Platform Trial in Stage 1 Diabetes: Comparing Golimumab vs Placebo
Adaptive Platform Trial to Delay Progression From Normoglycemia to Dysglycemia in Presymptomatic Type 1 Diabetes: Golimumab Substudy
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 2 Years to 44 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 3 years
- Procedures mentioned: Injections, Physical exams, Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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"
- "Golimumab or a saline placebo will be given as a subcutaneous injection."
- "Study visit procedures include OGTTs, physical exams, questionnaires, and other laboratory tests."
- "The study is expected to recruit for 3 years followed by an additional 3 years of follow-up for the last participant enrolled."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether golimumab can stop Stage 1 type 1 diabetes, which has no symptoms, from moving to Stage 2. It is for people ages 2 to 44 and is expected to last about 6 years. Participants get monthly shots of golimumab or placebo (a shot with no study drug) and have clinic tests every 6 months.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be ages 2 to 44 and weigh at least 15 kg (about 33 pounds).
- Agree to join the study. A parent or legal guardian must give permission for anyone under 18.
- Have repeat blood tests showing certain diabetes-related antibodies, which are immune proteins. The study requires IA2A alone or an allowed group of at least two antibodies, confirmed within 6 months before screening.
- Have normal blood sugar on a glucose tolerance test within 52 days before study group assignment. This test checks blood sugar after a sweet drink. If a past test was abnormal, the two latest tests must be normal.
- Meet blood test rules for CMV and EBV, two viruses. Have no illness that fits these viruses lasting more than 7 days in the 30 days before study group assignment.
- Meet the study's vaccine rules. Wait at least 4 weeks after a live vaccine, and avoid live vaccines during treatment and for 3 months afterward.
- Have a negative blood test for Coccidioides, a fungus, if your history of living in or visiting certain areas requires it.
- If able to become pregnant, agree to avoid pregnancy through 3 months after the last study dose and take a pregnancy test at each visit.
Who can't join
- Blood cell counts or liver blood tests outside study limits; abnormal blood sugar or diabetes; or past insulin treatment, except brief use during a serious illness or hospital stay.
- A live vaccine within 4 weeks or an inactivated vaccine within 2 weeks before study group assignment; or confirmed mono within 3 months.
- Past TB, signs or tests suggesting TB, or recent close contact with someone with active TB without proper prevention treatment. TB is an infection that often affects the lungs.
- An active infection, including COVID-19; frequent or long-lasting infections; an infected wound that will not heal; certain past fungal infections; past or current HIV or hepatitis B; or current hepatitis C.
- A disease that damages the protective covering of nerves, such as multiple sclerosis; or another disease where the immune system attacks the body. Well-controlled low thyroid function or celiac disease may be allowed.
- Past cancer, except fully treated basal cell or squamous cell skin cancer; or past or current moderate to severe heart failure.
- Recent non-insulin medicines that affect blood sugar; medicines expected to affect type 1 diabetes progression; or an active study drug from a diabetes prevention trial within 6 months of treatment.
- Being pregnant, breastfeeding, or planning pregnancy during the study; or any condition, past treatment, or test result that the study doctor thinks could make participation unsafe or affect the results.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Willing to provide informed consent or have a parent or legal guardians provide informed consent when the participant is \<18 years of age. 2. Weight ≥15 kg at the time of screening. 3. Aged ≥2 to \<45 years. 4. A confirmed history of either IA2A alone or at least two or more diabetes-related biochemical autoantibodies (mIAA, GADA, ICA, IA-2A, ZnT8A) present on the same sample. Confirmed autoantibody result means that the presence of the antibody has been verified on more than one occasion. For multiple autoantibody positivity, the same autoantibodies do not need to be present on the different tests. Confirmation must occur within the six months prior to screening. In the absence of other antibodies, ICA and GADA positivity alone will not suffice for eligibility in this study. 5. Oral glucose tolerance test (OGTT) results demonstrating normal glucose tolerance within 7 weeks (52 days) prior to randomization. If a participant has known previous abnormal glucose tolerance, the two most recent OGTTs must demonstrate normal glucose tolerance to be eligible. 6. CMV and/or EBV seronegative participants must be CMV and EBV PCR negative within 60 days of randomization and may not have had signs or symptoms of a CMV or EBV-compatible illness lasting longer than 7 days within 30 days of randomization. 7. CMV seropositive participants must be CMV PCR negative and all EBV seropositive participants must have EBV PCR \< 2,000 IU/mL within 60 days of randomization and may not have had signs or symptoms of a CMV or EBV-compatible illness lasting longer than 7 days within 30 days of randomization. 8. Be at least 4 weeks from last live immunization. 9. Be willing to forgo live vaccines during treatment and for 3 months after study drug treatment period. 10. Must meet TrialNet eligibility minimum immunization recommendations found in Appendix A of the manual of operations (MOO). 11. Negative Coccidioides serology testing for those who have in the past resided in for at least 2 months, currently reside in, or within the past 2 months have visited an endemic area (as defined in Protocol MOO Appendix B). 12. If a female participant with reproductive potential, willing to avoid pregnancy (abstinence or adequate contraceptive method) through up to 3 months after last study drug administration and undergo pregnancy testing at each study visit. Exclusion Criteria: 1. One or more screening laboratory values as stated: 1. Leukocytes \<3,500/μL or \>14,000/μL 2. Neutrophils \<1,500/mL 3. Platelet count \<100,000 /μL 4. Hemoglobin \<6.2 mmol/L (10.0 g/dL) 5. AST or ALT ≥ 2 times the upper limits of normal (2x ULN) 2. Abnormal Glucose Tolerance or Diabetes 1. Fasting plasma glucose ≥100 mg/dL (6.1 mmol/L), or 2. 2 hour plasma glucose ≥140 mg/dL (7.8 mmol/L), or 3. 30, 60, or 90 minute plasma glucose during OGTT ≥200 mg/dL (11.1 mmol/L) 3. History of treatment with insulin except transient use during acute illness or hospitalization. 4. Vaccination with a live vaccine within the last 4 weeks or killed/inactivated vaccine within the last 2 weeks prior to randomization. 5. A history of confirmed infectious mononucleosis within the 3 months prior to randomization, as documented by EBV serology (EBV VCA-IgM and VCA-IgG; PCR would be confirmatory). 6. Evidence of prior or current tuberculosis (TB) infection through any one or more of the following: 1. A history of latent or active TB 2. Signs and/or symptoms of TB 3. Recent close contact with a person with known or suspected active TB unless appropriate prophylaxis for TB was given 4. A history of a chest X-ray consistent with active TB or old, inactive TB 5. A history of a positive purified protein derivative (PPD) skin test result (\>10 mm induration), or positive/repeatedly indeterminate on an interferon-gamma release assay (IGRA; e.g., QuantiFERON-TB test). 7. Prone to infections or has chronic, recurrent or opportunistic infectious disease, including but not limited to Pneumocystis carinii, aspergillosis, latent or active granulomatous infection, or an open, draining, or infected non-healing skin wound or ulcer. 8. Known active infection or active signs or symptoms of acute or chronic infection at the time of randomization including SARS-Cov-2. 9. Have or had a demyelinating disorder such as multiple sclerosis or Guillain-Barré syndrome. 10. Current diagnosis of other autoimmune diseases except stable and/or adequately treated hypothyroidism and/or celiac disease (participants must be well controlled for the previous 6 months). 11. Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control within 14 days of the screening visit. 12. Has previously participated in a clinical trial for diabetes prevention and received active study agent within 6 months of treatment. 13. History of blastomycosis, histoplasmosis, or coccidioidomycosis. 14. A history of malignancies other than fully treated basal cell or squamous cell carcinoma of the skin. 15. Have or had moderate to severe congestive heart failure. 16. Ongoing or anticipated future use of any medications known to impact T1D progression. 17. Evidence of current or past HIV or Hepatitis B or current Hepatitis C infection. 18. Be pregnant or lactating or anticipate becoming pregnant during the study. 19. Any condition, prior treatment, or laboratory abnormality that in the investigator's opinion may adversely affect study participation or confound study results.
Study sites (1)
MA
- Joslin Diabetes Center · Boston, MA 02115Samantha Kateman · Study contact · 617-975-8269 · skateman@joslin.harvard.eduJason Gaglia, MD · Principal investigatorMore trials in Boston