VIENNA – Pretreating cannulas with a recombinant human hyaluronidase reduces the risk of hypoglycemia in patients with type 1 diabetes using insulin pumps, according to the results of a phase IV study.
In CONSISTENT-1 (Continuous Subcutaneous Insulin Infusion Study Enrolling Type 1), there were 23% fewer hypoglycemic events, defined as a blood glucose level below 56 mg/dL, and 21% fewer nocturnal hypoglycemic events in patients who received the infusion site pretreatment, compared with those who did not.
Importantly, the primary endpoint of noninferiority for glycemic control after 6 months was achieved, with comparable final mean and mean change from baseline hemoglobin A1c results.
“Current rapid-acting analogue insulin preparations are too slow to mimic the physiologic insulin meal response,” Dr. Jay Skyler, a study investigator with the University of Miami, explained at the annual meeting of the European Association for the Study of Diabetes.
He noted that hyaluronidase has been used for more than 60 years and recombinant human hyaluronidase (rHuPH20) is approved by the Food and Drug Administration as a means of improving the dispersion and absorption of injected or infused drugs. “Previously, we have demonstrated that adding recombinant human hyaluronidase [Halozyme Therapeutics’ Hylex] to rapid-acting insulin preparations accelerates the absorption and action of insulin,” Dr. Skyler said.
In this study, rHuPH20 was given in a single injection into the cannula prior to the placement of a pump for continuous subcutaneous insulin infusion (CSII), but Dr. Skyler observed that it could also be coformulated with insulin for use in pens or vials.