drugset / Trial / NCT05742243

Insulin and Abatacept in Recently-diagnosed Type 1 Diabetes

NCT05742243

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

EvaluationDrugModalityDoseRoute
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