Clinical Phase II/III Trial of Ustekinumab to Treat Type 1 Diabetes (UST1D2) (UST1D2)
Type 1 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring T1D, Ustekinumab, new-onset, diabetes
Eligibility Criteria
Inclusion Criteria:
- A diagnosis of type 1 diabetes mellitus in accordance with the ADA/CDA criteria.
- An interval of ≤100 days between the diagnosis and the first dose of the study drug.
- Ability to provide documented informed consent.
- Male or female, aged 18-35 years inclusive, at the time of the anticipated first dose of the study drug.
- Evidence of residual functioning β cells. This will be assessed by a C-peptide level over 0.2nmol/L in the MMTT test.
- Positive for at least one diabetes-related autoantibody.
- Willing to record all insulin taken and blood glucose levels that are required for monitoring during the study, including reporting any hypoglycaemic events.
Exclusion Criteria:
- No condition that, in the investigators' judgment, is likely to cause the subject to not be able to understand information in order to provide informed consent.
- History of malignancy.
- No significant and/or active disease in any body system that is likely to increase the risk to the subject or interfere with the subject's participation in the study.
- No significant systemic infection during the 6 weeks before the first dose of the study drug.
- No history of current or past active tuberculosis infection and no latent tuberculosis as per CDC guidelines.
- Have used any other investigational drug within the 3 months prior to the first dose and/or intend on using any investigational drug for the duration of the study.
- Prior or current treatment that is known to cause a significant, ongoing change in the course of T1D or immunological status.
- Current or prior (within 30 days prior to first study drug dose) use of medications known to influence glucose tolerance.
- No significant abnormal laboratory values during the screening period, other than those due to T1D.
- Not pregnant, breastfeeding or planning to become pregnant during the 60 days after the last dose of the study drug.
- Have not received any live vaccines within 30 days prior to the first study drug dose and are not expected to need to receive a vaccine during the study.
- No prior allergic reaction, including anaphylaxis, to any component of the study drug product.
- No prior allergic reaction, including anaphylaxis, to any human, humanized, chimeric or rodent antibody treatment.
- Have not undergone any major surgery within the 30 day period prior to the first drug dose and not anticipating requiring surgery during the study period.
- Negative results for Hepatitis B surface antigen and for antibodies to Hepatitis B core antigen, or evidence of Hepatitis B surface antibody > 10 IU, and negative for Hepatitis C. Negative results for HIV and not considered by the investigator to be at high risk for HIV infection.
Sites / Locations
- Mount Sinai Hospital/UHNRecruiting
- BCDiabetesRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Ustekinumab
Saline Solution - Placebo
Week 0: Loading dose of 6mg/kg Ustekinumab Intravenously. Weeks 8, 16, 24, 32, 40, and 48 (6 visits): 90mg Ustekinumab subcutaneously. Weeks 28, 52, 78: Non-dosing visits where a Mixed Meal Tolerance Test will be administered. Total of 11 visits
Patients allocated to receive placebo will receive respective amounts of a saline-placebo at the same intervals. Week 0: Loading dose of 6mg/kg saline intravenously. Weeks 8, 16, 24, 32, 40, and 48 (6 visits): 90mg saline subcutaneously. Weeks 28, 52, 78: Non-dosing visits where a Mixed Meal Tolerance Test will be administered. Total of 11 visits