Type 1 Diabetes (T1D)Phase 2NCT07683026
Platform Trial in Stage 1 Diabetes: Comparing Golimumab vs Placebo
A Phase 2 study testing Golimumab in people with Type 1 Diabetes (T1D), run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 44 years
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- Golimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 255 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2026to 1 Sep 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 44 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Willing to provide informed consent or have a parent or legal guardians provide informed consent when the participant is <18 years of age.
- Weight ≥15 kg at the time of screening.
- Aged ≥2 to <45 years.
- 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.
- 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.
- 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.
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- 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.
- Be at least 4 weeks from last live immunization.
- Be willing to forgo live vaccines during treatment and for 3 months after study drug treatment period.
- Must meet TrialNet eligibility minimum immunization recommendations found in Appendix A of the manual of operations (MOO).
- 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).
- 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.
Who cannot join
- One or more screening laboratory values as stated:
- Leukocytes <3,500/μL or >14,000/μL
- Neutrophils <1,500/mL
- Platelet count <100,000 /μL
- Hemoglobin <6.2 mmol/L (10.0 g/dL)
- AST or ALT ≥ 2 times the upper limits of normal (2x ULN)
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- Abnormal Glucose Tolerance or Diabetes
- Fasting plasma glucose ≥100 mg/dL (6.1 mmol/L), or
- 2 hour plasma glucose ≥140 mg/dL (7.8 mmol/L), or
- 30, 60, or 90 minute plasma glucose during OGTT ≥200 mg/dL (11.1 mmol/L)
- History of treatment with insulin except transient use during acute illness or hospitalization.
- Vaccination with a live vaccine within the last 4 weeks or killed/inactivated vaccine within the last 2 weeks prior to randomization.
- 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).
- Evidence of prior or current tuberculosis (TB) infection through any one or more of the following:
- A history of latent or active TB
- Signs and/or symptoms of TB
- Recent close contact with a person with known or suspected active TB unless appropriate prophylaxis for TB was given
- A history of a chest X-ray consistent with active TB or old, inactive TB
- 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).
- 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.
- Known active infection or active signs or symptoms of acute or chronic infection at the time of randomization including SARS-Cov-2.
- Have or had a demyelinating disorder such as multiple sclerosis or Guillain-Barré syndrome.
- 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).
- Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control within 14 days of the screening visit.
- Has previously participated in a clinical trial for diabetes prevention and received active study agent within 6 months of treatment.
- History of blastomycosis, histoplasmosis, or coccidioidomycosis.
- A history of malignancies other than fully treated basal cell or squamous cell carcinoma of the skin.
- Have or had moderate to severe congestive heart failure.
- Ongoing or anticipated future use of any medications known to impact T1D progression.
- Evidence of current or past HIV or Hepatitis B or current Hepatitis C infection.
- Be pregnant or lactating or anticipate becoming pregnant during the study.
- Any condition, prior treatment, or laboratory abnormality that in the investigator's opinion may adversely affect study participation or confound study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Joslin Diabetes Center
Boston, Massachusetts, 02115
Samantha Kateman, 617-975-8269, skateman@joslin.harvard.edu
Jason Gaglia, MD
About this study
Official title: Adaptive Platform Trial to Delay Progression From Normoglycemia to Dysglycemia in Presymptomatic Type 1 Diabetes: Golimumab Substudy
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
Read the detailed description
This is a double-masked, multicenter, randomized, placebo-controlled trial to determine whether treatment of participants with presymptomatic T1D (two or more diabetes autoantibodies or IA2 alone) and normal glycemia with golimumab results in delay or prevention of progression to confirmed dysglycemia or symptomatic diabetes. 225 participants with presymptomatic T1D will be randomly assigned to placebo or golimumab at a 1:2 randomization (75 placebo and 150 study drug). Golimumab or a saline placebo will be given as a subcutaneous injection. A loading dose regimen at 0 and 2 weeks will be followed by monthly doses for the duration of the participant's enrollment in the study. Study visits will occur every 6 months with some additional remote monitoring in between visits. Study visit procedures include OGTTs, physical exams, questionnaires, and other laboratory tests. The primary outcome is to determine if intervention with golimumab will prevent or delay the progression to confirmed dysglycemia or overt diabetes in persons less than 18 years of age with presymptomatic T1D. The study is expected to recruit for 3 years followed by an additional 3 years of follow-up for the last participant enrolled.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- Golimumab, Placebo (matching golimumab)
- Keywords
- TrialNet, T1D, Golimumab
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GolimumabDrug
Also called Simponi
Golimumab will be given as a subcutaneous formulation based on the participant's weight at baseline. A loading dose regimen at 0 and 2 weeks will be followed by monthly maintenance doses for the duration of the participant's enrollment in the study. For those weighing 15kg to less than 40 kg the dosing will be: 100mg (week 0), followed by 50mg monthly thereafter. For those weighing 40kg or more the loading dose will be 200mg (week 0) followed by 100mg thereafter.
Placebo (matching golimumab)Drug
Also called Saline
0.9% Sodium Chloride Injection USP ("Normal" saline) is to be dispensed as the placebo for this study. A loading dose regimen at 0 and 2 weeks will be followed by monthly maintenance doses for the duration of the participant's enrollment in the study.
| Study group | Role | What they receive |
|---|---|---|
| Golimumab | Experimental | Participants assigned to this arm will receive golimumab injections Receives: Drug: Golimumab |
| Placebo | Placebo comparator | Participants assigned to this arm will receive saline (placebo) to match Golimumab injections Receives: Drug: Placebo (matching golimumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression to Dysglycemia
The primary outcome is the elapsed time from random treatment assignment to the development of confirmed dysglycemia or overt hyperglycemia/symptomatic based upon ADA criteria.
Measured: From randomization to confirmed dysglycemia or clinical diagnosis of T1D, approximately 6 years from the first participant enrolled.
Secondary outcomes (1)
Progression to overt hyperglycemia/symptomatic Type 1 Diabetes
Elapsed time from study drug administration to the development of diabetes or time of last contact among those randomized
Measured: From Randomization to clinical diagnosis approximately 6 years from the first participant enrolled.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start8 Aug 2026 (estimated)
- Primary completion1 Sep 2032 (estimated)
- Study completion1 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jason Gaglia, MD, Study chair, TrialNet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683026
- Sponsor's protocol ID
- TN39A
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available at the NIDDK Central Repository
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Platform Trial to Delay Progression From Normoglycemia to Dysglycemia in Presymptomatic Type 1 Diabetes: Golimumab Substudy
- ClinicalTrials.gov ID
- NCT07683026
- Acronym / sponsor ID
- TN39A
- Conditions
- Type 1 Diabetes (T1D)
- Keywords
- TrialNet, T1D, Golimumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 8 Aug 2026 (estimated)
- Primary completion
- 1 Sep 2032 (estimated)
- Study completion
- 1 Sep 2032 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a double-masked, multicenter, randomized, placebo-controlled trial to determine whether treatment of participants with presymptomatic T1D (two or more diabetes autoantibodies or IA2 alone) and normal glycemia with golimumab results in delay or prevention of progression to confirmed dysglycemia or symptomatic diabetes. 225 participants with presymptomatic T1D will be randomly assigned to placebo or golimumab at a 1:2 randomization (75 placebo and 150 study drug). Golimumab or a saline placebo will be given as a subcutaneous injection. A loading dose regimen at 0 and 2 weeks will be followed by monthly doses for the duration of the participant's enrollment in the study. Study visits will occur every 6 months with some additional remote monitoring in between visits. Study visit procedures include OGTTs, physical exams, questionnaires, and other laboratory tests. The primary outcome is to determine if intervention with golimumab will prevent or delay the progression to confirmed dysglycemia or overt diabetes in persons less than 18 years of age with presymptomatic T1D. The study is expected to recruit for 3 years followed by an additional 3 years of follow-up for the last participant enrolled.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Golimumab | Experimental | Drug: GolimumabParticipants assigned to this arm will receive golimumab injections |
| Placebo | Placebo comparator | Drug: Placebo (matching golimumab)Participants assigned to this arm will receive saline (placebo) to match Golimumab injections |
Who may qualify
- Ages
- 2 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Willing to provide informed consent or have a parent or legal guardians provide informed consent when the participant is <18 years of age.
- Weight ≥15 kg at the time of screening.
- Aged ≥2 to <45 years.
- 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.
- 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.
Key exclusion criteria (32 listed)
- One or more screening laboratory values as stated:
- Abnormal Glucose Tolerance or Diabetes
- History of treatment with insulin except transient use during acute illness or hospitalization.
- Vaccination with a live vaccine within the last 4 weeks or killed/inactivated vaccine within the last 2 weeks prior to randomization.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GolimumabAlso: SimponiGolimumab will be given as a subcutaneous formulation based on the participant's weight at baseline. A loading dose regimen at 0 and 2 weeks will be followed by monthly maintenance doses for the duration of the participant's enrollment in the study. For those weighing 15kg to less than 40 kg the dosing will be: 100mg (week 0), followed by 50mg monthly thereafter. For those weighing 40kg or more the loading dose will be 200mg (week 0) followed by 100mg thereafter. | Drug | Golimumab |
| Placebo (matching golimumab)Also: Saline0.9% Sodium Chloride Injection USP ("Normal" saline) is to be dispensed as the placebo for this study. A loading dose regimen at 0 and 2 weeks will be followed by monthly maintenance doses for the duration of the participant's enrollment in the study. | Drug | Placebo |
Primary outcome
Progression to Dysglycemia
Time frame: From randomization to confirmed dysglycemia or clinical diagnosis of T1D, approximately 6 years from the first participant enrolled.
The primary outcome is the elapsed time from random treatment assignment to the development of confirmed dysglycemia or overt hyperglycemia/symptomatic based upon ADA criteria.
1 secondary outcome
Progression to overt hyperglycemia/symptomatic Type 1 Diabetes
Time frame: From Randomization to clinical diagnosis approximately 6 years from the first participant enrolled.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- TrialNet Public WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be available at the NIDDK Central Repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Gaglia, MD study chair
TrialNet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Golimumab in people with Type 1 Diabetes (T1D), run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ariana Rojas (813-974-6827, Ariana.Rojas@epi.usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression to Dysglycemia (time frame: From randomization to confirmed dysglycemia or clinical diagnosis of T1D, approximately 6 years from the first participant enrolled.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.