Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients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: Active Phase 2 study of Diabetes Mellitus, Type 1, sponsored by Tolerion.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome is the TOL-3021 treatment effect as determined by a repeated measures analysis of change from baseline in the log-transformed MMTT C-peptide AUC at 12, 16, and 24 weeks
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 |
What the registry record for NCT03895437 still lists
NCT03895437 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 1,265-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (94% lower).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 1
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03895437's enrollment target sits among peer trials
78 56th of 118 higher than 62 of 118 other Diabetes Mellitus, Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 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
-
Islet Transplantation in Type 1 Diabetic Kidney Allograft
RECRUITING · Phase 2
-
Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes
RECRUITING · Phase 2
-
Phase 2b Trial Comparing HDV-Insulin Lispro to Insulin Lispro in Adults With Type 1 Diabetes Receiving Insulin Degludec
ACTIVE NOT RECRUITING · Phase 2
-
Janus Kinase (JAK) Inhibitors to Preserve C-Peptide Production in New Onset Type 1 Diabetes (T1D)
ACTIVE NOT RECRUITING · Phase 2
-
Comparison of Hepatic Directed Vesicle (HDV)-Insulin Lispro Versus Insulin Lispro to Further Improve Glycemic Control
COMPLETED · Phase 2
-
To Examine the Lung When People With Diabetes Take an Inhaled Form of Insulin, Compared to Subcutaneous Insulin.
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02397668 · 78 participants · NA
CorMatrix Cor TRICUSPID ECM Valve Replacement Study
- NCT03321656 · 78 participants · Phase 2
Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
- NCT03687814 · 78 participants · NA
Low FODMAP Plus PEG 3350 for the Treatment of Patients with Irritable Bowel Syndrome-Constipation
- NCT04018872 · 78 participants · Phase 2
Evaluating the Effect of Itraconazole on Pathologic Complete Response Rates in Esophageal Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI