drugset / Trial / NCT02620332
Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)
Phase 1
Completed
27 enrolled
King's College London
Guy's and St Thomas' NHS Foundation Trust · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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
Timeline
- Start
- 2015-10-20
- Primary completion
- 2017-07-31
- Completion
- 2018-04-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MultiPepT1De | Peptide | 10 ug | Other |
| Subject | MultiPepT1De | Peptide | 100 ug | Other |
| Subject | MultiPepT1De | Peptide | 500 ug | Other |