Clinical trials are the only way to generate the evidence needed to bring new immunotherapy treatments into the care of people living with type 1 diabetes.
Participation in a clinical trial provides the opportunity to access promising new treatments and to be cared for by a highly motivated team of specialists. Connection with the clinical trial community also enables you to receive early notice of new therapeutic developments and new clinical trials.
You can also benefit from the knowledge that your effort in participating in a clinical trial will help others affected by type 1 diabetes, both now and into the future.
T1D RELAY – Rituximab-pvvr and Abatacept Newly Diagnosed Study
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.
Related Information
Key Requirements
Location: Melbourne, BrisbaneAge: 18 - 45 years (Mel), 8 - 18 years (Bris)
Within three months of diagnosis with type 1 diabetes
STOP-T1D – ATG Prevention Study
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).
Related Information
Key Requirements
Location: MelbourneAge: 18-35
Stage 2 type 1 diabetes: Two or more diabetes related antibodies and blood glucose levels outside of range.
Type1Screen – Screening for type 1 diabetes
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.
Related Information
Key Requirements
Location: Australia and New ZealandAge: Over 2 years of age
Participants must have a relative with type 1 diabetes
IAA trial – Abatacept combined with nasal insulin in recently-diagnosed type 1 diabetes
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.
Related Information
TrialNet Abatacept publication
INITI - Nasal insulin publication
Key Requirements
Location: Melbourne, Adelaide, Brisbane, Perth and SydneyAge: 6 - 21 years
Within 100 days of diagnosis with type 1 diabetes
IMPACT – IMCY-0098 Proof of Action in Type 1 Diabetes
Related Information
Key Requirements
Location: Melbourne, Brisbane and SydneyAge: 18 – 45 years
Within 9 weeks of diagnosis with type 1 diabetes
BANDIT – Baricitinib in New Onset Type 1 Diabetes Mellitus
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.
Related Information
ATIC position statement: Baricitinib use to treat type 1 diabetes
Key Requirements
Location: Victoria and South AustraliaAge: 10 – 30 years
Within 100 days of diagnosis with type 1 diabetes
Page last updated: 18 September 2024