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| Name | Class |
|---|---|
| Oxford Clinical Trials Research Unit (OCTRU) | UNKNOWN |
| Centre for Statistics in Medicine, Oxford | UNKNOWN |
| Juvenile Diabetes Research Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo | Placebo Comparator | Placebo sc, at a similar dose (expressed in ml) to the active drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aldesleukin | Drug | PROLEUKIN® 18 x 106 IU Powder for solution for injection or infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in slopes of DBS (Dried Blood Spot) C-peptide over the 6 month-treatment period between the active and placebo groups. | Weekly DBS C-peptide collected during the 6-month treatment period, and then monthly during the 6 months of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Treg, Teff and NK56bright cell frequencies and phenotypes from baseline | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Johnson, Professor | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford Children's Hospital | Oxford | Oxfordshire | OX3 9DU | United Kingdom | ||
| Bristol Royal Hospital for Children |
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| ID | Term |
|---|---|
| C082598 | aldesleukin |
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| Wellcome Trust |
| OTHER |
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| Placebo |
| Other |
sterile diluent used for the aldesleukin preparation and 5% glucose |
|
| 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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 | 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. | 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. | HbA1c - At baseline and then 3,6 and 12 months Insulin dose data -Baseline and then 1, 2, 3, 6 and 12 months |
| Bristol |
| United Kingdom |
| Addenbrooke's Hospital | Cambridge | United Kingdom |
| The Great North Children's Hospital | Newcastle upon Tyne | United Kingdom |
| Nottingham Children's Hospital | Nottingham | United Kingdom |