Halozyme Initiates Phase II Diabetes Trial

Halozyme Therapeutics started a Phase II study of recombinant human hyaluronidase enzyme (rHuPH20) co-formulations with Humulin R (regular insulin human injection) and with Humalog (insulin lispro) in Type 1 diabetic patients. This study is designed to compare glycemic control of a standardized liquid meal challenge and insulin pharmacokinetics (PK) after administration of each of four study drugs: Humulin R with and without rHuPH20 and Humalog with and without rHuPH20.

     This crossover design, single blind, open label study is designed to collect data on at least 20 patients who complete the study. The study allows for insulin dose titration and each patient will receive a minimum of four and as many as three additional study drug injections that include Humalog and Humulin R with and without rHuPH20. Study drug will be injected subcutaneously into the abdomen immediately prior to ingestion of a standardized liquid meal.

     The primary endpoint will be a PK measure of the plasma insulin concentration from zero to 60 minutes after injection. Secondary endpoints will include additional PK data, as well as blood glucose concentration at various time points. Safety data such as adverse reactions, hypoglycemia, blood chemistry, and injection site tolerability will be collected, measured and evaluated. Patients may be on study for as long as 14 weeks from screening to completion. Results from the study are expected in mid-2009.

     A Phase I euglycemic clamp study in 26 volunteer subjects who received an injection of Humulin R or Humalog with and without rHuPH20, showed that the co-injections were well tolerated and demonstrated faster insulin absorption and shorter time to peak concentration for the insulin plus enzyme combination compared to insulin alone. Metabolic effects such as glucose lowering activity for the combination of insulin plus rHuPH20 were also greater and occurred earlier than for insulin administered alone. Also, the combination of Humulin plus rHuPH20 demonstrated faster insulin absorption and a shorter time to peak concentration when compared to Humalog alone.