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NCT02002130 · ClinicalTrials.gov registry record · Phase 1
The Use of Glutamic Acid Decarboxylase (GAD) and Gamma-Amino Butyric Acid (GABA) in the Treatment of Type I Diabetes
A Phase 1 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 1
- Development phase
- 101
- Enrollment target
NCT02002130: Completed Phase 1 study, sponsored by University of Alabama at Birmingham.
NCT02002130 is a Phase 1 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 101 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02002130, a Phase 1 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 101 participants
- Enrollment target
Study Summary
Type I Diabetes is an auto immune disease in which the body's immune system attacks and destroys the insulin-producing beta cells of the pancreas. Therefore, children affected by this condition present with high blood sugars. This condition affects 1:400/500 persons worldwide.Type I Diabetes, previously known as Juvenile Diabetes,usually strikes in childhood, adolescence, or young adulthood, but lasts for a lifetime. To date, there has been no treatments that can arrest, or reverse the ongoing beta cell destruction. We hypothesize that GABA, a naturally occurring substance, has the potential to reduce the inflammation and protect the pancreatic beta cells from autoimmune destruction. GAD-alum may contribute to the preservation of residual insulin secretion in patients with recent onset, Type I Diabetes.
Primary Outcome
This will be assessed by meal stimulated c-peptide secretion in treatment cohorts compared to age matched placebo controls before and after 1 year of treatment.
Interventions
- DRUG Placebo GABA and Placebo GAD-alum
- DRUG GABA and Placebo GAD-alum
- DRUG Active Oral GABA and Active GAD-alum injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2015-01 |
| Est. Completion | 2022-04-15 |
| Phase | Phase 1 |
What the finished NCT02002130 record still lists
NCT02002130 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo GABA and Placebo GAD-alum is the first listed.
NCT02002130 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02002130 about?
NCT02002130 is a clinical study titled "The Use of Glutamic Acid Decarboxylase (GAD) and Gamma-Amino Butyric Acid (GABA) in the Treatment of Type I Diabetes". Type I Diabetes is an auto immune disease in which the body's immune system attacks and destroys the insulin-producing beta cells of the pancreas. Therefore, children affected by this condition present with high blood sugars. This condition affects 1:400/500 persons worldwide.Type I Diabetes, previo...
What is the current status of trial NCT02002130?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 101 participants. The study started on 2015-01. Estimated completion is 2022-04-15.
What interventions are being tested in trial NCT02002130?
The interventions under investigation include: Placebo GABA and Placebo GAD-alum (DRUG), GABA and Placebo GAD-alum (DRUG), Active Oral GABA and Active GAD-alum injection (DRUG).
Who is sponsoring clinical trial NCT02002130?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02002130's enrollment target sits among peer trials
101 546th of 2000 higher than 1,455 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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