Evidence mapPaperPMID 33782832Full record

Trial reportClinical pharmacokinetics2021

Effect of Oral Semaglutide on the Pharmacokinetics of Levonorgestrel and Ethinylestradiol in Healthy Postmenopausal Women and Furosemide and Rosuvastatin in Healthy Subjects.

Andreas B Jordy, Muna Albayaty, Astrid Breitschaft, Thomas W Anderson, Erik Christiansen, Azadeh Houshmand-Øregaard, Easwaran Manigandan, Tine A Bækdal

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Clinical pharmacokinetics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02845219. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 15% 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.

NCT02845219 phase1completed

A Trial Investigating the Influence of Oral Semaglutide on Pharmacokinetics of Ethinylestradiol and Levonorgestrel in an Oral Contraceptive Combination Drug in Healthy Postmenopausal Females

Ran2016Enrolled25Registered outcomes4Posted comparisons0ConditionsDiabetes, Diabetes Mellitus, Type 2ArmsMicrogynon®, semaglutide, SNAC
Open the trial in the graph
NCT03010475 phase1completed

A Trial Investigating the Effect of Oral Semaglutide on the Pharmacokinetics of Furosemide and Rosuvastatin in Healthy Subjects.

Ran2017Enrolled41Registered outcomes4Posted comparisons0ConditionsDiabetes, HealthyArmsFurosemide, Rosuvastatin, semaglutide, SNAC
Open the trial in the graph
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Clinical Pharmacokinetics of Semaglutide: A Systematic Review.Drug design, development and therapy · 2024
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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

8 authors at 3 institutions in 3 countries.

Andreas B JordyNovo Nordisk A/S, Vandtårnsvej 108-110, 2860, Søborg, Denmark.
Muna AlbayatyParexel Early Phase Clinical Unit, Northwick Park Hospital, Parexel International, Watford Road, Harrow, HA1 3UJ, UK.
Astrid BreitschaftParexel International GmbH, Klinikum Westend, Haus 18, Spandauer Damm 130, 14050, Berlin, Germany.
Thomas W AndersonNovo Nordisk A/S, Vandtårnsvej 108-110, 2860, Søborg, Denmark.
Erik ChristiansenNovo Nordisk A/S, Vandtårnsvej 108-110, 2860, Søborg, Denmark.
Azadeh Houshmand-ØregaardNovo Nordisk A/S, Vandtårnsvej 108-110, 2860, Søborg, Denmark.
Easwaran ManigandanNovo Nordisk Service Centre India Private Ltd., Plot No. 148, 2nd Floor, Prestige Featherlite Tech Park, 2nd Phase, EPIP Area, Whitefield, Bangalore, 560 066, India.
Tine A BækdalNovo Nordisk A/S, Vandtårnsvej 108-110, 2860, Søborg, Denmark. tabq@novonordisk.com.
Novo Nordisk (Denmark) · DKNovo Nordisk (India) · INPAREXEL International (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe first oral glucagon-like peptide-1 receptor agonist (GLP-1RA) comprises semaglutide co-formulated with the absorption enhancer, sodium N-(8-[2-hydroxybenzoyl] amino) caprylate (SNAC). Oral semaglutide may alter the pharmacokinetics of co-administered drugs via effects of semaglutide or SNAC. Two separate one-sequence crossover trials investigated the effects of oral semaglutide and SNAC on the pharmacokinetics of ethinylestradiol, levonorgestrel, furosemide and rosuvastatin.

methodsHealthy, postmenopausal women (n = 25) received once-daily combined ethinylestradiol and levonorgestrel (Trial 1) and healthy male and female subjects (n = 41) received single doses of furosemide and rosuvastatin (Trial 2), either alone, with SNAC alone or with oral semaglutide. Lack of drug-drug interaction was concluded if 90% confidence intervals (CIs) for the ratio of area under the plasma concentration-time curve (AUC) or maximum concentration (C

resultsThe AUC values of ethinylestradiol and levonorgestrel were not affected by oral semaglutide co-administration (estimated ratios [90% CI] 1.06 [1.01-1.10] and 1.06 [0.97-1.17], respectively); C

conclusionCo-administration with oral semaglutide did not affect the pharmacokinetics of ethinylestradiol or levonorgestrel. There was a small increase in exposure of furosemide and rosuvastatin; however, these increases are not expected to be of clinical relevance. CLINICAL TRIAL REGISTRATION NUMBERS: NCT02845219 and NCT03010475.

Indexed as

FurosemideLevonorgestrelEthinyl EstradiolFemaleGlucagon-Like PeptidesHealthy VolunteersHumansHypoglycemic AgentsMalePostmenopauseRosuvastatin CalciumSemaglutideEthinyl EstradiolFurosemideGlucagon-Like PeptidesHypoglycemic AgentsLevonorgestrelRosuvastatin CalciumSemaglutide

Identifiers

PMID33782832
PMCPMC8416862
OpenAlexW3152050242

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.