Safety Study to Assess Whether Proinsulin Peptide Injections Can Slow or Stop the Body Damaging Its Own Insulin-making Cells in the Pancreas in Patients Newly Diagnosed With Type 1 Diabetes

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

February 28, 2015

Study Completion Date

February 28, 2015

Conditions
Type 1 Diabetes
Interventions
DRUG

Pro insulin peptide

Patients will receive 10 micro gr of the peptide every 2 weeks (12 doses).

DRUG

Pro insulin peptide

Patients will receive 10 micro gr of the peptide monthly (ever 4 weeks, 6 doses) and saline injections monthly alternating with the peptide (2 weeks interval between the drug and saline).

DRUG

Saline

Patients will receive 0 micro gr of peptide, but have saline injections every 2 weeks (controls).

Trial Locations (5)

CH2 1UL

Countess of Chester, Chester

Unknown

Bristol Royal Infirmary, Bristol

University Hospital of Wales, Cardiff

Guy's Hospital, London

Royal Victoria Hospital, Newcastle

Sponsors
All Listed Sponsors
collaborator

Diabetes Vaccine Development Centre

OTHER

collaborator

Juvenile Diabetes Research Foundation

OTHER

lead

Cardiff University

OTHER