What the trial was testing
The T1GER enrolled 84 patients with type 1 diabetes. The study was sponsored by Janssen Research & Development, LLC and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was initial testing (phase 2). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
Golimumab helped preserve 49% more natural insulin production than placebo after one year.
The New England journal of medicine · 2020 · NCT02846545
These findings — that young patients on golimumab made nearly half again as much natural insulin as those on placebo — were published in the The New England journal of medicine and represent the headline result of the study.
Researchers tracked outcomes across 84 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with type 1 diabetes, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This was a mid-stage study and golimumab is not yet FDA-approved for type 1 diabetes. The drug is approved for other conditions in adults and children. If you or your child was recently diagnosed, ask your doctor about clinical trials testing immune-targeted treatments like this one.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open type 1 diabetes trials
The iLet Experience Study
A one-year, prospective single-arm cohort study to collect safety and effectiveness data on the iLet Dosing Decision Software during real-world use in people 6 years of age or older with type 1 diabetes (T1D) with 12 months follow-up.
Pharmacokinetic and Early Efficacy of OPT101 in Patients With Type 1 Diabetes Mellitus
This study will examine the safety of three times weekly SC injections of OPT101 at each of three dose levels over two weeks as well as one year of treatment with SC OPT101 or placebo to match at a single dose level.