drugset / Trial / NCT01526733

Randomized, Double Blind, 2 Way Crossover Study of CSII With, Versus Without, Pretreatment With Human Hyaluronidase

NCT01526733

Phase 4 Completed 25 enrolled Halozyme Therapeutics
RandomizedCrossoverTriple-blindTreatment

Summary

The purpose of this study is to evaluate consistency of accelerated insulin absorption and onset-of-action and shortened duration of action for bolus insulin infusions after pretreatment with 150 units (U) of Hylenex® (recombinant human hyaluronidase PH20 \[rHuPH20\]) injection at the time of infusion set insertion compared to sham injection.

Timeline

Start
2011-12
Primary completion
2012-08
Completion
2013-09

Drugs

EvaluationDrugModalityDoseRoute
Subject rHuPH20 Protein / enzyme biologic 150 iu Other
Background Insulin Lispro Protein / enzyme biologic 0.15 iu/kg Subcutaneous
Background insulin aspart Protein / enzyme biologic 0.15 iu/kg Subcutaneous