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CONSISTENT 1: Metabolic and Safety Outcomes of Hylenex Recombinant (Hyaluronidase Human Injection) Preadministered at CSII Infusion Site in Participants With Type 1 Diabetes Mellitus (T1DM)

NCT01848990 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 456

Last updated 2018-11-07

Study results available
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Summary

The primary objectives of this study are to compare the difference in glycosylated hemoglobin (HbA1c) from baseline to Month 6 using Hylenex recombinant preadministration in continuous subcutaneous insulin infusion (CSII) versus standard CSII and to evaluate the safety of Hylenex recombinant preadministration, including local tolerability, adverse events, and hypo- and hyperglycemia rates.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Commercial Hylenex® recombinant (hyaluronidase human injection)

DRUG

Precommercial Hylenex recombinant (hyaluronidase human injection)

DRUG

Insulin lispro

DRUG

Insulin aspart

DRUG

Insulin glulisine

Sponsors & Collaborators

  • Halozyme Therapeutics

    lead INDUSTRY

Principal Investigators

  • Douglas Muchmore, MD · Halozyme Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-02-28
Completion
2014-09-30

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 NCT01848990 on ClinicalTrials.gov