Evidence mapPaperPMID 29623579Full record

ArticleClinical pharmacokinetics2018

Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects with Renal Impairment.

Charlotte Granhall, Flemming L Søndergaard, Mette Thomsen, Thomas W Anderson

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

Article in Clinical pharmacokinetics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02014259. Cited by 49 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 2 pooled it
8.5field-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.

NCT02014259 phase1completed

Investigation of Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function

Ran2013Enrolled71Registered outcomes4Posted comparisons0ConditionsDiabetes, Diabetes Mellitus, Type 2, HealthyArmssemaglutide
Open the trial in the graph
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 2 syntheses or guidelines pooled it, 113 citations in OpenAlex.

  1. Cardiovascular Safety Profile of Semaglutide and Variations by Sex, Race, and Kidney Function: A Systematic Review and Meta-analysis.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2025 · on this map
    Pooled it
  2. Clinical Pharmacokinetics of Semaglutide: A Systematic Review.Drug design, development and therapy · 2024
    Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Article
  9. Review
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  11. Review
  12. Semaglutide - properties, action and chromatographic analysis.Journal of diabetes and metabolic disorders · 2025
    Review
  13. The expanding role of semaglutide: beyond glycemic control.Journal of diabetes and metabolic disorders · 2025
    Review
  14. Review
  15. Review
  16. Review
  17. Article
  18. Diabetes and Glucose Management in People on Hemodialysis.Diabetes spectrum : a publication of the American Diabetes Association · 2025
    Article
  19. Article
  20. Article
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

4 authors at 1 institution in 1 country.

Charlotte GranhallNovo Nordisk A/S, Vandtårnsvej 108-110, 2860, Søborg, Denmark. cogr@novonordisk.com.
Flemming L SøndergaardNovo Nordisk A/S, Vandtårnsvej 108-110, 2860, Søborg, Denmark.
Mette ThomsenNovo Nordisk A/S, Vandtårnsvej 108-110, 2860, Søborg, Denmark.
Thomas W AndersonNovo Nordisk A/S, Vandtårnsvej 108-110, 2860, Søborg, Denmark.
Novo Nordisk (Denmark) · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSemaglutide, a glucagon-like peptide-1 (GLP-1) analogue, has been co-formulated with the absorption enhancer sodium N-(8-[2-hydroxybenzoyl] amino) caprylate (SNAC) as a tablet for oral administration. This trial (NCT02014259) investigated the pharmacokinetics, safety and tolerability of oral semaglutide in subjects with and without renal impairment.

methodsSubjects were categorised as having normal renal function (n = 24), mild (n = 12), moderate (n = 12) or severe (n = 12) renal impairment, or end-stage renal disease (ESRD) requiring haemodialysis (n = 11) and received once-daily oral semaglutide (5 mg for 5 days followed by 10 mg for 5 days) in the fasting state, followed by 30 min fasting after dosing. Semaglutide plasma concentrations were measured during dosing and for up to 21 days after the last dose.

resultsSemaglutide exposure (area under the plasma concentration-time curve from time zero to 24 h after the tenth dose and maximum concentration after the tenth dose) did not vary in a consistent pattern across the renal function groups. Similarly, there was no apparent effect of renal impairment on the semaglutide half-life (geometric mean range 152-165 h). Except for one subject in the ESRD group, semaglutide was not detected in urine. Haemodialysis did not affect the pharmacokinetics of semaglutide. Adverse events were in line with those observed for other GLP-1 receptor agonists and no safety concerns were identified.

conclusionThere was no apparent effect of renal impairment or haemodialysis on the pharmacokinetics of oral semaglutide. Based on this trial, renal impairment should not affect dose recommendations for oral semaglutide.

Indexed as

Administration, OralAdultAgedArea Under CurveFemaleGlucagon-Like Peptide 1Glucagon-Like PeptidesHalf-LifeHumansHypoglycemic AgentsKidney Failure, ChronicMaleMiddle AgedRenal DialysisRenal InsufficiencySemaglutideGlucagon-Like Peptide 1Glucagon-Like PeptidesHypoglycemic AgentsSemaglutide

Identifiers

PMID29623579
PMCPMC6267549
OpenAlexW2795981708

What Socratic holds

Textmetadata
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.