Evidence mapPaperPMID 35867199Full record

Trial reportClinical drug investigation2022

Pharmacokinetics of Imeglimin in Caucasian and Japanese Healthy Subjects.

Pascale Fouqueray, Clémence Chevalier, Sébastien Bolze

Open access · hybridAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Clinical drug investigation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 12% 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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Imeglimin: A Clinical Pharmacology Review.Clinical pharmacokinetics · 2023
    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

3 authors.

Pascale FouquerayClinical Department, Poxel SA, Lyon, France.
Clémence ChevalierClinical Pharmacology Department, Poxel SA, Lyon, France.
Sébastien BolzeNon Clinical Department, Poxel SA, 259/261 Avenue Jean Jaurès, 69007, Lyon, France. sebastien.bolze@poxelpharma.com.ORCID http://orcid.org/0000-0002-5122-1415

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundImeglimin is a first-in-class novel oral antidiabetic marketed in Japan as TWYMEEG

objectiveTo assess the pharmacokinetic and safety profile of imeglimin in Caucasian and Japanese healthy individuals.

methodsTwo randomized placebo-controlled phase 1 clinical studies were conducted in Caucasian subjects after single (250-8000 mg) and multiple (250-2000 mg twice daily) ascending doses and in Japanese subjects after single (500-6000 mg) and multiple (500-2000 mg twice daily) ascending doses. Imeglimin plasma and urine concentrations were measured.

resultsAll imeglimin doses achieved maximal concentration between 1 and 3.5 h in Caucasians, and 1.5 and 3 h in Japanese subjects. The elimination half-lives (t

conclusionImeglimin was safe and well tolerated in these two phases 1 studies, with pharmacokinetics comparable between the two populations. CLINICAL TRIAL REGISTRATIONS: EudraCT 2005-001946-18 and 2014-004679-21.

Indexed as

Diabetes Mellitus, Type 2Area Under CurveDose-Response Relationship, DrugDouble-Blind MethodHealthy VolunteersHumansJapanTriazinesimegliminTriazines

Identifiers

PMID35867199
PMCPMC9427879
OpenAlexW4286433089

What Socratic holds

Textmetadata
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 Socratic graph.