Evidence mapPaperPMID 29536338Full record

Trial reportAdvances in therapy2018

A Randomized Trial Investigating the Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Semaglutide Once-Weekly in Healthy Male Japanese and Caucasian Subjects.

Ippei Ikushima, Lene Jensen, Anne Flint, Tomoyuki Nishida, Jeppe Zacho, Shin Irie

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Advances in therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02146079. Cited by 13 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing 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.

NCT02146079 phase1completed

A Single-centre, Parallel-group, Randomised, Double-blind, Placebocontrolled, Multiple-dose Trial to Assess the Pharmacokinetics, Pharmacodynamics, and the Safety and Tolerability of Semaglutide in Healthy Male Japanese and Caucasian Subjects

Ran2014Enrolled44Registered outcomes4Posted comparisons0ConditionsDiabetes, Diabetes Mellitus, Type 2, HealthyArmsPlacebo, semaglutide
Open the trial in the graph
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Clinical Pharmacokinetics of Semaglutide: A Systematic Review.Drug design, development and therapy · 2024
    Pooled it
  3. Pooled it
  4. Review
  5. Semaglutide - properties, action and chromatographic analysis.Journal of diabetes and metabolic disorders · 2025
    Review
  6. Article
  7. Article
  8. Article
  9. Review
  10. Semaglutide-eye-catching results.World journal of diabetes · 2023
    Review
  11. Safety of Semaglutide.Frontiers in endocrinology · 2021 · on this map
    Review
  12. Population Pharmacokinetics of Semaglutide for Type 2 Diabetes.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2019
    Article
  13. A review of lipidation in the development of advanced protein and peptide therapeutics.Journal of controlled release : official journal of the Controlled Release Society · 2019
    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

6 authors.

Ippei IkushimaLTA Sumida Hospital, Tokyo, Japan. ippei-ikushima@lta-med.com.
Lene JensenNovo Nordisk A/S, Søborg, Denmark.
Anne FlintNovo Nordisk A/S, Søborg, Denmark.
Tomoyuki NishidaNovo Nordisk Pharma Ltd, Tokyo, Japan.
Jeppe ZachoNovo Nordisk A/S, Søborg, Denmark.
Shin IrieSOUSEIKAI Global Clinical Research Center, Fukuoka, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSemaglutide is a glucagon-like peptide-1 analogue for once-weekly subcutaneous treatment of type 2 diabetes. This trial compared the pharmacokinetics, pharmacodynamics, and safety of semaglutide in Japanese and Caucasian subjects.

methodsIn this single-center, double-blind, parallel-group, 13-week trial, 44 healthy male subjects (22 Japanese, 22 Caucasian) were randomized within each race to semaglutide 0.5 mg (n = 8), 1.0 mg (n = 8), placebo 0.5 mg (n = 3) or 1.0 mg (n = 3). The primary endpoint was semaglutide exposure at steady state [area under the curve (AUC

resultsSteady-state exposure of semaglutide was similar for both populations: AUC

conclusionsThe pharmacokinetic, pharmacodynamic, and safety profiles of semaglutide were similar in Japanese and Caucasian subjects, suggesting that no dose adjustment is required for the clinical use of semaglutide in Japanese subjects.

fundingNovo Nordisk A/S, Denmark.

trial registrationClinicalTrials.gov identifier NCT02146079. Japanese trial registration number JapicCTI-142550.

Indexed as

AdultArea Under CurveAsian PeopleBody WeightDiabetes Mellitus, Type 2Double-Blind MethodGlucagon-Like Peptide 1Glucagon-Like PeptidesHalf-LifeHumansHypoglycemic AgentsInjections, SubcutaneousMaleMiddle AgedSemaglutideWeight LossGlucagon-Like Peptide 1Glucagon-Like PeptidesHypoglycemic AgentsSemaglutideGLP-1 receptor agonistJapanese subjectsPharmacodynamicsPharmacokineticsSemaglutideType 2 diabetes

Identifiers

PMID29536338
PMCPMC5910468

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC
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.