Ginger Vieira•4 days ago

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I was part of an inhalable insulin study several years ago, from a different pharma company, the study was eventually shut down because the inhaled form was causing a lot of irritation in the throat for participants. The other major drawback, and I mean major, was that the insulin could only be delivered in units of 3, 6, 9, etc. Definitely not ideal for a type 1 diabetic who is counting carbs and adjusting their dose precisely to their carbohydrate quantity...what amount of dosing is possible through the AFREEZA?

Ginger, in case you are reading this,according to Al Mann Afrezza is much more forgiving.You don't have to adjust your dose as precisely to your carb intake.Here's Al from a 2009 conference call..

Interestingly, some new data is evolving that not only supports this earlier use of AFRESA it indicates that AFRESA could be used very, very early in Type II disease progression. In fact maybe even stopping progression of Type II diabetes. 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. Most of the analyst community has failed to understand that AFRESA is not just for use in basal bullous therapy but will contribute to much better therapy for the entire spectrum of Type I and Type II diabetes