**7. Heat shock protein used in immune intervention**

Studies in experimental animals have shown that use of a 65-kDa heat shock protein can pre‐ vent diabetes [48]. A specific peptide, Diapep 277, seems to be the active component and this peptide has been tried with interesting effects.

Clinical trials in humans have shown that sc administration of Diapep 277 may preserve beta cell function in adults [49]. Thus 35 patients with type 1 diabetes and basal C-peptide above 0.1 nmol/L were assigned to subcutaneous injections of 1 mg Diapep277 and 40 mg mannitol in vegetable oil The primary endpoint was glucagon-stimulated C-peptide production. At 10 months, mean C-peptide concentrations had fallen in the placebo group (n=16) but were main‐ tained in the DiaPep277 group (n=15; p=0.039). Need for exogenous insulin was higher in the placebo than in the DiaPep277 group. There were no o adverse events. The treatment of newly diagnosed T1D adults with DiaPep277 seemed to preserve residual insulin secretion through induction of a shift from Thr-1 to Thr-2 cytokines. However, the efficacy seen in adults could not be confirmed in children and adolescents with T1D [50,51] in spite of interesting immu‐ nologcval results [52]. In a recent Phase III trial no immunological difference could be found between adults treated with Diapep 277 or those treated with placebo [53]. Treatment with Diapep 277 seemed to preserve C.peptide but only C-peptide after Glucagon stimulation, but not after Mixed Meal Tolerance Test [54]. Thus it is still unclear whether Diapep 277 has a place or not as future intervention to preserve residual insulin secretion in adults.
