Type 1 diabetes mellitus Nutritional, Metabolic, Endocrine Diabetes
Conditions
Interventions
A peptide corresponding to amino-acid C19-A3 of proinsulin will be administered in increasing doses, 10, 100 and 1000 micrograms intradermally in the upper arm. Subjects will be divided into three equ
Sponsors
Diabetes Vaccine Development Centre (Australia)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HLA-DRB1 0401 positive patients 2. Aged 18 - 50 with type 1 diabetes of five or more years duration 3. HbA1c less than 10% and no insulin C-peptide production
Exclusion criteria
Exclusion criteria: 1. C-peptide response to glucagon stimulation test greater than 2 nmol/l 2. Proliferative or pre-proliferative retinopathy or macula oedema 3. Diabetic nephropathy or other severe diabetic complications 4. Asthma 6. Atopy 7. Documented allergy 8. Use of steroids or immunosuppressive drugs 9. Other autoimmune diseases (except thyroiditis) 10. Women not taking effective contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Adverse event and side-effect profiles of peptide administration 2. Changes in proinsulin peptide-induced IFN-gamma+ or IL-10 response (ratio of maximal stimulation indices) as detected by Enzyme-Linked Immunosorbent Spot (ELISPOT) three months after the first injection compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in proinsulin peptide induced IFN-gamma+ or IL-10 response ratio six months after the first injection 2. Changes in IFN-gamma+ or IL-10 response ratio to epitopes of GAD65 and IA-2 eluted from HLA-DR4 3. Changes in IL-2, IL-4+ and IL-5+ T cell responses to the antigen panel 4. Changes in anti-insulin, proinsulin, GAD65 and IA-2 antibody levels versus baseline | — |
Countries
United Kingdom
Outcome results
None listed