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NCT00883558 · ClinicalTrials.gov registry record · Phase 2
Safety Study of Subcutaneously-Injected Prandial INSULIN-PH20 NP Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes Mellitus
A Phase 2 study of Diabetes Mellitus, Type 1, sponsored by Halozyme Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 8
- Study locations
NCT00883558: Completed Phase 2 study of Diabetes Mellitus, Type 1, sponsored by Halozyme Therapeutics.
NCT00883558 is a Phase 2 study of Diabetes Mellitus, Type 1 that has completed, run by Halozyme Therapeutics. The registered enrollment target is 48 participants, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (96% lower). The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00883558, a Phase 2 study of Diabetes Mellitus, Type 1, has completed, sponsored by Halozyme Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 8
- Study locations
Study Summary
Insulin lispro is approved by the Food and Drug Administration (FDA) 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 combined with a non-preserved (NP) formulation of regular human insulin (INSULIN-PH20 NP) will be compared to insulin lispro with respect to absorption and action of insulin.
Primary Outcome
A 2-hour postprandial glucose excursion was measured for 3 meals over 3 days during each treatment cycle (3 days during Week 14 of the first treatment cycle and 3 days during Week 26 of the second treatment cycle). For each of the 3 days, the mealtime (breakfast, lunch, and dinner) excursions were calculated as the post-meal glucose value minus the pre-meal value as determined by 8-point glucose monitoring. The average of all excursions over the 3 days for the corresponding treatment cycle is pr
Conditions Studied
Interventions
- DRUG Insulin glargine
- DRUG Insulin Lispro
- DRUG regular human insulin
- DRUG recombinant human hyaluronidase PH20
Study Locations (8)
Colorado
- Barbara Davis Center for Childhood Diabetes - Aurora
Florida
- Diabetes Research Institute - Miami
Michigan
- Henry Ford Health System - Detroit
Montana
- Mercury Street Medical - Butte
North Carolina
- UNC Diabetes Care Center/Highgate Specialty Center - Durham
Ohio
- Cleveland Clinic - Cleveland
Texas
- Texas Diabetes and Endocrinology - Austin
Washington
- West Olympia Internal Medicine - Olympia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2009-05 |
| Est. Completion | 2010-04 |
| Phase | Phase 2 |
What the finished NCT00883558 record still lists
NCT00883558 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 4 interventions - of which Insulin glargine is the first listed.
NCT00883558 lists 8 locations in 8 states (Colorado, Florida, Michigan).
Frequently Asked Questions
What is clinical trial NCT00883558 about?
NCT00883558 is a clinical study titled "Safety Study of Subcutaneously-Injected Prandial INSULIN-PH20 NP Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes Mellitus". Insulin lispro is approved by the Food and Drug Administration (FDA) 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 combined with a non-preserved (NP...
What is the current status of trial NCT00883558?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2009-05. Estimated completion is 2010-04.
What conditions does trial NCT00883558 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1.
What interventions are being tested in trial NCT00883558?
The interventions under investigation include: Insulin glargine (DRUG), Insulin Lispro (DRUG), regular human insulin (DRUG), recombinant human hyaluronidase PH20 (DRUG).
Who is sponsoring clinical trial NCT00883558?
This trial is sponsored by Halozyme Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00883558 being conducted?
This trial has 8 study locations across Colorado, Florida, Michigan, Montana, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 1
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00883558's enrollment target sits among peer trials
48 77th of 118 higher than 41 of 118 other Diabetes Mellitus, Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 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.
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