A preliminary (phase II) study in a recent issue of THE LANCET suggests that injection of a specific peptide in patients with early type 1 diabetes could stop disease progression by preventing the destruction of insulin-producing � -cells.
Type 1 diabetes is caused by the progressive destruction of the insulin-producing pancreatic �-cells through an autoimmune process (ie. caused by the body�s own immune response). Observational studies have shown that a protein derivative, the peptide DiaPep277, stopped � -cell destruction and maintained insulin production in newly diabetic mice.
Itamar Raz, Dana Elias, and colleagues from the Hadassah-Hebrew University Medical School, and Peptor Ltd. , Israel, did a randomised, double-blind, phase II study of peptide treatment in patients with newly diagnosed (less than 6 months) type 1 diabetes. 35 patients took part in the study; they had basal C-peptide concentrations above 0.1 nmol per litre (indicating that they still had some � -cell function). They were randomly assigned either DiaPep277 or placebo, both of which were contained in vegetable oil and given by subcutaneous injection at entry to the trial, and at one month and six months. Follow-up of patients was done at 10 months.
Average C-peptide concentrations had fallen in the placebo group at 10 months follow-up, but were maintained in the treatment group (0.26 compared with 0.93 nmol per litre). Patients in the placebo group required more insulin therapy than patients in the treatment group. The Diapep277 peptide altered the type of immune response of patients in the treatment group (resulting in an enhanced T-helper-2 cytokine phenotype).
Dana Elias comments: "Our research has shown that it is possible to modulate the immune system and prevent or stop it from attacking the insulin-producing cells. DiaPep277 holds the promise of becoming a breakthrough therapy for those already diagnosed with autoimmune diabetes, and perhaps a preventive treatment for those at high risk for the disease. If we reach patients early we may be able to improve the quality of their lives by significantly reducing their dependence on insulin. We may also halt or delay the development of complications and, possibly, extend patients' lives." (Quote by e-mail; it does not appear in the published paper).
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Source: Lancet
