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

NCT01526733 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-02-26

Study results available
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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

DRUG

Sham Injection

DRUG

Recombinant human hyaluronidase PH20

DRUG

Insulin aspart

DRUG

Insulin lispro

Sponsors & Collaborators

  • Halozyme Therapeutics

    lead INDUSTRY

Principal Investigators

  • Linda Morrow, MD · Profil Institute for Clinical Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-08-31
Completion
2013-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01526733 on ClinicalTrials.gov