Evidence mapPaperPMID 28349386Full record

ArticleClinical pharmacokinetics2017

Pharmacokinetics and Tolerability of a Single Dose of Semaglutide, a Human Glucagon-Like Peptide-1 Analog, in Subjects With and Without Renal Impairment.

Thomas C Marbury, Anne Flint, Jacob B Jacobsen, Julie Derving Karsbøl, Kenneth Lasseter

Registry-linked trialOpen access · hybridAbstract readControlled Clinical TrialMulticenter Study
In one paragraph

Article in Clinical pharmacokinetics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00833716. Cited by 56 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 3 pooled it
8.9field-weighted citation impact, top 2% 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.

NCT00833716 phase1completed

An Open-label Trial Investigating the Pharmacokinetics and the Tolerability of NN9535 in Subjects With Normal Renal Function and Various Degrees of Impaired Renal Function

Ran2009Enrolled62Registered outcomes2Posted comparisons0ConditionsDiabetes, Diabetes Mellitus, Type 2, Renal ImpairmentArmssemaglutide
Open the trial in the graph
3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 3 syntheses or guidelines pooled it, 115 citations in OpenAlex.

  1. Pooled it
  2. Clinical Pharmacokinetics of Semaglutide: A Systematic Review.Drug design, development and therapy · 2024
    Pooled it
  3. Pooled it
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  11. Article
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  13. Review
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  16. Observational
  17. Semaglutide - properties, action and chromatographic analysis.Journal of diabetes and metabolic disorders · 2025
    Review
  18. Molecular Design of Unimolecular Tetra-Receptor Agonists.Journal of the American Chemical Society · 2025
    Article
  19. Article
  20. 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

5 authors at 3 institutions in 2 countries.

Thomas C MarburyOrlando Clinical Research Center, 5055 South Orange Avenue, Orlando, FL, 32809, USA. tmarbury@ocrc.net.
Anne FlintNovo Nordisk A/S, Søborg, Denmark.
Jacob B JacobsenNovo Nordisk A/S, Søborg, Denmark.
Julie Derving KarsbølNovo Nordisk A/S, Søborg, Denmark.
Kenneth LasseterClinical Pharmacology of Miami, Inc., Miami, FL, USA.
Novo Nordisk (Denmark) · DKClinical Pharmacology of Miami · USOrlando Clinical Research Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe pharmacokinetics and tolerability of semaglutide, a once-weekly human glucagon-like peptide-1 analog in development for the treatment of type 2 diabetes mellitus, were investigated in subjects with/without renal impairment (RI).

methodsFifty-six subjects, categorized into renal function groups [normal, mild, moderate, severe, and end-stage renal disease (ESRD)], received a single subcutaneous dose of semaglutide 0.5 mg. Semaglutide plasma concentrations were assessed ≤480 h post-dose; the primary endpoint was the area under the plasma concentration-time curve from time zero to infinity.

resultsSemaglutide exposure in subjects with mild/moderate RI and ESRD was similar to that in subjects with normal renal function. In subjects with severe RI, the mean exposure of semaglutide was 22% higher than in subjects with normal renal function, and the 95% confidence interval (1.02-1.47) for the ratio exceeded the pre-specified limits (0.70-1.43). When adjusted for differences in sex, age, and body weight between the groups, all comparisons were within the pre-specified clinically relevant limits. Across RI groups there was no relationship between creatinine clearance (CL

conclusionWhen adjusted for differences in sex, age, and body weight, semaglutide exposure was similar between subjects with RI and subjects with normal renal function. Semaglutide (0.5 mg) was well-tolerated. Dose adjustment may not be warranted for subjects with RI. CLINICALTRIALS. GOV IDENTIFIER: NCT00833716.

Indexed as

AdolescentAdultAgedDiabetes Mellitus, Type 2FemaleGlucagon-Like Peptide 1Glucagon-Like PeptidesHumansHypoglycemic AgentsMaleMiddle AgedRenal InsufficiencySemaglutideYoung AdultGlucagon-Like Peptide 1Glucagon-Like PeptidesHypoglycemic AgentsSemaglutide

Identifiers

PMID28349386
PMCPMC5648736
OpenAlexW2599428142

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.