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 then be followed for at least 12-48 months after administration, depending on timepoint enrolled into the study. If the primary endpoint demonstrates a positive signal and as decided by TrialNet, there is potential for a study extention. This would extend follow-up visits for a possible study duration of about 9 years among the earliest enrollees of the initial study.
Description
This protocol will enroll 60 participants between the ages of 4 and 34 with Stage 2 Type 1 diabetes. Oral glucose tolerance testing will be done at the screening, baseline visit (V0) and at 3, 6 and 12 months in the first year after study drug administration. Eligible study participants will be randomized to recieve either 2 doses of ATG over 2-3 days or 14 doses of teplizumab given once daily over 14 consecutive days. Safety labs will also be done during select study visits to monitor the participant's health. Once the treatment phase has been completed, participants will have 3 in-person stu…
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