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NCT00979875 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic and Glucodynamic Study of Subcutaneously Administered Insulin Analogs With rHuPH20 Compared to Insulin Analogs Alone
A Phase 1 study, sponsored by Halozyme Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT00979875: Completed Phase 1 study, sponsored by Halozyme Therapeutics.
NCT00979875 is a Phase 1 study that has completed, run by Halozyme Therapeutics. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00979875, a Phase 1 study, has completed, sponsored by Halozyme Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This is a single-center, Phase 1, randomized, double-blind, 6-way crossover study to determine insulin pharmacokinetics, insulin glucodynamics, safety, and tolerability of subcutaneously administered dose(s) of insulin lispro + recombinant human hyaluronidase PH20 (rHuPH20), insulin lispro alone, insulin glulisine + rHuPH20, insulin glulisine alone, insulin aspart + rHuPH20, and insulin aspart alone.
Primary Outcome
Area under the concentration (AUC)-time curve was derived as the area under the serum insulin concentration profile from 0 to 60 minutes. Blood samples were taken 30, 20, and 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); and at 20, 25, 30, 45, and 60 mins after each injection.
Interventions
- DRUG Insulin aspart
- DRUG Insulin lispro
- DRUG Insulin glulisine
- DRUG Recombinant human hyaluronidase PH20 (rHuPH20)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2009-09 |
| Est. Completion | 2010-05 |
| Phase | Phase 1 |
What the finished NCT00979875 record still lists
NCT00979875 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 4 interventions - of which Insulin aspart is the first listed.
NCT00979875 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00979875 about?
NCT00979875 is a clinical study titled "A Pharmacokinetic and Glucodynamic Study of Subcutaneously Administered Insulin Analogs With rHuPH20 Compared to Insulin Analogs Alone". This is a single-center, Phase 1, randomized, double-blind, 6-way crossover study to determine insulin pharmacokinetics, insulin glucodynamics, safety, and tolerability of subcutaneously administered dose(s) of insulin lispro + recombinant human hyaluronidase PH20 (rHuPH20), insulin lispro alone, in...
What is the current status of trial NCT00979875?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2009-09. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00979875?
The interventions under investigation include: Insulin aspart (DRUG), Insulin lispro (DRUG), Insulin glulisine (DRUG), Recombinant human hyaluronidase PH20 (rHuPH20) (DRUG).
Who is sponsoring clinical trial NCT00979875?
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 NCT00979875's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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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