Halozyme Therapeutics reports results from a study in type I 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 NovoLogR, accelerates insulin absorption and shortened its duration of action. These preliminary results represent the first reported experience in a clinical trial where patients received rHuPH20 enzyme combined with an insulin analog as a continuous subcutaneous insulin infusion (CSII) over 72 hours administered with an insulin pump.
The first stage of this double blind crossover design phase I clinical trial compared Aspart-PH20 to aspart alone in type 1 diabetes patients who administered their insulin over 72 hours with an insulin pump. The cumulative insulin exposure during the first 60 minutes following a bolus infusion was 64% greater for the Aspart-PH20 formulation compared to aspart alone (p < 0.0001). Insulin exposure beyond 2 hours after the bolus decreased by 42% for the combination compared to aspart alone (p = 0.0003). These results clearly demonstrate the faster-in/faster-out pharmacokinetic (PK) profile for the combination Aspart-PH20. The faster PK also translated into accelerated insulin action for the combination treatment. As demonstrated with a euglycemic clamp procedure, Aspart-PH20 action in the first 2 hours was 20% greater relative to aspart alone (p =0.047) with 37% less insulin action beyond 4 hours after injection (p = 0.008).
These results have been obtained for the first 13 patients and enrollment of an additional 5 patients is continuing for the aspart stage of the study. So far, the overall safety and adverse event profiles for Aspart-PH20 and aspart alone were comparable and both treatments were well tolerated. Additional parameters important for pump use are being tested, with data available later in 2011.