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Platform Trial in Stage 1 Diabetes: Comparing Golimumab vs Placebo

StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07683026
Lead Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Type 1 Diabetes (T1D)
Enrollment 255 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov