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 (MonoPepT1De)

• Safety [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  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.
  
  

• Allergy and hypersensitivity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  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.
  
  
• Safety of frequent dosing [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  To explore the safety of extending peptide treatment to more frequent dosing (2−weekly) and for a longer time period (6 months)
  
  
• Protective effects of insulin preservation [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  To provide preliminary data on any protective effect on preservation of insulin production after 1 year of treatment
  
  
• T cell (immune) response to islet cell antigens [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  To provide preliminary data on changes in the T cell (immune) response to islet cell antigens in newly−diagnosed patients following PI peptide treatment.
  
  

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.