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
Anhydroglucitol in Children With Type 1 Diabetes
The investigators will measure blood levels of 1,5-anhydroglucitol in children with type 1 diabetes and correlate them with parameters related to functional beta-cell mass in diabetic patients. The values will be compared to those obtained in healthy volunteers. Children with newly diagnosed diabetes as well as children with longstanding disease will be included. The aim of the study is to test the validity of 1,5-anhydroglucitol as a novel biomarker of beta-cell mass and function in type 1 diabetes.
Montreal Immune-Related Adverse Events (MIRAE) Study
Immune checkpoint inhibitors (ICI) are among the most promising approaches to fighting cancer. However, a substantial percentage of patients experience off-target adverse effects in the form of mild to severe inflammation in different organs, commonly called immune-related adverse events (irAEs). irAEs can lead to treatment discontinuation, or can be life-threatening in extreme cases. The causes of irAEs are largely unknown and there are no reliable predictive biomarkers. The Montreal Immune-Related Adverse Events (MIRAE) study collects clinical information and biospecimens (blood, tissue, stool) from cancer patients treated with ICI to facilitate research on the identification of predictive biomarkers of irAEs, their causes, and the design of effective management strategies.