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NCT01781975 · ClinicalTrials.gov registry record · Phase 2
Imatinib Treatment in Recent Onset Type 1 Diabetes Mellitus
A Phase 2 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
NCT01781975: Completed Phase 2 study, sponsored by University of California, San Francisco.
NCT01781975 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 67 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01781975, a Phase 2 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
Study Summary
Type 1 diabetes mellitus (T1DM) results from the autoimmune destruction of insulin-producing ß cells. Although exogenous insulin is widely available, it is not possible for affected individuals to consistently achieve euglycemia with current technology, and thus they are at risk for devastating long-term complications. This phase II study is designed to evaluate the safety and efficacy of imatinib mesylate as a novel therapy for new-onset T1DM. Imatinib is a first-in-class tyrosine kinase inhibitor. This study will explore the potential role of short-term therapy with imatinib to induce tolerance and possibly lead to a durable long-term remission of T1DM.
Primary Outcome
The primary outcome of each participant is the area under the stimulated c-peptide curve (AUC) mean based on data collected at time 0 to 2 hours of a 4-hour mixed meal tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30, 60, 90, and 120 minutes. The term "AUC mean" comes from the mean value theorem in calculus. It is the value on the scale of the y-axis that is equal to the AUC divided by the range on the x-axis (in this case 120 minutes).
Interventions
- DRUG Imatinib Mesylate
- DRUG Placebo (For imatinib mesylate)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2014-01 |
| Est. Completion | 2018-05 |
| Phase | Phase 2 |
What the finished NCT01781975 record still lists
NCT01781975 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Imatinib Mesylate is the first listed.
NCT01781975 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01781975 about?
NCT01781975 is a clinical study titled "Imatinib Treatment in Recent Onset Type 1 Diabetes Mellitus". Type 1 diabetes mellitus (T1DM) results from the autoimmune destruction of insulin-producing ß cells. Although exogenous insulin is widely available, it is not possible for affected individuals to consistently achieve euglycemia with current technology, and thus they are at risk for devastating long...
What is the current status of trial NCT01781975?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2014-01. Estimated completion is 2018-05.
What interventions are being tested in trial NCT01781975?
The interventions under investigation include: Imatinib Mesylate (DRUG), Placebo (For imatinib mesylate) (DRUG).
Who is sponsoring clinical trial NCT01781975?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01781975's enrollment target sits among peer trials
67 974th of 2000 higher than 1,026 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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