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NCT01526733 · ClinicalTrials.gov registry record · Phase 4
Randomized, Double Blind, 2 Way Crossover Study of CSII With, Versus Without, Pretreatment With Human Hyaluronidase
A Phase 4 study, sponsored by Halozyme Therapeutics.
- Completed
- Registry status
- Phase 4
- Development phase
- 25
- Enrollment target
NCT01526733: Completed Phase 4 study, sponsored by Halozyme Therapeutics.
NCT01526733 is a Phase 4 study that has completed, run by Halozyme Therapeutics. The registered enrollment target is 25 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01526733, a Phase 4 study, has completed, sponsored by Halozyme Therapeutics.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 25 participants
- Enrollment target
Study 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.
Primary Outcome
Early insulin exposure, defined as the percentage of total insulin exposure (area under the insulin concentration curve \[AUC{0 360}\]) that occurs within the first hour following bolus dose of insulin during the 2 euglycemic clamps is presented. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, and 60 minutes postdose during a euglycemic clamp.
Interventions
- DRUG Insulin aspart
- DRUG Sham Injection
- DRUG Insulin lispro
- DRUG Recombinant human hyaluronidase PH20
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-09 |
| Phase | Phase 4 |
What the finished NCT01526733 record still lists
NCT01526733 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 4 interventions - of which Insulin aspart is the first listed.
NCT01526733 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01526733 about?
NCT01526733 is a clinical study titled "Randomized, Double Blind, 2 Way Crossover Study of CSII With, Versus Without, Pretreatment With Human Hyaluronidase". 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 infusi...
What is the current status of trial NCT01526733?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2011-12. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01526733?
The interventions under investigation include: Insulin aspart (DRUG), Sham Injection (DRUG), Insulin lispro (DRUG), Recombinant human hyaluronidase PH20 (DRUG).
Who is sponsoring clinical trial NCT01526733?
This trial is sponsored by Halozyme Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01526733's enrollment target sits among peer trials
25 1669th of 2000 higher than 302 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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