Type 1 DiabetesPhase 2IAANCT05742243
Insulin and Abatacept in Recently-diagnosed Type 1 Diabetes
A Phase 2 study testing Abatacept (CTLA4-Ig) and nasal insulin (Humulin R®) in people with Type 1 Diabetes and Diabetes Mellitus, Type 1, run by Melbourne Health at 6 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 21 years
- Conditions the study is for
- Type 1 Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- Abatacept (CTLA4-Ig) and nasal insulin (Humulin R®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 6 sitesAustralia
- Study dates
- 13 Feb 2023to 30 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Australia6 sites
Perth Children's Hospital
Nedlands, Western Australia, 6009
Women's and Children's Hospital
North Adelaide, South Australia, 5006
The Royal Melbourne Hospital
Parkville, Victoria, 3050
The Royal Children's Hospital
Parkville, Victoria, 3052
Queensland Children's Hospital
South Brisbane, Queensland, 4101
The Children's Hospital at Westmead
Westmead, New South Wales, 2145
About this study
Official title: Abatacept Combined With Nasal Insulin to Preserve Beta-cell Function in Recently-diagnosed Type 1 Diabetes
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.
Read the detailed description
Type 1 diabetes is caused by an immune attack on insulin-producing beta cells of the pancreas that impairs their ability to make insulin to control blood glucose levels. When diabetes is diagnosed, the pancreas is usually still able to make some insulin, but not enough to meet the body's needs. Over time, continued immune attack further decreases insulin production until after one to two years it is very low or undetectable. When type 1 diabetes is diagnosed, treatments that stop the immune attack may preserve residual beta-cell function. This decreases the requirement for injected insulin and improves glucose control. However, so far, immune therapies have not been shown to prevent ongoing loss of beta-cell function. In this clinical trial, two safe immune therapies called abatacept and nasal insulin will be used together to test if the combination can better preserve the function of beta cells to make insulin after diagnosis. If this occurs, it will be relatively simple to develop this treatment for routine use in recently-diagnosed people and to test whether it prevents high-risk individuals progressing to need insulin injections. This trial will also provide research samples to improve our understanding of how type 1 diabetes develops and how abatacept and nasal insulin might affect this process. The new knowledge created from studying these samples will improve our ability to use abatacept and nasal insulin to preserve pancreas function in type 1 diabetes.
- Conditions
- Type 1 Diabetes, Diabetes Mellitus, Type 1
- Being tested
- Abatacept (CTLA4-Ig) and nasal insulin (Humulin R®), Abatacept (CTLA4-Ig) and nasal placebo (0.9% sodium chloride)
- Keywords
- Abatacept, Nasal insulin, Beta-cell function, Glucose intolerance, Immune responses, Hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Glucose Intolerance, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abatacept (CTLA4-Ig) and nasal insulin (Humulin R®)Drug
Also called Abatacept and nasal insulin
Abatacept injected subcutaneously once per week and nasal insulin inhaled for 10 consecutive days initially and twice per week thereafter
Abatacept (CTLA4-Ig) and nasal placebo (0.9% sodium chloride)Drug
Also called Abatacept and nasal placebo
Abatacept injected subcutaneously once per week and nasal placebo inhaled for 10 consecutive days initially and twice per week thereafter
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Abatacept (CTLA4-Ig) and nasal placebo (0.9% sodium chloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta-cell function at 48 weeks
Change in average C-peptide concentration during a 2-hour mixed meal challenge
Measured: 0 weeks - 48 weeks
Secondary outcomes (10)
Beta-cell function at 24, 72 and 96 weeks
Change in average C-peptide concentration during a 2-hour mixed meal challenge
Measured: 0, 24, 72 and 96 weeks
Glucose regulation
Proportion of time in the range 3.9-10mmol/l, time below 3.9mmol/l and glucose %CV measured by continuous glucose monitoring (CGM)
Measured: 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72 and 96 weeks
Estimated C-peptide concentration
Average C-peptide concentration estimated from fasting glucose, C-peptide, HbA1c, body mass index, disease duration and insulin dose
Measured: -2, 24, 48, 72 and 96 weeks
Frequency of hypoglycemic events
Frequency of glucose readings <3.0mmol/l, determined by CGM and correcting for CGM wear time
Measured: 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72 and 96 weeks
Hemoglobin A1c levels
Change in HbA1c levels
Measured: 0, 12, 24, 36, 48, 60, 72 and 96 weeks
Insulin use
Daily insulin dose at all visits
Measured: Every 4 weeks for 96 weeks
Weight, body mass index and sitting blood pressure
Change in weight, body mass index and blood pressure
Measured: 0, 12, 24, 48, 60, 72 and 96 weeks
Diabetes antibody levels
Insulin, GAD, IA2 and ZnT8 autoantibody concentrations
Measured: -2, 0, 4, 12, 24, 48, 60, 72 and 96 weeks
Quality of life assessment
Assessed by questionnaire
Measured: -2, 0, 24, 48, 72 and 96 weeks
Adverse events
Frequency and severity of adverse events
Measured: All visits for 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start13 Feb 2023
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Juvenile Diabetes Research Foundation
- Responsible party
- Sponsor
- Investigators
- John Wentworth, Principal investigator, Melbourne Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742243
- Sponsor's protocol ID
- 2022.079
- Acronym
- IAA
- Status last verified
- Oct 2025
- First submitted
- 15 Feb 2023
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abatacept Combined With Nasal Insulin to Preserve Beta-cell Function in Recently-diagnosed Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05742243
- Acronym / sponsor ID
- IAA / 2022.079
- Conditions
- Type 1 Diabetes, Diabetes Mellitus, Type 1
- Keywords
- Abatacept, Nasal insulin, Beta-cell function, Glucose intolerance, Immune responses, Hypoglycemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Juvenile Diabetes Research Foundation
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Type 1 diabetes is caused by an immune attack on insulin-producing beta cells of the pancreas that impairs their ability to make insulin to control blood glucose levels. When diabetes is diagnosed, the pancreas is usually still able to make some insulin, but not enough to meet the body's needs. Over time, continued immune attack further decreases insulin production until after one to two years it is very low or undetectable. When type 1 diabetes is diagnosed, treatments that stop the immune attack may preserve residual beta-cell function. This decreases the requirement for injected insulin and improves glucose control. However, so far, immune therapies have not been shown to prevent ongoing loss of beta-cell function. In this clinical trial, two safe immune therapies called abatacept and nasal insulin will be used together to test if the combination can better preserve the function of beta cells to make insulin after diagnosis. If this occurs, it will be relatively simple to develop this treatment for routine use in recently-diagnosed people and to test whether it prevents high-risk individuals progressing to need insulin injections. This trial will also provide research samples to improve our understanding of how type 1 diabetes develops and how abatacept and nasal insulin might affect this process. The new knowledge created from studying these samples will improve our ability to use abatacept and nasal insulin to preserve pancreas function in type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abatacept and nasal insulin | Active comparator | Drug: Abatacept (CTLA4-Ig) and nasal insulin (Humulin R®)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. |
| Abatacept and nasal placebo | Placebo comparator | Drug: Abatacept (CTLA4-Ig) and nasal placebo (0.9% sodium chloride)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. |
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abatacept (CTLA4-Ig) and nasal insulin (Humulin R®)Also: Abatacept and nasal insulinAbatacept injected subcutaneously once per week and nasal insulin inhaled for 10 consecutive days initially and twice per week thereafter | Drug | Abatacept and nasal insulin |
| Abatacept (CTLA4-Ig) and nasal placebo (0.9% sodium chloride)Also: Abatacept and nasal placeboAbatacept injected subcutaneously once per week and nasal placebo inhaled for 10 consecutive days initially and twice per week thereafter | Drug | Abatacept and nasal placebo |
Primary outcome
Beta-cell function at 48 weeks
Time frame: 0 weeks - 48 weeks
Change in average C-peptide concentration during a 2-hour mixed meal challenge
10 secondary outcomes
Beta-cell function at 24, 72 and 96 weeks
Time frame: 0, 24, 72 and 96 weeks
Glucose regulation
Time frame: 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72 and 96 weeks
Estimated C-peptide concentration
Time frame: -2, 24, 48, 72 and 96 weeks
Frequency of hypoglycemic events
Time frame: 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72 and 96 weeks
Hemoglobin A1c levels
Time frame: 0, 12, 24, 36, 48, 60, 72 and 96 weeks
Insulin use
Time frame: Every 4 weeks for 96 weeks
Weight, body mass index and sitting blood pressure
Time frame: 0, 12, 24, 48, 60, 72 and 96 weeks
Diabetes antibody levels
Time frame: -2, 0, 4, 12, 24, 48, 60, 72 and 96 weeks
Quality of life assessment
Time frame: -2, 0, 24, 48, 72 and 96 weeks
Adverse events
Time frame: All visits for 96 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Link to clinical trialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Wentworth principal investigator
Melbourne Health
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abatacept (CTLA4-Ig) and nasal insulin (Humulin R®) in people with Type 1 Diabetes and Diabetes Mellitus, Type 1, run by Melbourne Health at 6 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beta-cell function at 48 weeks (time frame: 0 weeks - 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.