Insulin and Abatacept in Recently-diagnosed Type 1 Diabetes

What Was Tested

This registered phase 2 trial tested Insulin (regular human).

It had two arms (groups): Abatacept and nasal insulin (active comparator) and Abatacept and nasal placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

68 actual participants took part.

It was open to people of any sex aged from 6 years up to 21 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age between 6 and 21 years and weight at least 20kg at Visit 1. Presence of at least one antibody against insulin (if \<10 days since starting insulin therapy), GAD, IA2 or ZnT8. Willing to use CGM for the duration of the study. Willing to forego other forms of experimental treatment during the study. Willing to postpone any live vaccine immunisations for 3 months after treatment.

The full record lists 10 inclusion and 7 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Insulin (regular human).

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2023-02-13 with completion listed for 2025-09-30.

It ran at 6 sites in Australia (6).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Beta-cell function at 48 weeks (time frame: 0 weeks - 48 weeks).

It also tracked 10 secondary outcomes, for example Beta-cell function at 24, 72 and 96 weeks, Glucose regulation, Estimated C-peptide concentration, Frequency of hypoglycemic events, Hemoglobin A1c levels and Insulin use.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 68 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.