Type1 DiabetesPhase 2ITADNCT03782636
Interleukin-2 Therapy of Autoimmunity in Diabetes (ITAD)
A Phase 2 study testing Aldesleukin in people with Type1 Diabetes, run by University of Oxford at 5 sites in United Kingdom.
Trial summary
The main purpose of this study is to see if a drug called aldesleukin, can preserve insulin production in children and young adults recently diagnosed with type 1 diabetes. One group will receive aldesleukin and the other a placebo. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Type1 Diabetes
- What is being tested?
- Aldesleukin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 28 Jan 2019to Sep 2026
- Phase
- Phase 2
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Have given written informed consent to participate or assent with parental consent
- Be aged 6-18 years
- Be diagnosed with T1D (Type 1 Diabetes) (at least one autoantibody positive), requiring insulin treatment
- Be within 6 weeks from diagnosis of T1D (at screening)
- Have a random C-peptide > 200 pmol/l
- Normal full blood count
Who cannot join
- Non-type 1 diabetes (type 2 or monogenic diabetes) and secondary diabetes
- Pre-existing autoimmune disease (excluding type 1 diabetes)
- Hypersensitivity to aldesleukin or any of the excipients
- History of severe cardiac disease (NYHA Class III or IV)
- History of malignancy within the past 5 years (with the exception of adequately treated basal or squamous cell carcinoma or cervical carcinoma in situ)
- Clinically significant abnormal laboratory values (out of range and associated with clinical symptoms or signs) in haematology, biochemistry, thyroid, liver and kidney function
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- Pre-existing severe major organ dysfunction or seizure disorders
- Participation in another clinical trial (CTIMP) within 4 months prior to screening
- Females who are pregnant, lactating or intend to get pregnant during the study
- Females of childbearing potential who are unwilling or unable to comply with contraceptive advice and regular pregnancy testing throughout the trial
- Sexually active males who are unwilling or unable to comply with contraceptive advice
- Current use of immunosuppressive agents or steroids
- Current treatment with hepatotoxic, nephrotoxic, myelotoxic, or cardiotoxic products
- Active clinical infections - participants can be recruited after a minimum period of 48 h after last day of feeling unwell or last day of antibiotic/anti-viral treatment
- Any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the participant ineligible for inclusion because of a safety concern
- Children with compliance problems (families where the local investigators consider that problems with compliance may be an issue)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Bristol Royal Hospital for Children
Bristol
Addenbrooke's Hospital
Cambridge
The Great North Children's Hospital
Newcastle upon Tyne
Nottingham Children's Hospital
Nottingham
Oxford Children's Hospital
Oxford, Oxfordshire, OX3 9DU
About this study
The main purpose of this study is to see if a drug called aldesleukin, can preserve insulin production in children and young adults recently diagnosed with type 1 diabetes.
One group will receive aldesleukin and the other a placebo.
Read the detailed description
Investigators know that the longer people with diabetes can produce their own insulin, the better it is for the control of their blood glucose levels and long-term complications.
People get type 1 diabetes because their immune system, the part of the body, which helps fight infections, mistakenly attacks and destroys the beta cells in the pancreas that produce insulin. As the immune system destroys these insulin-producing cells, the body's own ability to produce insulin decreases and diabetes develops.
At diagnosis, there are usually a small number of beta cells (10-20%) left in the pancreas, which still produce small amounts of insulin. This is called 'beta cell function' and it is assessed by measuring C-peptide, which is a protein made by the pancreas when insulin is produced. Most people with type 1 diabetes eventually stop producing insulin themselves, this may occur rapidly in a few months, or more slowly over several years.
New treatments preserving insulin production could improve management of diabetes. This could be done by using drugs acting on cells of the immune system. In type 1 diabetes, there is an imbalance between cells of the immune system, and there is evidence that one protein produced by our body, called Interleukin-2, could help in resetting the balance between those cells. It is important to start this treatment soon after diagnosis because this when there is the best chance of saving the beta cells still left in the pancreas.
- Conditions
- Type1 Diabetes
- Being tested
- Aldesleukin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AldesleukinDrug
PROLEUKIN® 18 x 106 IU
Powder for solution for injection or infusion
PlaceboOther
sterile diluent used for the aldesleukin preparation and 5% glucose
| Study group | Role | What they receive |
|---|---|---|
| Aldesleukin | Experimental | Ultra-low dose aldesleukin injected subcutaneously, at a dose of 0.2 x 106 IU/m2 twice-weekly , three days apart, for 6 months. Receives: Drug: Aldesleukin |
| Placebo | Placebo comparator | Placebo sc, at a similar dose (expressed in ml) to the active drug Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in slopes of DBS (Dried Blood Spot) C-peptide over the 6 month-treatment period between the active and placebo groups.
Measured: Weekly DBS C-peptide collected during the 6-month treatment period, and then monthly during the 6 months of follow-up
Secondary outcomes (12)
Change in Treg, Teff and NK56bright cell frequencies and phenotypes from baseline
Measured: At baseline and then1, 2 , 3, 6 and 12 months from the beginning of treatment
Safety will be assessed at each visit (reported reactions using CTCAE grading v5.0)
Assessment of the most commonly reported reactions to low- or high-dose aldesleukin, namely influenza-like syndrome, skin reaction, diarrhoea, nausea using CTCAE grading v5.0
Measured: At screening, baseline and then 1, 2 , 3, 6 and 12 months from the beginning of treatment
Safety will be assessed at each visit (temperature in celsius)
Vital signs - temperature in celsius
Measured: At screening, baseline and then 1, 2 , 3, 6 and 12 months from the beginning of treatment
Safety will be assessed at each visit (weight, in kilograms)
Vital signs - weight, in kilograms
Measured: At screening, baseline and then 1, 2 , 3, 6 and 12 months from the beginning of treatment
Safety will be assessed at each visit (blood pressure: systolic/diastolic)
Vital signs - blood pressure: systolic/diastolic
Measured: At screening, baseline and then 1, 2 , 3, 6 and 12 months from the beginning of treatment
Safety will be assessed at each visit (heart rate: bpm)
Vital signs - heart rate: bpm
Measured: At screening, baseline and then 1, 2 , 3, 6 and 12 months from the beginning of treatment
Safety will be assessed at each visit (AST, ALT, ALP, GGT units per liter (U/L)
Abnormal laboratory parameters liver function (AST, ALT, ALP, GGT units per liter (U/L)
Measured: At screening, baseline and then 1, 2 , 3, 6 and 12 months from the beginning of treatment
Safety will be assessed at each visit total bilirubin - milligrams per deciliter (mg/dL)
Abnormal laboratory parameters liver function total bilirubin - milligrams per deciliter (mg/dL)
Measured: At screening, baseline and then 1, 2 , 3, 6 and 12 months from the beginning of treatment
Safety will be assessed at each visit (urea and creatinine - mmol/L)
Abnormal laboratory parameters kidney function (urea and creatinine - mmol/L)
Measured: At screening, baseline and then 1, 2 , 3, 6 and 12 months from the beginning of treatment
Safety will be assessed at each visit (full blood count - 109/L)
Abnormal laboratory parameters full blood count - 109/L
Measured: At screening, baseline and then 1, 2 , 3, 6 and 12 months from the beginning of treatment
Changes in the absolute numbers of T, B and NK (Natural Killer) cells.
Measured: At baseline and then, 1, 2 , 3, 6 and 12 months from the beginning of treatment
Change in HbA1c and daily insulin requirements during the trial period.
Measured: HbA1c - At baseline and then 3,6 and 12 months Insulin dose data -Baseline and then 1, 2, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start28 Jan 2019
- Primary completion16 Feb 2023
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford Clinical Trials Research Unit (OCTRU), Centre for Statistics in Medicine, Juvenile Diabetes Research Foundation, Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- Paul Johnson, Professor, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782636
- Sponsor's protocol ID
- 13341
- Acronym
- ITAD
- Status last verified
- Sep 2025
- First submitted
- 7 Sep 2018
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided