These Phase 2 clinical trials, one in type 1 diabetes patients and the other in type 2 patients, will compare two ultrafast insulin analog products formulated with rHuPH20 to an active comparator, Humalog (insulin lispro). Each study will enroll approximately 110 patients and begins with a 4 to 6 week titration period where patients optimize their basal insulin dosing. Patients will then be randomized to receive either the Lispro-PH20 or Aspart-PH20 investigational study drugs and the active comparator three times daily for 12 weeks each in a random sequence. The primary endpoint of each study will be a comparison of glycemic control, as assessed by the change in A1C from baseline. Data regarding postprandial glucose levels, the proportion of patients that safely achieve A1C targets, rates of hypoglycemia, weight change and additional endpoints will be collected.  

The goal of Halozyme's Ultrafast Insulin program is to develop a best-in-class mealtime insulin product compared to the currently prescribed analogs that participate in the growing $3.8 billion worldwide prandial insulin market. Additional information about these trials can be found at clinicaltrials using the identifiers NCT01194245 and NCT01194258.

SOURCE Halozyme Therapeutics, Inc.