|
Post by brentie on Jan 31, 2018 9:36:09 GMT -5
Basal insulin—"Well, that is medically incorrect." Great Quote. As I remember it the patch pump which Al envisioned was the next generation of the V-Go which would be similar to the Libre in size and care required. That ain't GrandMa's pump. Now for afrezza to squeeze basal insulin all we need is one company like Amazon to understand Diabetes is a huge expense and time is money and times is over for more studies which tell us afrezza mimics a healthy pancreas and is the only way to "stop the spike". What studies are in the hopper which will again tell us the same? STAT and OneDrop? Where did he say that? That could one day be proven correct. Just wondering when/where he actually said that. I've followed for a long time and don't remember that particular statement. SF: People with type 2 are usually started out on a basal insulin. AM: Well, that is medically incorrect. Starting a type 2 on basal insulin is done today because current prandial insulin products are not physically sound so they are delayed about as long as they can be. Lantus has been so successful as the first insulin used in type 2 because of the problems with current prandial products. www.diabetesincontrol.com/an-exclusive-interview-with-al-mann-founder-and-ceo-mannkind-corp/----------------------------------------------------------------------------------------- Aren't most Type 2s currently treated with a basal insulin only, instead of mealtime dosing? Al: Yes, but that's the wrong way around. The correct therapy should be a good prandial insulin and not long-term insulin — Afrezza in particular because it turns off glucose production and delivery from the liver. 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. www.healthline.com/diabetesmine/the-truth-about-afresa-inhalable-insulin-a-chat-with-al-mann#2
|
|
|
Post by dreamboatcruise on Jan 31, 2018 13:13:36 GMT -5
brentie... wonder which trial he was referring to in the second quote. It is really a shame there is apparently so much impressive data that was seemingly sidelined by the FDA. I do wonder with so many trials how they ended up with the cartridges that aren't really unit for unit comparable to RAA. Might that actually have been from differences in the dreamboat vs medtone?
|
|
|
Post by sayhey24 on Jan 31, 2018 16:36:42 GMT -5
It was the 118 trial clinicaltrials.gov/ct2/show/NCT00570687Per the 3Q2009 Quarterly call Al Mann said - I have long argued that AFRESA does not require complex meal titration. Certainly there is no need for carb counting and so forth. The basis of my view was derived from the dose escalation study with meal challenges in which better glucose control was achieved with ever greater doses of AFRESA, yet without any hypos. Yet based on decades of battling these challenges of conventional insulin therapy, some physicians have questioned my suggestion. Therefore, I proposed a meal escalation study in which patients would take a fixed dose of AFRESA and then a series of meal challenges. 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.
|
|
|
Post by brentie on Jan 31, 2018 16:49:42 GMT -5
brentie ... wonder which trial he was referring to in the second quote. It is really a shame there is apparently so much impressive data that was seemingly sidelined by the FDA. I do wonder with so many trials how they ended up with the cartridges that aren't really unit for unit comparable to RAA. Might that actually have been from differences in the dreamboat vs medtone? I may be wrong but I thought that the FDA came up with the unit to unit comparison numbers. I know they had concerns with dosage when it was submitted to the FDA for approval.... "Another concern raised: MannKind’s new drug application for Afrezza cited cartridges containing up to three units of injected insulin, and double-strength cartridges with up to six units, when its clinical trial used cartridges with up to four units and double-strength cartridges of up to eight. The company cited an equivalency study that compared its inhaled insulin with injected insulin from other companies; Afrezza would compete with two injectable insulins, Humalog sold by Eli Lilly, and Novolog sold by Novo Nordisk." www.genengnews.com/gen-news-highlights/one-small-step-for-mannkind-fda-panel-recommends-afrezza/81249695?kwrd=type%201%20diabetes
|
|
|
Post by dreamboatcruise on Jan 31, 2018 17:10:13 GMT -5
brentie ... wonder which trial he was referring to in the second quote. It is really a shame there is apparently so much impressive data that was seemingly sidelined by the FDA. I do wonder with so many trials how they ended up with the cartridges that aren't really unit for unit comparable to RAA. Might that actually have been from differences in the dreamboat vs medtone? I may be wrong but I thought that the FDA came up with the unit to unit comparison numbers. I know they had concerns with dosage when it was submitted to the FDA for approval.... "Another concern raised: MannKind’s new drug application for Afrezza cited cartridges containing up to three units of injected insulin, and double-strength cartridges with up to six units, when its clinical trial used cartridges with up to four units and double-strength cartridges of up to eight. The company cited an equivalency study that compared its inhaled insulin with injected insulin from other companies; Afrezza would compete with two injectable insulins, Humalog sold by Eli Lilly, and Novolog sold by Novo Nordisk." www.genengnews.com/gen-news-highlights/one-small-step-for-mannkind-fda-panel-recommends-afrezza/81249695?kwrd=type%201%20diabetesThanks, that does seem to suggest MNKD new better and presumably was then forced/pressured into accepting flawed scheme. It's a shame. It seems it would be nearly impossible to correct at this point. At least I don't think the idea of having different strength old "unit" product and new "unit" product floating out together would fly from a safety standpoint. I suppose they could just give up on "units" and switch to mg... though that was considered a flaw of Exubera if I remember correctly.
|
|
|
Post by sayhey24 on Jan 31, 2018 22:23:05 GMT -5
I think the idea to go with units was Al's. In the 4unit cartridge you have 10units of insulin in powder form. When you inhale you typically get slightly less than 40% or 4U. Al thought this would make dosing easier and would overcome one of the issues Exubera had. Now all the studies prior to the 171 and 175 used the Medtone which didn't use the current cartridges and why they can't use all the old studies or so I was told.
I always thought it was a bad idea going with "units" but after three years I think it was a really bad idea. They should have gone with XSmall 2u, small 4unit, medium 8u and large for the 12u.
When he got into the argument with Bernstein referenced in the article above about dosing aka "the doctor" Al should have realized not to go with old school thinking but they had the reports saying Exubera was too confusing to dose.
|
|