Actively Recruiting

ASITI-201 Study

A new trial called the ASITI-201 Study is looking for participants based in Queensland to test a potential new therapy designed to stop the immune system attack that occurs in type 1 diabetes. ASITI-201 is made of small lipid particles containing proteins 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 will be conducted in two parts (Part A and Part B). The first part of the study (Part A) has now commenced recruitment. The following details relate to Part A.

Who can get involved in Australia currently:

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

Treatment: Participants will be randomly selected to receive either ASITI-201 OR placebo. Two in every three participants will receive ASITI-201, 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 four study visits at the trial centre lasting approximately 1.5 hours, and a single baseline visit lasting approximately 6 hours. Funding may be available for participants in Queensland to travel to clinic visits.

Benefits: If this trial is successful, ASITI-201 will move to the next stage (Part B). 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 email [email protected] for further eligibility requirements and to enquire about participating in this trial.

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Actively Recruiting

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

Actively Recruiting

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. Relatives of people with type 1 diabetes aged between 2 and 30, living in Australia and New Zealand can register for a blood test.

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Sign up for T1D screening

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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

Closed

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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Closed

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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Related Information

BANDIT trial publication

ATIC position statement: Baricitinib use to treat type 1 diabetes