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Post by dh4mizzou on Jul 28, 2021 9:43:55 GMT -5
So in having folks in the RAA group for the first 26 weeks will allow Afrezza to show superiority and having them to switch to Afrezza after week 26 will show what?
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Post by peppy on Jul 28, 2021 9:50:35 GMT -5
So in having folks in the RAA group for the first 26 weeks will allow Afrezza to show superiority and having them to switch to Afrezza after week 26 will show what? Am I wrong? The study is done after 6 months, the additional 6 months Of Afrezza is the reward? Sounds like a reward.  Damn that randomization. "This is a six month trial with an optional six month extension for Afrezza. The monitoring will come down to the parents although there will be periodic check-ins so I wouldn't bet to heavily on consistent follow up dosing. However, everyone has been on MDI so they should be familiar with the concept of corrections. Brief Summary: INHALE-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. It looks to me like everyone will go for a full 52 weeks with the RAA switching over at week 26. I think this will be a great trial within a trial." |
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Post by wsulylecoug on Jul 28, 2021 10:21:52 GMT -5
So in having folks in the RAA group for the first 26 weeks will allow Afrezza to show superiority and having them to switch to Afrezza after week 26 will show what? From my perspective, randomization can't take into consideration the human factor. As much as a defined protocol tries to put everybody within a trial on a level playing field, every person is different and possibly even more so when it comes to individualized treatment of diabetes within a pediatric group of ages 5-17. There will be some participants that will probably be making insulin treatment decisions on their own, some having decisions made exclusively by their parents and others making joint decisions. By having the exact same group of participants go from RAA to Afrezza for an additional 26 weeks might minimize the influence of the human factor that might be present for the first 26 weeks. Maybe...maybe not, but I'll be interested to see a comparison of the results for the first 26 weeks when comparing two different groups of people and the following 26 weeks when comparing the RAA group of people to themselves with a different treatment. |
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Post by agedhippie on Jul 28, 2021 11:42:50 GMT -5
So in having folks in the RAA group for the first 26 weeks will allow Afrezza to show superiority and having them to switch to Afrezza after week 26 will show what? From my perspective, randomization can't take into consideration the human factor. As much as a defined protocol tries to put everybody within a trial on a level playing field, every person is different and possibly even more so when it comes to individualized treatment of diabetes within a pediatric group of ages 5-17. There will be some participants that will probably be making insulin treatment decisions on their own, some having decisions made exclusively by their parents and others making joint decisions. By having the exact same group of participants go from RAA to Afrezza for an additional 26 weeks might minimize the influence of the human factor that might be present for the first 26 weeks. Maybe...maybe not, but I'll be interested to see a comparison of the results for the first 26 weeks when comparing two different groups of people and the following 26 weeks when comparing the RAA group of people to themselves with a different treatment. This is pretty much correct. The primary and secondary outcomes are finished at week 26 and those are the headline results. Beyond that they want to swap the RAA group over to Afrezza and there are several outcomes they want to measure (outcomes 7 through 12). These are around changes in the RAA group now they are on Afrezza using the Afrezza group as the control now (7,8 & 9- change in HbA1c), and the rest ore looking for bad events. The 52 week extension is contained entirely within the Other Outcome Measures section which is where the sponsor puts stuff they would like to be able to talk about in publications. This tells you what Mannkind will want to publish after this trial. |
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Post by sr71 on Jul 28, 2021 11:49:16 GMT -5
So in having folks in the RAA group for the first 26 weeks will allow Afrezza to show superiority and having them to switch to Afrezza after week 26 will show what? From my perspective, randomization can't take into consideration the human factor. As much as a defined protocol tries to put everybody within a trial on a level playing field, every person is different and possibly even more so when it comes to individualized treatment of diabetes within a pediatric group of ages 5-17. There will be some participants that will probably be making insulin treatment decisions on their own, some having decisions made exclusively by their parents and others making joint decisions. By having the exact same group of participants go from RAA to Afrezza for an additional 26 weeks might minimize the influence of the human factor that might be present for the first 26 weeks. Maybe...maybe not, but I'll be interested to see a comparison of the results for the first 26 weeks when comparing two different groups of people and the following 26 weeks when comparing the RAA group of people to themselves with a different treatment. This is what VDEX has been saying and doing for a few years now. About time Mannkind finally gets with the times with this FDA-accepted study design. |
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Post by cretin11 on Jul 28, 2021 16:02:32 GMT -5
From my perspective, randomization can't take into consideration the human factor. As much as a defined protocol tries to put everybody within a trial on a level playing field, every person is different and possibly even more so when it comes to individualized treatment of diabetes within a pediatric group of ages 5-17. There will be some participants that will probably be making insulin treatment decisions on their own, some having decisions made exclusively by their parents and others making joint decisions. By having the exact same group of participants go from RAA to Afrezza for an additional 26 weeks might minimize the influence of the human factor that might be present for the first 26 weeks. Maybe...maybe not, but I'll be interested to see a comparison of the results for the first 26 weeks when comparing two different groups of people and the following 26 weeks when comparing the RAA group of people to themselves with a different treatment. This is what VDEX has been saying and doing for a few years now. About time Mannkind finally gets with the times with this FDA-accepted study design. It took them a few years, but better late than never. |
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Damn that randomization. 
