Cleveland Clinic in the Area of Type 1 Diabetes Described

[otherottawaguy]

Findings from Cleveland Clinic in the Area of Type 1 Diabetes Described (Understanding Inhaled Technosphere Insulin: Results of an Early Randomized Trial In Type 1 Diabetes Mellitus): Nutritional and Metabolic Diseases and Conditions - Type 1 Diabetes



Mon Sep 28 17:24:46 2020 EDT



2020 SEP 28 (NewsRx) -- By a News Reporter-Staff News Editor at Disease Prevention Daily -- Investigators publish new report on Nutritional and Metabolic Diseases and Conditions - Type 1 Diabetes. According to news reporting originating from Cleveland, Ohio, by NewsRx correspondents, research stated, “Technosphere Insulin (TI) is an inhaled insulin. Studies comparing TI with short-acting insulin analogues provide important insights on efficacy, dosing, and time course of action.”



Financial supporters for this research include MannKind Corporation, MannKind.



Our news editors obtained a quote from the research from Cleveland Clinic, “Planned enrollment of 230 subjects was limited to 138 due to premature study discontinuation. The primary efficacy endpoint was a noninferiority of glycosylated hemoglobin (HbA1c) of 0.4% for TI compared with insulin lispro (LIS) in a 16-week phase 3 randomized clinical trial in type 1 diabetes mellitus. HbA1c values were similar in the TI and LIS groups at the beginning of the trial (7.8% and 7.6%, respectively) and at trial endpoint (7.7% and 7.6%, respectively). Least squares mean changes from baseline were similar between study groups. Glucose values after a standard meal were significantly lower with TI in the first 90 minutes post meal compared with LIS. Mild or moderate hypoglycemia event rates were also significantly lower with TI compared with LIS (5.97 vs 8.01, respectively;P= .0269). Cough was the most commonly reported adverse event with TI. Pulmonary function as measured by forced expiratory volume in 1 second was not different between groups at baseline, 16 weeks, or 4 weeks off study drug. HbA1c was unchanged and overall glucose control was comparable between groups.”



According to the news editors, the research concluded: “Treatment with TI resulted in improved post-meal glucose and a lower risk of hypoglycemia compared with LIS.”



For more information on this research see: Understanding Inhaled Technosphere Insulin: Results of an Early Randomized Trial In Type 1 Diabetes Mellitus. Journal of Diabetes, 2020;():. Journal of Diabetes can be contacted at: Wiley, 111 River St, Hoboken 07030-5774, NJ, USA. (Wiley-Blackwell - www.wiley.com/; Journal of Diabetes - onlinelibrary.wiley.com/journal/10.1111/(ISSN)1753-0407)



The news editors report that additional information may be obtained by contacting Byron J. Hoogwerf, Cleveland Clinic, Endocrinol Diabet & Metab, Cleveland, OH 44106, United States. Additional authors for this research include Janet B. McGill, Daniel Weiss, Marshall Grant, Marisa C. Jones and David M. Kendall.



The direct object identifier (DOI) for that additional information is: doi.org/10.1111/1753-0407.13099. This DOI is a link to an online electronic document that is either free or for purchase, and can be your direct source for a journal article and its citation.



(Our reports deliver fact-based news of research and discoveries from around the world.)

[agedhippie]

This was the study - NCT00700622. It was terminated in 2014 because of the move from MedTone to DreamBoat inhaler. Interestingly the Cleveland Clinic was not involved in the trial.

[sayhey24]

Same old Same old - better PPG control, lower hypos, same A1c. The last I checked hypos are a big deal and so is stopping the spike. I see Kendall has his name on this.

Conclusions: HbA1c was unchanged and overall glucose control was comparable between groups. Treatment with TI resulted in improved post-meal glucose and a lower risk of hypoglycemia compared with LIS.

pubmed.ncbi.nlm.nih.gov/32737923/

[sayhey24]

In another thread Sports mentioned that Bill from VDex said - "We could do a study and report the results of the study. It would show dramatic HbA1c improvement AND no hypos, things the label doesn’t say or even imply. But as long as it’s true we’d be fine."

I would like to encourage Bill to do that study. These same old same old studies not optimally dosing afrezza show good results but not game changing results. With Bill's experience maybe he could do a game changing study.

[markado]

Sept 29, 2020 15:31:16 GMT -5 sayhey24 said:

In another thread Sports mentioned that Bill from VDex said - "We could do a study and report the results of the study. It would show dramatic HbA1c improvement AND no hypos, things the label doesn’t say or even imply. But as long as it’s true we’d be fine."

I would like to encourage Bill to do that study. These same old same old studies not optimally dosing afrezza show good results but not game changing results. With Bill's experience maybe he could do a game changing study.

I second that motion. How about this...start with a similar grooming if patients with A for one, and a top performing prandial for the other. Follow the "most suggestible / best protocol" for each for each set of patients, and see which yields better metrics. What you're looking for us best real world results regardless of medicine/solution offered. My money says, A wins - quite literally...I've got a tidy sum wrapped up in this stock with a bullish long-term view.

[agedhippie]

Sept 29, 2020 15:31:16 GMT -5 sayhey24 said:

In another thread Sports mentioned that Bill from VDex said - "We could do a study and report the results of the study. It would show dramatic HbA1c improvement AND no hypos, things the label doesn’t say or even imply. But as long as it’s true we’d be fine."

I would like to encourage Bill to do that study. These same old same old studies not optimally dosing afrezza show good results but not game changing results. With Bill's experience maybe he could do a game changing study.

That all costs money and I cannot see VDEX being able to afford to fund this, and for obvious reasons I doubt they will get help in that area from Mannkind.

[mytakeonit]

Maybe after double digit royalties kick in Tomorrow starts the last quarter of the year. And as Let It Ride says ... "Let's Go !!!"

But, that's mytakeonit

[sayhey24]

Sept 30, 2020 8:33:29 GMT -5 agedhippie said:

Sept 29, 2020 15:31:16 GMT -5 sayhey24 said:

In another thread Sports mentioned that Bill from VDex said - "We could do a study and report the results of the study. It would show dramatic HbA1c improvement AND no hypos, things the label doesn’t say or even imply. But as long as it’s true we’d be fine."

I would like to encourage Bill to do that study. These same old same old studies not optimally dosing afrezza show good results but not game changing results. With Bill's experience maybe he could do a game changing study.

That all costs money and I cannot see VDEX being able to afford to fund this, and for obvious reasons I doubt they will get help in that area from Mannkind.

Its about time VDex gets serious about this and gets some financing.  Virta Health has raised at least $80M selling the diabetes story by using a keto diet.  The VDex story crushes Virta's and if they can demonstrate game changing results with their study as Bill says they can - Boom.

[sportsrancho]

“Working on it.”

[agedhippie]

Sept 30, 2020 17:55:11 GMT -5 sayhey24 said:

Sept 30, 2020 8:33:29 GMT -5 agedhippie said:

That all costs money and I cannot see VDEX being able to afford to fund this, and for obvious reasons I doubt they will get help in that area from Mannkind.

Its about time VDex gets serious about this and gets some financing.  Virta Health has raised at least $80M selling the diabetes story by using a keto diet.  The VDex story crushes Virta's and if they can demonstrate game changing results with their study as Bill says they can - Boom.

Just to be clear, it is the pharma's (Mannkind in this case) job to improve the label by running trials. It's the clinic's (VDex) job to treat patients, not fund Mannkind's business development costs.

Right now there is only down side for VDEX in funding trials since they already have their protocol established and seem to be expanding steadily. My guess is with funding they could expand a lot faster, but they don't need new trials or studies to do that. On the other hand new trial data could drive wider adoption of Afrezza and with it competition for VDEX eroding their USP.

In a nutshell what can Mannkind offer VDEX in exchange?

[sayhey24]

Aged - IMO, the biggest help MNKD can provide VDex is to continue to manufacture afrezza. In the near term prior to their Series A funding completion, MNKD can provide VDex more, lots more free samples. Longer term I would expect VDex to buy direct at a significant discount under a formal agreement.

Long term, VDex can do more for MNKD than MNKD can do for VDex by completing a game changing study and by some means making afrezza the defacto SoC even as the ADA resists. VDex has a great deal more flexibility in bulldozing the diabetes community than MNKD has. I doubt a newly minted T2 has ever heard of the SoC. IMO I doubt many long time T2s have ever heard of it. Back in 2016 Matt Pfiefer said VDex was going to have 100 clinics in a year. I will offer to sweep the floor of one if they hit that number and I have one local to my area.

If VDex can provide a nationally known defacto solution which stops and in some cases reverses T2 diabetes I wouldn't mind owning some of their stock if and when they go public.

[sportsrancho]

Look I’ve heard this like six times now ( from others ) and I’ve kept my mouth shut ..but what Matt said that day was coming from Matt not Vdex. There was talks of nine clinics in New Jersey too.

We have the direct source here now to talk to ...so everything I have said and that I have said Bill has said is actually happening or has already happened.

[agedhippie]

Oct 1, 2020 11:04:48 GMT -5 sayhey24 said:

Aged - IMO, the biggest help MNKD can provide VDex is to continue to manufacture afrezza. In the near term prior to their Series A funding completion, MNKD can provide VDex more, lots more free samples. Longer term I would expect VDex to buy direct at a significant discount under a formal agreement.

Long term, VDex can do more for MNKD than MNKD can do for VDex by completing a game changing study and by some means making afrezza the defacto SoC even as the ADA resists. VDex has a great deal more flexibility in bulldozing the diabetes community than MNKD has. I doubt a newly minted T2 has ever heard of the SoC. IMO I doubt many long time T2s have ever heard of it. Back in 2016 Matt Pfiefer said VDex was going to have 100 clinics in a year. I will offer to sweep the floor of one if they hit that number and I have one local to my area.

If VDex can provide a nationally known defacto solution which stops and in some cases reverses T2 diabetes I wouldn't mind owning some of their stock if and when they go public.

My thought is that I cannot see what is in it for VDEX. VDEX has their own protocol which their staff apply so the SoC is irrelevant to them (there is a get out clause in the SoC that says the treatment should be tailored to the patient anyway). Nobody in VDEX needs to be convinced because the protocol is clear and if you are uncomfortable with that you don't join the staff. Arguably it is in VDEX interest not to change the SoC because right now nobody will get results approaching theirs, change the SoC or present a sufficiently compelling case and doctors will change and VDEX is no longer getting unique results.

Right now if I was VDEX I would not run a formal trial although I would collect metric internally to provide to insurers. I would want to get my new clinics rolled out and established. That make VDEX Mannkind's biggest writer by a long way. In doing that it ensures that Mannkind continues providing samples to VDEX as they do to everyone else (you don't try and cripple your biggest channel), and Afrezza revenue gets a hefty boost from the VDEX clinics. VDEX are confident in their protocol, they don't need the trial. More to the point, how does VDEX justify spending several million of their backers money on a move that will destroy their intellectual property, the protocol?

If I was Bill I would not lift a finger to help Mike. Mannkind will survive and Mannkind will keep on producing Afrezza. By not helping when he could have and, worse, by being publicly negative about VDEX Mike burnt that bridge. Now it will be on Mannkind to buy VDEX support somehow, Mike's head on a plate?

[sayhey24]

Oct 1, 2020 14:43:46 GMT -5 sportsrancho said:

Look I’ve heard this like six times now ( from others ) and I’ve kept my mouth shut ..but what Matt said that day was coming from Matt not Vdex. There was talks of nine clinics in New Jersey too.

We have the direct source here now to talk to ...so everything I have said and that I have said Bill has said is actually happening or has already happened.

Sports - I am not sure where Matt got his info but he put it on a slide and pitched it as truth.  The first clinic was originally suppose to be in NJ.  I am assuming and maybe incorrectly Bill had a partner at the time who had urgent care clinics.  At this point it really doesn't matter.

What matters is getting proper funding, expanding their Teledoc offering, getting a nice app like Nutrisense has, getting a first class digital marketing campaign and figuring out a billing model which does not rely on charging insurance for office visits.  Offices are nice but expensive.  Teaming with urgent  care centers is a fast way to physical space since they do not currently treat chronic issues.