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NCT00529399 · ClinicalTrials.gov registry record · Phase 2
Effects of Recombinant Human Glutamic Acid Decarboxylase on the Progression of Type 1 Diabetes in New Onset Subjects
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 145
- Enrollment target
NCT00529399: Completed Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT00529399 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 145 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00529399, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 145 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether treatment with multiple injections of GAD-Alum will preserve the body's own (endogenous) insulin production in patients who have been recently diagnosed with type 1 diabetes mellitus (T1DM).
Primary Outcome
The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes.
Interventions
- DRUG GAD-Alum
- DRUG GAD-Alum and Aluminum hydroxide
- DRUG Aluminum hydroxide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2009-02 |
| Est. Completion | 2012-05 |
| Phase | Phase 2 |
What the finished NCT00529399 record still lists
NCT00529399 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which GAD-Alum is the first listed.
NCT00529399 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00529399 about?
NCT00529399 is a clinical study titled "Effects of Recombinant Human Glutamic Acid Decarboxylase on the Progression of Type 1 Diabetes in New Onset Subjects". The purpose of this study is to determine whether treatment with multiple injections of GAD-Alum will preserve the body's own (endogenous) insulin production in patients who have been recently diagnosed with type 1 diabetes mellitus (T1DM).
What is the current status of trial NCT00529399?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 145 participants. The study started on 2009-02. Estimated completion is 2012-05.
What interventions are being tested in trial NCT00529399?
The interventions under investigation include: GAD-Alum (DRUG), GAD-Alum and Aluminum hydroxide (DRUG), Aluminum hydroxide (DRUG).
Who is sponsoring clinical trial NCT00529399?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00529399's enrollment target sits among peer trials
145 498th of 2000 higher than 1,501 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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