Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients
(SUNRISE Trial)

Recruiting in Palo Alto (17 mi)

+22 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Tolerion, Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests TOL-3021, a muscle injection, in people aged 12 to under 41 who have had Type 1 Diabetes for less than 5 years. The goal is to see if it helps control their blood sugar levels better.

Eligibility Criteria

Inclusion Criteria

Presence of antibodies to at least one of the following antigens: GAD65, IA-2, ZnT8, or insulin if obtained within 10 days of the onset of exogenous insulin therapy, or documentation of positive antibodies. In the absence of a positive result for one of the specified antibodies, diagnosis of T1D as per the ADA guidelines..

Age at randomization of 12.0 - <41.0 years of age .

Diagnosis of Type 1 Diabetes Mellitus based on American Diabetes Association (ADA) criteria and within 5.0 years from diagnosis, defined as the first day of insulin administration.

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Exclusion Criteria

You are currently using biotin or supplements that contain biotin.

Body Mass Index (BMI) >32 kg/m² for patients 18 and older (>85th percentile for ages 12-17).

Previous immunotherapy for T1D within 2 years of enrollment.

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