Overview

Pilot Clinical Trial of Ustekinumab in Patients With New-onset T1D

Status:
Unknown status
Trial end date:
2017-06-01
Target enrollment:
0
Participant gender:
All
Summary
In type 1 diabetes (T1D), immune defense cells in the body attack and destroy insulin-producing beta cells leaving affected people with a lifelong need for daily insulin injections. Even with insulin injections, blood glucose (sugar) control is imperfect and leads to many health complications and a shortened life span. This is a pilot clinical trial to test the safety of a drug, ustekinumab, in 20 adult subjects with recent-onset T1D. Ustekinumab is currently licensed for use in psoriasis where it has proven to be both highly effective and safe and so the investigators hope to see a similar effect in T1D. This trial will also be used to determine the best dosage and frequency of the drug to be given to people with T1D to help design future studies on the drug's effectiveness. The investigators hope that if the drug can block immune cells soon after the development of diabetes, any remaining insulin-producing cells may be protected, and regenerate, thus producing more insulin so that individuals may be insulin free, or require less insulin.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of British Columbia
Collaborator:
Juvenile Diabetes Research Foundation
Treatments:
Ustekinumab
Criteria
Inclusion Criteria:

1. A diagnosis of type 1 diabetes mellitus in accordance with the canadian diabetes
association criteria.

2. An interval of ≤100 days between the diagnosis and the first dose of the study drug

3. Ability to provide documented informed consent.

4. Male or female, aged 18-35 years inclusive, at the time of the anticipated first dose
of the study drug.

5. Evidence of residual functioning β cells. This will be assessed by a C-peptide level
over 0.2nmol/L in the MMTT test.

6. Positive for at least one diabetes-related autoantibody.

7. 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:

1. 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.

2. History of malignancy.

3. 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.

4. No significant systemic infection during the 6 weeks before the first dose of the
study drug.

5. No history of current or past active tuberculosis infection and no latent
tuberculosis.

6. 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.

7. Prior or current treatment that is known to cause a significant, ongoing change in the
course of T1D or immunological status.

8. Current or prior (within 30 days prior to first study drug dose) use of medications
known to influence glucose tolerance.

9. No significant abnormal laboratory values during the screening period, other than
those due to T1D.

10. Not pregnant, breastfeeding or planning to become pregnant during the 60 days after
the last dose of the study drug.

11. 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.

12. No prior allergic reaction, including anaphylaxis, to any component of the study drug
product.

13. No prior allergic reaction, including anaphylaxis, to any human, humanized, chimeric
or rodent antibody treatment.

14. 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.

15. 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.