Halozyme Therapeutics announced results from CONSISTENT 1, a trial evaluating the use of Hylenex recombinant (hyaluronidase human injection) and a new formulation of Hylenex when used as pretreatment at the insulin infusion site in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion in comparison to no pre-treatment, at the 2014 American Diabetes Association Scientific Sessions.
The CONSISTENT 1 (CONtinuous Subcutaneous Insulin infusion STudy ENrolling Type 1 Diabetes) trial is evaluating the safety and efficacy of Hylenex recombinant and a new formulation of Hylenex under FDA review in a six-month trial with an 18-month extension phase in 455 patients with type 1 diabetes. The primary efficacy endpoint is a comparison of the change from baseline in A1C levels at six months.
RELATED: Investigational Diabetes Therapy May Reduce HbA1c
Results demonstrated that the study’s primary endpoint of non-inferiority for A1C at six months between the use of Hylenex and the new formulation of Hylenex in comparison to no pre-treatment was met. In addition to other trial data, the poster also presented data indicating that there was a potential reduction in the rate of hypoglycemic events associated with the use of the Hylenex formulations in comparison to no pre-treatment.
Hylenex recombinant is a tissue permeability modifier indicated as an adjuvant to increase the dispersion and absorption of other injected or subcutaneously infused drugs, to facilitate subcutaneous fluid administration and in subcutaneous urography.
For more information visit Halozyme.com.