Halozyme Begins Phase 2 Clinical Trial of Insulin-PH20 in Type 2 Diabetic Patients

Halozyme Therapeutics, Inc. (Nasdaq:HALO) today announced the commencement of patient dosing in a Phase 2 clinical study of Insulin-PH20 in patients with Type 2 Diabetes Mellitus. This randomized cross-over design study is designed to compare the postprandial glycemic excursions following a standardized test meal after treatment with either insulin lispro+PH20 or regular insulin+PH20 relative to treatment with lispro (Humalog) alone.

"This study is designed to confirm in type 2 diabetes patients the benefit of reduced postprandial hyperglycemia observed in a previous Phase 2 study conducted in type 1 diabetes patients for which interim results were reported earlier this year," explained Douglas Muchmore, M.D., Halozyme's vice president of clinical development for endocrinology. "Unlike the previous study where identical doses of lispro were given with and without PH20 to facilitate a direct pharmacokinetic comparison, the doses of each of the three drugs will be titrated independently in this study to directly compare the glycemic response under optimum treatment conditions."

This Phase 2 study will investigate the pharmacokinetics (PK) and glucodynamics of insulin lispro+PH20 and regular insulin+PH20 versus lispro alone. The primary endpoint of this study is the glycemic excursion over the first 4 hours. Secondary endpoints include the comparison of optimum doses of insulin required for glycemic control, as well as various PK, PD and safety endpoints. A number of clinical trials investigating Halozyme's Insulin-PH20 are currently underway and more trials are planned.