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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05742243




Registration number
NCT05742243
Ethics application status
Date submitted
15/02/2023
Date registered
23/02/2023
Date last updated
10/04/2024

Titles & IDs
Public title
Insulin and Abatacept in Recently-diagnosed Type 1 Diabetes
Scientific title
Abatacept Combined With Nasal Insulin to Preserve Beta-cell Function in Recently-diagnosed Type 1 Diabetes
Secondary ID [1] 0 0
2022.079
Universal Trial Number (UTN)
Trial acronym
IAA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 0 0
Diabetes Mellitus, Type 1 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Abatacept (CTLA4-Ig) and nasal insulin (Humulin R®)
Treatment: Drugs - Abatacept (CTLA4-Ig) and nasal placebo (0.9% sodium chloride)

Active comparator: Abatacept and nasal insulin - 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.

Placebo comparator: Abatacept and nasal placebo - 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.


Treatment: Drugs: 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

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Beta-cell function at 48 weeks
Timepoint [1] 0 0
0 weeks - 48 weeks
Secondary outcome [1] 0 0
Beta-cell function at 24, 72 and 96 weeks
Timepoint [1] 0 0
0, 24, 72 and 96 weeks
Secondary outcome [2] 0 0
Glucose regulation
Timepoint [2] 0 0
0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72 and 96 weeks
Secondary outcome [3] 0 0
Estimated C-peptide concentration
Timepoint [3] 0 0
-2, 24, 48, 72 and 96 weeks
Secondary outcome [4] 0 0
Frequency of hypoglycemic events
Timepoint [4] 0 0
0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72 and 96 weeks
Secondary outcome [5] 0 0
Hemoglobin A1c levels
Timepoint [5] 0 0
0, 12, 24, 36, 48, 60, 72 and 96 weeks
Secondary outcome [6] 0 0
Insulin use
Timepoint [6] 0 0
Every 4 weeks for 96 weeks
Secondary outcome [7] 0 0
Weight, body mass index and sitting blood pressure
Timepoint [7] 0 0
0, 12, 24, 48, 60, 72 and 96 weeks
Secondary outcome [8] 0 0
Diabetes antibody levels
Timepoint [8] 0 0
-2, 0, 4, 12, 24, 48, 60, 72 and 96 weeks
Secondary outcome [9] 0 0
Quality of life assessment
Timepoint [9] 0 0
-2, 0, 24, 48, 72 and 96 weeks
Secondary outcome [10] 0 0
Adverse events
Timepoint [10] 0 0
All visits for 96 weeks

Eligibility
Key inclusion criteria
* 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
Minimum age
6 Years
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/02/2027
Actual
Sample size
Target
62
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [3] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment hospital [4] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [5] 0 0
The Royal Children's Hospital - Parkville
Recruitment hospital [6] 0 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
5006 - North Adelaide
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment postcode(s) [6] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Juvenile Diabetes Research Foundation
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT05742243
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John Wentworth
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05742243