drugset / Trial / NCT05742243
Insulin and Abatacept in Recently-diagnosed Type 1 Diabetes
Phase 2
Completed
68 enrolled
Melbourne Health
Juvenile Diabetes Research Foundation · collabNational Health and Medical Research Council, Australia · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2023-02-13
- Primary completion
- 2025-09-30
- Completion
- 2025-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Insulin | Protein / enzyme biologic | — | Intranasal |
| Comparator | Abatacept | Other / unclassified | 50 mg | Subcutaneous |
| Comparator | Abatacept | Other / unclassified | 87.5 mg | Subcutaneous |
| Comparator | Abatacept | Other / unclassified | 125 mg | Subcutaneous |