drugset / Trial / NCT02620332

Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)

NCT02620332 ↗

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

EvaluationDrugModalityDoseRoute
Subject MultiPepT1De Peptide 10 ug Other
Subject MultiPepT1De Peptide 100 ug Other
Subject MultiPepT1De Peptide 500 ug Other