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NCT00862849 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic and Glucodynamic Crossover Study of Subcutaneously (SC) Administered Insulin Lispro + Recombinant Human Hyaluronidase (rHuPH20) and Regular Human Insulin + rHuPH20 Compared to Insulin Lispro Alone
A Phase 1 study, sponsored by Halozyme Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT00862849: Completed Phase 1 study, sponsored by Halozyme Therapeutics.
NCT00862849 is a Phase 1 study that has completed, run by Halozyme Therapeutics. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00862849, a Phase 1 study, has completed, sponsored by Halozyme Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
Insulin lispro and regular human insulin are Food and Drug Administration (FDA)-approved medications for the treatment of diabetes mellitus. Recombinant human hyaluronidase (rHuPH20) is approved by the FDA as an aid to the absorption and dispersion of other injectable drugs. In this study, rHuPH20 will be co-administered with both insulin lispro and regular human insulin in order to determine if it improves the absorption of these insulins to more closely mimic the body's natural increase in insulin in response to a meal.
Primary Outcome
Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); and every 5 mins (from 15 to 30 mins) after each injection. The percent coefficient of variation (CV%) was calculated as 100\*(standard deviation/mean). The intra-participant CV% was calculated directly from the 2 replications of each treatment. The CV% for percentage of total AUC is reported from 0 to 30 minutes.
Interventions
- DRUG rHuPH20
- DRUG Insulin Lispro
- DRUG Regular Human Insulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2009-03 |
| Est. Completion | 2009-08 |
| Phase | Phase 1 |
What the finished NCT00862849 record still lists
NCT00862849 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 3 interventions - of which rHuPH20 is the first listed.
NCT00862849 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00862849 about?
NCT00862849 is a clinical study titled "Pharmacokinetic and Glucodynamic Crossover Study of Subcutaneously (SC) Administered Insulin Lispro + Recombinant Human Hyaluronidase (rHuPH20) and Regular Human Insulin + rHuPH20 Compared to Insulin Lispro Alone". Insulin lispro and regular human insulin are Food and Drug Administration (FDA)-approved medications for the treatment of diabetes mellitus. Recombinant human hyaluronidase (rHuPH20) is approved by the FDA as an aid to the absorption and dispersion of other injectable drugs. In this study, rHuPH20 w...
What is the current status of trial NCT00862849?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2009-03. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00862849?
The interventions under investigation include: rHuPH20 (DRUG), Insulin Lispro (DRUG), Regular Human Insulin (DRUG).
Who is sponsoring clinical trial NCT00862849?
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 NCT00862849's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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