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The SAFEGUARD Study

• People aged between 5 and 17 years currently
• Diagnosed with type 1 diabetes in the last 100 days
• Currently trial sites are open in Australia (Victoria, New South Wales, Queensland, Western Australia), and New Zealand (Auckland, Christchurch, Hamilton, Dunedin, Wellington)

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MT-101-101 trial for type 1 diabetes

This study evaluates a new therapy designed to treat type 1 diabetes (T1D) by restoring healthy immune system function. T1D occurs when the body’s immune system mistakenly attacks insulin-producing cells in the pancreas. The study drug is designed to intervene within the network of immune cells to prevent pancreatic cell destruction and preserve or potentially improve insulin production Doctors are studying this drug in people with T1D to ensure it is safe, to see how it works in the body, and whether it impacts the body’s ability to produce insulin.

Who can get involved in Australia currently:

• Between 18 and 45 years old
• Diagnosed with type 1 diabetes
• Currently using insulin (via injections or by pump)
• Willing to attend study visits in Victoria or Queensland

Study visits: You will first have a screening visit (physical exam and blood tests) to confirm you meet the criteria for participation. If eligible, you will receive 2 doses of the study drug four weeks apart. Between study medication dosing and for approximately 6 months after you start the study, you will attend clinic visits so the study doctor can monitor your general health, T1D including insulin production, and evaluate how the study drug is working.

Risks: The study medication was well-tolerated by 24 people without type 1 diabetes. Comprehensive safety data for the study drug in people with T1D is not yet available. However, data from participants already enrolled in this study show possible side effects are mostly mild or moderate, although serious side effects can occur. The study team will closely monitor your health and provide treatment if any adverse effects occur.

Benefits: Every participant will receive 2 doses of study medication. This is the first study in participants with type 1 diabetes, so it is not yet known if the study drug can delay progression of and/or improve diabetes. Data from the study’s first group of T1D participants shows insulin production was stable for up to 20 weeks in those who received a higher dose of the study drug. The number of patients treated at this dose was small, and additional research is needed to confirm these findings. Regardless of whether participants receive any direct benefit, involvement in this study will help determine if the study medicine will move to the next stage of clinical testing and will contribute valuable scientific knowledge that may lead to new treatments for type 1 diabetes.

Remuneration: Participants will be reimbursed (up to $9,750) to compensate for their time and inconvenience associated with participation in the clinical trial. In addition, pre-approved travel, accommodation, and meal expenses will be reimbursed.

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ASITI-201 Study

The ASITI-201 Study is looking for participants based in Queensland/Northern NSW to test a potential new therapy designed to stop the immune system attack that occurs in type 1 diabetes. The trial treatment is made of small lipid particles containing an islet protein combined with a form of vitamin D, designed to reprogram the immune system in type 1 diabetes. When tested in animals, this type of medication worked to halt the attack on insulin producing beta cells and allowed them to continue to function normally. The ASITI-201 trial aims to find out if whether this medication is safe, whether it works the same way in humans as it did in pre-clinical trials and whether a single dose or multiple doses are required for it to be effective. The study is being conducted in two parts (Part A and Part B). The first part of the study (Part A) has now completed. The following details relate to Part B.

Who can participate?

• People aged between 18 and 55 years
• Diagnosed with type 1 diabetes within the last 5 years

Treatment: Participants will be randomly selected to receive either trial treatment OR placebo. Two in every three participants will receive the trial treatment, while one in three will receive placebo. The treatment will be given as a single injection into the upper arm just under the skin, just like an insulin injection.

Study visits: Study activities are undertaken in person at the Princess Alexandra Hospital, Brisbane. Participants will be required to attend six study visits at the trial centre lasting approximately 1.5 hours. Funding may be available for participants outside Queensland to travel to clinic visits.

Benefits: If this trial is successful, ASITI-201 will move to the next stage (Phase 2). This would bring us closer to a breakthrough treatment that could slow down the progression of type 1 diabetes. In future this new drug could potentially help people make their own insulin for longer, delaying or even preventing the need for injected insulin.

Please contact the ASITI-201 Study research team via the link below for further eligibility requirements and to enquire about participating in this trial.

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BETA-PRESERVE TRIAL

The Beta-Preserve trial is currently enrolling young people with newly diagnosed type 1 diabetes across Queensland, South Australia and Western Australia. This trial is to compare teplizumab with placebo to see if insulin-producing cells can be preserved.

To do this, the study will measure if teplizumab changes blood glucose levels or the amount of insulin needed before meals compared to placebo.

Who can get involved in Australia currently:

• Children and adolescents aged 1 to 17 years old
• People diagnosed with type 1 diabetes in the last month
• People living in Queensland, South Australia or Western Australia

Treatment: Participants will be randomly assigned to receive either Teplizumab or placebo.

Study Duration: The total duration of this clinical trial is around 19 months.

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BARICADE-DELAY

Baricitinib is a medication currently used to treat adults with rheumatoid arthritis, atopic dermatitis and alopecia areata. In 2024, Australian researchers showed that Baricitinib may help maintain the body’s ability to make and use some of its own insulin in newly diagnosed type 1 diabetes. The purpose of this study is to learn more about baricitinib in early-stage type 1 diabetes. The study aims to learn:

• Whether baricitinib may be able to delay the start of Stage 3 type 1 diabetes in people who are in the early stages of the disease (Stage 1b or Stage 2)
• Whether baricitinib works better than a placebo (a placebo is an inactive or “pretend” study drug)
• The possible side effects people might have when taking baricitinib.

In this study 2 out of every 3 people will receive baricitinib and 1 out of every 3 people will receive a placebo. Baricitinib (and the study placebo) is taken in tablet form or as a liquid for those who cannot swallow tablets. Who can get involved in Australia currently:

• People with stage 1b or 2 type 1 diabetes (have screened positive for two or more type 1 diabetes autoantibodies)
• People aged between 1 and 35 years of age
• Able to attend study visits in: Victoria, South Australia, Western Australia, New South Wales or Queensland

Study Visits: If you meet the criteria to enter this clinical trial, the study treatment will be given for at least 117 weeks (approximately 2 years and 3 months). To monitor your health closely, you will need to attend the clinic for study related visit approximately 16 times over 2.5 years. At each visit the study team will monitor your blood glucose levels, insulin production and overall health to ensure that you are well and that the study treatment is safe and effective. Risks: Baricitinib has been taken by over 1.5 million people around the world, so the possible side effects of this treatment are well known. The most common side effects reported for baricitinib in people without type 1 diabetes are infections and elevated blood cholesterol. Participants will be closely monitored for any side effects by the study team who will address any concerns. Full safety information will be available to participants to read prior to consenting to participate in this trial. Benefits: Although there is no guarantee that the treatment will be effective, it may help protect insulin-producing cells and preserve the body’s natural insulin production. Participants will receive regular medical check-ups from diabetes specialists throughout the trial. Participants may be able to receive reimbursement for travel expenses, please discuss this with the trial staff.

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Type1Screen – Screening for type 1 diabetes

The ATIC network is dedicated to the early detection of markers for type 1 diabetes, called antibodies. Identification of people with antibodies can lead to a better prognosis and management of type 1 diabetes long term. Those with a positive antibody test can also participate in clinical trials aimed at delaying the onset of symptomatic type 1 diabetes. Australians who are aged over 1 year old can register for a free blood test via Type1Screen.

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Recruitment complete

BARICADE-PRESERVE

Baricitinib is a medication currently used to treat adults with rheumatoid arthritis, atopic dermatitis and alopecia areata. In 2024, Australian researchers showed that baricitinib may help maintain the body’s ability to make and use some of its own insulin in newly diagnosed type 1 diabetes. The purpose of this study is to learn more about baricitinib in newly diagnosed type 1 diabetes. The study aims to learn:

• Whether baricitinib can help in managing newly diagnosed type 1 diabetes
• Whether baricitinib works better than a placebo (a placebo is an inactive or “pretend” study drug)
• The possible side effects people might have when taking baricitinib

In this study 2 out of every 3 people will receive baricitinib and 1 out of every 3 people will receive a placebo. Baricitinib (and the study placebo) is taken in tablet form or as a liquid for those who cannot swallow tablets.   Who can get involved in Australia currently:

• People diagnosed with type 1 diabetes within the last 100 days
• People aged between 1 and 35 years of age
• Able to attend study visits in: Victoria,Western Australia, Queensland, New South Wales or South Australia

Study Visits: If you meet the criteria to enter this clinical trial, the study treatment will be given for at least 52 weeks (1 year). To monitor your health closely, you will need to attend the clinic for study related visit approximately 10 times over 14 months. At each visit the study team will monitor your blood glucose levels, insulin production and overall health to ensure that you are well and that the study treatment is safe and effective. Risks: Baricitinib has been taken by over 1.5 million people around the world, so the possible side effects of this treatment are well known. The most common side effects reported for baricitinib in people without type 1 diabetes are infections and elevated blood cholesterol. Participants will be closely monitored for any side effects by the study team who will address any concerns. Full safety information will be available to participants to read prior to consenting to participate in this trial. Benefits: Although there is no guarantee that the treatment will be effective, it may help protect insulin-producing cells and preserve the body’s natural insulin production. Participants will receive regular medical check-ups from diabetes specialists. Participants may be able to receive reimbursement for travel expenses, please discuss this with the trial staff.  

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T1D-Plus Study

T1D-Plus will test different study treatments that aim to prevent damage to the body’s insulin-producing cells (known as beta cells) by the immune system. There is evidence to suggest that each study treatment might be helpful on its own. In T1D-Plus, we will determine if being treated with more than one of the study treatments is more effective than just one.

Who can get involved in Australia currently:

• Aged between 18-44 years
• Type 1 diabetes diagnosed and commenced insulin therapy within last 6 weeks
• People living in Victoria

Treatment: Participants will be randomly assigned to one of three treatment groups. All participants will take a verapamil tablet daily for 12 months, either alone or in combination with one of two other medications. The other treatments combined with verapamil include golimumab (‘Simponi’), which is administered under the skin with a short needle every two weeks for 12 months, or anti-thymocyte globulin (ATG), which is given by infusion into a vein over two days in the clinic.

Study visits: After signing the consent form, participants will be invited for a screening visit to determine eligibility for the study.  If eligible, participants will attend a randomisation visit, during which the study medication will be assigned by chance.  This is followed by 7 treatment visits and 3 phone visits, plus an optional clinic visit.  The amount of time spent at the clinic at each visit may vary due to the differing tests and checks.

Risks: Your hospital research team will monitor for potential side effects throughout your participation in the trial. Like all medicines, side effects may occur and will be treated as necessary.

Benefits: Every participant in this trial will receive at least one study treatment. Participants will know which treatment(s) they receive.  

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T1D OBTAIN (ACT18368) Study

The T1D OBTAIN (ACT18368) study is testing a new treatment designed to protect insulin-producing cells in people recently diagnosed with type 1 diabetes (T1D). The goal of this trial is to see if the new treatment is safe and can protect the body’s own insulin production, making it easier to manage blood glucose levels, lower HbA1c levels, and reduce the need for insulin.

Who can get involved in Australia currently:

• Part A: People aged between 18 and 35 years
• Recently diagnosed with type 1 diabetes
• Started insulin treatment in the past 90 days
• Live in Victoria, New South Wales or Queensland

Treatment: Participants will receive an injection of active study drug or placebo once every two weeks for one year. The placebo is essential to help researchers be sure that any effects that happen are caused by the active treatment and not by something else. Participants will have a 3 in 4 chance of receiving the study drug and will continue using insulin as part of their regular treatment, as recommended by their doctor.

Study visits: Participants will be required to attend 10 study visits at a clinical centre over about 18 months, this includes;

• Screening Period: 1 visit to collect medical history and do some tests to assess eligibility for the trial
• Treatment Period: 7 visits over 1 year to review participants health, including blood glucose levels (CGM data), and do some tests. Some of these visits will take about 3 hours and include a fasting mixed-meal tolerance test (MMTT)
• Follow-up Period: 2 visits over 6 months after the final dose, to review participants health and do some tests. One of these visits will take about 3 hours and include a fasting mixed-meal tolerance test (MMTT)

Risks: Like all medical treatments, there may be side effects. The most common side effect reported for this study in people without type 1 diabetes, was mild to moderate headaches. Participants will be closely monitored by the study team who will address any concerns.

Benefits: There is no guarantee that the treatment will help, but it may protect insulin-producing cells and help preserve the body’s own insulin production. Participants will also receive regular medical check-ups from diabetes specialists. If the study drug is confirmed to be effective in people with type 1 diabetes, participants may be able to choose to continue the treatment if they meet appropriate conditions.

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JAKPOT T1D – JAK inhibitors to preserve C-peptide production in new onset type 1 diabetes

A recent Australian trial called BANDIT, showed that a JAK inhibitor called baricitinib can delay progression of type 1 diabetes and preserve the body’s ability to make its own insulin. The JAKPOT study will test if other JAK inhibitors called abrocitinib and ritlecitanib can also preserve pancreas function and slow down progression of type 1 diabetes. Abrocitinib is approved in Australia, to treat an allergic skin condition called atopic dermatitis, and ritlecitanib is approved in the U.S. and in Europe to treat a hair loss condition called alopecia areata. Neither of these JAK inhibitors are approved to treat type 1 diabetes.

Who can get involved in Australia currently:

• Aged between 12 and 35 years
• Type 1 diabetes diagnosed within the last 100 days
• Body weight above 35kg

Treatment: There are three treatment groups in this trial and all participants will take a daily tablet for 12 months. One group will receive abrocitinib tablets, one will receive ritlecitanib tablets and one will receive placebo tablets. Participants will be randomly selected to one of the three groups. Neither the researchers or the participant will know which group has been allocated until the end of the trial. The placebo group is essential to help researchers be sure that any effects that happen are caused by the active treatment (abrocitinib or ritlecitinib) and not by something else.

Study visits: Participants will be required to attend 9 visits at a participating clinical centre over a two-year period. Seven visits will occur during the first year during the ‘treatment’ phase, and a further two visits the following year during the ‘monitoring’ phase of the trial. The first visit, called the ‘screening’ visit will take up to six hours, along with three of the subsequent visits over the two year trial. The remaining visits will take 1-4 hours, with a fasting mixed-meal tolerance test (MMTT) at some visits.

Benefits: Two in every three participants in this trial will receive active treatment, either abrocitinib or ritlecitanib. Current evidence suggests that these two medications can help suppress the immune attack that causes type 1 diabetes and help the body continue to produce its own insulin. In addition to potential positive effects of treatment, participants will be closely monitored and blood glucose levels managed intensively. This may reduce the risk of long-term complications of type 1 diabetes, as well as helping remaining beta cells in the pancreas to continue making insulin on their own.

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SAB-142-101 – Assessing the Safety and Tolerability of SAB-142 in type 1 diabetes

The SAB-142-101 study is a phase 1 clinical trial (first-time in humans). This clinical trial will test the safety and dosing of a new class of medicine in the treatment of type 1 diabetes called ‘anti-thymocyte immunoglobulin’ or ATG. An ATG medicine called thymoglobulin is already approved by the Australian Therapeutic Goods Association (TGA) for patients who have had an organ transplant. Trials of thymoglobulin have been successful in helping the pancreas continue to produce its own insulin in people with type 1 diabetes, however it has unwanted side effects (e.g. urinary tract infection, abdominal pain, flu-like symptoms). This trial will test whether a new ATG treatment has similar benefits for people with type 1 diabetes without the side effects associated with thymoglobulin.

Who can get involved in Australia currently:

• People aged between 18 and 45 years
• Diagnosed with type 1 diabetes within the last 5 years
• Living in Victoria

Treatment: Participants in this trial will be randomly selected to receive either study treatment or placebo, (which is a comparison treatment that looks the same but has no medication). The treatment will be given intravenously (via vein in the arm), as a single dose given over 2 days.

Study visits: At the beginning of the trial, participants are required to stay in the trial centre in Bayswater for a 7-night/8-day period. Following the initial stay, participants will attend the trial centre for six visits over four months.

Risks: The trial treatment is an innovative therapy entering its first human trials. While the trial team anticipate a favourable safety profile based on extensive preclinical studies, as with all new treatments, unforeseen effects are always possible. Participants will be monitored closely by medical professionals within the clinical trial unit and treated immediately if they occur.

Benefits: If you agree to take part in this study, there will be no direct benefit to you. However, your participation in this study may help researchers gain important scientific knowledge that could contribute to the development of a new treatment for type 1 diabetes. We hope the information learned from this study will benefit patients with type 1 diabetes in the future. All participants will be compensated for their time.

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T1D RELAY – Rituximab-pvvr and Abatacept Newly Diagnosed Study

Rituximab-pvvr and abatacept have both independently been shown to protect insulin producing beta cells and allow people with newly diagnosed type 1 diabetes to continue producing their own insulin for longer after diagnosis. ATIC are conducting the TrialNet T1D RELAY study which looks at whether rituximab-pvvr together with abatacept is better at protecting beta cells than rituximab alone.

Who can get involved in Australia currently:

• Aged between 18 and 45 years
• Evidence of insulin production, determined by: one or more diabetes-related antibodies and detectable c-peptide during a mixed-meal tolerance test (MMTT)
• Up to date with immunisation schedule including COVID-19 and flu boosters

Treatment: Participants in this study will receive weekly rituximab-pvvr by intravenous infusion (into a vein in the arm) for four weeks. Participants will then receive weekly injections of abatacept OR placebo (inactive equivalent). Two in every three participants will receive active treatment (abatacept), while one in three will receive placebo.

Study visits: Participants will be required to attend 16 visits at a participating clinical centre over a two-year treatment period and a further five visits over a two year follow up period after the treatment. The first four visits for the rituximab-pvvr infusion will take up to 8 hours. The remaining visits will vary in duration from 1-4 hours with a MMTT at some visits.

Benefits: All participants in this study will receive active treatment in the form of rituximab-pvvr. Two in every three participants will then receive a second active treatment called abatacept. In addition to the potential for these study medications to delay the progression of type 1 diabetes, participants will be closely monitored and blood glucose levels managed intensively. This may reduce the risk of long-term complications of type 1 diabetes, as well as helping remaining beta cells in the pancreas to continue making insulin on their own.

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T1D RELAY flyer

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STOP-T1D – ATG Prevention Study

Antithymocyte globulin (ATG) is commonly used to prevent transplant rejection. An earlier TrialNet study showed that ATG improved blood glucose management and preserved pancreas function in people with recently-diagnosed type 1 diabetes. STOP-T1D will test if ATG can delay or prevent progression from stage 2 to stage 3 type 1 diabetes. Read more about the stages of type 1 diabetes below.

Who can get involved in Australia currently:

• Aged between 18 and 35 years
• Be at high risk of progressing to stage 3 type 1 diabetes, determined by a positive screening blood test for antibodies and slightly elevated glucose
• Up to date with immunisation schedule, including COVID-19 and flu boosters

Treatment: The study medication in this trial is given by intravenous infusion (through a vein in the arm) on two consecutive days. For every three participants, two will receive ATG and one will receive placebo.

Study visits: The two treatment visits will take 6 to 10 hours for the infusion and a further 2 hours for monitoring (8-12 hours in total). Participants will visit the trial site two weeks after the second treatment, then every three to six months for one year. Participants will continue to visit the trial site for monitoring twice a year for up to four years following treatment.

Benefits of participation: In addition to potentially delaying or preventing progression of type 1 diabetes, benefits to participating in the study include close monitoring and follow up by the research team. If you progress to stage 3 type 1 diabetes, the study blood tests will likely show this before any symptoms appear. Early diagnosis and commencement of insulin treatment largely eliminates the risk of a serious condition called diabetic ketoacidosis (DKA).

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Stages of type 1 diabetes

TrialNet ATG publication

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IAA trial – Abatacept combined with nasal insulin in recently-diagnosed type 1 diabetes

IAA (Insulin And Abatacept) is a randomised controlled trial testing whether the combination of two safe disease-modifying therapies called abatacept and nasal insulin slows down the immune attack on the insulin-producing (beta) cells of people with newly-diagnosed type 1 diabetes. Abatacept is a disease-modifying medication approved for treatment of rheumatoid arthritis in both adults and children. Abatacept has previously been shown to preserve beta cell function in people with recently-diagnosed type 1 diabetes (link to publication below). It is given as an injection under the skin, similar to an insulin injection.

Nasal insulin has also been previously tested by researchers in Melbourne. It is administered as a nasal spray, and is known to dampen the immune attack observed in type 1 diabetes (link to publication below). Combining both therapies could be more effective than either treatment alone and, if effective, could delay the need for insulin injections.

Approximately 60 participants will receive abatacept in combination with either nasal insulin or placebo over a 48-week period. Participants will be required to attend their local trial centre 16 times over two years. Five of these are extended visits lasting 3-4 hours, however the majority of visits will take less than one hour.

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TrialNet Abatacept publication

INITI - Nasal insulin publication

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IMPACT – IMCY-0098 Proof of Action in Type 1 Diabetes

ATIC researchers are trialling a new medication called IMCY-0098 to see whether it preserves pancreas function by dampening the immune attack on insulin-producing cells that occurs in people with type 1 diabetes. IMCY-0098 is administered as an injection under the skin in 7 doses over a 24-week period. Participants in this study will be required to attend 9 visits at their nearest clinical centre over a 12-month period and two follow-up visits in the second year.

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BANDIT – Baricitinib in New Onset Type 1 Diabetes Mellitus

The BANDIT trial tested whether a drug called baricitinib could halt the immune attack on insulin-producing cells in the pancreas, called beta cells, treating the cause of type 1 diabetes. The BANDIT trial results were published in the New England Journal of Medicine on the 7^th of November 2023.

Baricitinib was found to help people with newly diagnosed type 1 diabetes continue to produce insulin for longer. A once-daily tablet of baricitinib, over a 48-week period preserved beta cell function and reduced the need for insulin in those who had been diagnosed within the past 100 days.

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BANDIT trial publication

ATIC position statement: Baricitinib use to treat type 1 diabetes