Insulin and Abatacept (IAA) Trial in Type 1 Diabetes

Study overview

If effective, the combination of these two therapies 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 17 times over two years, with majority of visits lasting less than one hour.

1. Study participation: 17 visits across 2 years, including

• Screening visit
• 48-week treatment period with 13 visits
• 48-week follow-up period with 3 visits

2. Treatments will be administered by participant/carer at home:

• Insulin or placebo will be taken via nasal spray every day for 10 days and then 2 days each week
• Abatacept will be injected under the skin using a syringe once each week

3. In addition to standard health assessments (vital signs, physical exam, side effects), the following tests will be performed:

• Urine and blood samples
• Mixed meal tolerance test (MMTT)
• Questionnaires to assess quality of life

Study objectives

In people with recently diagnosed Type 1 Diabetes (T1D), determine if treatment with the combination of nasal insulin and abatacept, compared to nasal placebo and abatacept:

• preserves the ability of the pancreas to make insulin
• improves glucose control and decreases the need for insulin injections; and
• induces immune tolerance to beta cell autoantigens.

Eligibility criteria

• Aged 6 –21 years
• Within 100 days of T1D diagnosis
• Have at least 1 diabetes antibody
• Have random C-peptide >0.3 nmol/L
• Willing to use CGM for duration of trial
• Fully vaccinated against Covid-19 and up to date with other vaccinations.

Find out more

Website: atic.svi.edu.au/clinical-trials
Contact: Kate.murphy3@mh.org.au
Insulin and Abatacept (IAA) Trial in Type 1 Diabetes Flyer.

This study has been approved by the Melbourne Health Human Research Ethics Committee HREC/85039/MH-2022