Halozyme reports positive results from Phase II ultrafast insulin trials.
M2 PHARMA-October 24, 2011-Halozyme reports positive results from Phase II ultrafast insulin trials(C)2011 M2 COMMUNICATIONS
24 October 2011 - US biopharmaceutical company Halozyme Therapeutics Inc (NASDAQ:HALO) reported on Friday positive results from two Phase II 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 American Association of Clinical Endocrinologists (AACE) 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.
More than 110 patients enrolled in each of the trials and received an insulin analog alone and one of the Analog-PH20 treatments for 12 weeks along with basal insulin glargine. The primary endpoint of each study was a comparison of glycemic control. Data regarding post-prandial glucose levels, the proportion of patients that safely achieve HbA1C targets, rates of hypoglycemia, weight change and additional endpoints were collected as well.
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|Article Type:||Clinical report|
|Date:||Oct 24, 2011|
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