Diabetes Mellitus, Type 1Phase 2NCT04729296
Anti-TNFα to Delay or Prevent Progression to Stage 3 T1D
A Phase 2 study testing Golimumab in people with Diabetes Mellitus, Type 1, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Trial summary
This will be a study conducted as a placebo-controlled, double blind, 1:1 randomized controlled clinical trial testing a Tumor Necrosis Factor Blocker (Anti-TNFα) substance versus placebo in subjects with a 2-year 50% risk of progression to stage 3 T1D across multiple centers. Read more about this study
- Who is it for?
- Ages 3 to 46 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 1 Jul 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 3 to 46 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Potential participants must meet all of the following inclusion criteria:
- Age > 3 and < 46 years
- Willing to provide Informed Consent or have a parent or legal guardian provide informed consent if the subject is <18 years of age
- At least two or more diabetes-related biochemical autoantibodies insulin (mIAA), glutamic acid decarboxylase antibody (GADA), Islet cytoplasmic antibodies (ICA), islet antigen 2 (IA-2A), zinc transporter 8 (ZnT8A) present on the same sample. Of note, ICA and GADA positivity alone cannot be used to define eligibility in this trial).
- Must have at least two of the high-risk markers defined below (within 7 weeks (52 days) of screening visit if performed as part of TN01 Pathway to Prevention (PTP) study at time of screening; defining a 50% two-year progression risk):
- Abnormal glucose tolerance: i. 2-hr glucose ≥ 140 and <200 mg/dL, fasting glucose ≥ 110 and <126, or 30-, 60-, or 90-minute glucose ≥ 200 mg/dL b. HbA1c ≥ 5.7 c. Index60 ≥ 1.4 d. Diabetes Prevention Trial-Type 1 Risk Score (DPTRS) ≥ 7.4
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- Females of childbearing potential must agree to use abstinence or an effective birth control through the treatment period.(
- Males able to father children, must agree to use abstinence or an effective birth control during the treatment period.
- Subjects who are Epstein-Barr virus (EBV) seronegative at screening must be EBV Polymerase chain reaction (PCR) negative within 30 days of randomization and may not have had signs or symptoms of an 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 through and 3 months after study drug treatment period
- Be up to date on all recommended vaccinations based on age of subject and willing to receive killed influenza vaccine when available for current or upcoming season.
- If prior treatment with active study agent from previous clinical trial, approval of medical monitor and investigator that such prior treatment does not impact risk for current study.
- Subjects who have met all above criteria must have the qualifying oral glucose tolerance test (OGTT) within 7 weeks (52 days) of randomization and baseline visit.
Who cannot join
- Potential participants must not meet any of the following exclusion criteria:
- 1. Be immunodeficient or have clinically significant chronic lymphopenia: (Leukopenia (< 3,000 leukocytes /μL), neutropenia (<1,500 neutrophils/μL), lymphopenia (<800 lymphocytes/μL), or thrombocytopenia (<100,000 platelets/μL).
- 2. Have active signs or symptoms of acute infection at the time of randomization including Sars-Cov2.
- 3. Have evidence of prior or current tuberculosis infection as assessed interferon gamma release assay (QuantiFERON).
- 4. Be currently pregnant or lactating, or anticipate getting pregnant within the study period
- 5. Require chronic use of other immunosuppressive agents including use of inhaled, intranasal, or systemic steroids
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- 6. Have evidence of current or past HIV, Hepatitis B, histoplasmosis, coccidioidomycosis, or current Hepatitis C infection.
- 7. Have any complicating medical issues or abnormal clinical laboratory results that may interfere with study conduct, or cause increased risk to include pre-existing pulmonary, GI, renal, cardio-vascular disease, neurological disease (i.e. demyelinating disease), psychiatric disease or blood count abnormalities. Note pre-existing treated celiac or thyroid disease are not exclusionary diagnoses.
- 8. Have a history of malignancies other than of skin
- 9. Evidence of liver dysfunction with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2 times the upper limits of normal
- 10. Evidence of renal dysfunction with creatinine greater than 1.5 times the upper limit of normal for age and sex.
- 11. Known history of congestive heart failure or left ventricular dysfunction.
- 12. Vaccination with a live virus within the last 4 weeks
- 13. Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control within 30 days of screening (see section 4.5 for list of exclusionary pharmaceuticals).
- 14. Active participation in another intervention study in the previous 30 days
- 15. Known allergy to Anti-TNFα or latex.
- 16. Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results
- 17. Previously diagnosed with T1D according to American Diabetes Association (ADA) criteria
About this study
Official title: Tumor Necrosis Factor Blocker (Anti-TNFα) to Delay or Prevent Progression to Stage 3 T1D
This will be a study conducted as a placebo-controlled, double blind, 1:1 randomized controlled clinical trial testing a Tumor Necrosis Factor Blocker (Anti-TNFα) substance versus placebo in subjects with a 2-year 50% risk of progression to stage 3 T1D across multiple centers. The trial will investigate the ability of Anti-TNFα to prevent or delay progression to Stage 3 T1D in the targeted patient population.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Golimumab, Placebo
- 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
For participants ≥45 kg, 50 mg of golimumab will be administered subcutaneously For participants <45 kg, the dose of golimumab is 30 mg/m2 to maximum of 50 mg
PlaceboDrug
Inactive Drug
| Study group | Role | What they receive |
|---|---|---|
| Golimumab | Experimental | Golimumab for subcutaneous use Receives: Drug: Golimumab |
| Placebo | Placebo comparator | Placebo syringes and vials matching active drug Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the elapsed time from random treatment assignment to the development of diabetes (T1D) or time of last contact among those randomized
The primary outcome is the elapsed time from random treatment assignment to the development of diabetes (T1D) or time of last contact among those randomized
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start1 Jul 2021 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Why it stopped: Withdrawn due to COVID-19 related clinical limitations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Model description
- Treatment assignment (active drug: placebo) will be assigned in a parallel, randomized, 1:1 model. Randomization will be conducted using block randomization with variable block sizes with stratification on TrialNet study site and age group (\< 12 years old vs. 12 years old or older).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of South Florida
- Responsible party
- Sponsor
- Investigators
- Carla Greenbaum, MD, Study chair, Type 1 Diabetes TrialNet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729296
- Sponsor's protocol ID
- TN30 Anti-TNFα
- Other IDs
- 2U01DK106993-02, 1UC4DK117009-01
- Status last verified
- Nov 2021
- First submitted
- 20 Jan 2021
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available at the National Institute of Diabetes Digestive and Kidney Diseases (NIDDK) Central Repository
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Necrosis Factor Blocker (Anti-TNFα) to Delay or Prevent Progression to Stage 3 T1D
- ClinicalTrials.gov ID
- NCT04729296
- Acronym / sponsor ID
- TN30 Anti-TNFα
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn due to COVID-19 related clinical limitations
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- University of South Florida
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 28 Jan 2021 (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.
This will be a study conducted as a placebo-controlled, double blind, 1:1 randomized controlled clinical trial testing a Tumor Necrosis Factor Blocker (Anti-TNFα) substance versus placebo in subjects with a 2-year 50% risk of progression to stage 3 T1D across multiple centers. The trial will investigate the ability of Anti-TNFα to prevent or delay progression to Stage 3 T1D in the targeted patient population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Treatment assignment (active drug: placebo) will be assigned in a parallel, randomized, 1:1 model. Randomization will be conducted using block randomization with variable block sizes with stratification on TrialNet study site and age group (< 12 years old vs. 12 years old or older).
| Arm | Type | Receives |
|---|---|---|
| Golimumab | Experimental | Drug: GolimumabGolimumab for subcutaneous use |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo syringes and vials matching active drug |
Who may qualify
- Ages
- 3 to 46 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- Age > 3 and < 46 years
- Willing to provide Informed Consent or have a parent or legal guardian provide informed consent if the subject is <18 years of age
- At least two or more diabetes-related biochemical autoantibodies insulin (mIAA), glutamic acid decarboxylase antibody (GADA), Islet cytoplasmic antibodies (ICA), islet antigen 2 (IA-2A), zinc transporter 8 (ZnT8A) present on the same sample. Of note, ICA and GADA positivity alone cannot be used to define eligibility in this trial).
- Must have at least two of the high-risk markers defined below (within 7 weeks (52 days) of screening visit if performed as part of TN01 Pathway to Prevention (PTP) study at time of screening; defining a 50% two-year progression risk):
- Females of childbearing potential must agree to use abstinence or an effective birth control through the treatment period.(
Key exclusion criteria (18 listed)
- 1. Be immunodeficient or have clinically significant chronic lymphopenia: (Leukopenia (< 3,000 leukocytes /μL), neutropenia (<1,500 neutrophils/μL), lymphopenia (<800 lymphocytes/μL), or thrombocytopenia (<100,000 platelets/μL).
- 2. Have active signs or symptoms of acute infection at the time of randomization including Sars-Cov2.
- 3. Have evidence of prior or current tuberculosis infection as assessed interferon gamma release assay (QuantiFERON).
- 4. Be currently pregnant or lactating, or anticipate getting pregnant within the study period
- 5. Require chronic use of other immunosuppressive agents including use of inhaled, intranasal, or systemic steroids
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: SimponiFor participants ≥45 kg, 50 mg of golimumab will be administered subcutaneously For participants <45 kg, the dose of golimumab is 30 mg/m2 to maximum of 50 mg | Drug | Golimumab |
| PlaceboInactive Drug | Drug | Placebo |
Primary outcome
The primary outcome is the elapsed time from random treatment assignment to the development of diabetes (T1D) or time of last contact among those randomized
Time frame: 6 years
The primary outcome is the elapsed time from random treatment assignment to the development of diabetes (T1D) or time of last contact among those randomized
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
- TrialNet Public WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be made available at the National Institute of Diabetes Digestive and Kidney Diseases (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. This study is not recruiting at the moment.
Carla Greenbaum, MD study chair
Type 1 Diabetes TrialNet
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Golimumab in people with Diabetes Mellitus, Type 1, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
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 14 inclusion and 18 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: withdrawn, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the elapsed time from random treatment assignment to the development of diabetes (T1D) or time of last contact among those randomized (time frame: 6 years). 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 2 Dec 2021.