Just an observation

[bones1026]

I see that Kevinmik has posted Dexcom trial abstracts on Stocktwits more than an hour ago. Pretty big deal. Not a peep about it over here, bc nobody posts here anymore. I know some have changed their tune on management, but what am I missing?

[longliner]

Jun 9, 2020 22:05:36 GMT -5 bones1026 said:

I see that Kevinmik has posted Dexcom trial abstracts on Stocktwits more than an hour ago. Pretty big deal. Not a peep about it over here, bc nobody posts here anymore. I know some have changed their tune on management, but what am I missing?

We are in the waiting place. It's a big week.

[sellhighdrinklow]

Jun 9, 2020 23:01:52 GMT -5 longliner said:

Jun 9, 2020 22:05:36 GMT -5 bones1026 said:

I see that Kevinmik has posted Dexcom trial abstracts on Stocktwits more than an hour ago. Pretty big deal. Not a peep about it over here, bc nobody posts here anymore. I know some have changed their tune on management, but what am I missing?

We are in the waiting place. It's a big week.

The data will be huge imho

[peppy]

Jun 9, 2020 22:05:36 GMT -5 bones1026 said:

I see that Kevinmik has posted Dexcom trial abstracts on Stocktwits more than an hour ago. Pretty big deal. Not a peep about it over here, bc nobody posts here anymore. I know some have changed their tune on management, but what am I missing?

bones, sports, all, please post the trial abstracts here.
thanks.

copy and paste.

[matt]

Abstract is here: diabetes.diabetesjournals.org/content/69/Supplement_1/990-P


Summary:  The study failed to achieve its primary endpoint of significant increase of time spent in glycemic goal range.  Other benefits were seen as detailed further in the abstract.



In other news: diabetes.diabetesjournals.org/content/69/Supplement_1/1023-P

Summary: Dosing with Afrezza was compared to injectable prandial insulin and found that to achieve the same glycemic control it takes 1.3 to 2.5 times as many units of Afrezza to get the same result as injectable insulins.  This is not news to anybody who follows MNKD, but it does have cost of therapy implications if an insurer is comparing the cost of administering 10 units of injectable to the cost of administering 20 units of Afrezza.

[hellodolly]

Although this interim analysis did not achieve its primary endpoint of significant increase of time spent in glycemic goal range, possibly caused by patients not self-adjusting post-prandial dosing as instructed. Patients treated with inhaled insulin with background basal insulin for 14 weeks experienced significant reduction of A1c and significant improvements of Useful, Freeing, and Difficult QoL subdomains compared to baseline.

EDIT:  Source: diabetes.diabetesjournals.org/content/69/Supplement_1/990-P

[cppoly]

Jun 10, 2020 7:52:25 GMT -5 matt said:

Abstract is here: diabetes.diabetesjournals.org/content/69/Supplement_1/990-P


Summary:  The study failed to achieve its primary endpoint of significant increase of time spent in glycemic goal range.  Other benefits were seen as detailed further in the abstract.



In other news: diabetes.diabetesjournals.org/content/69/Supplement_1/1023-P

Summary: Dosing with Afrezza was compared to injectable prandial insulin and found that to achieve the same glycemic control it takes 1.3 to 2.5 times as many units of Afrezza to get the same result as injectable insulins.  This is not news to anybody who follows MNKD, but it does have cost of therapy implications if an insurer is comparing the cost of administering 10 units of injectable to the cost of administering 20 units of Afrezza.


"Patients treated with inhaled insulin with background basal insulin for 14 weeks experienced significant reduction of A1c and significant improvements of Useful, Freeing, and Difficult QoL subdomains compared to baseline".

[hellodolly]

Conclusion: The current analyses across 4 unique studies support the titration of individual patients to TI doses that are approximately 1.3 - 2.5x those of their comparable SC analog insulin doses. These data show that greater “unit doses” of TI should be used to achieve glycemic control in T1D and thus, insulins should be dosed based on glycemic responses rather than “insulin units.”

Source: diabetes.diabetesjournals.org/content/69/Supplement_1/1023-P

[barnstormer]

Jun 10, 2020 8:01:32 GMT -5 cppoly said:

Jun 10, 2020 7:52:25 GMT -5 matt said:

Abstract is here: diabetes.diabetesjournals.org/content/69/Supplement_1/990-P


Summary:  The study failed to achieve its primary endpoint of significant increase of time spent in glycemic goal range.  Other benefits were seen as detailed further in the abstract.



In other news: diabetes.diabetesjournals.org/content/69/Supplement_1/1023-P

Summary: Dosing with Afrezza was compared to injectable prandial insulin and found that to achieve the same glycemic control it takes 1.3 to 2.5 times as many units of Afrezza to get the same result as injectable insulins.  This is not news to anybody who follows MNKD, but it does have cost of therapy implications if an insurer is comparing the cost of administering 10 units of injectable to the cost of administering 20 units of Afrezza.


"Patients treated with inhaled insulin with background basal insulin for 14 weeks experienced significant reduction of A1c and significant improvements of Useful, Freeing, and Difficult QoL subdomains compared to baseline".

[barnstormer]

If only the insurance companys cared about patients quality of life.

[agedhippie]

Jun 10, 2020 8:01:34 GMT -5 hellodolly said:

Conclusion: The current analyses across 4 unique studies support the titration of individual patients to TI doses that are approximately 1.3 - 2.5x those of their comparable SC analog insulin doses. These data show that greater “unit doses” of TI should be used to achieve glycemic control in T1D and thus, insulins should be dosed based on glycemic responses rather than “insulin units.”

Source: diabetes.diabetesjournals.org/content/69/Supplement_1/1023-P

This second poster is the important poster of the two. It is the beginning of the work to get dosing on the label changed which in turn will deliver better results to the patient and make Afrezza a better choice.

[agedhippie]

Jun 10, 2020 8:01:32 GMT -5 cppoly said:

Jun 10, 2020 7:52:25 GMT -5 matt said:

Abstract is here: diabetes.diabetesjournals.org/content/69/Supplement_1/990-P


Summary:  The study failed to achieve its primary endpoint of significant increase of time spent in glycemic goal range.  Other benefits were seen as detailed further in the abstract.



In other news: diabetes.diabetesjournals.org/content/69/Supplement_1/1023-P

Summary: Dosing with Afrezza was compared to injectable prandial insulin and found that to achieve the same glycemic control it takes 1.3 to 2.5 times as many units of Afrezza to get the same result as injectable insulins.  This is not news to anybody who follows MNKD, but it does have cost of therapy implications if an insurer is comparing the cost of administering 10 units of injectable to the cost of administering 20 units of Afrezza.

"Patients treated with inhaled insulin with background basal insulin for 14 weeks experienced significant reduction of A1c and significant improvements of Useful, Freeing, and Difficult QoL subdomains compared to baseline".

That was not the primary target. The aim was to prove that Afrezza improved TIR and the study failed at that. The A1c evidence will get disregarded for two reasons; it was not the focus of the trial, and it runs counter to trials that have an order of magnitude more participants that say it is not better. In a clash like that the bigger trial always wins. That poster is a washout. The second poster is far more significant.

[matt]

Jun 10, 2020 9:21:30 GMT -5 agedhippie said:

Jun 10, 2020 8:01:34 GMT -5 hellodolly said:

Conclusion: The current analyses across 4 unique studies support the titration of individual patients to TI doses that are approximately 1.3 - 2.5x those of their comparable SC analog insulin doses. These data show that greater “unit doses” of TI should be used to achieve glycemic control in T1D and thus, insulins should be dosed based on glycemic responses rather than “insulin units.”

Source: diabetes.diabetesjournals.org/content/69/Supplement_1/1023-P

This second poster is the important poster of the two. It is the beginning of the work to get dosing on the label changed which in turn will deliver better results to the patient and make Afrezza a better choice.

I agree that getting the label changed is important to delivering efficacy.  Will MNKD deliver more units for the same price, or will there be a comparable increase in pricing?  Given that Afrezza is already the most expensive option in the market, bumping the price by any significant amount will be counterproductive.  Which begs the question of what is the true incremental cost of Afrezza in various dosage forms.  I would think that the cost of the insulin and FDKP particles would have to increase proportionately, but the other costs (inhaler, cartridge, packaging, overhead) could stay approximately the same.

[Deleted]

Jun 10, 2020 9:31:24 GMT -5 matt said:

Jun 10, 2020 9:21:30 GMT -5 agedhippie said:

This second poster is the important poster of the two. It is the beginning of the work to get dosing on the label changed which in turn will deliver better results to the patient and make Afrezza a better choice.

I agree that getting the label changed is important to delivering efficacy.  Will MNKD deliver more units for the same price, or will there be a comparable increase in pricing?  Given that Afrezza is already the most expensive option in the market, bumping the price by any significant amount will be counterproductive.  Which begs the question of what is the true incremental cost of Afrezza in various dosage forms.  I would think that the cost of the insulin and FDKP particles would have to increase proportionately, but the other costs (inhaler, cartridge, packaging, overhead) could stay approximately the same.

I think MNKD missed the boat.  They should have labeled the cartridges Small, Medium, Large and maybe an XL down the road?  This would make the diabetics avoid comparing units and the anxiety of over dosing.

[bill]

Jun 10, 2020 10:17:08 GMT -5 @chuckbass said:

Jun 10, 2020 9:31:24 GMT -5 matt said:

I agree that getting the label changed is important to delivering efficacy.  Will MNKD deliver more units for the same price, or will there be a comparable increase in pricing?  Given that Afrezza is already the most expensive option in the market, bumping the price by any significant amount will be counterproductive.  Which begs the question of what is the true incremental cost of Afrezza in various dosage forms.  I would think that the cost of the insulin and FDKP particles would have to increase proportionately, but the other costs (inhaler, cartridge, packaging, overhead) could stay approximately the same.

I think MNKD missed the boat.  They should have labeled the cartridges Small, Medium, Large and maybe an XL down the road?  This would make the diabetics avoid comparing units and the anxiety of over dosing.

I'd be surprised if those type of cartridge labels weren't considered. Like many things I suspect there were advantages / disadvantages of doing it either way.