[Survey of recent clinical trials of the prevention and immunointervention of type 1 diabetes mellitus].
Immunomodulatory strategies in the management of type 1 diabetes mellitus (T1DM) have as their primary target the prevention of initiating islet autoimmunity (primary-), the secondary one is the progression to diabetes (secondary-) in non-diabetic persons at risk, and the decline of beta-cell function in new-onset patients (tertiary-prevention). This article reviews four recent immunointervention trials in patients with T1DM. (1) The Pre-POINT study is a primary prevention trial that will test whether vaccination with oral or nasal insulin can prevent the progression of islet autoimmunity and of T1DM in autoantibody-negative children who are genetically at high diabetes risk. (2) The Cord Blood study is a tertiary immunointervention trial that will test whether administration of autologous umbilical cord blood to children with T1DM can lead to regeneration of pancreatic islet insulin-producing beta-cells and improved blood glucose control. (3) The GAD Vaccination study will test whether vaccination with alum-formulated rhGAD65 (recombinant human glutamic acid decarboxylate) can preserve beta-cell function in 320 children with newly diagnosed T1DM, as has been suggested in a recent phase II study. (4) The AIDA study will test the beta-cell protective effect of interleukin-1-receptor antagonist Anakinra in 80 patients with T1DM, which has recently been shown to improve beta-cell function in patients with type 2 diabetes.
Boerschmann
H
H
Forschergruppe Diabetes der Technischen Universität München.
Walter
M
M
Achenbach
P
P
Ziegler
A-G
AG
D000281:Administration, Intranasal; D000284:Administration, Oral; D018501:Antirheumatic Agents / Q000627:therapeutic use; D001323:Autoantibodies / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D001803:Blood Transfusion; D002648:Child; D002675:Child, Preschool; D003922:Diabetes Mellitus, Type 1 / Q000235:genetics / Q000276:immunology / Q000517:prevention & control* / Q000628:therapy; D018450:Disease Progression; D005312:Fetal Blood / Q000637:transplantation; D005968:Glutamate Decarboxylase / Q000276:immunology / Q000627:therapeutic use; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007328:Insulin / Q000008:administration & dosage / Q000276:immunology; D050417:Insulin-Secreting Cells / Q000276:immunology; D053590:Interleukin 1 Receptor Antagonist Protein / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic; D017472:Receptors, Interleukin-1 / Q000037:antagonists & inhibitors; D011994:Recombinant Proteins / Q000627:therapeutic use; D014612:Vaccines / Q000627:therapeutic use
D018501:Antirheumatic Agents; D001323:Autoantibodies; D001786:Blood Glucose; D005968:Glutamate Decarboxylase; D006442:Glycated Hemoglobin; D007328:Insulin; D053590:Interleukin 1 Receptor Antagonist Protein; D017472:Receptors, Interleukin-1; D011994:Recombinant Proteins; D014612:Vaccines; C517652:hemoglobin A1c protein, human; C401141:glutamate decarboxylase 2