Consistent I

CONtinuous Subcutaneous Insulin Infusion STudy ENrolling Type 1 (CONSISTENT 1) 1: Evaluation of Metabolic Outcomes and Safety of Hylenex Recombinant (Hyaluronidase Human Injection) Used as a Preadministration Infusion Site Treatment in Subjects With Type 1 Diabetes (T1DM) Using Continuous Subcutaneous Insulin Infusion (CSII)

Consistent I [NCT01848990]

Description: The primary objectives of this study are to compare the difference in A1C from baseline to month 4 using Hylenex recombinant preadministration in CSII versus standard CSII and to evaluate the safety of Hylenex recombinant preadministration, including local tolerability, immunogenicity, adverse events and hypo- and hyperglycemia rates.

Drug: Commercial Hylenex® recombinant (hyaluronidase human injection);
Drug: Pre-commercial formulation of Hylenex recombinant (hyaluronidase human injection);
Procedure: Preadministration of commercial Hylenex® recombinant (hyaluronidase human injection);
Procedure: Preadministration of pre-commercial Hylenex recombinant (hyaluronidase human injection);
Device: Continuous Subcutaneous Insulin Infusion (CSII) via insulin infusion pumps

Primary Investigator: Kereiakes

Drug/Device Information
Hylenex recombinant as preadministration infusion site treatment in T1DM on continuous subcutaneous insulin infusion
Hylenex recombinant (hyaluronidase human injection) is a tissue permeability modifier to increase absorption and dispersion
Randomized to open label pre-commercial Hylenex, commercial Hylenex or control
Halozyme Therapeutics, Inc.
Major Inclusion and Exclusion
Age 18 or older with T1DM for at least 12 months and Insulin dose <300 U/day
A1C between 6.5 - 9.5 % and Fasting C-peptide < 0.6 ng/mL
No severe proliferative retinopathy, maculopathy, MI, CHF or uncontrolled HTN
Must be currently using an insulin pump and tubing compatible with Hylenex or willingness to switch to compatible system