Skip to content
type1.science
Phase 2CompletedNCT02846545

T1GER: Golimumab in youth with new-onset type 1 diabetes

What this study tests

Randomized Phase 2 trial of golimumab in 84 children and young adults with new-onset type 1 diabetes. It preserved more C-peptide and reduced insulin use at 52 weeks versus placebo, while HbA1c was similar.

Editorial review: .

Registry checked: 2026-09-17. Registry’s own update: 2025-02-04.

Most recent recorded citation date: 2025-02-04. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.

Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
Ages 6-21 with new-onset type 1 diabetes, at least one diabetes autoantibody and stimulated C-peptide at least 0.2 pmol/mL. Important infection and immunosuppression exclusions applied; see the registry for full criteria. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
Reported benefit and results
Week-52 4-hour C-peptide AUC was 0.64 vs 0.43 pmol/mL with placebo (P<0.001). HbA1c was similar, insulin use was lower, and partial remission was more common with golimumab.Read the result sources and their limitations →
Important harms
Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
Research access and approval
Study regions: United States. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
What remains uncertain?
Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.

Research status alone does not establish approval, clinical benefit or local availability.

Primary endpoints

  • 4-hour mixed-meal stimulated C-peptide AUC at week 52

The full picture

T1GER randomized 84 participants to golimumab (56) or placebo (28). The NEJM paper reported higher mean 4-hour mixed-meal C-peptide AUC with golimumab at week 52 (0.64 versus 0.43 pmol/mL; P<0.001), with lower insulin use and similar HbA1c. This supports preservation of residual beta-cell function during treatment, not freedom from insulin.1

The NEJM paper reported hypoglycemia recorded at investigators' discretion as an adverse event in 13 golimumab participants (23%) and two placebo participants (7%), although mean hypoglycemic event counts did not differ significantly. Anti-golimumab antibodies were detected in 30 of the 56 treated participants. Benefits and harms both matter when interpreting this small trial.1

Sources

  1. [1]
    Golimumab and Beta-Cell Function in Youth with New-Onset Type 1 Diabetes · Peer-reviewed study · 2020-11-19

    Quattrin et al. Golimumab and Beta-Cell Function in Youth with New-Onset Type 1 Diabetes. NEJM (2020).

  2. [2]