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Can a drug duo save insulin-making cells in type 1 diabetes?

NCT ID NCT05742243

Disease control Sponsor: Melbourne Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether combining two safe immune therapies—abatacept injections and nasal insulin—can help preserve the pancreas's ability to make insulin in people recently diagnosed with type 1 diabetes. The goal is to make blood sugar control easier and reduce the need for injected insulin. The trial involved 68 participants aged 6 to 21, who received treatment for 48 weeks and were followed for another 48 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

68 people

The number who actually took part.

Started

Feb 2023

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 condition that would interfere with study conduct or participant safety

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Conditions

The condition(s) this trial relates to.

glucose intolerance hypoglycemia type 1 diabetes mellitus type 1 diabetes mellitus 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus, type 1 Type 1 diabetes

Contacts and locations

Locations

  • Perth Children's Hospital

    Nedlands, Western Australia, 6009, Australia

  • Queensland Children's Hospital

    South Brisbane, Queensland, 4101, Australia

  • The Children's Hospital at Westmead

    Westmead, New South Wales, 2145, Australia

  • The Royal Children's Hospital

    Parkville, Victoria, 3052, Australia

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050, Australia

  • Women's and Children's Hospital

    North Adelaide, South Australia, 5006, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.