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Post by peppy on Mar 26, 2018 9:01:30 GMT -5
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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Post by goyocafe on Mar 26, 2018 9:10:28 GMT -5
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. I want to see a trial (for T2s) that shows that Afrezza works best as a stand alone therapy. Add a column to this chart. First column: Afrezza only. My suspicion is that T2s, started early enough in the progression of the disease, would rarely advance beyond column one, and if they did, they would be put on basal with one shot a day. Look at it this way, everyone will save a lot of money printing this chart if it gets reduced to one or two columns.  |
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Post by mnholdem on Mar 26, 2018 9:29:52 GMT -5
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. It would appear that MannKind has already been, and continues to be, actively positioning Afrezza for early type 2 treatment as evidenced by being a collaborator in the Levin study: clinicaltrials.gov/ct2/show/NCT03324776?term=mannkind&recrs=abdf&rank=3
Detailed Description:
Clinical inertia in intensifying treatment of type 2 diabetes patients occurs in the range of 70% in numerous real world database assessments. The investigator proposes treating patients with Afrezza who have an index HbA1c between 8% and 11% despite being treated with diabetes medications for at least 6 months. The response to Afrezza will be assessed with Continuous Glucose Monitoring Systems (CGMS) studies and initial and follow-up HbA1cs. The goal is to assess how the investigator can rapidly and safely initiate intensification in this patient population, where extensive delays in HbA1c improvement often occur.
Primary Outcome Measures:
1. Percentage change from baseline HbA1c [ Time Frame: 3 months ]. Demonstrate that the addition of mealtime Afrezza can significantly lower HbA1c within 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 8 or higher, despite at least 6 months of prior therapy with diabetes medications.
Secondary Outcome Measures:
1. Percentage of patients having HbA1c under 7% [ Time Frame: 3 months ]. Demonstrate that the addition of mealtime Afrezza can significantly lower HbA1c within 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 8 or higher, despite at least 6 months of prior therapy with diabetes medications.
2. Percent of time that Blood glucose (BG) is under 70 mg/dL on CGMS [ Time Frame: 3 months ]. Demonstrate that the addition of mealtime Afrezza can lower blood glucose in uncontrolled type 2 diabetes patients.
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Actual Study Start Date: October 16, 2017
Estimated Primary Completion Date: April 15, 2018
Estimated Study Completion Date: April 15, 2018
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This study, if endpoints are met, will demonstrate "significant" lowering of HbA1c within 3 months for uncontrolled type 2 diabetes patients who have been on therapy with other diabetes medications and will support positioning Afrezza as a more effective early treatment therapy than "oral agents, basal insulin or GLP-1 in any combination".
Estimated study completion is just 3 weeks away.
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Post by dh4mizzou on Mar 26, 2018 9:43:09 GMT -5
But how long before the study results are made public?
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Post by boca1girl on Mar 26, 2018 9:44:51 GMT -5
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 omnly 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.Exactly the way my family views diabetes. The dreaded eventual move to insulin, especially injections. Your diabetes is really bad if you have to go on insulin in my Mom’s mind. But she is probably right based on today’s protocol. By the time a PWD T2 starts on insulin, damage has already been done. |
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Post by nadathing on Mar 26, 2018 10:35:52 GMT -5
Prescribing insulin for non-insulin dependent T2’s is going to be a tougher sell than prescribing Afrezza to adults with T1. I’ve been T2 for 15 years or so. As great as Afrezza is and as much as it may help, the medical community is not going to embrace this regardless of what the trials indicate. We can’t even get endos to prescribe Afrezza to T1’s.
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Post by digger on Mar 26, 2018 11:19:03 GMT -5
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. It would appear that MannKind has already been, and continues to be, actively positioning Afrezza for early type 2 treatment as evidenced by being a collaborator in the Levin study: clinicaltrials.gov/ct2/show/NCT03324776?term=mannkind&recrs=abdf&rank=3
Detailed Description:
Clinical inertia in intensifying treatment of type 2 diabetes patients occurs in the range of 70% in numerous real world database assessments. The investigator proposes treating patients with Afrezza who have an index HbA1c between 8% and 11% despite being treated with diabetes medications for at least 6 months. The response to Afrezza will be assessed with Continuous Glucose Monitoring Systems (CGMS) studies and initial and follow-up HbA1cs. The goal is to assess how the investigator can rapidly and safely initiate intensification in this patient population, where extensive delays in HbA1c improvement often occur.
Primary Outcome Measures:
1. Percentage change from baseline HbA1c [ Time Frame: 3 months ]. Demonstrate that the addition of mealtime Afrezza can significantly lower HbA1c within 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 8 or higher, despite at least 6 months of prior therapy with diabetes medications.
Secondary Outcome Measures:
1. Percentage of patients having HbA1c under 7% [ Time Frame: 3 months ]. Demonstrate that the addition of mealtime Afrezza can significantly lower HbA1c within 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 8 or higher, despite at least 6 months of prior therapy with diabetes medications.
2. Percent of time that Blood glucose (BG) is under 70 mg/dL on CGMS [ Time Frame: 3 months ]. Demonstrate that the addition of mealtime Afrezza can lower blood glucose in uncontrolled type 2 diabetes patients.
---
Actual Study Start Date: October 16, 2017
Estimated Primary Completion Date: April 15, 2018
Estimated Study Completion Date: April 15, 2018
---
This study, if endpoints are met, will demonstrate "significant" lowering of HbA1c within 3 months for uncontrolled type 2 diabetes patients who have been on therapy with other diabetes medications and will support positioning Afrezza as a more effective early treatment therapy than "oral agents, basal insulin or GLP-1 in any combination".
Estimated study completion is just 3 weeks away.
According to the website, they're still recruiting, so I presume either they haven't updated the site or else they won't make the deadline. One thing I don't understand is it says they'll be using CGMS, yet an exclusion criteria is "Unwilling to test blood glucose before or after each meal." Well, if they're using CGMs why would they need to test before and after each meal? |
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Post by mnholdem on Mar 26, 2018 11:49:25 GMT -5
"Patients will be instructed to follow a Weekly Treat-to-Target BG Testing Regimen and make Afrezza dose changes according to an Afrezza Titration Algorithm."
Perhaps adherence to this protocol is crucial and requires a willingness by every patient to take pre- and post-meal measurements (even with a CGM) necessary to strictly follow the algorithm for determining and making dose changes. An unwillingness to take these crucial steps would render that patient's data useless for purposes of validating the algorithm.
It would be like those pre-market trials where patients dosed way too soon, which affected the outcome of the trial data by showing more hypoglycemic excursions that may have occurred if dosed properly.
I think this exclusion is simply meant to protect the integrity of the data collection.
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Post by bill on Mar 26, 2018 12:34:46 GMT -5
Prescribing insulin for non-insulin dependent T2’s is going to be a tougher sell than prescribing Afrezza to adults with T1. I’ve been T2 for 15 years or so. As great as Afrezza is and as much as it may help, the medical community is not going to embrace this regardless of what the trials indicate. We can’t even get endos to prescribe Afrezza to T1’s. - I'm obviously missing something... Why does it take major studies and tons of education to see the obvious. If you hook T1s and T2s and non-PWDs up to CGMs and then dose the T1s and T2s with their preferred full range of PWD solutions across a variety of meals it would be obvious that Afrezza works better, is safer, and requires less precise dosing. You could do what I just described in a one calendar week with volunteers and some video cameras. When all's said and done we're just trying to either replace insulin that's not being produced, or reduce the amount of blood sugar that's not eliminated for a lack of insulin. Yes, it's complicated biology but with CGMs, who cares--just look at the results! Of course, some would say: "Don't trust your lying eyes." |
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Post by alethea on Mar 26, 2018 15:35:29 GMT -5
Prescribing insulin for non-insulin dependent T2’s is going to be a tougher sell than prescribing Afrezza to adults with T1. I’ve been T2 for 15 years or so. As great as Afrezza is and as much as it may help, the medical community is not going to embrace this regardless of what the trials indicate. We can’t even get endos to prescribe Afrezza to T1’s. Bingo. You nailed it. Especially when it is so ridiculously high priced. The Brain Trust at MNKD can't seem to figure out that they could triple or quadruple sales or more by significantly UNDER-pricing Novalog and Humalog. If they did that, it would amount to medical malpractice for a doctor to NOT put Type 1s on Afrezza. Sales would skyrocket. |
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Post by dreamboatcruise on Mar 26, 2018 15:50:07 GMT -5
Prescribing insulin for non-insulin dependent T2’s is going to be a tougher sell than prescribing Afrezza to adults with T1. I’ve been T2 for 15 years or so. As great as Afrezza is and as much as it may help, the medical community is not going to embrace this regardless of what the trials indicate. We can’t even get endos to prescribe Afrezza to T1’s. Bingo. You nailed it. Especially when it is so ridiculously high priced. The Brain Trust at MNKD can't seem to figure out that they could triple or quadruple sales or more by significantly UNDER-pricing Novalog and Humalog. If they did that, it would amount to medical malpractice for a doctor to NOT put Type 1s on Afrezza. Sales would skyrocket.If that were what doctors believe they would now be prescribing Afrezza to all their patients that are with insurers that cover it, which the script numbers clearly indicate is not the case. Whether price is or isn't a major issue, few doctors currently believe that Afrezza is a superior prandial insulin. |
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Post by agedhippie on Mar 26, 2018 15:51:49 GMT -5
Prescribing insulin for non-insulin dependent T2’s is going to be a tougher sell than prescribing Afrezza to adults with T1. I’ve been T2 for 15 years or so. As great as Afrezza is and as much as it may help, the medical community is not going to embrace this regardless of what the trials indicate. We can’t even get endos to prescribe Afrezza to T1’s. - I'm obviously missing something... Why does it take major studies and tons of education to see the obvious. If you hook T1s and T2s and non-PWDs up to CGMs and then dose the T1s and T2s with their preferred full range of PWD solutions across a variety of meals it would be obvious that Afrezza works better, is safer, and requires less precise dosing. You could do what I just described in a one calendar week with volunteers and some video cameras. When all's said and done we're just trying to either replace insulin that's not being produced, or reduce the amount of blood sugar that's not eliminated for a lack of insulin. Yes, it's complicated biology but with CGMs, who cares--just look at the results! Of course, some would say: "Don't trust your lying eyes." The medical world will say that It would need to be for much longer than 1 week, probably at least 3 months. You would also need to select the participants randomly rather than have them self-select, also to randomly assign them between the Afrezza and RAA groups (again rather than self-select). What they are looking for is whether Afrezza out-performs RAA in a random group of users over a period of time. Basically a superiority trial  |
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Post by bill on Mar 26, 2018 16:06:45 GMT -5
nadathing - I'm obviously missing something... Why does it take major studies and tons of education to see the obvious. If you hook T1s and T2s and non-PWDs up to CGMs and then dose the T1s and T2s with their preferred full range of PWD solutions across a variety of meals it would be obvious that Afrezza works better, is safer, and requires less precise dosing. You could do what I just described in a one calendar week with volunteers and some video cameras. When all's said and done we're just trying to either replace insulin that's not being produced, or reduce the amount of blood sugar that's not eliminated for a lack of insulin. Yes, it's complicated biology but with CGMs, who cares--just look at the results! Of course, some would say: "Don't trust your lying eyes." The medical world will say that It would need to be for much longer than 1 week, probably at least 3 months. You would also need to select the participants randomly rather than have them self-select, also to randomly assign them between the Afrezza and RAA groups (again rather than self-select). What they are looking for is whether Afrezza out-performs RAA in a random group of users over a period of time. Basically a superiority trial @agedhipped - I wonder about whether you'd really want randomness in an Afrezza superiority trial. Is the goal to show that Afrezza is superior, or perhaps that PWDs using Afrezza and CGMs can get superior results compared to alternatives. I think the latter is more relevant and may be easier to prove. A PWD doesn't really care whether their individual medication, delivery mechanism, monitoring device, and dosing is, or is not superior. What they care about is that their results using some combination of these products and dosing are superior. Essentially, let everyone bring their best game to the trial and let the CGM videos dictate the winners. |
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Post by babaoriley on Mar 26, 2018 16:41:30 GMT -5
Wow Sports! Very nice! I never saw the creative side of you before. Your emotional intelligence is clearly brilliant. You’re communication skills are tops. I find you’re array of intelligence very attractive. You can connect quickly with anyone. I sincerely believe Mannkind should beg to hire you to sell Afrezza. Serioulsy. 👍😉 brotherm1, your communication skills aren't bad, either!!  I think you may have won an all expenses free trip to So Cal.* *Your all expenses paid trip does not cover your cost of travel to and from, nor any lodging or meals. Pretty sure it does include a tour of the wine country and a special outing to La Jolla. |
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Post by brotherm1 on Mar 26, 2018 16:47:48 GMT -5
haha. I’m looking forward to it and as soon as our share price hits 7 in the next month or so. 😁
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