Evidence map›Paper›PMID 17429083›Full record

Trial reportThe New England journal of medicine2007

Interleukin-1-receptor antagonist in type 2 diabetes mellitus.

Claus M Larsen, Mirjam Faulenbach, Allan Vaag, Aage Vølund, Jan A Ehses, Burkhardt Seifert, Thomas Mandrup-Poulsen, Marc Y Donath

3 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 864 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
864citing papers in PubMed, 3 pooled it
82.8field-weighted citation impact, top 1% of its field
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.

NCT00303394 phase2completednot on this map

Phase 2 Study of IL-1Ra in Patients With Type 2 Diabetes

TypeinterventionalSponsorUniversity of ZurichRan2004 to 2006Enrolled72ConditionsType 2 DiabetesArmsIL-1Ra
NCT00928876 phase2unknown statusnot on this mapstarted 2009, after this paper: background citation

Effect of Interleukin-1 Receptor Antagonist on Insulin Sensitivity in Obese, Insulin Resistant Individuals

TypeinterventionalSponsorRadboud University Medical CenterRan2009 to 2010Enrolled12ConditionsDiabetes Mellitus, Type 2, Insulin ResistanceArmsAnakinra (Kineret), Placebo
NCT01477476 phase2withdrawnnot on this mapstarted 2012, after this paper: background citation

Anti-IL-1 Treatment in Children Diabetic Keto-Acidosis (DKA) at Diagnosis of Type 1 Diabetes.

TypeinterventionalSponsorUniversity of Colorado, DenverRan2012 to 2016Enrolled0ConditionsType I DiabetesArmsAnakinra, Placebo Comparator
3 · Its place in the literature

Who cites it

864 citing papers in PubMed, 3 syntheses or guidelines pooled it, 1,781 citations in OpenAlex.

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  19. Adipose tissue releases nucleosides.American journal of physiology. Cell physiology · 2026
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804 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 6 institutions in 3 countries.

Claus M LarsenSteno Diabetes Center, Gentofte, Denmark.
Mirjam Faulenbach
Allan Vaag
Aage Vølund
Jan A Ehses
Burkhardt Seifert
Thomas Mandrup-Poulsen
Marc Y Donath
Steno Diabetes Center · DKSwiss Integrative Center for Human Health · CHKarolinska Institutet · SENovo Nordisk (Denmark) · DKUniversity Hospital of Zurich · CHUniversity of Zurich · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe expression of interleukin-1-receptor antagonist is reduced in pancreatic islets of patients with type 2 diabetes mellitus, and high glucose concentrations induce the production of interleukin-1beta in human pancreatic beta cells, leading to impaired insulin secretion, decreased cell proliferation, and apoptosis.

methodsIn this double-blind, parallel-group trial involving 70 patients with type 2 diabetes, we randomly assigned 34 patients to receive 100 mg of anakinra (a recombinant human interleukin-1-receptor antagonist) subcutaneously once daily for 13 weeks and 36 patients to receive placebo. At baseline and at 13 weeks, all patients underwent an oral glucose-tolerance test, followed by an intravenous bolus of 0.3 g of glucose per kilogram of body weight, 0.5 mg of glucagon, and 5 g of arginine. In addition, 35 patients underwent a hyperinsulinemic-euglycemic clamp study. The primary end point was a change in the level of glycated hemoglobin, and secondary end points were changes in beta-cell function, insulin sensitivity, and inflammatory markers.

resultsAt 13 weeks, in the anakinra group, the glycated hemoglobin level was 0.46 percentage point lower than in the placebo group (P=0.03); C-peptide secretion was enhanced (P=0.05), and there were reductions in the ratio of proinsulin to insulin (P=0.005) and in levels of interleukin-6 (P<0.001) and C-reactive protein (P=0.002). Insulin resistance, insulin-regulated gene expression in skeletal muscle, serum adipokine levels, and the body-mass index were similar in the two study groups. Symptomatic hypoglycemia was not observed, and there were no apparent drug-related serious adverse events.

conclusionsThe blockade of interleukin-1 with anakinra improved glycemia and beta-cell secretory function and reduced markers of systemic inflammation. (ClinicalTrials.gov number, NCT00303394 [ClinicalTrials.gov].).

Indexed as

Blood GlucoseBody Mass IndexC-Reactive ProteinDiabetes Mellitus, Type 2Double-Blind MethodFemaleGene Expression RegulationGlucose Tolerance TestGlucose Transporter Type 4Glycated HemoglobinHeat-Shock ProteinsHumansInsulin ResistanceInsulin-Secreting CellsInterleukin 1 Receptor Antagonist ProteinInterleukin-6Blood GlucoseC-Reactive ProteinGlucose Transporter Type 4Glycated HemoglobinHeat-Shock ProteinsInterleukin 1 Receptor Antagonist ProteinInterleukin-6Peroxisome Proliferator-Activated Receptor Gamma Coactivator 1-alphaPPARGC1A protein, humanReceptors, Interleukin-1Recombinant ProteinsRNA, MessengerTranscription Factors

Identifiers

PMID17429083
OpenAlexW2024378513

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.