CompletedPhase 2

Insulin and Abatacept in Recently-diagnosed Type 1 Diabetes

Australia68 participantsStarted 2023-02-13

Plain-language summary

The goal of this clinical trial is to test whether the combination of two safe immune therapies called abatacept and nasal insulin can preserve pancreas function in recently-diagnosed type 1 diabetes. When type 1 diabetes is first diagnosed, the pancreas is still able to make small amounts of insulin, which helps control glucose levels. Preserving pancreas function can make glucose control easier and reduce the need to use injected insulin. Participants will be asked to inject abatacept under their skin once per week and inhale nasal insulin or nasal placebo using a spray for 10 consecutive days initially and twice per week thereafter. The treatment period is for 48 weeks, with another 48-week follow-up period.

Who can participate

Age range

6 Years – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 6 and 21 years and weight at least 20kg at Visit 1 * Diabetes mellitus diagnosed according to ADA criteria (53) within 100 days of Visit 2 * Presence of at least one antibody against insulin (if \<10 days since starting insulin therapy), GAD, IA2 or ZnT8 * Random C-peptide \>0.3nmol/l, measured by a NATA-accredited pathology laboratory within 2 weeks of Visit 2 * Willing to use CGM for the duration of the study * Demonstrated ability to record home glucose measurements and insulin doses, as judged by the study doctor * Willing to forego other forms of experimental treatment during the study * Fully vaccinated against Covid-19, as recommended by the Australian Technical Advisory Group on Immunisation * Up to date with other vaccinations recommended by the Australian Technical Advisory Group on Immunisation * Willing to postpone any live vaccine immunisations for 3 months after treatment Exclusion Criteria: * Clinical or laboratory evidence of active infection other than localised skin infection, including viral hepatitis, EBV, CMV or tuberculosis * Immunodeficiency or chronic use of immunosuppressive drugs other than topical or inhaled glucocorticoid * Vaccination with live or dead virus within 4 weeks of Visit 2 * History of malignancy * Pregnant or lactating, or of child-bearing potential not using an effective method of contraception * Any pathology of the nasal passages that would preclude safe application of the nasal spray * Any condi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Beta-cell function at 48 weeks

Timeframe: 0 weeks - 48 weeks

Trial details

NCT IDNCT05742243

SponsorMelbourne Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More Type 1 Diabetes trials