Evidence map›Paper›PMID 26507721›Full record

Trial reportClinical pharmacokinetics2016

Clinical Pharmacokinetics of Dulaglutide in Patients with Type 2 Diabetes: Analyses of Data from Clinical Trials.

Jeanne S Geiser, Michael A Heathman, Xuewei Cui, Jennifer Martin, Corina Loghin, Jenny Y Chien, Amparo de la Peña

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase IIClinical Trial, Phase III
PubMed Publisher
In one paragraph

Trial report in Clinical pharmacokinetics, 2016. 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 21251178PMID 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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  10. Contractile effects of dulaglutide in the human atrium.Naunyn-Schmiedeberg's archives of pharmacology · 2026
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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

7 authors.

Jeanne S GeiserEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Michael A HeathmanEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Xuewei CuiEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Jennifer MartinEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Corina LoghinEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Jenny Y ChienEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Amparo de la PeñaEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA. de_la_pena_amparo@lilly.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveDulaglutide is a long-acting glucagon-like peptide-1 receptor agonist administered as once-weekly subcutaneous injections for the treatment of type 2 diabetes (T2D). The clinical pharmacokinetics of dulaglutide were characterized in patients with T2D and healthy subjects.

methodsThe pharmacokinetics of dulaglutide were assessed throughout clinical development, including conventional pharmacokinetic analysis in clinical pharmacology studies and population pharmacokinetic analyses of data from combined phase 2 and phase 3 studies in patients with T2D. The effects of potential covariates on dulaglutide population pharmacokinetics were evaluated using nonlinear mixed-effects models.

resultsDulaglutide gradually reached the maximum concentration in 48 h and had a terminal elimination half-life of 5 days. Steady state was achieved between the second and fourth doses. The accumulation ratio was 1.56 for the 1.5 mg dose. Intra-individual variability estimates for the area under the plasma concentration-time curve and the maximum concentration were both <17% [coefficient of variation (CV)]. There was no difference in pharmacokinetics between injection sites (arm, thigh or abdomen). Dulaglutide pharmacokinetics were well described by a two-compartment model with first-order absorption and elimination. The population clearance was estimated at 0.126 L/h [inter-individual variability (CV) 33.8%]. Age, body weight, sex, race and ethnicity did not influence dulaglutide pharmacokinetics to any clinically relevant degree.

conclusionThe pharmacokinetics of dulaglutide support once-weekly administration in patients with T2D. The pharmacokinetic findings suggest that dose adjustment is not necessary on the basis of body weight, sex, age, race or ethnicity or site of injection.

Indexed as

AdultAgedAged, 80 and overDiabetes Mellitus, Type 2Drug Administration RoutesFemaleGlucagon-Like PeptidesHumansHypoglycemic AgentsImmunoglobulin Fc FragmentsMaleMiddle AgedRecombinant Fusion ProteinsYoung AdultdulaglutideGlucagon-Like PeptidesHypoglycemic AgentsImmunoglobulin Fc FragmentsRecombinant Fusion Proteins

Identifiers

PMID26507721

What Socratic holds

Textmetadata
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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 Socratic graph.