NCT05742243

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

December 24, 2025

Status Verified

October 1, 2025

Enrollment Period

2.6 years

First QC Date

February 15, 2023

Last Update Submit

December 17, 2025

Conditions

Type 1 DiabetesDiabetes Mellitus, Type 1

Keywords

AbataceptNasal insulinBeta-cell functionGlucose intoleranceImmune responsesHypoglycemia

Outcome Measures

Primary Outcomes (1)

  • Beta-cell function at 48 weeks

    Change in average C-peptide concentration during a 2-hour mixed meal challenge

    0 weeks - 48 weeks

Secondary Outcomes (10)

  • Beta-cell function at 24, 72 and 96 weeks

    0, 24, 72 and 96 weeks

  • Glucose regulation

    0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72 and 96 weeks

  • Estimated C-peptide concentration

    -2, 24, 48, 72 and 96 weeks

  • Frequency of hypoglycemic events

    0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72 and 96 weeks

  • Hemoglobin A1c levels

    0, 12, 24, 36, 48, 60, 72 and 96 weeks

  • +5 more secondary outcomes

Study Arms (2)

Abatacept and nasal insulin

ACTIVE COMPARATOR

Abatacept (CTLA4-Ig; 50 mg for participant weight \<25 kg, 87.5 mg for participant weight 25-50 kg, 125 mg for participant weight \>50 kg) will be injected subcutaneously once per week and nasal insulin (Humulin R®, 100 Units/mL) will be inhaled for 10 consecutive days initially and twice per week thereafter, for 48-weeks.

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

Abatacept and nasal placebo

PLACEBO COMPARATOR

Abatacept (CTLA4-Ig; 50 mg for participant weight \<25 kg, 87.5 mg for participant weight 25-50 kg, 125 mg for participant weight \>50 kg) will be injected subcutaneously once per week and nasal placebo (0.9% sodium chloride) will be inhaled for 10 consecutive days initially and twice per week thereafter, for 48-weeks.

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

Interventions

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

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

Also known as: Abatacept and nasal insulin
Abatacept and nasal insulin
Abatacept (CTLA4-Ig) and nasal placebo (0.9% sodium chloride)DRUG

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

Also known as: Abatacept and nasal placebo
Abatacept and nasal placebo

Eligibility Criteria

Age6 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • History of malignancy
  • 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
  • Any condition that would interfere with study conduct or participant safety

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

The Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

Location

Queensland Children's Hospital

South Brisbane, Queensland, 4101, Australia

Location

Women's and Children's Hospital

North Adelaide, South Australia, 5006, Australia

Location

The Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

The Royal Children's Hospital

Parkville, Victoria, 3052, Australia

Location

Perth Children's Hospital

Nedlands, Western Australia, 6009, Australia

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Glucose IntoleranceHypoglycemia

Interventions

AbataceptInsulinSodium Chloride

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHyperglycemia

Intervention Hierarchy (Ancestors)

ImmunoconjugatesAntibodiesImmunoglobulinsSerum GlobulinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsGlobulinsProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • John Wentworth

    Melbourne Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2023

First Posted

February 23, 2023

Study Start

February 13, 2023

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

December 24, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

AU(6)