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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

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05742243