Evidence map›Paper›PMID 28361463›Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2017

Clinical Outcomes of Patients with Diabetes Who Exhibit Upper-Quartile Insulin Antibody Responses After Treatment with LY2963016 or Lantus

Liza L Ilag, Timothy M Costigan, Mark A Deeg, Robyn K Pollom, Curtis L Chang, Robert J Konrad, Melvin J Prince

Open access · goldAbstract read
In one paragraph

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 25% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Lilly Insulin Glargine Versus LantusDiabetes therapy : research, treatment and education of diabetes and related disorders · 2019
    Article
  5. Article
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 1 institution in 2 countries.

Liza L IlagLilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA. ilag_liza_l@lilly.com.
Timothy M CostiganLilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA.
Mark A DeegLilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA.
Robyn K PollomLilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA.
Curtis L ChangLilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA.
Robert J KonradLilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA.
Melvin J PrinceLilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA.
Eli Lilly (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionWe compared insulin antibody response (IAR) profiles in patients with type 1 diabetes (T1D) or type 2 diabetes (T2D) who received LY2963016 insulin glargine (LY IGlar) or Lantus

methodsData from ELEMENT-1 (52-week open-label in T1D) and ELEMENT-2 (24-week, double-blind study in T2D) were analyzed. Maximum postbaseline IAR levels and proportions of patients in the upper quartile of maximum antibody percent binding (UQMAPB; patients with maximum postbaseline percent binding in the highest 25% of maximum values observed) were compared for differential treatment effects on clinical efficacy outcomes and incidence of adverse events. Continuous outcomes were analyzed by analysis of covariance. Categorical data were analyzed by the Cochran-Mantel-Haenszel or Breslow-Day test.

resultsIn both studies (N = 532 evaluable patients with T1D; N = 730 with T2D), no statistically significant differences between LY IGlar and IGlar were observed for maximum antibody percent binding (MAPB) levels or for proportions of patients in the respective UQMAPB. No statistically significant differential treatment effects were observed in the relationship between MAPB and clinical efficacy and safety outcomes.

conclusionsMaximum postbaseline IAR levels and the proportion of patients with high IAR levels were similar for LY IGlar and IGlar. High antibody levels did not affect clinical outcomes. These results add further evidence supporting similar IARs of LY IGlar and IGlar.

fundingEli Lilly and Company and Boehringer-Ingelheim.

Indexed as

Insulin antibody responseInsulin glargineLY2963016 insulin glargine

Identifiers

PMID28361463
PMCPMC5446380
OpenAlexW2599506405

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.