SAN DIEGO, March 31, 2014 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the primary endpoint of non-inferiority of A1C levels at six months was met for the CONSISTENT 1 trial. The trial is evaluating Hylenex ® recombinant and a new formulation of Hylenex currently under U.S Food and Drug Administration (FDA) review, when used as pretreatment of the insulin infusion site in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion (CSII) in comparison to no pre-treatment. In accordance with the trial protocol pre-specified analysis of the endpoints, data from the two patient groups treated with Hylenex formulations (treatment groups) were pooled in comparison to a group consisting of patients using standard CSII with rapid acting analog insulin alone (control group). Adverse events were similar across the treatment and control groups. The most common treatment related adverse event in the Hylenex groups was mild infusion site discomfort.
With respect to secondary endpoints, the rate of overall hypoglycemic events (serum glucose of ≤70mg/dL) in the combined treatment groups was reduced by 12% (p=.08) compared to the control group. In addition, the rate of hypoglycemic events where serum glucose was<56mg/dL was reduced by 23% (p=.02) in the combined treatment groups compared to the control group. The rate of nocturnal hypoglycemia events (≤70mg/dL) was reduced by 21% (p=.02) in the combined treatment groups in comparison to the control group. The rate of severe hypoglycemic events (i.e. those requiring the assistance of a third party) was reduced by 61% (p=.08) in the combined treatment groups, in comparison to the control group. Glycemic excursions after meals, and glucose variability as assessed by blood glucose standard deviation, were not different between treatment groups versus the control group.
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