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Diabetes Type 1

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Diabetes Autoimmunity Withdrawn in New Onset Patients (DAWN)

A Phase 2b Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of TOL-3021 in Patients With New Onset Type 1 Diabetes Mellitus

Phase 2


Doctors at the University of Miami Diabetes Research Institute in Miami, FL, are seeking many patients with new onset Diabetes Mellitus Type 1.. These participants may be eligible to trial a genetic therapy intended to impart the human proinsulin (hINS) gene.

The investigatory treatment, TOL-3021, is designed to stop parts of the immune system that attack pancreatic cells and cause type 1 diabetes. A loop of DNA is absorbed by cells, which then produce proinsulin to decrease the immune system’s attack on pancreatic beta cells and improve their functioning.

Half the participants will receive a placebo.


  • Be 12 to 35 years of age
  • Diagnosis of Type 1 Diabetes Mellitus based on American Diabetes Association (ADA) criteria and ≤100 days since diagnosis
  • Willingness to wear a continuous glucose monitoring (CGM) device for specified periods of time.


  1. Prescreening tests to confirm eligibility and safety of the patient to participate.
  2. A single infusion of the investigatory drug or a placebo (you will not know which)
  3. Follow up through lab assessments and remote biomonitors for 52 weeks.


The study site is Doctors at the University of Miami Diabetes Research Institute in Miami, FL (Map).


Nilay Shah, MD  |  301-251-1161  |  [email protected]

Anne Hoehn  |  301-251-1161  |  [email protected]



Tolerion, Inc.


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