Platform Trial in Stage 1 Diabetes: Comparing Golimumab vs Placebo

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ID
NCT07683026
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Type 1 Diabetes (T1D)

Eligibility Criteria

Sex
ALL
Age
2 Years - 44 Years
Healthy Volunteers
Not accepted

Interventions

  • Golimumab — DRUG
    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.
  • Placebo (matching golimumab) — DRUG
    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.

Study Details

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

Key Dates

Start date
Aug 8, 2026
Status verified
Jun 2026
Primary completion
Sep 1, 2032
Completion
Sep 1, 2032

Study Design

Enrollment
255 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Golimumab
    Participants assigned to this arm will receive golimumab injections
  • Placebo Comparator: Placebo
    Participants assigned to this arm will receive saline (placebo) to match Golimumab injections

Primary Outcome Measure

Progression to Dysglycemia [ Time Frame: From randomization to confirmed dysglycemia or clinical diagnosis of T1D, approximately 6 years from the first participant enrolled. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Joslin Diabetes CenterBostonMassachusetts02115
Samantha Kateman
[email protected]
617-975-8269
Jason Gaglia, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Joslin Diabetes Center· Boston, MA

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