drugset / Trial / NCT03662334

A Study of Continuous Subcutaneous Insulin Infusion (CSII) Pump Function in Subjects With Type 1 Diabetes With Recombinant Human Hyaluronidase (rHuPH20)

NCT03662334 ↗

Phase 4 Completed 14 enrolled Halozyme Therapeutics
RandomizedCrossoverTriple-blindTreatment

Summary

The goal of this study is to determine if Hylenex recombinant leads to changes in the insulin time-action profiles and glucose responses when preadministered in the setting of continuous subcutaneous insulin infusion (CSII) compared to CSII without Hylenex recombinant (sham injection).

Timeline

Start
2013-10-03
Primary completion
2014-02-27
Completion
2014-02-27

Outcome

Met primary endpoint

release “the primary endpoint of non-inferiority of A1C levels at six months was met for the CONSISTENT 1 trial” halozyme.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject rHuPH20 Protein / enzyme biologic — Subcutaneous
Background Insulin Lispro Protein / enzyme biologic — Subcutaneous