NCT01526733

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

A Phase 4, Randomized, Double-Blind, 2-Way Crossover Study of Continuous Subcutaneous Insulin Infusion (CSII) With, Compared to Without, Pretreatment With Recombinant Human Hyaluronidase (rHuPH20)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Halozyme Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Sham Injection
DRUG	Recombinant human hyaluronidase PH20
DRUG	Insulin aspart
DRUG	Insulin lispro

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-08-01
• Completion: 2013-09-01
• First posted: 2012-02-06
• Last updated: 2019-02-26
• Results posted: 2014-09-29

Locations

1 site across 1 country: United States