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Post by sayhey24 on Nov 10, 2022 7:16:54 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-technology |
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Post by cppoly on Nov 10, 2022 8:49:18 GMT -5
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Post by cjm18 on Nov 10, 2022 8:57:54 GMT -5
Study demonstrated similar glucose control between the three treatment groups;
Isn’t that bad?
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Post by sayhey24 on Nov 10, 2022 9:34:02 GMT -5
Study demonstrated similar glucose control between the three treatment groups; Isn’t that bad? No - all three groups groups showed superior results - its a GREAT thing. In fact Mike has more ammo to get the URAI class created. He showed it as URAA on his slide but if the A stands for analog it needs to change. This would then lead to changes to the T1 SoC. Subjects will be randomized to one of three treatment groups (two Afrezza groups and one control group): Afrezza + AID: Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a continuous subcutaneous insulin infusion (CSII) pump with an automatic insulin delivery (AID) algorithm using rapid acting analogs (RAA) for their basal and correction insulin coverage. Afrezza + Insulin Degludec: Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage. AID Control: Subjects in this group will use a CSII pump with an AID algorithm using RAA for all bolus (mealtime and correction) and basal insulin coverage (control group). |
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Post by cjm18 on Nov 10, 2022 9:49:37 GMT -5
Study demonstrated similar glucose control between the three treatment groups; Isn’t that bad? No - all three groups groups showed superior results - its a GREAT thing. In fact Mike has more ammo to get the URRI class created. He showed it as URRA on his slide but if the A stands for analog it needs to change. This would then lead to changes to the T1 SoC. Subjects will be randomized to one of three treatment groups (two Afrezza groups and one control group): Afrezza + AID: Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a continuous subcutaneous insulin infusion (CSII) pump with an automatic insulin delivery (AID) algorithm using rapid acting analogs (RAA) for their basal and correction insulin coverage. Afrezza + Insulin Degludec: Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage. AID Control: Subjects in this group will use a CSII pump with an AID algorithm using RAA for all bolus (mealtime and correction) and basal insulin coverage (control group). Superior to what? |
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Post by sayhey24 on Nov 10, 2022 9:58:22 GMT -5
The other RAAs including fiasp and Lyumjev
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Post by celo on Nov 10, 2022 9:58:26 GMT -5
Glucose control was the same but time of onset was much faster.
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Post by agedhippie on Nov 10, 2022 10:02:05 GMT -5
Study demonstrated similar glucose control between the three treatment groups; Isn’t that bad? No - all three groups groups showed superior results - its a GREAT thing. In fact Mike has more ammo to get the URRI class created. He showed it as URRA on his slide but if the A stands for analog it needs to change. This would then lead to changes to the T1 SoC. ... The primary outcome measure was change in HbA1c and the press release makes no mention of that. The 60 minute level is interesting, but it's not even a secondary outcome measure. We need to see the study results. This is pretty PR is meaningless since there is no world in which Afrezza scores a higher 60 minute level than RAA, we already know that and have data for it! |
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Post by sayhey24 on Nov 10, 2022 10:24:11 GMT -5
No - all three groups groups showed superior results - its a GREAT thing. In fact Mike has more ammo to get the URRI class created. He showed it as URRA on his slide but if the A stands for analog it needs to change. This would then lead to changes to the T1 SoC. ... The primary outcome measure was change in HbA1c and the press release makes no mention of that. The 60 minute level is interesting, but it's not even a secondary outcome measure. We need to see the study results. This is pretty PR is meaningless since there is no world in which Afrezza scores a higher 60 minute level than RAA, we already know that and have data for it! OK - I was waiting for Debbie Downer. 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. If the baseline was 85mg/dl before the "meal" at 60 minutes the PWD would be at 142.9mg/dl vs 186.4mg/dl. For the time being you can extrapolated what the A1c might be but the job of the RAA is to get the PWD back to baseline and out of the system so we don't have hypos. The job of the basal is to maintain baseline. Now we have the URAI - a new class. I see the primary outcome is A1c but if we don't bring down the average BG (A1c) with a freaking pump once afrezza has done the heavy lifting- good grief. |
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Post by cjm18 on Nov 10, 2022 10:35:15 GMT -5
No - all three groups groups showed superior results - its a GREAT thing. In fact Mike has more ammo to get the URRI class created. He showed it as URRA on his slide but if the A stands for analog it needs to change. This would then lead to changes to the T1 SoC. ... The primary outcome measure was change in HbA1c and the press release makes no mention of that. The 60 minute level is interesting, but it's not even a secondary outcome measure. We need to see the study results. This is pretty PR is meaningless since there is no world in which Afrezza scores a higher 60 minute level than RAA, we already know that and have data for it! Red flag that A1c wasn’t mentioned. |
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Post by sayhey24 on Nov 10, 2022 10:37:44 GMT -5
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Post by oldfishtowner on Nov 10, 2022 11:07:22 GMT -5
The primary outcome measure was change in HbA1c and the press release makes no mention of that. The 60 minute level is interesting, but it's not even a secondary outcome measure. We need to see the study results. This is pretty PR is meaningless since there is no world in which Afrezza scores a higher 60 minute level than RAA, we already know that and have data for it! OK - I was waiting for Debbie Downer. 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. If the baseline was 85mg/dl before the "meal" at 60 minutes the PWD would be at 142.9mg/dl vs 186.4mg/dl. For the time being you can extrapolated what the A1c might be but the job of the RAA is to get the PWD back to baseline and out of the system so we don't have hypos. The job of the basal is to maintain baseline. Now we have the URAI - a new class. I see the primary outcome is A1c but if we don't bring down the average BG (A1c) with a freaking pump once afrezza has done the heavy lifting- good grief. Good grief, is right! But hasn't this been the crux of the problem with Afrezza all along?
In fact, the ABC study is just one more demonstration of the fact that has been well known for some time, that Afrezza provides superior meal time glucose control.
Will the ABC study make a difference? We can all hope so. But I am afraid that it is more likely that the story will not change.
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Post by sellhighdrinklow on Nov 10, 2022 11:25:02 GMT -5
How can it be, " similar glucose control" if Afrezza kept glucose levels from hitting UNHEALTHY levels? -- AKA, those w a healthy pancreas don't have glucose levels that reach the extreme level(s) implied.
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Post by sellhighdrinklow on Nov 10, 2022 11:33:24 GMT -5
Those with a fully functioning pancreas ( non diabetic) walk around w a blood glucose of 85-95 ( non fasting) and after a full meal their level may increase to 140+/- mg/dl . Therefore, this study proves your glucose level can remain in "normal range" using Afrezza if a diabetic starts at a "normal baseline" of 85-95.
The study results are pure gold. Final answer.
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Post by sayhey24 on Nov 10, 2022 11:37:04 GMT -5
OK - I was waiting for Debbie Downer. 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. If the baseline was 85mg/dl before the "meal" at 60 minutes the PWD would be at 142.9mg/dl vs 186.4mg/dl. For the time being you can extrapolated what the A1c might be but the job of the RAA is to get the PWD back to baseline and out of the system so we don't have hypos. The job of the basal is to maintain baseline. Now we have the URAI - a new class. I see the primary outcome is A1c but if we don't bring down the average BG (A1c) with a freaking pump once afrezza has done the heavy lifting- good grief. Good grief, is right! But hasn't this been the crux of the problem with Afrezza all along?
In fact, the ABC study is just one more demonstration of the fact that has been well known for some time, that Afrezza provides superior meal time glucose control.
Will the ABC study make a difference? We can all hope so. But I am afraid that it is more likely that the story will not change.
Yes, this seems like groundhog day but maybe not. I think the crux of the issue is a confluence of fiascos. Including that Affinty-1 showed non-inferiority but was significantly under dosed. Affinity-2 showed superiority but there was a concerted effort to conflated this study with the Affinity-1 results and have people believe this too was non-inferior. Mike is also a lot smarter now than he was 6 years ago and hopefully has figured out how to leverage todays results. Lets not kid ourselves the community still wants to kill afrezza and bankrupt MNKD but with growing income from UTHR its not going to happen. This study properly dosed afrezza and had outstanding results. That alone is a huge step forward. It will show A1c reduction but A1c is an average over 24hrs and then 3 months. Without seeing the AGPs and how fast after 60minutes the RAA got the BG down and then down to what its hard to say how much we will see in A1c change. During fasting periods like when sleeping the BG should be the same unless afrezza is creating a lower fasting baseline. Assuming its the same then we have maybe 12hours to effect. IMO without seeing the data the mealtime reduction is so significant we should see some pretty good superiority in A1c but we will have to see. |
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