Well, as best I can tell, this is a 1st time blog by someone who lists no credentials other than he/she is an occasional investor. Right off the bat, I'm having a hard time with the timeframes listed. "Planbee" lists 12 wk "titration" and 12 wk "experimental" periods for Affy 2. I come up with 6wk "run-in" and 24 wk "treatment" (from yesterday's PR). "Planbee" also lists 24 wk titration followed by 12 wk experimental for the diabetes journal study. I come up with 24 wks of "titration" - which appears to be treatment (amount of insulin given based on blood glucose level). So I'm confused...
The author is comparing 2 very different treatment modalities (Afrezza vs long-acting insulins), and that's OK. When you have a new form of treatment, you want to compare it to the existing standard of care. A1c is the typical measurement of how effective diabetes treatment is, but there are subtlties to this. A1c is a measure of average blood glucose over a 2-3 month period, but does not reflect the extremes that can be so damaging. He shows A1c reduction for Afrezza as .82% vs 1.8 - 1.9% for the sc insulins tested. Hard for me to comment on this - different study designs, and I don't know the specifics of the Afrezza trial. On the surface, Afrezza looks inferior - but very, very hard to make that call without a head to head comparison. You need to control all factors and just vary the comparator drugs.
Hypos - the d.j. study doesn't give clear definition (it might be in their online appendix, which I haven't seen a link to). But their 26% and 16% numbers are I believe patients with no hypo events. Affy 2 numbers were 67% had mild / mod hypo event; 5% had severe hypo event - so 28% had "no" hypo event?
Lack of wt gain seems to be favored by the Afrezza study.
Bottom line, you could make this comparison say whatever you want it to say, but unless you do a head to head study under identical conditions, you'll never know
