What side effects are associated with this type of intervention?

Immune-modulating therapies for Type 1 Diabetes, such as Ustekinumab, Abatacept, and Rituximab, aim to protect and regenerate insulin-producing beta cells by targeting immune cells. Common side effects of these treatments include increased risk of infections, infusion-related reactions (fever, rash, nausea), and potential liver enzyme elevation. Specific to Ustekinumab, it has been found safe in recent-onset T1D patients, but long-term effects are still being studied. Rituximab may cause fever, rash, and pruritus, particularly after the first infusion, while Abatacept can lead to headaches and upper respiratory infections. IL-1 inhibitors, though less effective in maintaining beta-cell function, can cause injection site reactions and increased risk of infections.

What prior FDA approvals exist?

FDA-approved treatments for Type 1 Diabetes primarily focus on insulin therapy to manage blood glucose levels. However, there are emerging immunomodulatory therapies under investigation. Teplizumab, an anti-CD3 monoclonal antibody, has shown promise in delaying the onset of T1D by modulating the immune response. Other investigational treatments include anti-CD20 and oral anti-CD3 combination therapies, which have demonstrated efficacy in preclinical models. While Ustekinumab, an anti-IL-12/23 antibody, is being studied for its potential to protect and regenerate beta cells, it has not yet received FDA approval for T1D.

What other types of research exist?

Promising novel alternatives to Ustekinumab for Type 1 Diabetes patients include anti-CD3 monoclonal antibodies, which have shown efficacy in delaying autoimmune responses and preserving beta cell function. Additionally, IL-1-targeted biologics like anakinra and canakinumab, which modulate inflammatory responses, may also be considered. These alternatives focus on immune modulation to protect and potentially regenerate insulin-producing beta cells.

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Monoclonal Antibodies

Ustekinumab for Type 1 Diabetes (UST1D2 Trial)

Phase 2 & 3

Recruiting

Led By Jan Dutz, MD FRCPC

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

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

Must not have

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

History of current or past active tuberculosis infection and no latent tuberculosis as per CDC guidelines

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial tests Ustekinumab, a drug used for psoriasis, in adults aged 18-35 with recent-onset type 1 diabetes. The drug aims to protect and regenerate insulin-producing cells by blocking harmful immune cells. This could reduce the need for insulin injections.

Who is the study for?

This trial is for 18-35 year olds recently diagnosed with Type 1 Diabetes, who still produce some insulin and have not used medications affecting glucose tolerance in the last month. Participants must be free from significant diseases, HIV, Hepatitis B/C, tuberculosis, and cannot be pregnant or planning pregnancy soon.

What is being tested?

The study tests Ustekinumab's ability to preserve insulin-producing cells in newly diagnosed Type 1 Diabetics against a placebo. The goal is to see if patients can become insulin-free or need less insulin by protecting these cells.

What are the potential side effects?

Ustekinumab may cause side effects similar to those seen in its use for psoriasis which include infections, allergic reactions, possibly cancer but this is rare. Specific side effects related to diabetes treatment will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 35 years old.

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I am between 18 and 35 years old.

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I have been diagnosed with type 1 diabetes.

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I have been diagnosed with type 1 diabetes.

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I have tested positive for a diabetes-related autoantibody.

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I have tested positive for a diabetes-related autoantibody.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have used medication that affects blood sugar levels in the last 30 days.

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I do not have, nor have I ever had, an active tuberculosis infection.

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I have not had a serious infection in the last 6 weeks.

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I am able to understand information and make decisions about my health.

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I haven't had major surgery in the last 30 days and don't expect to need any during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2018 Phase 4 trial • 43 Patients • NCT02187172

50%

Upper respiratory infection

27%

Common cold

Skin and subcutaneous tissue disorders

Fracture

Anxiety

Dizziness

Back pain

Urinary tract infection

Toothache

Rash/Rash Acneiform/Maculo-Papular

Hypertension

Pain/Pain in extremity

100%

80%

60%

40%

20%

Study treatment Arm

Ustekinumab (Stelara)

Placebo (RCT Period)

Placebo (Active Treatment Period)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: UstekinumabExperimental Treatment1 Intervention

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

Group II: Saline Solution - PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ustekinumab

2015

Completed Phase 4

~4080

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Type 1 Diabetes primarily focus on managing blood glucose levels through insulin therapy, which involves regular injections or an insulin pump to replace the insulin that the body can no longer produce. However, emerging treatments like Ustekinumab aim to address the underlying autoimmune cause of the disease. Ustekinumab works by blocking specific immune cells that attack and destroy insulin-producing beta cells in the pancreas. By inhibiting these immune cells, the treatment hopes to protect any remaining beta cells and potentially allow for their regeneration, reducing the need for external insulin and improving blood glucose control. This approach is significant for Type 1 Diabetes patients as it targets the root cause of the disease rather than just managing its symptoms, potentially leading to better long-term outcomes and quality of life.