Evidence map›Paper›PMID 20225393›Full record

Trial reportDiabetologia2010

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.

B Keymeulen, M Walter, C Mathieu, L Kaufman, F Gorus, R Hilbrands, E Vandemeulebroucke, U Van de Velde, L Crenier, C De Block and 5 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetologia, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 151 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
151citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00627146 phase2completednot on this map

Extension of Phase II Therapeutic Trial With a Humanized Non-Mitogenic CD3 (ChAgly CD3) Monoclonal Antibody in Recently Diagnosed Type 1 Diabetic Patients

TypeinterventionalSponsorUniversitair Ziekenhuis BrusselRan2000 to 2007Enrolled80ConditionsDiabetes Mellitus, Type 1ArmsChAgly CD3, Placebo
NCT01123083 phase3completednot on this map

Durable-Response Therapy Evaluation For Early- or New-Onset Type 1 Diabetes

TypeinterventionalSponsorGlaxoSmithKlineRan2010 to 2012Enrolled179ConditionsDiabetes Mellitus, Type 1ArmsOtelixizumab, Placebo
3 · Its place in the literature

Who cites it

151 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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91 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

B KeymeulenDiabetes Research Center and University Hospital, Brussels Free University-VUB, Laarbeeklaan 103, 1090 Brussels, Belgium.
M Walter
C Mathieu
L Kaufman
F Gorus
R Hilbrands
E Vandemeulebroucke
U Van de Velde
L Crenier
C De Block
S Candon
H Waldmann
A G Ziegler
L Chatenoud
D Pipeleers

Funding

Medical Research Council G1000215
6 · The paper itself

Abstract

aims/hypothesisThe 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.

methodsEighty 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.

resultsTreatment 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 <27 years old, antibody treatment preserved initial beta cell function for 36 months (vs >80% decline within 24 months in the placebo subgroup <27 years old), resulted in lower HbA1c concentrations and tended to reduce glycaemic variability (p=0.08). No longterm adverse events were observed. CONCLUSIONS/

interpretationA 6 day ChAglyCD3 treatment can suppress the rise in insulin requirements of recent-onset type 1 diabetic patients over 48 months, depending on their age and initial residual beta cell function. In younger patients this effect is associated with reduced deterioration of metabolic variables. These observations help to define inclusion criteria for prevention trials.

trial registrationClinicalTrials.gov NCT00627146

fundingCenter grants from the Juvenile Diabetes Research Foundation (4-2001-434, 4-2005-1327) and grants from the Belgian Fund for Scientific Research-Flanders and from Brussels Free University-VUB.

Indexed as

AdultAge FactorsAntibodiesBelgiumCD3 ComplexDiabetes Mellitus, Type 1FemaleFollow-Up StudiesGlycated HemoglobinHumansInsulin-Secreting CellsLymphocyte SubsetsMalePlacebosRegistriesTime FactorsAntibodiesCD3 ComplexGlycated HemoglobinPlacebos

Identifiers

PMID20225393

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.