Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2026-03-08 @ 11:01 PM
Study NCT ID:
NCT02620332
Status:
COMPLETED
Last Update Posted:
2019-08-14
First Post:
2015-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)
Sponsor:
King's College London
Organization:
Study Overview
Official Title:
Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MultiPepT1De
Brief 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
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: