Evidence map›Paper›PMID 34080123›Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2021

Effect of Various Dosing Conditions on the Pharmacokinetics of Oral Semaglutide, a Human Glucagon-Like Peptide-1 Analogue in a Tablet Formulation.

Tine A Bækdal, Astrid Breitschaft, Morten Donsmark, Stine J Maarbjerg, Flemming L Søndergaard, Jeanett Borregaard

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01572753. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
4.3field-weighted citation impact, top 5% 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.

NCT01572753 phase1completed

A Single Centre, Multiple Dose, Open Label Randomised Trial to Evaluate the Effect of Post Dose Meal Timings and the Effect of Volume of Water With Dosing on the Pharmacokinetic Properties of Oral Semaglutide in Healthy Male Subjects

Ran2012Enrolled161Registered outcomes4Posted comparisons0ConditionsDiabetes, Diabetes Mellitus, Type 2, HealthyArmssemaglutide
Open the trial in the graph
NCT02172313 phase1completed

Effect of Food on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects

Ran2014Enrolled78Registered outcomes5Posted comparisons0ConditionsDiabetes, HealthyArmssemaglutide
Open the trial in the graph
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.

  1. Clinical Pharmacokinetics of Semaglutide: A Systematic Review.Drug design, development and therapy · 2024
    Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Article
  8. Article
  9. Review
  10. Review
  11. Semaglutide - properties, action and chromatographic analysis.Journal of diabetes and metabolic disorders · 2025
    Review
  12. Article
  13. Review
  14. Review
  15. A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025
    Article
  16. Incretin-based therapy: a new horizon in diabetes management.Journal of diabetes and metabolic disorders · 2024
    Review
  17. Review
  18. Weight Loss Pharmacotherapy: Current and Future Therapies.Gastrointestinal endoscopy clinics of North America · 2024
    Review
  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

6 authors at 1 institution in 1 country.

Tine A BækdalNovo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark. tabq@novonordisk.com.
Astrid BreitschaftEarly Phase Clinical Unit - Berlin, Parexel International GmbH, Klinikum Westend - Haus 18, Spandauer Damm 130, 14050, Berlin, Germany.
Morten DonsmarkNovo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.
Stine J MaarbjergNovo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.
Flemming L SøndergaardNovo Nordisk A/S, Alfred Nobels Vej 27, 9220, Aalborg Ø, Denmark.
Jeanett BorregaardNovo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.
Novo Nordisk (Denmark) · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionOral semaglutide is a novel tablet formulation of the human glucagon-like peptide-1 analogue semaglutide. In two trials, the effects of prior food ingestion (food effect), post-dose fasting period and water volume with dosing (dosing conditions) on oral semaglutide pharmacokinetics were investigated.

methodsSubjects received once-daily oral semaglutide for 10 days. In the food-effect trial, 78 healthy subjects were randomised 1:1:1 to fed (meal 30 min pre-dose; 240 mL water with dosing), fasting (overnight until 4 h post-dose; 240 mL) or reference (fasting overnight until 30 min post-dose; 120 mL) arms. In the dosing conditions trial, 161 healthy men were randomised into eight dosing groups (overnight fasted with 50/120 mL water and 15/30/60/120 min post-dose fasting). Semaglutide plasma concentrations were measured frequently until 504 h after the 10th dose.

resultsIn the food-effect trial, limited or no measurable semaglutide exposure was observed in the fed arm, while all subjects in the fasting arm had measurable semaglutide exposure. Area under the semaglutide concentration-time curve (AUC

conclusionAdministration of oral semaglutide in the fasting state with up to 120 mL water and at least 30 min post-dose fasting results in clinically relevant semaglutide exposure. These dosing conditions have been used in the oral semaglutide phase 3 trials and are part of the approved label.

trial registrationClinicalTrials.gov identifiers NCT02172313, NCT01572753.

Indexed as

Dosing conditionsFood effectGlucagon-like peptide-1Oral semaglutidePharmacokineticsSodium N-(8-[2-hydroxybenzoyl] amino) caprylate

Identifiers

PMID34080123
PMCPMC8266944
OpenAlexW3164680927

What OpenQuestion 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 OpenQuestion graph.