drugset / Trial / NCT01848990

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

Phase 4 Completed 456 enrolled Halozyme Therapeutics
RandomizedFactorialOpen-labelTreatment

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.

Timeline

Start
2013-03
Primary completion
2014-02
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Subject hyaluronidase human injection Unknown 150 iu Subcutaneous
Background Insulin Lispro Protein / enzyme biologic Subcutaneous
Background Insulin glulisine Protein / enzyme biologic Subcutaneous
Background insulin aspart Protein / enzyme biologic Subcutaneous