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| Name | Class |
|---|---|
| Guy's and St Thomas' NHS Foundation Trust | OTHER |
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Type 1 diabetes is an autoimmune disease in which the insulin secreting βcells of the pancreas are destroyed such that the patient is reliant on injection of insulin to adequately control blood glucose levels for the remainder of his/her life. The autoimmune process targets proteins in beta-cells which are termed autoantigens. This is a Phase 1 study using a novel investigational medicinal product (IMP) known as MultiPepT1De in a study of safety and tolerability of administration in patients with recent onset Type 1 diabetes. MultiPepT1De is a mixture of peptides from islet auto antigens. The mixture has been designed to induce or restore immunological tolerance to the beta-cell and thus control or limit autoimmunity to protect beta-cells
Recent onset type 1 diabetes patients will be randomized into 4 groups of 6 subjects and each group will receive 6 injections of either placebo, low, medium or high dose of IMP; each injection is intradermal and spaced 1 month apart.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo injection | Placebo Comparator | Water for injection |
|
| MultiPepT1De injection low dose | Experimental | Mix of peptides administered once a month over a period of 20 weeks (6 injections in total) |
|
| MultiPepT1De injection medium dose | Experimental | Mix of peptides administered once a month over a period of 20 weeks (6 injections in total) |
|
| MultiPepT1De injection high dose | Experimental | Mix of peptides administered once a month over a period of 20 weeks (6 injections in total) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MultiPepT1De injection | Drug | A mix of peptides |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of MultiPepT1De safety profile | Safety assessed through measurement and comparison of any reactions or hypersensitivity to MultipepT1De injection vs placebo. Number of adverse events will also be compared between groups with the addition of safety monitoring blood tests | Every 28 days for 147 days |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of residual beta cell function and markers of metabolic control | Measured by a change in stimulated C-peptide production, daily insulin usage, glycated haemoglobin levels and amplitude of glucose excursions from baseline and between groups | 24 weeks versus baseline |
| Assessment of T lymphocyte immune response to islet cell antigens |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jake Powrie, MD FRCP | Guy's and St Thomas' NHS Foundation Trust | Principal Investigator |
| Mark Peakman, MBBS PhD | King's College London | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy's Hospital | London | SE1 9RT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35073398 | Derived | Liu YF, Powrie J, Arif S, Yang JHM, Williams E, Khatri L, Joshi M, Lhuillier L, Fountoulakis N, Smith E, Beam C, Lorenc A, Peakman M, Tree T. Immune and Metabolic Effects of Antigen-Specific Immunotherapy Using Multiple beta-Cell Peptides in Type 1 Diabetes. Diabetes. 2022 Apr 1;71(4):722-732. doi: 10.2337/db21-0728. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Placebo | Other | Water for injection |
|
Comparison of changes in antigen specific T lymphocyte responses longitudinally following peptide treatment and versus placebo. |
| 24 weeks versus 12 weeks |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |