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)

• Status: Completed
• Trial end date: 2014-09-01

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.

• Phase: Phase 4

Details

• Lead Sponsor: Halozyme Therapeutics
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin glulisine; Insulin Lispro; Insulin, Globin Zinc; Insulin, Long-Acting