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Post by agedhippie on Mar 24, 2018 20:54:32 GMT -5
The studies were "lost". Sent from Paramus when it was shut down to Danbury in boxes. Mike had no idea they existed. The lung safety study is an interesting one. It came out of a Adcom discussion which focused on Exubera. Pfizer did great job of FUD. It would be nice if Dr. Kendall could get rid of the study just to reduce cost. From a practical matter people have been using afrezza for about 9 years now with no issues. For bragging rights it would be good to do the study as current users are reporting no issues and some say they have not been this healthy in years. The lung safety study is a requirement from the approval so it is very unlikely to go away. The fact that a few people have been using Afrezza for 9 years is not a good sample statistically. The FDA want " a 5-year, randomized, controlled trial in 8,000-10,000 patients with type 2 diabetes". Since the trial has to be completed by April 2023 it is going to need to start very soon unless there is an extension (which I seem to dimly remember happening). |
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Post by sportsrancho on Mar 24, 2018 20:56:33 GMT -5
Brotherm1 .....Thank you that’s amazingly generous:-)
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Post by boca1girl on Mar 25, 2018 10:18:01 GMT -5
The studies were "lost". Sent from Paramus when it was shut down to Danbury in boxes. Mike had no idea they existed. The lung safety study is an interesting one. It came out of a Adcom discussion which focused on Exubera. Pfizer did great job of FUD. It would be nice if Dr. Kendall could get rid of the study just to reduce cost. From a practical matter people have been using afrezza for about 9 years now with no issues. For bragging rights it would be good to do the study as current users are reporting no issues and some say they have not been this healthy in years. I said previous managent (prior to Mike becoming CEO). Maybe Matt could get a pass too since he was the CFO, but Haken and the previous CMO’s? What excuse would they use? |
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Post by goyocafe on Mar 25, 2018 10:50:54 GMT -5
What kind of study would it take to change the standard of care to recommend prandial insulin, specifically Afrezza, as first line, single therapy over metformin? Is it possible it’s among the lost studies? Can Dr. Kendall sell the case?
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Post by mnholdem on Mar 25, 2018 11:16:16 GMT -5
I think that it would take something like this study, with a few caveats:
- It would be a major study using Afrezza, funded by the Gates Foundation or other benefactors;
- It would have to be widely published or, at least, in the major medical journals, and;
- There would have to be an ADA/AACE that is not influenced by giant pharmaceutical companies to down-play the results.
Early Short-term Intensive Insulin Causes the Remission of Type 2 Diabetes
September 10th, 2016
Source: www.diabetesincontrol.com/early-short-term-intensive-insulin-causes-the-remission-of-type-2-diabetes/
Excerpts:
In early type 2 diabetes (T2DM), short-term intensive insulin therapy (IIT) for 2-4 weeks can decrease insulin resistance, reduce glucagonemia, improve β-cell function, and even induce a remission of diabetes that can last up to one year in some patients.
Data was evaluated from the placebo arm of a double-blind randomized controlled trial in which patients with early T2DM (≤7 years duration) underwent 4 weeks of IIT (basal detemir, bolus aspart), followed by placebo therapy for 48 weeks (n=25). Participants underwent an oral glucose tolerance test every 12 weeks, enabling serial assessment of insulin sensitivity, α-cell response, and β-cell function. Diabetes remission was defined as A1c<6.5% on no medication for T2DM.
For the study design, data from the placebo arm of the double-blind randomized controlled trial in which 25 patients within 7 y of T2D diagnosis received 4 weeks of intensive basal/bolus insulin therapy followed by placebo for 48 wk. An oral glucose tolerance test (OGTT) every 12 weeks used to assess insulin sensitivity and beta-cell function. Then diabetes remission was defined as HbA1c <6.5% with no T2D medications.
The results showed that at 48 weeks after stopping intensive insulin, 14 participants (56%) were in diabetes remission. At baseline, the remission group had shorter duration of diabetes (1.2 vs 2.6 y; p=.03), lower A1c (6.2% vs 7.1%, p=.006), and better β-cell function.
The 2 groups did not differ in clinical characteristics such as age, gender, ethnicity, pre-study diabetes treatment, body mass index, waist circumference, blood pressure, liver enzymes, or insulin sensitivity.
Then, in logistic regression analyses, shorter duration of diabetes supplanted baseline A1c (p=.24) and β-cell function (p=.19) as an independent predictor of remission at 48 weeks (OR, 0.22; 95% CI 0.05-0.92; p=.04)
At 48 weeks post-IIT, 56% of the participants remained in remission. Comparison of remitters to non-remitters revealed no differences in waist, body mass index, insulin sensitivity (Matsuda index), or glucagon profile, either at baseline or over 48 weeks. Compared to non-remitters, the remission group had lower baseline A1c (p=0.006) and better baseline β-cell function
The key determinant of the likelihood of inducing sustained drug-free diabetes remission with short-term IIT is early intervention, particularly within the first 2 years after diagnosis. And reversing or delaying type 2 diabetes may help prevent morbidity and reduce healthcare costs.
Read more: mnkd.proboards.com/thread/3407/blood-sugar-101-tell-diabetes#ixzz5AmHOB6zV
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Post by akemp3000 on Mar 25, 2018 11:16:51 GMT -5
What kind of study would it take to change the standard of care to recommend prandial insulin, specifically Afrezza, as first line, single therapy over metformin? Is it possible it’s among the lost studies? Can Dr. Kendall sell the case? Good question regarding the necessary protocol. Seeing as how Dr. Kendall was the Chief Scientific Medical Officer for the American Diabetes Association, he likely knows the answer and is hopefully planning the best path. In the mean time, an article or even a letter-to-the-editor by him would certainly help advance this idea. Without directly promoting Afrezza, he could challenge the science and effectiveness of the current standards of care and then introduce the science for what should be happening...which just happens to be what Afrezza offers. |
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Post by agedhippie on Mar 25, 2018 13:23:10 GMT -5
What kind of study would it take to change the standard of care to recommend prandial insulin, specifically Afrezza, as first line, single therapy over metformin? Is it possible it’s among the lost studies? Can Dr. Kendall sell the case? Good question regarding the necessary protocol. Seeing as how Dr. Kendall was the Chief Scientific Medical Officer for the American Diabetes Association, he likely knows the answer and is hopefully planning the best path. In the mean time, an article or even a letter-to-the-editor by him would certainly help advance this idea. Without directly promoting Afrezza, he could challenge the science and effectiveness of the current standards of care and then introduce the science for what should be happening...which just happens to be what Afrezza offers. Devising protocols and trials should be Dr Kendell's strong point since that was part of his job at Eli Lilly. I would not overestimate his influence medically though. His work at the ADA and Eli Lilly was not performing research but rather administration. He does have a solid background as an endo before that though. Since he is now working as CMO for Mannkind nobody is going to see him as unbiased! |
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Post by goyocafe on Mar 25, 2018 14:04:42 GMT -5
Good question regarding the necessary protocol. Seeing as how Dr. Kendall was the Chief Scientific Medical Officer for the American Diabetes Association, he likely knows the answer and is hopefully planning the best path. In the mean time, an article or even a letter-to-the-editor by him would certainly help advance this idea. Without directly promoting Afrezza, he could challenge the science and effectiveness of the current standards of care and then introduce the science for what should be happening...which just happens to be what Afrezza offers. Devising protocols and trials should be Dr Kendell's strong point since that was part of his job at Eli Lilly. I would not overestimate his influence medically though. His work at the ADA and Eli Lilly was not performing research but rather administration. He does have a solid background as an endo before that though. Since he is now working as CMO for Mannkind nobody is going to see him as unbiased! You mean a biased CMO talking to a biased ADA doesn't have a certain irony to it? |
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Post by sayhey24 on Mar 25, 2018 15:36:24 GMT -5
What kind of study would it take to change the standard of care to recommend prandial insulin, specifically Afrezza, as first line, single therapy over metformin? Is it possible it’s among the lost studies? Can Dr. Kendall sell the case? The 118 is a good start. Its been known for a very long time the best way to treat T2s is with early insulin intervention. The issue has always been the concern about Hypos and needles. The 118 demonstrated that afrezza put the liver back in sync by blocking the alpha cells and then getting out fast so the liver can prevent the low. If you have an insulin which requires no needles and does not present a hypo risk and works as fast as afrezza you have the holy grail of diabetes care. I think Hilliard's doctor experienced it first hand an could not believe what he saw. Why should he? Few believe its real. |
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Post by golfeveryday on Mar 25, 2018 16:42:15 GMT -5
What kind of study would it take to change the standard of care to recommend prandial insulin, specifically Afrezza, as first line, single therapy over metformin? Is it possible it’s among the lost studies? Can Dr. Kendall sell the case? The 118 is a good start. Its been known for a very long time the best way to treat T2s is with early insulin intervention. The issue has always been the concern about Hypos and needles. The 118 demonstrated that afrezza put the liver back in sync by blocking the alpha cells and then getting out fast so the liver can prevent the low. If you have an insulin which requires no needles and does not present a hypo risk and works as fast as afrezza you have the holy grail of diabetes care. I think Hilliard's doctor experienced it first hand an could not believe what he saw. Why should he? Few believe its real. glad people are beginning to realize what Afrezza offers. |
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Post by mnholdem on Mar 25, 2018 20:43:53 GMT -5
Devising protocols and trials should be Dr Kendell's strong point since that was part of his job at Eli Lilly. I would not overestimate his influence medically though. His work at the ADA and Eli Lilly was not performing research but rather administration. He does have a solid background as an endo before that though. Since he is now working as CMO for Mannkind nobody is going to see him as unbiased! You mean a biased CMO talking to a biased ADA doesn't have a certain irony to it? Actually it has a certain appeal to it, since David probably knows which closets where the ADA may have some skeletons hidden.  |
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Post by cedafuntennis on Mar 25, 2018 21:30:43 GMT -5
The studies were "lost". Sent from Paramus when it was shut down to Danbury in boxes. Mike had no idea they existed. The lung safety study is an interesting one. It came out of a Adcom discussion which focused on Exubera. Pfizer did great job of FUD. It would be nice if Dr. Kendall could get rid of the study just to reduce cost. From a practical matter people have been using afrezza for about 9 years now with no issues. For bragging rights it would be good to do the study as current users are reporting no issues and some say they have not been this healthy in years. I said previous managent (prior to Mike becoming CEO). Maybe Matt could get a pass too since he was the CFO, but Haken and the previous CMO’s? What excuse would they use? Incompetence and stupidity seem to pass muster every day in American Courts so why not for Hakan and Matt? |
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Post by mnholdem on Mar 25, 2018 21:40:57 GMT -5
The 118 is a good start. Its been known for a very long time the best way to treat T2s is with early insulin intervention. The issue has always been the concern about Hypos and needles. The 118 demonstrated that afrezza put the liver back in sync by blocking the alpha cells and then getting out fast so the liver can prevent the low. If you have an insulin which requires no needles and does not present a hypo risk and works as fast as afrezza you have the holy grail of diabetes care. I think Hilliard's doctor experienced it first hand an could not believe what he saw. Why should he? Few believe its real. glad people are beginning to realize what Afrezza offers. Michael Castagna (4Q17 earnings call): The only thing limiting our growth is our lack of execution on the plans that we're rolling out today. And finally, we focus energy on 2017 on a switch, multi-daily injection market, but because we got the product back from Sanofi, we had fix several critical things around packaging, sampling, managed care et cetera.
We're now through all those things and as you'll hear from Pat, we're looking forward to positioning the product in the earlier lines of treatment, because of the change we made especially with the payers in the type 2 market.
In the first half of this year, our focus will be moving up to help people in early lines of treatment and in second half of this year, once our STAT results are public we'll really focus on the type 1 market.
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Post by goyocafe on Mar 25, 2018 23:18:58 GMT -5
glad people are beginning to realize what Afrezza offers. Michael Castagna (4Q17 earnings call): The only thing limiting our growth is our lack of execution on the plans that we're rolling out today. And finally, we focus energy on 2017 on a switch, multi-daily injection market, but because we got the product back from Sanofi, we had fix several critical things around packaging, sampling, managed care et cetera.
We're now through all those things and as you'll hear from Pat, we're looking forward to positioning the product in the earlier lines of treatment, because of the change we made especially with the payers in the type 2 market.
In the first half of this year, our focus will be moving up to help people in early lines of treatment and in second half of this year, once our STAT results are public we'll really focus on the type 1 market.
Makes me wonder how far along they are in “positioning“ Afrezza in earlier lines of treatment. Seems that would take at least the ADA to buy into this thesis, unless they’re planning on going rogue. |
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Post by agedhippie on Mar 26, 2018 8:23:53 GMT -5
Michael Castagna (4Q17 earnings call): The only thing limiting our growth is our lack of execution on the plans that we're rolling out today. And finally, we focus energy on 2017 on a switch, multi-daily injection market, but because we got the product back from Sanofi, we had fix several critical things around packaging, sampling, managed care et cetera.
We're now through all those things and as you'll hear from Pat, we're looking forward to positioning the product in the earlier lines of treatment, because of the change we made especially with the payers in the type 2 market.
In the first half of this year, our focus will be moving up to help people in early lines of treatment and in second half of this year, once our STAT results are public we'll really focus on the type 1 market.
Makes me wonder how far along they are in “positioning“ Afrezza in earlier lines of treatment. Seems that would take at least the ADA to buy into this thesis, unless they’re planning on going rogue. i think the operative part of that sentence is "we're looking forward to". In other words they are anticipating being able to rather than are actively positioning. The issues blocking insulin as a first line drug remain the ADA Standard of Care, the cost to insurers (both for insulin and for strips), and patients fears of insulin. I think the first and last points are tied together and gretting insulin adopted as a first line therapy will partially over come the fear of insulin. There is a perception that diabetes is only really serious once you are on insulin so if that can be removed it would be helpful and making insulin a first line treatment would eliminate that. |
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