Four-year metabolic outcome of a randomised controlled CD3-antibody trial in recent-onset type 1 diabetic patients depends on their age and baseline residual beta cell mass.

Bart Keymeulen, M Walter, Chantal Mathieu, Leonard Kaufman, Frans Gorus, Robert Hilbrands, Evy Vandemeulebroucke, Ursule Van De Velde, L. Crenier, C. De Block, S Candon, H. Waldmann, A.g. Ziegler, Lucienne Chatenoud, Daniel Pipeleers

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242 Citations (Scopus)

Abstract

AIMS/HYPOTHESIS: The aim of the study was to examine the 48 month outcome of treating recent-onset type 1 diabetic patients for 6 days with humanised CD3-antibody, ChAglyCD3. METHODS: Eighty patients, aged 12-39 years, were recruited for a phase 2 multicentre trial and randomised to placebo (n=40) or ChAglyCD3 (n=40) treatment by a third party member; participants and care-givers were blinded. The change in insulin dose (U kg(-1)day(-1)) over 48 months was chosen as primary endpoint and compared in 31 placebo-and 33 ChAglyCD3-treated patients. Adverse events were followed in 35 and 38 patients, respectively. RESULTS: Treatment with ChAglyCD3 delayed the rise in insulin requirements of patients with recent-onset diabetes and reduced its amplitude over 48 months (+0.09 vs +0.32 U kg(-1)day(-1) in the placebo group). Using multivariate analysis this effect was correlated with higher baseline residual beta cell function and a younger age. It was associated with better outcome variables in subgroups selected according to these variables. In the ChAglyCD3 subgroup with higher initial beta cell function, 0/11 patients became C-peptide-negative over 48 months vs 4/9 in the corresponding placebo subgroup. In the subgroup aged 80% decline within 24 months in the placebo subgroup
Original languageEnglish
Pages (from-to)614-623
Number of pages10
JournalDiabetologia
Volume53
Issue number4
Publication statusPublished - Apr 2010

Keywords

  • CD3-antibody
  • type 1 diabetes
  • beta cell mass

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