CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 14 enrolled
Drug / intervention
Rapid Acting insulin with pre-treatment of rHuPH20 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03662334
NCT03662334Phase 4Completed
CompareCT.gov

A Phase 4, Double Blind, Single Center, Randomized, Cross-Over Study of Continuous Subcutaneous Insulin Infusion (CSII) Pump Functionality in Subjects With Type 1 Diabetes Comparing Pretreatment vs. No Pretreatment With Recombinant Human Hyaluronidase (rHuPH20)

Halozyme Therapeutics·interventional·Posted Sep 7, 2018·Updated Feb 1, 2019

In Brief

A Phase 4 clinical trial evaluating Rapid Acting insulin with pre-treatment of rHuPH20 and Sham injection for Type 1 Diabetes Mellitus. Completed, enrolled 14 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 7, 2018
Enrollment StartOct 3, 2013
Primary CompletionFeb 27, 2014
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.8 years ago

Interventions

Rapid Acting insulin with pre-treatment of rHuPH20drug

Hylenex recombinant will be administered via infusion sets and insulin pumps. These will be compatible with component tubing system attached to the insulin infusion site and will be placed in the lower abdominal area.

Sham injectiondevice

A sham injection will be administered via infusion sets and insulin pumps. These will be compatible with component tubing system attached to the insulin infusion site and will be placed in the lower abdominal area.