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Diabetes Type 1 - Healing Genes
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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Diabetes Autoimmunity Withdrawn in New Onset Patients (DAWN)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

DESCRIPTION:

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.


PATIENT MUST:

  • 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.

THE STUDY INVOLVES:

  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.

LOCATIONS AND CONTACTS:

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

Contacts:

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

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

 

SPONSOR INFORMATION:

Tolerion, Inc.

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03794973

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