. The secondary outcome measure of TIR is the best measurement for glucose homeostasis we have today. ... In which case Mannkind shouldn't have chosen A1c as the primary outcome measurement. Neither PPG nor TIR were secondary outcome measurements in this study at all which I thought was odd since the pumps all include CGMs so for the price of 9 CGMs for the non-pump arm they could have had TIR and AGP. |
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Post by mango on Nov 10, 2022 16:30:08 GMT -5
... We should not even be using A1C anymore since it’s just a proxy and not an accurate measure of glucose homeostasis. The secondary outcome measure of TIR is the best measurement for glucose homeostasis we have today. ... In which case Mannkind shouldn't have chosen A1c as the primary outcome measurement. Neither PPG nor TIR were secondary outcome measurements in this study at all which I thought was odd since the pumps all include CGMs so for the price of 9 CGMs for the non-pump arm they could have had TIR and AGP. They have numerous TIR secondary outcome measurements in the clinical trial: • Change in Time in Range (70 - 180 mg/dL) [ Time Frame: 90 days ] Change in percent time in range (TIR) based on continuous glucose monitoring derived glucose values • Change in Time Below Range (glucose <70 mg/dL) [ Time Frame: 90 days ] Change in percent time below range (TBR), defined as time spent with glucose <70 mg/dL based on continuous glucose monitoring derived glucose values • Change in Percent Time with Glucose <54 mg/dL [ Time Frame: 90 days ] Change in percent time spent with glucose <54 mg/dL based on continuous glucose monitoring derived glucose values • Change in Time Above Range (glucose >180 mg/dL) [ Time Frame: 90 days ] Change in percent time above range (TAR), defined as time spent with glucose >180 mg/dL based on continuous glucose monitoring derived glucose values • Change in Percent Time with Glucose >250 mg/dL [ Time Frame: 90 days ] Change in percent time spent with glucose >250 mg/dL based on continuous glucose monitoring derived glucose values • Change in Coefficient of variation (CV) [ Time Frame: 90 days ] Change in glycemic variability as measured by coefficient of variation (CV) based on continuous glucose monitoring derived glucose values |
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Post by peppy on Nov 10, 2022 16:41:06 GMT -5
... We should not even be using A1C anymore since it’s just a proxy and not an accurate measure of glucose homeostasis. The secondary outcome measure of TIR is the best measurement for glucose homeostasis we have today. ... In which case Mannkind shouldn't have chosen A1c as the primary outcome measurement. Neither PPG nor TIR were secondary outcome measurements in this study at all which I thought was odd since the pumps all include CGMs so for the price of 9 CGMs for the non-pump arm they could have had TIR and AGP. MNKD needs to work with the FDA when setting up trials. These trials are set up MNKD is the comparator, so set up against subq, which you know. The A1c primary outcome is probably standard of care. I think the A1c is lazy. Go low enough frequently it even outs the highs. A1c is a tool for medications not for care. |
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Post by agedhippie on Nov 10, 2022 17:15:34 GMT -5
In which case Mannkind shouldn't have chosen A1c as the primary outcome measurement. Neither PPG nor TIR were secondary outcome measurements in this study at all which I thought was odd since the pumps all include CGMs so for the price of 9 CGMs for the non-pump arm they could have had TIR and AGP. They have numerous TIR secondary outcome measurements in the clinical trial: ... You are correct. So why are they messing around with A1c and not making TIR the primary? It doesn't make sense. |
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Post by peppy on Nov 10, 2022 17:30:23 GMT -5
They have numerous TIR secondary outcome measurements in the clinical trial: ... You are correct. So why are they messing around with A1c and not making TIR the primary? It doesn't make sense. Probably because A1c is the Standard of care...... they have to? |
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Post by sayhey24 on Nov 10, 2022 18:40:32 GMT -5
They have numerous TIR secondary outcome measurements in the clinical trial: ... You are correct. So why are they messing around with A1c and not making TIR the primary? It doesn't make sense. Aged - did you extrapolate the numbers as I suggested? You ask why are they messing around with A1c and not making TIR the primary. When they use this study as one point of justification for the new URAI class with the ADA the obvious question will be what was the A1c change. Thats all some of these folks know. I will be surprised if the change is not only good but near great. We will see. The poster session was free but I had a conflict. I wonder if anyone on the board attended. |
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Post by oldfishtowner on Nov 11, 2022 6:59:27 GMT -5
You are correct. So why are they messing around with A1c and not making TIR the primary? It doesn't make sense. Aged - did you extrapolate the numbers as I suggested? You ask why are they messing around with A1c and not making TIR the primary. When they use this study as one point of justification for the new URAI class with the ADA the obvious question will be what was the A1c change. Thats all some of these folks know. I will be surprised if the change is not only good but near great. We will see. The poster session was free but I had a conflict. I wonder if anyone on the board attended. But how can you say that A1c is all some of these folks know, which is the point and also claim that the TIR data will make a difference? |
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Post by hellodolly on Nov 11, 2022 7:45:08 GMT -5
Technosphere® Insulin (TI) peaked 30 minutes faster and significantly reduced postprandial glucose excursions (PPGE) at 60 minutes compared to subcutaneous insulins The Afrezza with Basal Combination (ABC) Study demonstrated similar glucose control between the three treatment groups; MNKD will present data from two posters on November 10 during the 22nd Annual Diabetes Technology Meeting’s virtual poster session and will publish in 2023 TI peaked 30 minutes faster and significantly reduced glucose at 60 minutes compared to subcutaneous insulins – including recently approved versions. The mean PPGE at 60 minutes for TI measured 57.9 mg/dL compared to 101.4 mg/dL for subcutaneous insulins – a reduction of 43.5 mg/dL. investors.mannkindcorp.com/news-releases/news-release-details/mannkind-present-two-posters-22nd-annual-diabetes-technologyJesus, Joseph and Mary so many people twisted and bent out of shape, read the release from MNKD: “We are excited to present initial findings from the Afrezza with Basal Combination (ABC) proof-of-concept study, which demonstrated significantly improved postprandial glucose excursions with TI compared to subcutaneous insulin during an in-office meal challenge,” said Dr. Kevin Kaiserman, Vice President of Medical Affairs and Safety for MannKind’s Endocrine Business Unit. Thanks Sayhey for the post. In the mean time, everyone slow their roll and let the rest of the analysis become available after they submit this for publication. It's up to MC if he wants to release any further details on A1c, TIR, etc. Otherwise, enjoy the price action the last few days and we have something to look forward to when ALL the data is released at a later time. |
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Post by akemp3000 on Nov 11, 2022 8:13:03 GMT -5
Monitoring blood glucose throughout every day versus obtaining a three-month average will make a huge difference in managing diabetes. It's hard to imagine any debate. When compared to the giant healthcare industry, those talking about TIR currently exist in a very small bubble whereas A1c is common language discussed by everyone. TIR discussions seem to only appear alongside CGM discussions and educated message boards. Hopefully, new test results, articles, anecdotal stories, social media and certain drug companies can begin to change this though it will be slow and resisted by the diabetic drugs cartel. I'm not aware of any significant influencers promoting TIR be it people, drug companies or the ADA. CGM device companies are the exception as they're certainly trying to promote change but haven't yet won over the public at large. The challenge is how to speed up the shift and make TIR common knowledge and language. If and when this happens, Afrezza moves to the front of the line in discussion. Afrezza should also move to the front of the line following pediatric approval. All IMO.
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Post by sayhey24 on Nov 11, 2022 8:30:36 GMT -5
How can I say that A1c is all some of these folks know? How many are reading Proboards - Ha! We are discussing things 3 to 5 years before they become mainstream.
Maybe I should rephase the statement and say "want to know". The people at the ADA now know TIR because of CGMs but how many were talking CGMs and connected apps 5 years ago? I know when Mike first showed up 6 years ago and I told him CGMs and tech would save afrezza but without them it was doomed he thought I was nuts. My associate who was with me thought he just didn't understand what I was talking about. OK, maybe both.
The last thing BP wants to talk about especially in the T2 market with their antiglycemics is TIR and TAR. Then again this study used 70 - 180 mg/dL. Why are we still using 180mg/dl for TAR? Probably for the same reason these people are still using A1c as the gold standard.
Lets try a similar study with the SGLT1s, metformin and the GLP1s and see what we get but take Age's suggestion of making TIR the primary goal or better yet TAR.
Could you imagine if the ADA does make the new class URAI and makes that step 2 in the T2 SoC based on TAR first, then A1c? Heads at BP would start exploding.
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Post by stevil on Nov 11, 2022 9:38:44 GMT -5
If you guys want Afrezza to become the standard of care, this is MNKDs time to shine by proving superior long term outcomes and listing measurable improvements to comorbid conditions with better PPGE control. I know there is already data out there that shows benefit, but Afrezza has never been studied to this extent and there's never been a tool that can replicate the control Afrezza gives.
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Post by sayhey24 on Nov 11, 2022 9:58:30 GMT -5
Stevil - what you are asking for are 10 year studies. These studies are now starting and are now using CGMs and have gotten a ton of money from Covid. How plugged into the research community Mike is, IDK. I hope he is but I am not sure. With that said MNKD is not a research firm, we are a manufacturer.
For the time being we have decades of old studies which can be refactored which covered things like early insulin intervention and vascular degeneration above 140. We know the limitations these old studies had and if we properly account for the limitations we can get some pretty good bench studies.
In the mean time I think Mike is on the right track with the new class URAA. His words from the transcript - "We pivoted this year to focus on a subset of doctors as well as ultra-acting analog insulin, URAA. And so that market share, as you look amongst our key targets has continued to grow after years of decline and watching our competition continue to take attractive market share away from us that we believe they're reaching for a faster insulin and Afrezza should be the fastest in [ton] of choice. And with that refocus this year, we've continued to grow market share quarter-over-quarter, month-over-month."
There has been a lot of talk about the "URAA" class for years and it was being pushed by BP so I think the ADA is close. However, here comes MNKD and screws things up again. Then you got guys like me saying - Whoo what does the A stand for analog?" After thinking about it and the T2 market I like URAA as long as the A stands for "Agent" or "Antiglycemic". Now Mike has to make the URAA class happen and make this class top and center for T1s and step 2 for the T2 SoC.
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Post by mango on Nov 12, 2022 7:52:21 GMT -5
A1c is a proxy but is the dogma monopoly of the Insulin Cartel and they indeed do whatever they need to do to protect it from competition. They know Afrezza and CGMs are direct threats to their A1c hypothesis. A1c is a nice measurement, but it by no means should be the Gold Standard for assessing glucose homeostasis in today’s modern medical and scientific knowledge and technological advancements. TIR is the new Gold Standard.
All this push back by the experts and the monopoly controllers reminds me of how mainstream academic archeologists behave against all the new unearthed (pun intended) evidence disproving their human history theories. The mainstream archeologists are a small group of people who hold a monopoly on human history and are so reluctant and dead set on maintaining the currently flawed and outdated human history theories they hold dear and have worked their entire careers around.
This is what we are seeing with the current ADA SoC and A1c. The current theories of treating diabetes are being threatened by Afrezza and MannKind. Afrezza is the only insulin today that matches physiologic insulin and you don’t hear a damn thing about it from ADA. Afrezza could seize to exist tomorrow and ADA wouldn’t blink an eye. If you’re wondering as to why, the answer is simply money and power. MannKind is not a pay to play participant and Afrezza directly competes with the entire fundamental structure of the ADA SoC. There is companies who have built their entire diabetes enterprises around this SoC and ADA gets paid handsomely for maintaining and supporting it.
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