PEPIDIA-1

• Research type

  Research Study

• Full title

  Phase I Study of Proinsulin (PI) Peptide Immunotherapy in New-Onset Type 1 Diabetes

• Sponsor organisation

  Cardiff University

• Eudract number

  2007-003759-35

• ISRCTN Number

  Unknown

• Research summary

  Type 1 diabetes is an autoimmune disease in which white blood cells of the body's own immune system (known as T cells) gradually destroy the insulin making cells of the pancreas (Beta cells). Peptide immunotherapy represents a novel approach to stopping this "autoimmune" process without suppressing the whole immune system. This approach, which involves giving injections of carefully chosen small fragments of the molecules in the in beta cells, has proven effective in animal models but at present is at an early phase of development in humans. We have recently conducted a safety (phase 1) giving a proinsulin peptide under the skin of the arm (like a "vaccine") to 36 individuals with longstanding type 1 diabetes (who by this stage no longer make any insulin). No treatment related side-effects were seen other than redness at the injection and laboratory studies suggest some patients showed potentially favourable immune system changes.In the present study, we will extend this work to a safety study in patients with newly-diagnosed type 1 diabetes (diagnosed in the last 3 months) as this is ultimately the population we will treat. These individuals still have some insulin production left. Our aim is to show that the treatment does not damage the insulin production they have left and hopefully provide preliminary evidence that it stops further loss of insulin production. We will also be confirming the safety of the treatment, particularly looking to make sure allergic reactions do not develop after giving the treatment for longer (6 versus 3 months) and more frequently (2 rather than 4 weekly).Participants will have treatment injections (or placebo injections) for 6 months followed by a 6 months observation period. Insulin production will be measured with a 2 hour mixed meal test every 3 months.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  08/H0206/58

• Date of REC Opinion

  2 Dec 2008

• REC opinion

  Further Information Favourable Opinion