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NCT00774800 · ClinicalTrials.gov registry record · Phase 2
Phase II Pharmacokinetics Study of Humalog and Humulin-R With and Without rHuPH20 in Type 1 Diabetes Mellitus
A Phase 2 study, sponsored by Halozyme Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT00774800: Completed Phase 2 study, sponsored by Halozyme Therapeutics.
NCT00774800 is a Phase 2 study that has completed, run by Halozyme Therapeutics. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00774800, a Phase 2 study, has completed, sponsored by Halozyme Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
Humalog and Humulin-R (recombinant human insulin) are Food and Drug Administration (FDA) approved medications for the treatment of diabetes mellitus. Recombinant human hyaluronidase PH20 (rHuPH20) is approved by the FDA for use as an aid in the absorption and dispersion of other injectable drugs. In this study, rHuPH20 will be co-administered with both Humalog and Humulin-R 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
AUC was derived as the area under the serum insulin concentration profile from 0 to time "t." Samples were taken 30, 20, and 10 minutes (mins) prior to treatment; every 3 mins from mins 0 through 15; and at 20, 30, 45, and 60 mins postdose.
Interventions
- OTHER Liquid meal
- DRUG Humalog
- DRUG Humulin-R
- DRUG Recombinant human hyaluronidase PH20 (rHuPH20)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2008-10 |
| Est. Completion | 2009-03 |
| Phase | Phase 2 |
What the finished NCT00774800 record still lists
NCT00774800 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 4 interventions - of which Liquid meal is the first listed.
NCT00774800 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00774800 about?
NCT00774800 is a clinical study titled "Phase II Pharmacokinetics Study of Humalog and Humulin-R With and Without rHuPH20 in Type 1 Diabetes Mellitus". Humalog and Humulin-R (recombinant human insulin) are Food and Drug Administration (FDA) approved medications for the treatment of diabetes mellitus. Recombinant human hyaluronidase PH20 (rHuPH20) is approved by the FDA for use as an aid in the absorption and dispersion of other injectable drugs. In...
What is the current status of trial NCT00774800?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2008-10. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00774800?
The interventions under investigation include: Liquid meal (OTHER), Humalog (DRUG), Humulin-R (DRUG), Recombinant human hyaluronidase PH20 (rHuPH20) (DRUG).
Who is sponsoring clinical trial NCT00774800?
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 NCT00774800's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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