Halozyme Initiates Patient Dosing In Phase 2 Diabetes Trial

Halozyme has initiated patient dosing in a Phase 2 clinical study of Insulin-PH20 in patients with type 2 diabetes mellitus.

The company said that the phase 2 study would investigate the pharmacokinetics and glucodynamics of insulin lispro+PH20 and regular insulin+PH20 versus lispro alone.

The primary endpoint of the study is the glycemic excursion over the first four hours. Secondary endpoints include the comparison of optimum doses of insulin required for glycemic control, as well as various PK, PD and safety endpoints.

Douglas Muchmore, vice president of clinical development for endocrinology at Halozyme, said: “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.

“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, he added.