title: Effect of ingested interferon-alpha on beta-cell function in children with new-onset type 1 diabetes.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of ingested human recombinant interferon-alpha (hrIFN-alpha) for preservation of beta-cell function in young patients with recent-onset type 1 diabetes.
  
  
  METHODS
  Subjects aged 3-25 years in whom type 1 diabetes was diagnosed within 6 weeks of enrollment were randomly assigned to receive ingested hrIFN-alpha at 5,000 or 30,000 units or placebo once daily for 1 year. The primary outcome was change in C-peptide secretion after a mixed meal.
  
  
  RESULTS
  Individuals in the placebo group (n = 30) lost 56 +/- 29% of their C-peptide secretion from 0 to 12 months, expressed as area under the curve (AUC) in response to a mixed meal. In contrast, children treated with hrIFN-alpha lost 29 +/- 54 and 48 +/- 35% (for 5,000 [n = 27] and 30,000 units [n = 31], respectively, P = 0.028, ANOVA adjusted for age, baseline C-peptide AUC, and study site). Bonferroni post hoc analyses for placebo versus 5,000 units and placebo versus 30,000 units demonstrated that the overall trend was determined by the 5,000-unit treatment group. Adverse events occurred at similar rates in all treatment groups.
  
  
  CONCLUSIONS
  Ingested hrIFN-alpha was safe at the doses used. Patients in the 5,000-unit hrIFN-alpha treatment group maintained more beta-cell function 1 year after study enrollment than individuals in the placebo group, whereas this effect was not observed in patients who received 30,000 units hrIFN-alpha. Further studies of low-dose ingested hrIFN-alpha in new-onset type 1 diabetes are needed to confirm this effect.
authors: National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA. kr58q@nih.gov
authors: Kristina I
authors: KI
authors: Rother
authors: Rebecca J
authors: RJ
authors: Brown
authors: Miriam M
authors: MM
authors: Morales
authors: Elizabeth
authors: E
authors: Wright
authors: Zhigang
authors: Z
authors: Duan
authors: Carol
authors: C
authors: Campbell
authors: Dana S
authors: DS
authors: Hardin
authors: Jadranka
authors: J
authors: Popovic
authors: Robert C
authors: RC
authors: McEvoy
authors: David M
authors: DM
authors: Harlan
authors: Philip R
authors: PR
authors: Orlander
authors: Staley A
authors: SA
authors: Brod
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000974:Antibodies, Antinuclear / Q000097:blood / Q000187:drug effects; D002096:C-Peptide / Q000097:blood* / Q000378:metabolism; D002648:Child; D002675:Child, Preschool; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D003928:Diabetic Nephropathies / Q000517:prevention & control; D004311:Double-Blind Method; D004435:Eating / Q000502:physiology; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage / Q000627:therapeutic use; D050417:Insulin-Secreting Cells / Q000187:drug effects / Q000502:physiology*; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use*; D010919:Placebos; D055815:Young Adult
chemical_list: D000974:Antibodies, Antinuclear; D002096:C-Peptide; D007155:Immunologic Factors; D016898:Interferon-alpha; D010919:Placebos