Adaptive Platform Trial to Delay Progression From Stage 2 to Stage 3 Type 1 Diabetes: Comparing Teplizumab With Low-dose Anti-Thymocyte Globulin (ATG) Protocol TN-40A
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Summary
This is a 2-arm, multi-center, open label study to learn if ATG works the same or better than teplizumab in delaying or preventing Stage 3 Type 1 diabetes. Participants will be administered either 2 infusions of ATG or 14 infusions of teplizumab and will be followed for 12 months after administration.
Description
This protocol will enroll 60 participants with Stage 2 diabetes. Oral glucose tolerance testing will be done at the screening, baseline visit (V0) and at 3, 6 and 12 months after study drug administration. Participants will continue follow-up visits until 12 months from the baseline visit.
Eligibility
- Age range
- 4–34 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Willing to provide informed consent or have a parent or legal guardians provide informed consent when the participant is \<18 years of age. * Aged ≥4 to \<35 years * A history of at least two or more diabetes-related biochemical autoantibodies (mIAA, GADA, ICA, IA-2A, ZnT8A) present on the same sample. In the absence of other antibodies, ICA and GADA positivity alone will not suffice for eligibility in this trial. * Participants must meet ADA stage 2 T1D glycemic criteria\* by TrialNet testing within 100 days of the baseline visit. \*The ADA definition of stage 2 T1D…
Interventions
- DrugAntithymocyte Globulin (ATG)
Thymoglobulin
- DrugTeplizumab
Intravenous infusions of teplizumab given for 14 consecutive days. Each infusion takes about 30 minutes and is followed by an observation period of at least 30 minutes.
Location
- University of FloridaGainesville, Florida