Low-Dose ATG for Type 1 Diabetes

(TN28 Trial)

Recruiting at 21 trial locations

Overseen By Melissa A Parker, MHA

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

A multi-center, placebo-controlled, double blind, 2:1 randomized control clinical trial testing low-dose ATG vs. placebo in subjects with a 2 year 50% risk of progression to stage 3 T1D.

Eligibility Criteria

This trial is for people aged 12-35 with a high risk of developing stage 3 Type 1 Diabetes, as indicated by specific blood markers. They must be healthy, not pregnant, willing to avoid live vaccines and comply with COVID-19 safety measures. Participants cannot have certain infections or immune conditions.

Inclusion Criteria

Willingness to comply with study directed social distancing and protection from SARS-Cov-2 infection

I have received or will receive the flu shot at least 2 weeks before joining the study.

I am up to date on vaccinations and have no untreated health issues.

Exclusion Criteria

My hemoglobin levels are below the normal range for my age and gender.

You have had tuberculosis in the past or currently have tuberculosis.

My autoimmune thyroid or celiac disease has been under control for the last 6 months.

Treatment Details

Interventions

• Antithymocyte Globulin (Immunosuppressant)
• Placebo (for ATG) (Other)

Trial Overview The study tests if low-dose Antithymocyte Globulin (ATG) can prevent progression to stage 3 Type 1 Diabetes compared to a placebo. It's double-blind and participants are randomly assigned in a ratio of two ATG recipients for every one placebo recipient.

Participant Groups

Group I: Antithymocyte globulin (ATG) Experimental Treatment 1 Intervention

Antithymocyte globulin (ATG) will be intravenously administered over two days, with a total of 2 infusion periods. The first infusion is given at baseline visit (day 1), the second is given the next day at baseline visit (day 2). Body weight at baseline (Day 0- admission for the ATG/placebo infusion) will be used in calculating the doses for all infusions. The first dose (0.5mg/kg) will be infused over a minimum of 4 hours, and the second dose (2mg/kg) over a minimum of 4 hours with a maximum infusion time for each infusion of 10 hours. The second dose should be given no less than 12 and no more than 30 hours from the start of the first infusion. The final prepared product is to be labeled to protect the blind. Infusions may be administered either in a hospital or outpatient setting at the investigator's or institutions discretion.

Group II: Placebo Placebo Group 1 Intervention

0.9% Sodium Chloride Injection USP ("Normal" saline) is to be dispensed as the placebo for this study. The placebo is to be prepared dispensing an infusion bag of 0.9% Sodium Chloride Injection USP ("Normal" saline) with no additives (no ATG, no premedications) and label the product to protect the blind. The placebo will also be administered over a minimum of 4 hours for the first and second doses with a maximum infusion time of 10 hours. The second dose of the placebo arm should be given no less than 12 and no more than 30 hours from the start of the first infusion. Infusions may be administered either in a hospital or outpatient setting at the investigator's or institutions discretion.

Who Is Running the Clinical Trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Lead Sponsor

Trials

2,513

Recruited

4,366,000+