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Post by myocat on Jan 20, 2022 10:50:12 GMT -5
The study enrolled first patient in October 4, 2021. Prelim read out could be available any day now.
INHALE-1 is a 26-week open-label, randomized clinical trial with a 26-week extension.
The primary endpoint is change in HbA1c level after 26 weeks. Secondary endpoints include change in fasting plasma glucose after 26 weeks and rate of hypoglycemic events.
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Post by Deleted on Jan 20, 2022 10:57:42 GMT -5
The study enrolled first patient in October 4, 2021. Prelim read out could be available any day now. INHALE-1 is a 26-week open-label, randomized clinical trial with a 26-week extension. The primary endpoint is change in HbA1c level after 26 weeks. Secondary endpoints include change in fasting plasma glucose after 26 weeks and rate of hypoglycemic events. The Pediatric Trial is more about the superiority of Afrezza vs RAA's than the efficacy and safety in Children. Now I know why it took so long to get it started. |
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Post by Clement on Jan 20, 2022 11:45:22 GMT -5
clinicaltrials.gov/ct2/show/NCT04974528?term=pediatric+mannkind&recrs=ab&cond=Diabetes&draw=2&rank=1INHALE-1 is a Phase 3, open-label, randomized clinical study evaluating the efficacy and safety of Afrezza in combination with a basal insulin (i.e., the Afrezza group) versus insulin aspart or insulin lispro in combination with a basal insulin (i.e., the RAA injection group) in pediatric subjects with type 1 or type 2 diabetes mellitus. Following 26 weeks of randomized treatment (i.e., Afrezza or RAA injection combined with a basal insulin), all subjects will enter a treatment extension where subjects will receive Afrezza until Week 52. The purpose of the treatment extension is to assess safety and efficacy with continued use of Afrezza. Outcome Measures Primary Outcome Measures : Change in HbA1c After 26 Weeks [ Time Frame: 26 weeks ] HbA1c change after 26 weeks of Afrezza compared to Rapid-Acting Analog (RAA) Secondary Outcome Measures : Change in Fasting Plasma Glucose (FPG) After 26 weeks [ Time Frame: 26 weeks ] FPG change after 26 weeks of Afrezza compared to Rapid-Acting Analog (RAA) Rate of Hypoglycemic Events After 26 weeks [ Time Frame: 26 weeks ] Event rate of hypoglycemia (SMBG <70 mg/dL) after 26 weeks of Afrezza compared to Rapid-Acting Analog (RAA). Other Outcome Measures: Time in Range (70 - 180 mg/dL) [ Time Frame: 26 weeks ] Time in Range after 26 weeks of Afrezza compared to Rapid-Acting Analog (RAA), based on continuous glucose monitoring derived glucose values. (and a lot more) . . .
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Post by mango on Jan 21, 2022 9:02:54 GMT -5
The study enrolled first patient in October 4, 2021. Prelim read out could be available any day now. INHALE-1 is a 26-week open-label, randomized clinical trial with a 26-week extension. The primary endpoint is change in HbA1c level after 26 weeks. Secondary endpoints include change in fasting plasma glucose after 26 weeks and rate of hypoglycemic events. The Pediatric Trial is more about the superiority of Afrezza vs RAA's than the efficacy and safety in Children. Now I know why it took so long to get it started. The Peds trial is not a superiority trial. It’s a non-inferiority trial. However, depending on the trial design superiority can still be demonstrated in a non-inferiority clinical trial. |
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Post by phdedieu12 on Jan 21, 2022 11:33:41 GMT -5
The Pediatric Trial is more about the superiority of Afrezza vs RAA's than the efficacy and safety in Children. Now I know why it took so long to get it started. The Peds trial is not a superiority trial. It’s a non-inferiority trial. However, depending on the trial design superiority can still be demonstrated in a non-inferiority clinical trial. This is precisely what is happening. There is no upside in a superiority trial if it fails, only bad consequences. However a non-inferiority trial can indeed prove superiority, and that's what we're shooting for. |
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Post by mango on Jan 21, 2022 11:42:05 GMT -5
The Peds trial is not a superiority trial. It’s a non-inferiority trial. However, depending on the trial design superiority can still be demonstrated in a non-inferiority clinical trial. This is precisely what is happening. There is no upside in a superiority trial if it fails, only bad consequences. However a non-inferiority trial can indeed prove superiority, and that's what we're shooting for. Are we though? It all depends on how the trial is designed and the methodology used to measure the data. |
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Post by cjm18 on Jan 21, 2022 12:59:26 GMT -5
This is precisely what is happening. There is no upside in a superiority trial if it fails, only bad consequences. However a non-inferiority trial can indeed prove superiority, and that's what we're shooting for. Are we though? It all depends on how the trial is designed and the methodology used to measure the data. Mc said it should prove superiority. |
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Post by mango on Jan 21, 2022 13:06:11 GMT -5
Are we though? It all depends on how the trial is designed and the methodology used to measure the data. Mc said it should prove superiority. Can you post a link to the transcript where he says that? |
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Post by cjm18 on Jan 21, 2022 13:27:01 GMT -5
Mc said it should prove superiority. Can you post a link to the transcript where he says that? Honestly I don’t know which call he said it. It wasn’t recent. If I can find it without too much searching I’ll post it. |
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Post by mango on Jan 21, 2022 14:36:34 GMT -5
Can you post a link to the transcript where he says that? Honestly I don’t know which call he said it. It wasn’t recent. If I can find it without too much searching I’ll post it. I searched “superior” and “superiority” in a handful of transcripts from last year and got nothing regarding the Peds trial. Was it this you were referring to? “And as we think about long-term disease, and you look back at insulin pumps, you look back at CGM, a lot of new innovation and technology was adopted in children, and then moves into adults. And that's really what we think about is how do we show in our new trial we're doing here, really strong clinical results in that head-to-head against multiple injections and how does that translate ultimately as these kids grow up into adults. Hopefully, we can show people that there's a way to have great sugar control and live your life at the same time.” |
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Post by beardawg on Jan 26, 2022 14:25:46 GMT -5
It seems even the CDC recognizes that time in range is important. Afrezza has shown to be superior in that metric. Shouldn't that be the standard then? : A1C: Just Part of the ToolkitA1C is an important tool for managing diabetes, but it doesn’t replace regular blood sugar testing at home. Blood sugar goes up and down throughout the day and night, which isn’t captured by your A1C. Two people can have the same A1C, one with steady blood sugar levels and the other with high and low swings.
If you’re reaching your A1C goal but having symptoms of highs or lows, check your blood sugar more often and at different times of day. Keep track and share the results with your doctor so you can make changes to your treatment plan if needed. Source: www.cdc.gov/diabetes/managing/managing-blood-sugar/a1c.html#:~:text=A%20normal%20A1C%20level%20is,for%20developing%20type%202%20diabetes. |
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Post by sayhey24 on Jan 26, 2022 15:07:24 GMT -5
It seems even the CDC recognizes that time in range is important. Afrezza has shown to be superior in that metric. Shouldn't that be the standard then? : A1C: Just Part of the ToolkitA1C is an important tool for managing diabetes, but it doesn’t replace regular blood sugar testing at home. Blood sugar goes up and down throughout the day and night, which isn’t captured by your A1C. Two people can have the same A1C, one with steady blood sugar levels and the other with high and low swings.
If you’re reaching your A1C goal but having symptoms of highs or lows, check your blood sugar more often and at different times of day. Keep track and share the results with your doctor so you can make changes to your treatment plan if needed. Source: www.cdc.gov/diabetes/managing/managing-blood-sugar/a1c.html#:~:text=A%20normal%20A1C%20level%20is,for%20developing%20type%202%20diabetes. Shouldn't that be the standard then? - NO! Think of the disruption this would cause to the BP industry and the B$$$ of lost money to BP if afrezza became the T1 and T2 SoC. BP will do everything possible to stop this and that includes keeping A1C around. The T2 antiglycemics only make sense when measuring A1C. They are not about stopping the post meal spike and keeping the PWD in range. Every TV commercial talks A1C. Does it make clinical sense - NO! The discussion around afrezza is not whether or not its a better mouse trap. In the treatment of T2s there is nothing close. Give them afrezza day 1 and the PWD will have the best chance of stopping progression with little fear of severe hypoglycemia. The entire ADA step program gets thrown in the trash if afrezza is the standard. The only way for an RAA to even compete with afrezza in a T1 for TIR is to add in the sleeping hours of the day when afrezza is already out of the system. When looking at TIR only during hours where the T1 is awake and afrezza is properly dosed the RAAs have zero chance of competing. A1c and the current SoC are going no where until Mike can partner with someone who can totally disrupt this industry. BP does not want either to change. |
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Post by lennymnkd on Jan 26, 2022 16:57:13 GMT -5
I don’t doubt what your saying about BP being in the picture and having a negative effect.
But you would think at this point if they truly were so concerned after all this time, wouldn’t you think
Some sort of deal would have already been put together. And at such a great value at this time
🤔 or has it !
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Post by peppy on Jan 26, 2022 17:07:02 GMT -5
I don’t doubt what your saying about BP being in the picture and having a negative effect. But you would think at this point if they truly were so concerned after all this time, wouldn’t you think Some sort of deal would have already been put together. And at such a great value at this time The way I see it, the dream boat delivery is an IV into the vascular. It has been developed. It allows for alveolar delivery. Mannkind is experiencing a pandemic, a respiratory pandemic. The UTHR deal put together, UTHR needs Alveolar delivery. UTHR market cap is 8.9 billion and it is steady. I think there will be more deals. Tick-tock. We will see. added, afrezza, we may be on our own |
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Post by prcgorman2 on Jan 26, 2022 21:24:13 GMT -5
I don’t doubt what your saying about BP being in the picture and having a negative effect. But you would think at this point if they truly were so concerned after all this time, wouldn’t you think Some sort of deal would have already been put together. And at such a great value at this time 🤔 or has it ! It’s an interesting question. The RAA folks know very well what it takes to be able to prove there should be a change in the SoC and they have fat wallets which can afford fat rebates to PBMs to buy Tier 1 insurance coverage. I don’t think they’re afraid. I think they’re like, “Bring it on! Let’s see what you can do little Mannkind!”. I just hope they’re like the rail barons who paid little attention to the horseless carriage. |
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