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001-es BibID:BIBFORM024362
Első szerző:Schloot, Nanette C.
Cím:Effect of heat shock protein peptide DiaPep277 on beta-cell function in paediatric and adult patients with recent-onset diabetes mellitus type 1 : two prospective, randomized, double-blind phase II trials / Nanette C. Schloot, Guido Meierhoff, Csaba Lengyel, Gyözö Vándorfi, József Takács, Pál Pánczél, László Barkai, László Madácsy, Tamás Oroszlán, Peter Kovács, Gábor Sütö, Tadej Battelino, Nora Hosszufalusi, György Jermendy
Dátum:2007
Megjegyzések:Background: Aim of this trial was to test whether heat shock protein peptide DiaPep277 treatment in adult and paediatric patients with recent-onset type 1 diabetes (T1D) is safe and whether it can preserve endogenous insulin production. Methods: Two studies were performed in a prospective, multicentre, double-blind, placebo-controlled trial. Fifty adult (study p520, aged 16-44 years) and 49 paediatric patients (study p521, 4-15 years) with recent-onset T1D were treated subcutaneously at four different time points with 0.2 mg or 1.0 mg DiaPep277 versus placebo and followed for 18 months. Adult patients were treated with 0.2 mg, 1.0 mg or 2.5 mg DiaPep277 versus placebo. Stimulated C-peptide served as readout for functional ?-cell-mass. Results: DiaPep277-treatment was not associated with severe side effects. No differences were found in placebo and DiaPep277 treated groups. In adults, a modest trend towards better maintenance of ?-cell function was observed in the 0.2 mg and 1.0 mg group, while there was significant loss of stimulated C-peptide in the placebo and 2.5 mg group. Paediatric patients with low HLA risk showed stable C-peptide levels until 13 months upon treatment with 1 mg DiaPep277. Despite similar stimulated C-peptide levels at baseline, children exhibited a more pronounced loss of ?-cell function over 18 months than adults (p = 0.0003). Conclusion: Administration of DiaPep277 seems safe and may have beneficial effects on C-peptide levels over time in some patients with T1D, but this finding was not accompanied by reduced HbA<sub>1c</sub> or insulin requirement. Studies with more patients and longer follow-up are needed to further study the effect of DiaPep277.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
PEPTIDES
Islets of Langerhans
INSULIN-SECRETING CELLS
INSULIN
Injections, Subcutaneous
Hypoglycemic Agents
Humans
HLA Antigens
Hemoglobin A, Glycosylated
Drug Therapy, Combination
Double-Blind Method
Dose-Response Relationship, Drug
Diabetes Mellitus, Type 1
Child
C-peptide
AUTOANTIBODIES
Adult
Adolescent
urticaria
unspecified side effect
randomized controlled trial
protein blood level
priority journal
phase 2 clinical trial
pancreas islet cell function
pancreas islet beta cell
multiple drug dose
multicenter study
menstrual irregularity
Male
major clinical study
insulin synthesis
insulin dependent diabetes mellitus
injection site dermatitis
immunotherapy
hypoglycemia
human
HLA matching
high risk population
hemoglobin blood level
Female
drug tolerance
drug safety
drug fever
drug dose increase
drug dose comparison
double blind procedure
dizziness
controlled study
controlled clinical trial
clinical trial
cell density
ARTICLE
antibody titer
Age Distribution
unclassified drug
placebo
peptide p277
mannitol
HLA DR3 antigen
HLA DR antigen
hemoglobin A1c
heat shock protein 60
diapep277
C peptide
antidiabetic agent
Type 1 diabetes mellitus
PREVENTION
Human trials
Hsp60
HbA<sub>1c</sub>
Megjelenés:Diabetes/metabolism research and reviews. - 23 : 4 (2007), p. 276-285. -
További szerzők:Meierhoff, Guido Lengyel Csaba (Miskolc) Vándorfi Győző Takács József Pánczél Pál Barkai László (1958-) (gyermekgyógyász) Madácsy László (Szeged) Oroszlán Tamás Kovács Péter (1947-) (belgyógyász, kardiológus, klinikai farmakológus) Sütő Gábor Battelino, Tadej Hosszúfalusi Nóra Jermendy György
Internet cím:DOI
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