Quite frankly I am surprised HALO moved up so much or maybe I (naively) thought non-inferiority was highly likely. I actually had hoped that there may be some reduced side effects.
Halozyme Announces Positive Results From Phase 2 Ultrafast Insulin Trials in Patients with Type 1 and Type 2 Diabetes
PH20-prandial insulin analogs achieve primary HbA1C endpoint with superior management of post-prandial glucose compared to the insulin analogs available today
SAN DIEGO, Oct. 21, 2011 /PRNewswire via COMTEX/ --
Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the diabetes, cancer, dermatology and drug delivery markets, today announced positive results from two Phase 2 clinical trials of its ultrafast PH20 insulin analog formulations in patients with Type 1 and Type 2 diabetes. Both trials met the primary endpoint of non-inferiority of HbA1C compared to the insulin analog comparator, with superior reductions in post-prandial glucose excursions in the PH20 insulin analog arms. Compared to insulin analog alone, PH20 insulin analog use resulted in a greater than 50% increase in the proportion of patients able to consistently achieve AACE (American Association of Clinical Endocrinologists) guidelines for post-prandial glucose targets in both Type 1 and Type 2 patients. Across all of the treatment groups, there was no meaningful difference in hypoglycemia incidence or event rates. Hypoglycemia events were generally mild, and adverse events with PH20 insulin analog formulations were similar to those observed during the insulin analog comparator phase.
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