Halozyme Therapeutics announced the initiation of two Phase 2 Ultrafast Insulin treatment studies that utilize its rHuPH20 hyaluronidase enzyme (PH20) for the treatment of type 1 and type 2 diabetes. The two 12-week studies will compare rHuPH20 in combination with insulin aspart or insulin lispro to the active comparator, insulin lispro (Humalog, from Lilly), alone. 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 HbA1c from baseline. Data regarding postprandial glucose levels, the proportion of patients that safely achieve HbA1c targets, rates of hypoglycemia, weight change and additional endpoints will be collected.
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