Low-Dose ATG for Type 1 Diabetes
(TN28 Trial)
What You Need to Know Before You Apply
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.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it does exclude those using non-insulin drugs that affect blood sugar control within 7 days of screening. It's best to discuss your specific medications with the trial team.
Is low-dose ATG safe for humans?
Antithymocyte globulin (ATG) has been used in various conditions like type 1 diabetes and aplastic anemia. While it can cause mild reactions like fever and chills, serious side effects are rare but can include severe allergic reactions and lung issues. It's important that ATG is given by experienced doctors in specialized centers to manage any potential risks.12345
How does the drug Antithymocyte Globulin (ATG) differ from other treatments for type 1 diabetes?
Antithymocyte Globulin (ATG) is unique because it targets the immune system by depleting T cells, which are responsible for attacking insulin-producing cells in type 1 diabetes. This approach aims to preserve the function of the remaining insulin-producing cells, potentially reducing the need for insulin therapy.25678
What data supports the effectiveness of the drug Antithymocyte Globulin (ATG) for treating type 1 diabetes?
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive low-dose ATG or placebo intravenously over two days
Follow-up
Participants are monitored for safety and effectiveness after treatment, including general and laboratory assessments
Long-term follow-up
Additional follow-up visits for participants enrolled in the first year if progression to stage 3 T1D does not occur
What Are the Treatments Tested in This Trial?
Interventions
- Antithymocyte Globulin
- Placebo (for ATG)
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead Sponsor