Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients
NCT03895437 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tolerion, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03895437 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03895437?
The interventions under investigation include: TOL-3021 (BIOLOGICAL), TOL-3021 Placebo (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03895437?
This trial is sponsored by Tolerion, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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