Evidence map›Paper›PMID 21251179›Full record

Trial reportDiabetes, obesity & metabolism2011

LY2189265, a long-acting glucagon-like peptide-1 analogue, showed a dose-dependent effect on insulin secretion in healthy subjects.

P Barrington, J Y Chien, F Tibaldi, H D H Showalter, K Schneck, B Ellis

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05459285 (Pharmacokinetics, Safety and Immunogenicity of 14028 Injection Versus Dulaglutide Injection in Healthy Subjects), which is not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 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.

NCT05459285 phase1completedstarted 2022, after this paper: background citation

Pharmacokinetics, Safety and Immunogenicity of 14028 Injection Versus Dulaglutide Injection in Healthy Subjects: a Phase I ，Single-center, Randomized, Open-label, Single-dose, Parallel-controlled Clinical Study

Ran2022Enrolled68Registered outcomes8Posted comparisons0ConditionsType 2 DiabetesArms14028 injection, dulaglutide injection
PMID 21251178PMID 26507721PMID 28357715other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  15. Glucagon-like peptide 1 (GLP-1).Molecular metabolism · 2019 · on this map
    Review
  16. Review
  17. Article
  18. Review
  19. Advances in the treatment of type 2 diabetes: impact of dulaglutide.Diabetes, metabolic syndrome and obesity : targets and therapy · 2016
    Review
  20. Choosing Appropriate Glucagon-like Peptide 1 Receptor Agonists: A Patient-Centered Approach.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2014
    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

6 authors.

P BarringtonEli Lilly and Company, Erl Wood Manor, Surrey, UK Eli Lilly and Company, Indianapolis, IN, USA GSK Biologicals, Rixensart, Belgium.
J Y Chien
F Tibaldi
H D H Showalter
K Schneck
B Ellis

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo assess the safety, tolerability, pharmacokinetics, pharmacodynamics and potential immunogenicity of single, escalating subcutaneous injections of a once-weekly glucagon-like peptide-1 analogue in healthy subjects.

methodsThis phase 1, three-period, crossover, double-blind, placebo-controlled study investigated single, escalating subcutaneous doses of LY2189265 (LY) ranging from 0.1 to 12 mg; approximately six subjects were randomized to each dose. Parameters of safety, including adverse events, were assessed. The pharmacokinetic profile was assessed over 14 days. Pharmacodynamic parameters (glucose and insulin concentrations) were measured following a step-glucose infusion (day 3) and as part of an oral glucose tolerance test (OGTT) (day 5).

resultsLY was generally well tolerated with some increase in gastrointestinal symptoms with escalating doses. There were small dose-dependent increases in pulse rate with doses ≥1.0 mg and diastolic blood pressure with doses ≥3.0 mg. The half-life of LY was approximately 90 h, with C(max) occurring between 24 and 48 h in most subjects. Evidence of increase in glucose-dependent insulin secretion and suppression of serum glucose excursions were observed during an OGTT at all doses compared to placebo; no episodes of hypoglycaemia occurred. No subjects developed antibodies to LY2189265.

conclusionsLY showed an acceptable safety profile and exhibited the expected glucagon-like peptide-1 pharmacological effects on glucose suppression and insulin secretion with a half-life that supports once-weekly dosing.

Indexed as

AdolescentAdultArea Under CurveCross-Over StudiesDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDouble-Blind MethodFemaleGlucagon-Like Peptide 1Glucagon-Like PeptidesGlucose Tolerance TestHalf-LifeHumansHypoglycemic AgentsImmunoglobulin Fc FragmentsInjections, SubcutaneousdulaglutideGlucagon-Like Peptide 1Glucagon-Like PeptidesHypoglycemic AgentsImmunoglobulin Fc FragmentsInsulinRecombinant Fusion Proteins

Identifiers

PMID21251179

What Socratic 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 Socratic graph.