Evidence map›Paper›PMID 21251178›Full record

Trial reportDiabetes, obesity & metabolism2011

A 5-week study of the pharmacokinetics and pharmacodynamics of LY2189265, a novel, long-acting glucagon-like peptide-1 analogue, in patients with type 2 diabetes.

P Barrington, J Y Chien, H D H Showalter, K Schneck, S Cui, F Tibaldi, B Ellis, T A Hardy

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter StudyRandomized 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 45 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing 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.

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 26507721PMID 28357715PMID 21251179other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

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

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  20. Immediate Glucose-Lowering Effect After the First Administration of Dulaglutide: A Retrospective, Single-Center, Observational Study.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2021
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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

8 authors.

P BarringtonEli Lilly and Company, Erl Wood, Surrey, UK. barringtonph@lilly.com
J Y Chien
H D H Showalter
K Schneck
S Cui
F Tibaldi
B Ellis
T A Hardy

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of LY2189265 (LY), a novel, long-acting glucagen-like peptide-1 analogue, administered once weekly to subjects with type 2 diabetes.

methodsThis was a placebo-controlled, parallel-group, subject- and investigator-blind study of LY in subjects (N = 43) with type 2 diabetes mellitus controlled with diet and exercise alone or with a single oral antidiabetic medication. Subjects taking metformin or thiazolidinediones continued on their therapy. Subjects receiving sulfonylurea, acarbose, repaglinide or nateglinide were switched to metformin prior to enrollment. Subjects received five once-weekly doses of 0.05, 0.3, 1, 3, 5 or 8 mg. Effects on glucose, insulin and C-peptide concentrations were determined during fasting and following standard test meals. The pharmacokinetics of LY and its effects on HBA1c, glucagon, body weight, gastric emptying and safety parameters were assessed.

resultsOnce-weekly administration of LY significantly reduced (p < 0.01) fasting plasma glucose, 2-h post-test meal postprandial glucose and area under the curve (AUC) of glucose after test meals at doses ≥1 mg. These effects were seen after the first dose and were sustained through the weekly dosing cycle. Most doses produced statistically significant increases in insulin and C-peptide AUC when normalized for glucose AUC. Statistically significant reductions in HBA1c were observed for all dose groups except 0.3 mg. The most commonly reported adverse effects (AEs) were nausea (35 events), headache (20 events), vomiting (18 events) and diarrhoea (8 events).

conclusionsLY showed improvement in fasting and postprandial glycaemic parameters when administered once weekly in subjects with type 2 diabetes. The pharmacokinetics and safety profiles also support further investigation of this novel agent.

Indexed as

AdultAgedArea Under CurveBlood GlucoseCohort StudiesDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFastingFemaleGlucagon-Like Peptide 1Glucagon-Like PeptidesHumansHypoglycemic AgentsImmunoglobulin Fc FragmentsBlood GlucosedulaglutideGlucagon-Like Peptide 1Glucagon-Like PeptidesHypoglycemic AgentsImmunoglobulin Fc FragmentsMetforminRecombinant Fusion ProteinsThiazolidinediones

Identifiers

PMID21251178

What Socratic holds

Texttitle and abstract
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.