The purpose of this study is to address the safety issue of whether, in patients with newly-diagnosed diabetes who still make some insulin, proinsulin peptide therapy adversely affects the rate of damage to the insulin making cells.
Type 1 Diabetes (also known as insulin-dependent diabetes) is caused by destruction of the insulin producing cells (Beta Cells) in the pancreas. Our group is interested in how this destruction could be stopped or reversed, as this may lead to development of a new generation of diabetes treatments which can prevent or slow down the damage, reducing or possibly even removing there need for insulin injections. In a previous study we examined the safety of our novel approach to this problem, proinsulin (PI) peptide immunotherapy, in longstanding diabetes patients (diagnosed more than 5 years before), and found it to be well tolerated and free of major hypersensitivity reactions. However, it remains theoretically possible that this form of immunotherapy could make the immune reaction to the insulin making cells worse rather than better. This cannot be studied directly in longstanding patients as they have no or almost no insulin making cells left. So,the principle objective of the current study is to address the safety issue of whether, in patients with newly-diagnosed diabetes who still make some insulin, proinsulin peptide therapy adversely affects the rate of damage to the insulin making cells.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
27
Patients will receive 10 micro gr of the peptide every 2 weeks (12 doses).
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).
Patients will receive 0 micro gr of peptide, but have saline injections every 2 weeks (controls).
Countess of Chester
Chester, England, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
Guy's Hospital
London, United Kingdom
Royal Victoria Hospital
Safety
To address the safety issue of whether, in patients with newly-diagnosed diabetes who still make some insulin, proinsulin peptide therapy adversely affects the rate of damage to the insulin making cells.
Time frame: 3 years
Allergy and hypersensitivity
To confirm that PI peptide treatment does not induce allergy or hypersensitivity and has a good safety profile in new-onset type 1 diabetes patients.
Time frame: 3 years
Safety of frequent dosing
To explore the safety of extending peptide treatment to more frequent dosing (2-weekly) and for a longer time period (6 months)
Time frame: 3 years
Protective effects of insulin preservation
To provide preliminary data on any protective effect on preservation of insulin production after 1 year of treatment
Time frame: 3 years
T cell (immune) response to islet cell antigens
To provide preliminary data on changes in the T cell (immune) response to islet cell antigens in newly-diagnosed patients following PI peptide treatment.
Time frame: 3 years
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Newcastle, United Kingdom