Withdrawn
PHASE2
INTERVENTIONAL
NCT03794973
Diabetes Autoimmunity Withdrawn in New Onset Patients (DAWN)
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The study is a prospective, randomized, double-blind, placebo-controlled, multi-center trial in subjects with new onset T1D.
Detailed Description
The study will include 210 male or female subjects aged 12 to 35 years diagnosed with T1D, as defined by the American Diabetes Association (ADA) criteria and meeting enrollment criteria as follows. Initial enrollment will be restricted to subjects aged 18 and older until an analysis of data from subjects with 3 months' exposure to drug confirms safety. Upon completion of this assessment, enrollment will be open without further restrictions for subjects aged 12-35.
Interventions
Name:
TOL-3021
Type:
BIOLOGICAL
Description:
TOL-3021 1 mg is a bacterial plasmid expression vector containing the coding sequences for the human proinsulin (hINS) gene.
Name:
TOL-3021 Placebo
Type:
OTHER
Description:
TOL-3021 Placebo
Primary Outcomes
Measure:
Treatment effect on log-transformed MMTT C-peptide area under the curve (AUC)
TimeFrame:
52 weeks
Description:
The primary outcome is the treatment effect on log-transformed MMTT C-peptide area under the curve (AUC)
Trial Information
NCT ID
NCT03794973
Status
Withdrawn
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
Tolerion, Inc.
Last Updated
December 15, 2025