Adaptive Platform Trial to Delay Progression From Normoglycemia to Dysglycemia in Presymptomatic Type 1 Diabetes: Golimumab Substudy
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Summary
The goal of this clinical trial is to learn if golimumab is effective at preventing progression to Stage 2 diabetes in participants with presymptomatic Type 1 Diabetes. The expected duration of this study is approximately 6 years. Participants will: * Take golimumab or placebo injections monthly for the duration of the study or until they are diagnosed with either stage 2 or stage 3 Type 1 Diabetes * Visit a study clinic every 6 months for Oral Glucose Tolerance Tests (OGTTs) and other tests until the end of the study
Description
This is a double-masked, multicenter, randomized, placebo-controlled trial to determine whether treatment of participants with presymptomatic T1D (two or more diabetes autoantibodies or IA2 alone) and normal glycemia with golimumab results in delay or prevention of progression to confirmed dysglycemia or symptomatic diabetes. 225 participants with presymptomatic T1D will be randomly assigned to placebo or golimumab at a 1:2 randomization (75 placebo and 150 study drug). Golimumab or a saline placebo will be given as a subcutaneous injection. A loading dose regimen at 0 and 2 weeks will be foll…
Eligibility
- Age range
- 2–44 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Willing to provide informed consent or have a parent or legal guardians provide informed consent when the participant is \<18 years of age. 2. Weight ≥15 kg at the time of screening. 3. Aged ≥2 to \<45 years. 4. A confirmed history of either IA2A alone or at least two or more diabetes-related biochemical autoantibodies (mIAA, GADA, ICA, IA-2A, ZnT8A) present on the same sample. Confirmed autoantibody result means that the presence of the antibody has been verified on more than one occasion. For multiple autoantibody positivity, the same autoantibodies do not need to be…
Interventions
- DrugGolimumab
Golimumab will be given as a subcutaneous formulation based on the participant's weight at baseline. A loading dose regimen at 0 and 2 weeks will be followed by monthly maintenance doses for the duration of the participant's enrollment in the study. For those weighing 15kg to less than 40 kg the dosing will be: 100mg (week 0), followed by 50mg monthly thereafter. For those weighing 40kg or more the loading dose will be 200mg (week 0) followed by 100mg thereafter.
- DrugPlacebo (matching golimumab)
0.9% Sodium Chloride Injection USP ("Normal" saline) is to be dispensed as the placebo for this study. A loading dose regimen at 0 and 2 weeks will be followed by monthly maintenance doses for the duration of the participant's enrollment in the study.
Location
- Joslin Diabetes CenterBoston, Massachusetts