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
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 followed by monthly doses for the duration of the participant's enrollment in the study. Study visits will occur every 6 months with some additional remote monitoring in between visits. Study visit procedures include OGTTs, physical exams, questionnaires, and other laboratory tests. The primary outcome is to determine if intervention with golimumab will prevent or delay the progression to confirmed dysglycemia or overt diabetes in persons less than 18 years of age with presymptomatic T1D. The study is expected to recruit for 3 years followed by an additional 3 years of follow-up for the last participant enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
255
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.
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.
Joslin Diabetes Center
Boston, Massachusetts, United States
Progression to Dysglycemia
The primary outcome is the elapsed time from random treatment assignment to the development of confirmed dysglycemia or overt hyperglycemia/symptomatic based upon ADA criteria.
Time frame: From randomization to confirmed dysglycemia or clinical diagnosis of T1D, approximately 6 years from the first participant enrolled.
Progression to overt hyperglycemia/symptomatic Type 1 Diabetes
Elapsed time from study drug administration to the development of diabetes or time of last contact among those randomized
Time frame: From Randomization to clinical diagnosis approximately 6 years from the first participant enrolled.
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