Halozyme Therapeutics has announced final results from a study in type 1 diabetes patients who receive their insulin treatment with a pump demonstrating that Aspart-PH20, a formulation of Halozyme's rHuPH20 (recombinant human hyaluronidase) with the active ingredient in NovoLog, reduces the variability of insulin absorption and reduces post-meal glycemic excursions compared to NovoLog alone.
Halozyme presented these findings in a late-breaking poster titled: "Addition of Human Hyaluronidase to Rapid Analog Insulin Reduces the Absolute Variability of Early Insulin Absorption across Infusion Set Life" at the American Diabetes Association 71st Scientific Sessions June 26 in San Diego.
The double-blind crossover design phase I clinical trial compared Aspart-PH20 to Aspart alone in 16 type 1 diabetes patients who administered their insulin over 72 hours with an insulin pump. The data demonstrated the following key results: addition of rHuPH20 reduced the absolute variability of early insulin absorption over the 72-hour infusion set life; addition of rHuPH20 to aspart consistently reduced post-meal glycemic excursions compared to NovoLog alone over the 72-hour infusion set life; infusion site biopsy data from patients supports the safety of the rHuPH20 enzyme, its local and transient effect at the skin infusion site, and full restoration of hyaluronan within 24 hours after cannula removal; and individual patient skin biopsy histopathology data demonstrated similar tolerability for Aspart-PH20 compared to NovoLog.
"Patients on an insulin pump face unique challenges over the their three-day infusion cycle as analog insulin tends to be absorbed differently over the course of the infusion set life," stated William V. Tamborlane, M.D., Yale University School of Medicine. "Reduced absorption variability attributed to the coadministration of rHuPH20 with analog insulin may offer an intriguing solution to this problem."
The findings from this pump study indicate that the absorption of analog insulin is slowest early in the infusion set life. As a result of these scientific observations, Halozyme has initiated a proof-of-concept study to investigate the administration of a single dose of rHuPH20 at the catheter site before starting the insulin infusion with a pump for a three-day treatment cycle. The presence of rHuPH20 used in this leading edge design may serve to "prime the pump" and reduce the variability of absorption associated with the aging of an infusion set.