At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 25 enrolled
Drug / intervention
Sham Injection +3 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.
A Phase 4, Randomized, Double-Blind, 2-Way Crossover Study of Continuous Subcutaneous Insulin Infusion (CSII) With, Compared to Without, Pretreatment With Recombinant Human Hyaluronidase (rHuPH20)
In Brief
A Phase 4 clinical trial evaluating Sham Injection, Recombinant human hyaluronidase PH20, and 2 other interventions for Type 1 Diabetes Mellitus. Completed, enrolled 25 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate consistency of accelerated insulin absorption and onset-of-action and shortened duration of action for bolus insulin infusions after pretreatment with 150 units (U) of Hylenex® (recombinant human hyaluronidase PH20 \[rHuPH20\]) injection at the time of infusion set insertion compared to sham injection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2011
First PostedFeb 2012
Primary CompletionAug 2012
Study CompletionSep 2013
TodayJul 2026
First PostedFeb 6, 2012
Enrollment StartDec 1, 2011
Primary CompletionAug 1, 2012
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.4 years ago
Interventions
Sham Injectiondrug
Recombinant human hyaluronidase PH20drug
Insulin aspartdrug
Insulin lisprodrug