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NCT02215200 · ClinicalTrials.gov registry record · Phase 2
ATG-GCSF in New Onset Type 1 Diabetes
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 89
- Enrollment target
NCT02215200: Completed Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT02215200 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 89 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02215200, 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
- 89 participants
- Enrollment target
Study Summary
This is a three-arm, 1:1:1 randomized, placebo controlled, double- blinded trial in which at least 28 subjects will receive active Anti-Thymocyte Globulin and Granulocyte colony-stimulating factor (ATG-GCSF), at least 28 subjects will receive ATG alone and at least 28 subjects will receive placebo alone within 100 days from diagnosis of Type 1 Diabetes (T1D). The primary objective of the study will be to determine the safety and ability of low dose ATG plus GCSF and low dose ATG alone to retain/enhance C-peptide production in new onset T1D patients demonstrating residual beta cell function.
Primary Outcome
The C-peptide 2 hour area under the curve (AUC) mean is calculated at baseline and 12 months and measured in nmol/L. The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the "AUC mean" and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis").
Interventions
- DRUG Anti-Thymocyte Globulin (ATG)
- DRUG Granulocyte colony stimulating factor (GCSF)
- DRUG Placebo (for ATG)
- DRUG Placebo (for GCSF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2014-12 |
| Est. Completion | 2018-08 |
| Phase | Phase 2 |
What the finished NCT02215200 record still lists
NCT02215200 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 4 interventions - of which Anti-Thymocyte Globulin (ATG) is the first listed.
NCT02215200 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02215200 about?
NCT02215200 is a clinical study titled "ATG-GCSF in New Onset Type 1 Diabetes". This is a three-arm, 1:1:1 randomized, placebo controlled, double- blinded trial in which at least 28 subjects will receive active Anti-Thymocyte Globulin and Granulocyte colony-stimulating factor (ATG-GCSF), at least 28 subjects will receive ATG alone and at least 28 subjects will receive placebo a...
What is the current status of trial NCT02215200?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 89 participants. The study started on 2014-12. Estimated completion is 2018-08.
What interventions are being tested in trial NCT02215200?
The interventions under investigation include: Anti-Thymocyte Globulin (ATG) (DRUG), Granulocyte colony stimulating factor (GCSF) (DRUG), Placebo (for ATG) (DRUG), Placebo (for GCSF) (DRUG).
Who is sponsoring clinical trial NCT02215200?
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 NCT02215200's enrollment target sits among peer trials
89 802nd of 2000 higher than 1,198 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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