Evidence map›Paper›PMID 26930607›Full record

Trial reportPloS one2016

A Study to Investigate the Efficacy and Safety of an Anti-Interleukin-18 Monoclonal Antibody in the Treatment of Type 2 Diabetes Mellitus.

Elizabeth A McKie, Juliet L Reid, Prafull C Mistry, Stephen L DeWall, Lee Abberley, Philip D Ambery, Blas Gil-Extremera

Registry-linked trialOpen access · goldFull text readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01648153 (A Single Blind), which is not on this map. Cited by 45 papers.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed
7.2field-weighted citation impact, top 3% 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.

NCT01648153 phase2completednot on this map

A Single Blind (Sponsor-unblinded), Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of GSK1070806 in the Treatment of Obese Subjects With T2DM.

TypeinterventionalSponsorGlaxoSmithKlineRan2012 to 2014Enrolled37ConditionsDiabetes MellitusArmsGSK1070806, Placebo (saline)
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 78 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Review
  7. Article
  8. Article
  9. Review
  10. Perioperative Levels of IL8 and IL18, but not IL6, are Associated with Nucleus Basalis Magnocellularis Atrophy Three Months after Surgery.Journal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology · 2024
    Article
  11. Review
  12. Review
  13. IL-18 biology in severe asthma.Frontiers in medicine · 2024
    Review
  14. Article
  15. Review
  16. Pyroptosis: a new therapeutic strategy in cancer.Molecular biology reports · 2023
    Review
  17. Review
  18. Review
  19. Article
  20. Review
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

7 authors at 3 institutions in 3 countries.

Elizabeth A McKieRespiratory R&D, GlaxoSmithKline, Uxbridge, United Kingdom.
Juliet L ReidImmunoinflammation Therapy Area Unit, GlaxoSmithKline, Stevenage, United Kingdom.
Prafull C MistryClinical Statistics, GlaxoSmithKline, Stevenage, United Kingdom.
Stephen L DeWallClinical Immunology, Biopharm R&D, GlaxoSmithKline, King of Prussia, Pennsylvania, United States of America.
Lee AbberleyDrug Metabolism and Pharmacokinetics, GlaxoSmithKline, King of Prussia, Pennsylvania, United States of America.
Philip D AmberyGlaxoSmithKline, Clinical development, Cardiovascular and Metabolic Medicines Development Centre, London, United Kingdom.
Blas Gil-ExtremeraDepartment of Medicine, University Hospital San Cecilio, Granada, Spain.
GlaxoSmithKline (United Kingdom) · GBGlaxoSmithKline (United States) · USInstituto de Investigación Biosanitaria de Granada · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveEvidence suggests that chronic subclinical inflammation plays an important role in the pathogenesis of type 2 diabetes (T2DM). Circulating levels of interleukin (IL)-18 appear to be associated with a number of micro- and macrovascular comorbidities of obesity and T2DM. This study was designed to investigate whether inhibition of IL-18 had any therapeutic benefit in the treatment of T2DM. Preliminary efficacy, safety and tolerability, pharmacokinetics, and pharmacodynamics of the anti-IL-18 monoclonal antibody, GSK1070806, were assessed. RESEARCH DESIGN AND

methodsThis was a multicentre, randomized, single-blind (sponsor-unblinded), placebo-controlled, parallel-group, phase IIa trial. Obese patients of either sex, aged 18-70 years, with poorly controlled T2DM on metformin monotherapy were recruited. Patients received two doses, of placebo (n = 12), GSK1070806 0.25 mg/kg (n = 13) or GSK1070806 5 mg/kg (n = 12). The primary end-point was the change from baseline in fasting plasma glucose and weighted mean glucose area under the curve (AUC)(0-4 hours) postmixed meal test on Days 29, 57, and 85.

resultsThirty-seven patients were randomized to one of the three treatment arms. There were no statistically significant effects of GSK1070806 doses on fasting plasma glucose levels, or weighted mean glucose AUC(0-4 hours) compared with placebo.

conclusionsGSK1070806 was well tolerated, and inhibition of IL-18 did not lead to any improvements in glucose control. However, because of study limitations, smaller, potentially clinically meaningful effects of IL-18 inhibition cannot be excluded.

trial registrationClinicalTrials.gov NCT01648153.

Indexed as

Blood GlucoseAgedAntibodies, Monoclonal, HumanizedDiabetes Mellitus, Type 2Drug Therapy, CombinationFemaleHumansHypoglycemic AgentsInterleukin-18MaleMetforminMiddle AgedObesitySingle-Blind MethodTreatment OutcomeAntibodies, Monoclonal, HumanizedBlood GlucoseGSK1070806Hypoglycemic AgentsInterleukin-18Metformin

Identifiers

PMID26930607
PMCPMC4773233
OpenAlexW2291703807

What OpenQuestion holds

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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.