Halozyme Has Safest Ultrafast Insulin
MNKD's Ph3 Study 171-
Reported "Significantly less total hypoglycemia was observed in the AFREZZA-Gen2 group (9.80 events per subject-month) compared to the insulin aspart group (13.97 events per subject-month; p<0.0001). The event rate of severe hypoglycemia was also lower in the AFREZZA-Gen2 group (8.05 events per 100 subject-months) than in the insulin aspart group (14.45 events per 100 subject-months); however, this difference was not statistically significant (p=0.1022)."
Now assuming that this is a typo and that what is being reported n the mild to moderate insulin group is not 100x the rate of the severe group, I am taking the number for AFREZZA-Gen2 mild to moderate as 9.80 events per 100 subject months. Someone please correct me if I'm wrong.
That's positive news, but is eclipsed by the injectable Ultrafast insulin chosen by Yale University for study in their Artificial Pancreas, Halozyme's Analog Insulin-pH20- ph2 study showed only 5.89 hypoglycemic events in 100 subject-months.
HALO is studying two forms of Ultrafast insulin- a separately injected form in Ph4, and a coformulation of recombinant hyaluronidase and insulin Lispro in Ph2. They will begin reporting on their insulin pump study Consistent-1 in Q1 2014 (see below) and are participating in Yale's Closed Loop Artificial Pancreas study- NCT01945099 currently as well.
Consistent-1 400 patient Phase 4 clinical study - The CONtinuous SubcutaneousInsulin infusion STudy ENrolling Type 1 Diabetes (CONSISTENT 1) - that will evaluate Hylenex use in conjunction with rapid analog insulin in people with Type 1 diabetes using insulin pumps. The primary endpoints include metabolic and safety outcomes.
The Cost to Society of Hypoglycemia is high-
Am J Manag Care. 2011 Oct;17(10):673-80.
The incidence and costs of hypoglycemia in type 2 diabetes.
Quilliam BJ, Simeone JC, Ozbay AB
College of Pharmacy, University of Rhode Island, Kingston, RI
Regardless of age group, rates of hypoglycemia were greater in women than in men (P < .001). Total hypoglycemia costs were $52,223,675 over the study period and accounted for 1.0% of all inpatient costs, 2.7% of ED costs, and 0.3% of outpatient costs. The mean costs for hypoglycemia visits were $17,564 for an inpatient admission, $1387 for an ED visit, and $394 for an outpatient visit.CONCLUSIONS:
- The overall incidence of visits for hypoglycemia was considerable in this large database, and was associated with high per-episode costs. Continued vigilance and the development of strategies to decrease potentially avoidable hypoglycemic episodes requiring medical intervention are needed.
Final Thought- Inhaled "insulin effects are likely to result in increased airway contractility,cell proliferation & fibrosis"- recent research from
Journal of Allergy
Volume 2013 (2013), Article ID 627384
Insulin and the Lung: Connecting Asthma and Metabolic Syndrome
So, Subcutaneous injection, while less space-aged may actually be safer and the best delivery method -until the artificial pancreas is perfected. And Halozyme insulin, which causes far fewer episodes of hypoglycemia than does Mannkind Affrezza, is more cost effective as well.
Disclosure: I am long HALO.