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)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |