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Post by itellthefuture777 on Sept 12, 2017 13:17:16 GMT -5
Our clinical team designed a protocol to set a standard meal with 50 g of carbohydrates. That was the 100% challenge. This was followed by challenges at 200%, 50% and zero percent. When I heard of zero I was shocked. Surely there would be severe hypo. The remarkable thing was that with the regular prescribed dose of AFRESA regardless of carbohydrate intake between zero and 100 grams the range of excursion is only plus or minus 30-35 mg [reduction] from baseline for all of the Type II patients in the study. At the ASDA meeting I described to Dr. [Jay Skyler] the finding that in Type II diabetes with a fixed dose of AFRESA and even with no food there is excellent control without hypo risk. I asked him how that was possible. "Obvious," he responded. He was basing his comments on our recently reported 118 trial in which we showed rapid and virtually complete sensation of [hepatic] glucose relief with AFRESA and the common inability of the remaining endogenous insulin to maintain control, as is the case for a healthy person without diabetes. Indeed, I mentioned this result to a number of KOL's who agree with Jay. So I say to you that AFRESA is what no other insulin has ever done for Type II diabetes. AFRESA restores more physiologic hepatic function, takes a load off the pancreas and avoids the hyperinsulinemia resulting from resistance of other insulins. It better mimics the normal pancreas response. So what does all this mean? First let me say that we will need to follow these findings with much larger trials. If the results of the larger trials support the earlier findings then I state to you that AFRESA should be used very early, certainly after failure with Metformin and as a first sign therapy for a significant portion of patients who are not candidates for Metformin or who do not do well with Metformin. It should be used well before fasting glucose is out of control and as we have seen, AFRESA even leads to lower fasting levels by eliminating the excessive gluconeogenesis. Of course, we will have to repeat some of these findings with specific trials but we have already seen the possibilities for AFRESA as we evaluate the timing of hypos in our already completed trials to date. From what we have seen in our extensive clinical program, AFRESA should benefit the entire progression spectrum of Type II diabetes with a very simple therapy and the experts tell us that it could even stop the progression of the disease. www.healthline.com/diabetesmine/the-truth-about-afresa-inhalable-insulin-a-chat-with-al-mann |
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Post by itellthefuture777 on Sept 12, 2017 13:21:58 GMT -5
Our latest trials of 600 patients are showing even more significant benefits from the product than our original trials; the most recent trial appears to show that this should replace frontline treatment for all Type 2 patients
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Post by itellthefuture777 on Sept 12, 2017 13:23:53 GMT -5
Afrezza is for prandial control — mealtime only - not basal doses. For about 70% of Type 2s, all you'll need is a regular set dose of Afrezza. This will work for everyone except the "late-stage" Type 2s, who will need to take basal insulin as well.
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Post by ghochr on Sept 12, 2017 17:18:23 GMT -5
Is this trial registered with FDA and results published? May be we need to let Mike know so he can take a look
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Post by mnkdfann on Sept 12, 2017 17:47:45 GMT -5
Is this trial registered with FDA and results published? May be we need to let Mike know so he can take a look Yes, I sure hope Mike is aware of those trials from 2009 and earlier that Mannkind submitted to the FDA for approval.  Also, cute how the article spells it 'Afresa' in places. Was that actually how it was done, way back then? |
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Post by mnholdem on Sept 12, 2017 17:54:04 GMT -5
That was its trade name early in its development
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Post by dreamboatcruise on Sept 12, 2017 18:06:35 GMT -5
That was its trade name early in its development Didn't the FDA have some problem with that spelling? I'm dragging that notion out of the deep recesses of my memory... so that means it's covered in cobwebs. |
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Post by derek2 on Sept 12, 2017 19:13:50 GMT -5
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Post by edvarney on Sept 12, 2017 19:21:43 GMT -5
One big point that sticks well in my mind from your message here is that; Mr. Al. Mann made these very exact claims for Afrezza when he developed the product!!! If you go back and read his reporting how it should be used by diabetics he said; Afrezza should be uses to head off the development of the disease from the get-go in any person diagnosed as pre-diabetics!!
Just wish Al. had been given more time to present his case for Afrezza ,personally !! I was convinced from hearing his very first presentation that he had developed something no one in the business had done, and he truly wanted to help people with the disease, not just get rich like so many before him!!! True genius!! God Bless Al Mann!!!
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Post by dreamboatcruise on Sept 12, 2017 19:33:06 GMT -5
One big point that sticks well in my mind from your message here is that; Mr. Al. Mann made these very exact claims for Afrezza when he developed the product!!! If you go back and read his reporting how it should be used by diabetics he said; Afrezza should be uses to head off the development of the disease from the get-go in any person diagnosed as pre-diabetics!! Just wish Al. had been given more time to present his case for Afrezza ,personally !! I was convinced from hearing his very first presentation that he had developed something no one in the business had done, and he truly wanted to help people with the disease, not just get rich like so many before him!!! True genius!! God Bless Al Mann!!! Al telling people wouldn't cut it... he needed to fund some studies proving that early intervention with Afrezza would 1) slow or stop progression and 2) unlike RAA's could be done with acceptably low risk of severe hypos. Mike could easily be out telling people this just as well as Al had done, but most doctors and close to all payers aren't going to act until their are clinical trials. |
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Post by itellthefuture777 on Sept 12, 2017 20:35:36 GMT -5
One big point that sticks well in my mind from your message here is that; Mr. Al. Mann made these very exact claims for Afrezza when he developed the product!!! If you go back and read his reporting how it should be used by diabetics he said; Afrezza should be uses to head off the development of the disease from the get-go in any person diagnosed as pre-diabetics!! Just wish Al. had been given more time to present his case for Afrezza ,personally !! I was convinced from hearing his very first presentation that he had developed something no one in the business had done, and he truly wanted to help people with the disease, not just get rich like so many before him!!! True genius!! God Bless Al Mann!!! Al telling people wouldn't cut it... he needed to fund some studies proving that early intervention with Afrezza would 1) slow or stop progression and 2) unlike RAA's could be done with acceptably low risk of severe hypos. Mike could easily be out telling people this just as well as Al had done, but most doctors and close to all payers aren't going to act until their are clinical trials. Alfred Mann discussed this study in their conference call held on February 1st, 2010 and had this to say about it: “The objective of this study was to demonstrate conclusively that complex meal titration is not needed. Almost from the beginning of the AFREZZA program, I have expected a very wide therapeutic window for AFREZZA, and especially so in type 2. But I was surprised when the subject(s) had no hypo problems at all, even if they ate absolutely nothing. Let me be more specific. Both prandial excursions for the type 2 patients were within plus or minus 35 milligrams per deciliter, no matter what they ate, even if they ate nothing. The patients all achieved good glycemic control by taking a standard dose of AFREZZA, no matter what they ate and without the risk of hypo. And if there is no need for titration and little risk of hypos, there would be little need for regular prandial glucose [measurement] regimens. We will need to conduct more of these studies in order to demonstrate these findings on a larger scale.” |
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Post by sayhey24 on Sept 12, 2017 20:44:36 GMT -5
OMG, the good old 118 trial. I remember Al talking about this on a call as it was the first thing that got me excited about afresa. I still have my afresa t-shirt. I see Howard Zisser still says he is doing trials for safety and efficacy of inhaled insulin. chemengr.ucsb.edu/people/howard-c-zisser I wonder what he is doing? I sure hope Mike has a plan for getting some of this info out to the world. For starters maybe a PR on this 8 person pilot which announces a larger follow-up study. I also hope Mike knows about all the work Al did before he put $1B into this and that Mike has spent a lot of time talking with Zisser, Boss and Skylar. Its a good thing Matt is still around. If I remember correctly there is also a lot of info on T2s showing regression. Maybe Matt can dust off some of the old file cabinets. |
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