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Post by sayhey24 on Sept 15, 2017 17:34:55 GMT -5
Most T2s are spiking 180+ after meals and then spend the next 24hr on their metformin trying to get back under 100 but then get slammed with another meal. Its a mess. You don't even need to add the snack. Add the snack and its even worse.
The issue all T2s deal with is not fasting BG, its mealtime sugar spikes. If the T2 got back to <90 after the meals handling the snacks would be more doable without more insulin. But if it were not for the cost if they needed a little more afrezza for the snacks, no big deal.
The reason why the ADA first step in Type 2 insulin being basal is because of the historic fear of injections and hypoglycemia. Limiting the shots reduces the risk. According to Dr. Ralph DeFronzo at the BeyondA1c forum, insulin historically is viewed as dangerous and requires education.
If treated with afrezza first as proposed by VDex the T2 would never progress and basal would never be needed. The current problem is most people including the doctors do not know of or understand afrezza but given time that will change.
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Post by babaoriley on Sept 15, 2017 18:23:36 GMT -5
Just got off the phone with my cousin. He's been around and playing stocks for a long time. He told me you can never know if there is a better drug in the wings until it actually comes out and hits the market. I would think we would have heard if there is a competitive drug going through trials with the FDA or comparable foreign agency? Did we know about Fiasp - for example - before it was approved oversees? Any chance the shorts could be aware of a drug in the making comparable or better than Afrezza that we are unaware of? Of course even if there was a better drug waiting to be approved, it would still take time to be a success, but if it would be owned by a BP like Merck with mega cash, the time to success would be a much shorter route than a drug owned by a small company short on cash. You're describing part of the charm of investing in developmental biotech; the bigger pharmas can take a hit from a competitor, we little guys, not so much. Nothing new or sinister, though, just part of the reason rewards are potentially high.
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Post by agedhippie on Sept 15, 2017 18:24:38 GMT -5
Most T2s are spiking 180+ after meals and then spend the next 24hr on their metformin trying to get back under 100 but then get slammed with another meal. Its a mess. You don't even need to add the snack. Add the snack and its even worse. Metformin doesn't come into it, we are talking about insulin. At this point Metformin is useful because it reduces your insulin resistance and hence the amount of insulin you need (either external or you own). The rationale behind basal insulin is that it addresses the basal loads and lets you save your own insulin for meal times. There is nothing better than your own insulin so you want to use it where you need a smart response like meals rather than a dumb response like basal. There will come a point where basal alone will not control meal time spikes and then you should add meal time insulin.
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Post by mango on Sept 15, 2017 18:50:20 GMT -5
Most T2s are spiking 180+ after meals and then spend the next 24hr on their metformin trying to get back under 100 but then get slammed with another meal. Its a mess. You don't even need to add the snack. Add the snack and its even worse. Metformin doesn't come into it, we are talking about insulin. At this point Metformin is useful because it reduces your insulin resistance and hence the amount of insulin you need (either external or you own). The rationale behind basal insulin is that it addresses the basal loads and lets you save your own insulin for meal times. There is nothing better than your own insulin so you want to use it where you need a smart response like meals rather than a dumb response like basal. There will come a point where basal alone will not control meal time spikes and then you should add meal time insulin. That rationale is dangerous. Put someone on Afrezza early and that rationale is tossed out the window. Why delay the inevitable? That's being irresponsible. Tightly control blood sugar, AFREZZA can restore glucose homeostasis. Not Metformin, not basal insulins and not RAAs.
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Post by sayhey24 on Sept 15, 2017 18:54:40 GMT -5
The rationale behind the use of basal is the orals don't work and they need insulin but limit the risk to one shot a day. To quote Dr. Ralph DeFronzo “The most waste in type 2 diabetes is to continuously put people on metformin and sulfonylureas (glyburide, glimepiride, etc.). These drugs have no protective effect on the beta cell, and by the time you figure out what you’re doing, there are no beta cells left to save.” – BeyoundA1c forum.
The T2 doesn't have a "basal load" issue. They are producing enough insulin to deal with liver glucose during fasting. Their problem is with meal time spikes. If they are spiking 180+ at meal time they are not producing enough insulin at mealtime. Metformin does nothing to address this and in most cases a walk does much better than metformin to reduce their resistance. I agree with DeFronzo stop giving the metformin especially with afrezza since it affects liver glucose production which will protect from any afrezza over-dosing and prevents the hypo.
Now, if you follow the VDex protocol there will NOT come a point for most T2s that they will ever need a basal. The bottom line is it would have killed Lantus sales. The fact is Al Mann talked about study data which shows a regression using afrezza. Lets hope MNKD can find it and get it published.
Now the concept of GRI is great. The problem is how do you program each molecule so it knows its for breakfast or lunch or dinner and not a snack? Its a great research project for Merck. I love the idea of space transporters too but I don't expect to see one in the next 10 years.
Right now, today we have Tresiba/afrezza/CGMs/"Cloud Diabetes". What we don't have is a company which has put those four components together on the scale needed. It will come in the the next year and IMO that's the investment opportunity.
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Post by agedhippie on Sept 15, 2017 21:51:20 GMT -5
The T2 doesn't have a "basal load" issue. They are producing enough insulin to deal with liver glucose during fasting. Their problem is with meal time spikes. If they are spiking 180+ at meal time they are not producing enough insulin at mealtime. You are missing the point. A Type 2 can meet a certain percentage of their glucose needs from their existing production. As an example suppose they can produce 60% of the insulin needed and their basal requirement is 50%, that leaves 10% to meet their meal time requirement rather than the 50% needed. Now if they take a basal insulin which provides that 50% to cover basal then 50+60 = 110%, they now have no deficit and should remain in range. Now if their production dropped below 50% in the above example you would start to have problems and get mealtime spikes. One of the problems of basal first regimes is that some doctors have a habit of simply raising the basal rate to bring down the numbers - using the basal to cover mealtimes. This is a bad idea and leads to hypos if meals are skipped or delayed. A lot of times when people are getting hypos they need to do basal testing (which is a complete pain to do BTW which is why people skip it) to bring their basal back to where it should be. You should never cover meals with basal, it's a recipe for disaster.
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Post by itellthefuture777 on Sept 15, 2017 22:53:17 GMT -5
Afrezza takes the load off a stressed pancreas..with some restoritive..also reduces insulin resistance..when ised with a basal has 65% reduction in hypos compaired to the gold standard insulins..when used alone in type 2 even when they eat nothing had zero hypos in all cases...70% of diabetics should only need Afrezza at meal time which is where a pre diabetic starts to lose control. Less then a 30 seconds difference between the healthy pancreas..mimics with the same human monomeric active insulin...while everyone else in the industry is stuck in inactive hexomeric insulins that no matter how delivered are to slow in..to slow out..Afrezza should be frontline therapy as Metformin doesn't halt progression of the disease..towards loss of vision, heart, liver, arms, leg amputations..while leading KOL's say it's obvoius Afrezza halts progression...so..no complex carb counting, no daily titration, no site scaring, reduced insulin resistance, oh..and no shot..small sleek whistle inhaler superior glucose control..A1C's are also dropping...no wieght gain..or weight neutral..93% satisfaction survey in quality of life...why this is under $4000. share is beyond me
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Post by sayhey24 on Sept 16, 2017 8:12:24 GMT -5
The T2 doesn't have a "basal load" issue. They are producing enough insulin to deal with liver glucose during fasting. Their problem is with meal time spikes. If they are spiking 180+ at meal time they are not producing enough insulin at mealtime. You are missing the point. A Type 2 can meet a certain percentage of their glucose needs from their existing production. As an example suppose they can produce 60% of the insulin needed and their basal requirement is 50%, that leaves 10% to meet their meal time requirement rather than the 50% needed. Now if they take a basal insulin which provides that 50% to cover basal then 50+60 = 110%, they now have no deficit and should remain in range. Now if their production dropped below 50% in the above example you would start to have problems and get mealtime spikes. One of the problems of basal first regimes is that some doctors have a habit of simply raising the basal rate to bring down the numbers - using the basal to cover mealtimes. This is a bad idea and leads to hypos if meals are skipped or delayed. A lot of times when people are getting hypos they need to do basal testing (which is a complete pain to do BTW which is why people skip it) to bring their basal back to where it should be. You should never cover meals with basal, it's a recipe for disaster. Aged - its like driving a car. Sometimes you need to go fast and sometimes slow. Even if your "average" speed is 40mph who wants a car whose maximum speed is 45mph? Its the same with diabetes. After meals you need it to go really fast. If the speed limit is 70mph do you really want to be doing 45mph? Yes, doing 45mph in a 70mph zone will get me there but it may also get me run off the road and killed. A T2 has a pancreas which without the afrezza can only do 45mph. What we have here is an example of the paradigm shift in thinking about treating diabetes. What you are outlining is "Old School" thinking. Who wants to be driving a Model T in 2017? New school says for the T2s give the afrezza first, no hypos, non-diabetic control and in many cases beta cell improvement. It sounds so crazy to current diabetes "experts" getting the word out will requirement a huge advertising and education campaign. The reason the doctors are doing what they are doing is based on the tools they had. They only had the horse and wagon and the Model T. From the 118 study and what VDex is saying just use the afrezza with the T2s and hypos are not a concern. In both the study and the VDex paper both showed the result taking afrezza and no food - no hypo.
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Post by brotherm1 on Sept 16, 2017 9:06:51 GMT -5
Afrezza takes the load off a stressed pancreas..with some restoritive..also reduces insulin resistance..when ised with a basal has 65% reduction in hypos compaired to the gold standard insulins..when used alone in type 2 even when they eat nothing had zero hypos in all cases...70% of diabetics should only need Afrezza at meal time which is where a pre diabetic starts to lose control. Less then a 30 seconds difference between the healthy pancreas..mimics with the same human monomeric active insulin...while everyone else in the industry is stuck in inactive hexomeric insulins that no matter how delivered are to slow in..to slow out..Afrezza should be frontline therapy as Metformin doesn't halt progression of the disease..towards loss of vision, heart, liver, arms, leg amputations..while leading KOL's say it's obvoius Afrezza halts progression...so..no complex carb counting, no daily titration, no site scaring, reduced insulin resistance, oh..and no shot..small sleek whistle inhaler superior glucose control..A1C's are also dropping...no wieght gain..or weight neutral..93% satisfaction survey in quality of life...why this is under $4000. share is beyond me Not doubting the numbers you posted itell, just curious where you got the "93% satisfaction survey in quality of life". I don't remember reading or catching that before.
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Post by itellthefuture777 on Sept 16, 2017 11:28:12 GMT -5
online.liebertpub.com/doi/abs/10.1089/dia.2009.0115#/doi/abs/10.1089/dia.2009.0115Effect of Technosphere Inhaled Insulin on Quality of Life and Treatment Satisfaction Mark Peyrot Richard R. Rubin Address correspondence to: Mark Peyrot, Ph.D. Department of Sociology Loyola University Maryland 4501 North Charles Street Baltimore, MD 21210 E-mail: mpeyrot@loyola.eduDiabetes Technology & TherapeuticsVol. 12: , Issue. 1, : Pages. 49-55 (Issue publication date: January 2010)https://doi.org/10.1089/dia.2009.0115 Abstract Aims: This randomized controlled trial assessed the impact of Technosphere® insulin (MannKind Corp., Valencia, CA) delivered via the MedTone® inhaler (MannKind Corp.) on quality of life and treatment satisfaction in adults with type 2 diabetes. Methods: Subjects were 119 insulin-naive subjects with starting hemoglobin A1c >6.5%: 58 in the active inhaled insulin arm and 61 in the inhaled placebo arm (67% male; mean age 55 years; mean duration of diagnosed diabetes 7 years). Subjects completed a measure of health-related quality of life (the SF-36) and a measure of treatment satisfaction (the Insulin Treatment Questionnaire [ITQ]) before starting insulin treatment and approximately 12 weeks later. The ITQ assesses Diabetes Worries, Perceptions of Insulin Therapy, and Inhaler Performance. Results: There was no significant change in any SF-36 factor or Diabetes Worries during the trial in either arm, and there were no significant between-arm differences in change on any of these measures. Perceptions of Insulin Therapy improved significantly during the trial in the active medication arm (effect size for composite measure = 0.56, P = 0.002) but not in the placebo arm; there were no significant between-arm differences in change. The majority of subjects gave positive ratings of Inhaler Performance on all items (median = 93% positive ratings). Conclusions: In this study treatment with inhaled Technosphere insulin was well tolerated, clinically efficacious, and associated with positive patient-reported outcomes, including improved attitudes toward insulin therapy and high treatment satisfaction. This treatment strategy was implemented without a negative impact on health-related quality of life or worries about diabetes. More info www.investorvillage.com/dialogs/Print.asp?msgid=15055302
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Post by itellthefuture777 on Sept 16, 2017 11:32:28 GMT -5
In a study published early this year entitled, “Effect of Technosphere Inhaled Insulin on Quality of Life and Treatment Satisfaction” (Mark Peyrot, Richard R. Rubin. Diabetes Technology & Therapeutics. January 2010, 12(1): 49-55. doi:10.1089/dia.2009.0115,) the authors explain that, “research suggests that insulin-naive patients offered an option of taking inhaled insulin are much more likely to initiate insulin therapy than those offered an option of subcutaneous insulin. Thus, availability of the Technosphere insulin system might contribute to reduced delay in the initiation of insulin therapy, a goal suggested by recent clinical guidelines. In addition, research suggests that inhaled insulin is preferred to subcutaneous insulin. Most (85%) patients who received an inhaled insulin during the main phase of a clinical trial chose to continue doing so during the open-label extension phase, and 75% of patients using subcutaneous insulin during the parallel group phase chose to switch to the inhaled insulin.”
The graph below shows the superior kinetics of Afrezza, practically mimicking a normal person’s insulin response to a meal. This is the key for reducing Hypoglycemia and improving post prandial glucose levels.
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Post by lennymnkd on Sept 16, 2017 11:56:16 GMT -5
In a study published early this year entitled, “Effect of Technosphere Inhaled Insulin on Quality of Life and Treatment Satisfaction” (Mark Peyrot, Richard R. Rubin. Diabetes Technology & Therapeutics. January 2010, 12(1): 49-55. doi:10.1089/dia.2009.0115,) the authors explain that, “research suggests that insulin-naive patients offered an option of taking inhaled insulin are much more likely to initiate insulin therapy than those offered an option of subcutaneous insulin. Thus, availability of the Technosphere insulin system might contribute to reduced delay in the initiation of insulin therapy, a goal suggested by recent clinical guidelines. In addition, research suggests that inhaled insulin is preferred to subcutaneous insulin. Most (85%) patients who received an inhaled insulin during the main phase of a clinical trial chose to continue doing so during the open-label extension phase, and 75% of patients using subcutaneous insulin during the parallel group phase chose to switch to the inhaled insulin.” The graph below shows the superior kinetics of Afrezza, practically mimicking a normal person’s insulin response to a meal. This is the key for reducing Hypoglycemia and improving post prandial glucose levels. Itell ; as always appreciate your effort: 👍
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Post by itellthefuture777 on Sept 16, 2017 12:10:32 GMT -5
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Post by sayhey24 on Sept 16, 2017 12:53:20 GMT -5
Afrezza takes the load off a stressed pancreas..with some restoritive..also reduces insulin resistance..when ised with a basal has 65% reduction in hypos compaired to the gold standard insulins..when used alone in type 2 even when they eat nothing had zero hypos in all cases...70% of diabetics should only need Afrezza at meal time which is where a pre diabetic starts to lose control. Less then a 30 seconds difference between the healthy pancreas..mimics with the same human monomeric active insulin...while everyone else in the industry is stuck in inactive hexomeric insulins that no matter how delivered are to slow in..to slow out..Afrezza should be frontline therapy as Metformin doesn't halt progression of the disease..towards loss of vision, heart, liver, arms, leg amputations..while leading KOL's say it's obvoius Afrezza halts progression...so..no complex carb counting, no daily titration, no site scaring, reduced insulin resistance, oh..and no shot..small sleek whistle inhaler superior glucose control..A1C's are also dropping...no wieght gain..or weight neutral..93% satisfaction survey in quality of life...why this is under $4000. share is beyond me Not doubting the numbers you posted itell, just curious where you got the "93% satisfaction survey in quality of life". I don't remember reading or catching that before. ltell - got a study for "with some restoritive..also reduces insulin resistance "? I know Al said it many times.
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Post by agedhippie on Sept 16, 2017 13:39:57 GMT -5
In a study published early this year entitled, “Effect of Technosphere Inhaled Insulin on Quality of Life and Treatment Satisfaction” (Mark Peyrot, Richard R. Rubin. Diabetes Technology & Therapeutics. January 2010, 12(1): 49-55. doi:10.1089/dia.2009.0115,) the authors explain that, “research suggests that insulin-naive patients offered an option of taking inhaled insulin are much more likely to initiate insulin therapy than those offered an option of subcutaneous insulin. Thus, availability of the Technosphere insulin system might contribute to reduced delay in the initiation of insulin therapy, a goal suggested by recent clinical guidelines. In addition, research suggests that inhaled insulin is preferred to subcutaneous insulin. Most (85%) patients who received an inhaled insulin during the main phase of a clinical trial chose to continue doing so during the open-label extension phase, and 75% of patients using subcutaneous insulin during the parallel group phase chose to switch to the inhaled insulin.” The graph below shows the superior kinetics of Afrezza, practically mimicking a normal person’s insulin response to a meal. This is the key for reducing Hypoglycemia and improving post prandial glucose levels. It helps if you read the paper itself. Lets be clear on what this trial was: - First of all this was a comparison of Afrezza as the active arm, and Technosphere only (no insulin) as the placebo arm. - At no point was subcutaneous insulin used or compared. This was Mannkind products only. - The study used Medtone inhalers which is why it had to be rerun as study 175 in the ADCOM presentation. - The 93% satisfaction number is with the inhaler device (Medtone), not with Afrezza. This score is basically useless since the Medtone device is no longer used hence the need to rerun the trial. Still, it seems people like the Medtone device - Those numbers at the end (85% continue, 75% swap) were from an entirely different trial not involving Mannkind at all, it was for Exubera. The bottom line here? This is a comparison of inhaled insulin vs. Technosphere, at no point was subcutaneous insulin involved.
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