NCT05742243CompletedPhase 2
Insulin and Abatacept in Recently-diagnosed Type 1 Diabetes
Abatacept Combined With Nasal Insulin to Preserve Beta-cell Function in Recently-diagnosed Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 24 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 68 (actual)
- First submitted
- 15 Feb 2023
- Start date
- 13 Feb 2023
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- Melbourne Health
- Diseases
- Type 1 diabetes
- NCT number
- NCT05742243
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 68
- From 13 Feb 2023 to the primary completion date, 30 Sept 2025
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Immunodeficiency or chronic use of immunosuppressive drugs other than topical or inhaled glucocorticoid
Other illness
- History of malignancy
- Any condition that would interfere with study conduct or participant safety
Lab values
- Clinical or laboratory evidence of active infection other than localised skin infection, including viral hepatitis, EBV, CMV or tuberculosis
Other
- Vaccination with live or dead virus within 4 weeks of Visit 2
- 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
Who the study is looking for
- 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
Age in the registry: 6 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Perth Children's Hospital Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Women's and Children's Hospital Coordinator of this site? Confirm its status | North Adelaide | Australia | Unknown status |
| The Royal Children's Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
| The Royal Melbourne Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
| Queensland Children's Hospital Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| The Children's Hospital at Westmead Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.