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NCT03895437 · ClinicalTrials.gov registry record · Phase 2
Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients
A Phase 2 study of Diabetes Mellitus, Type 1, sponsored by Tolerion.
- Active
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
- 20
- Study locations
NCT03895437 is a Phase 2 study of Diabetes Mellitus, Type 1 that is active but no longer recruiting, run by Tolerion. The registered enrollment target is 78 participants, below the 1,265-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT03895437, a Phase 2 study of Diabetes Mellitus, Type 1, is active but no longer recruiting, sponsored by Tolerion.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study is a prospective, randomized, 52-week double-blind, placebo-controlled, multicenter trial in subjects with T1D followed by a 2-year safety follow-up.
Conditions Studied
Interventions
- BIOLOGICAL TOL-3021
- OTHER TOL-3021 Placebo
Study Locations (20)
California
- Altman Clinical and Translational Research Institute UCSD - San Diego
- University of California San Francisco - San Francisco
- Mills-Peninsula Medical Center - San Mateo
- Stanford University - Stanford
Florida
- University of Florida - Gainesville
- Baptist Health Research Institute - Jacksonville
- University of Miami Diabetes Research Institute - Miami
- University of South Florida Diabetes Center - Tampa
Maryland
- MedStar Health Research Institute - Baltimore
- MedStar Health Research Institute - Hyattsville
New York
- Naomi Berrie Diabetes Center, Columbia University - New York
- SUNY Upstate Medical University - Syracuse
Colorado
- Barbara Davis Center - University of Colorado Denver - Denver
Connecticut
- Yale University - New Haven
Georgia
- Emory University - Atlanta
Idaho
- Rocky Mountain Clinical Research - Idaho Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2019-06-17 |
| Est. Completion | 2023-09-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03895437
The ClinicalTrials.gov registry entry for NCT03895437 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,265-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (94% lower). The listed sponsor is Tolerion, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 2 interventions - of which TOL-3021 is the first listed.
NCT03895437 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, Maryland.
Frequently Asked Questions
What is clinical trial NCT03895437 about?
NCT03895437 is a clinical study titled "Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients". The study is a prospective, randomized, 52-week double-blind, placebo-controlled, multicenter trial in subjects with T1D followed by a 2-year safety follow-up.
What is the current status of trial NCT03895437?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2019-06-17. Estimated completion is 2023-09-30.
What conditions does trial NCT03895437 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1.
What interventions are being tested in trial NCT03895437?
The interventions under investigation include: TOL-3021 (BIOLOGICAL), TOL-3021 Placebo (OTHER).
Who is sponsoring clinical trial NCT03895437?
This trial is sponsored by Tolerion, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03895437 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.