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Platform Trial in Stage 1 Diabetes: Comparing Golimumab vs Placebo

ConditionType 1 Diabetes (T1D)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-44
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Golimumab

    Drug

    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

    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.

Treatment groups

255 Participants
are divided into 2 treatment groups
Group A: GolimumabExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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

Time frame
From Randomization to clinical diagnosis approximately 6 years from the first participant enrolled.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: