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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 28 and 78
Awards & highlights
UST1D2 Trial Summary
This trial will assess if Ustekinumab can decrease C-peptide decline in participants with recent onset type 1 diabetes, in order to see if the drug is effective in protecting insulin-producing cells.
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.Check my eligibility
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.See study design
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.
UST1D2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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 am willing to track and report my insulin use, blood sugar levels, and any low blood sugar events.
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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.
UST1D2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 28 and 78
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 28 and 78
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Baseline change in 2-hour mixed meal-stimulated C-peptide AUC at week 52.
Rate, frequency and severity of all adverse events including; hypoglycemic episodes; injection reactions; hypersensitivity reactions; evidence of infection and posterior leukoencephalopathy syndrome.
Secondary outcome measures
2-hour MMTT-stimulated C-peptide AUC at weeks 28 and 78)
Basic immune phenotyping of WBC subsets
CD154 and CD134 (OX40) based assays to determine diabetogenic antigen specific responses of T helper cells.
+10 moreSide effects data
From 2018 Phase 4 trial • 43 Patients • NCT0218717250%
Upper respiratory infection
27%
Common cold
9%
Urinary tract infection
9%
Anxiety
9%
Back pain
9%
Dizziness
9%
Fracture
9%
Skin and subcutaneous tissue disorders
5%
Rash/Rash Acneiform/Maculo-Papular
5%
Hypertension
5%
Pain/Pain in extremity
5%
Toothache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ustekinumab (Stelara)
Placebo (RCT Period)
Placebo (Active Treatment Period)
UST1D2 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
2013
Completed Phase 4
~4140
Find a Location
Who is running the clinical trial?
Janssen, LPIndustry Sponsor
160 Previous Clinical Trials
307,924 Total Patients Enrolled
University of British ColumbiaLead Sponsor
1,415 Previous Clinical Trials
2,466,950 Total Patients Enrolled
Juvenile Diabetes Research FoundationOTHER
232 Previous Clinical Trials
141,718 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have used medication that affects blood sugar levels in the last 30 days.The patient must have received the study drug within the last 100 days of the study.I do not have, nor have I ever had, an active tuberculosis infection.I've had treatments that significantly changed my Type 1 Diabetes or immune system.I am between 18 and 35 years old.Your body still makes insulin, as shown by a C-peptide level over 0.2nmol/L in a special test.I am between 18 and 35 years old.I have been diagnosed with type 1 diabetes.I have had cancer before.You do not have HIV and are not at high risk for getting HIV, according to the investigator.I am willing to track my insulin and blood sugar levels, including any low blood sugar events.I haven't had any live vaccines in the last 30 days and don't plan to during the study.Your body still produces insulin from the pancreas, as shown by a C-peptide level over 0.2nmol/L in a specific test.Your lab test results are mostly normal, except for those related to Type 1 diabetes.I am willing to track and report my insulin use, blood sugar levels, and any low blood sugar events.I have not had a serious infection in the last 6 weeks.I have been diagnosed with type 1 diabetes.I do not have any severe illnesses that could worsen my condition or affect my study participation.I have tested positive for a diabetes-related autoantibody.You haven't had a severe allergic reaction to any type of antibody treatment in the past.You don't have Hepatitis B or Hepatitis C.I am able to understand information and make decisions about my health.I haven't had major surgery in the last 30 days and don't expect to need any during the study.I have tested positive for a diabetes-related autoantibody.
Research Study Groups:
This trial has the following groups:- Group 1: Ustekinumab
- Group 2: Saline Solution - Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are the individuals in this experiment at least 18 years of age?
"Only people aged 18-35 can take part in this trial, and there are 233 similar trials for people under 18 and 997 for people over 65."
Answered by AI
What are the conditions that Ustekinumab is most often prescribed for?
"Ustekinumab can be used to regulate adrenal cortex hormone levels. In addition, it is an effective treatment for conditions like an insufficient response to other TNF therapies, psoriasis, and Crohn's disease."
Answered by AI
What is the previous research on Ustekinumab?
"Ustekinumab is being studied in 35 different clinical trials, 18 of which are Phase 3 studies. The majority of these studies are based in Gdansk, Pomorskie, but there are 2789 total locations running trials for Ustekinumab."
Answered by AI
Who does this clinical trial require as participants?
"This trial is enrolling 66 people with diabetes, autoimmune aged 18 and 35. Most importantly, applicants should meet the following 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"
Answered by AI
Are recruitment efforts for this clinical trial ongoing?
"The trial, which has been open since January 4th 2021, is still recruiting patients according to the listing on clinicaltrials.gov. The study was last updated on June 3rd, 2022."
Answered by AI
How many test subjects are currently involved in this clinical trial?
"Yes, that is accurate. The clinical trial is currently ongoing and is looking for 66 participants from 2 different sites. The first posting was on 1/4/2021, with the most recent update on 6/3/2022."
Answered by AI
Who else is applying?
What state do they live in?
Ontario
How old are they?
18 - 65
What site did they apply to?
Mount Sinai Hospital/UHN
What portion of applicants met pre-screening criteria?
Met criteria
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