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Type 1 DiabetesPhase 1/2UST1DNCT02117765

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

A Phase 1/2 study testing Ustekinumab in people with Type 1 Diabetes, run by University of British Columbia at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Ustekinumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
Mar 2015to Jun 2017
Phase
Phase 1/2
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 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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.
  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • BC Diabetes

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

About this study

Official title: Phase I/II Study of Ustekinumab in Patients With New-onset Type 1 Diabetes

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.

Read the detailed description

The investigators will perform an open-label pilot safety study (Phase I/II clinical trial) with a total of 20 adult (18-35 years old) subjects with recent-onset T1D. There will be four study cohorts, which will be recruited sequentially all to the treatment arm: five subjects will be given ustekinumab, 45mg subcutaneously (SC) at 0, 4, 16, 28 and 40weeks, five subjects will be given ustekinumab, 90mg SC at weeks 0, 4, 16, 28 and 40, five subjects will be given 45mg SC at weeks 0, 4 and 16 and five subjects will be given 90mg subcutaneously (SC) at weeks 0, 4 and 16. Recruitment and screening for the pilot study will be completed within the first 6 months. The follow up period is 1 year from the first dose.

Conditions
Type 1 Diabetes
Being tested
Ustekinumab
Keywords
T1D, ustekinumab, new-onset, diabetes
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UstekinumabDrug

    Also called Stelara

Study groups in NCT02117765
Study groupRoleWhat they receive
TreatmentExperimentalFour cohorts of 5 subjects will be recruited: Group 1: Five subjects will be given Ustekinumab 45mg SC at 0, 4, 16, 28 and 40 weeks. Group 2: Five subjects will be given Ustekinumab 90mg SC at 0, 4, 16, 28 and 40 weeks. Group 3: Five subjects will be given Ustekinumab 45 mg SC at 0,4 and 16 weeks. Group 4: Five subjects will be given Ustekinumab 90mg SC at 0, 4 and 16 weeks.
Receives: Drug: Ustekinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Safety Endpoints (composite outcome measure)

    1. Rate, frequency and severity of all adverse events including; hypoglycemic episodes; injection reactions; hypersensitivity reactions; evidence of infection and posterior leukoencephalopathy syndrome.
    2. Vital signs, standard hematology and chemistry tests, physical examinations.

    Measured: 12 months

Secondary outcomes (2)

  1. Immunological Endpoints (composite outcome measure)

    1. Immune phenotyping via flow cytometry of all Interleukin (IL)-12, IL-23, IL-17, Interferon(IFN)-γ secreting immune subsets.
    2. Basic immune phenotyping of white blood cell subsets.
    3. Human leukocyte antigen(HLA)- A, B, C, DR, DP, DQ typing.
    4. Fluorospot (ELISpot) analysis for IL-17 and IFN-γ secretion in response to whole insulin and antigens for Cluster of differentiation (CD)8+ and CD4+ T cells .
    5. Luminex assessment of serum cytokines IL-17, IFN-γ, IL-12 and IL-23.
    6. Regulatory T cell : Effector T cell ratio
    7. CD154 based assays to determine diabetogenic antigen specific responses of T helper cells.
    8. Epigenetic assessment of Treg phenotype and function.

    Measured: 12 months

  2. Exploratory (composite outcome measure)

    1. Mixed-meal tolerance test (MMTT) - stimulated 2-hour C-peptide area under the curve (AUC) at weeks 4, 28 and 52.
    2. Insulin use in units per kg body weight per day at weeks 4, 16, 28, 40 and 52.
    3. HbA1C levels at weeks 4, 16, 28, 40 and 52.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2014 (estimated)
  2. Study startMar 2015
  3. Primary completionFeb 2017 (estimated)
  4. Study completionJun 2017 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02117765
Sponsor's protocol ID
H14-00939
Acronym
UST1D
Status last verified
May 2016
First submitted
7 Apr 2014
Last updated
25 May 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Marwaha AK, Chow S, Pesenacker AM, Cook L, Sun A, Long SA, Yang JHM, Ward-Hartstonge KA, Williams E, Domingo-Vila C, Halani K, Harris KM, Tree TIM, Levings MK, Elliott T, Tan R, Dutz JP. A phase 1b open-label dose-finding study of ustekinumab in young adults with type 1 diabetes. Immunother Adv. 2021 Nov 13;2(1):ltab022. doi: 10.1093/immadv/ltab022. eCollection 2022.

    PubMed 35072168

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ustekinumab in people with Type 1 Diabetes, run by University of British Columbia at 1 site in Canada.

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 7 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 25 May 2016. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Results are not available in the source record.

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?

Primary Safety Endpoints (composite outcome measure) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02117765, which also lists 1 linked publication.

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 25 May 2016.

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