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Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients

NCT03895437 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-05-20

Study results available
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Summary

The study is a prospective, randomized, 52-week double-blind, placebo-controlled, multicenter trial in subjects with Type 1 diabetes (T1D) followed by a 2-year safety follow-up.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

BIOLOGICAL

TOL-3021

TOL-3021 1 mg is a bacterial plasmid expression vector containing the coding sequences for the human proinsulin (hINS) gene.

OTHER

TOL-3021 Placebo

TOL-3021 Placebo

Sponsors & Collaborators

  • Tolerion, Inc.

    lead INDUSTRY

Principal Investigators

  • Alexander Fleming, M.D. · Tolerion, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-17
Primary Completion
2020-12-21
Completion
2020-12-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03895437 on ClinicalTrials.gov