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Insulin and Abatacept in Recently-diagnosed Type 1 Diabetes

NCT05742243 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-12-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Abatacept (CTLA4-Ig) and nasal insulin (Humulin R®)

Abatacept injected subcutaneously once per week and nasal insulin inhaled for 10 consecutive days initially and twice per week thereafter

DRUG

Abatacept (CTLA4-Ig) and nasal placebo (0.9% sodium chloride)

Abatacept injected subcutaneously once per week and nasal placebo inhaled for 10 consecutive days initially and twice per week thereafter

Sponsors & Collaborators

  • National Health and Medical Research Council, Australia

    collaborator OTHER

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • Melbourne Health

    lead OTHER

Principal Investigators

  • John Wentworth · Melbourne Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-13
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05742243 on ClinicalTrials.gov