Evidence map›Paper›PMID 25475122›Full record

ArticleJournal of clinical pharmacology2015

Semaglutide, a once-weekly human GLP-1 analog, does not reduce the bioavailability of the combined oral contraceptive, ethinylestradiol/levonorgestrel.

Christoph Kapitza, Leszek Nosek, Lene Jensen, Helle Hartvig, Christine B Jensen, Anne Flint

Open access · hybridAbstract read
In one paragraph

Article in Journal of clinical pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 74 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 2 pooled it
4.7field-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.

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

74 citing papers in PubMed, 2 syntheses or guidelines pooled it, 160 citations in OpenAlex.

  1. Pooled it
  2. Clinical Pharmacokinetics of Semaglutide: A Systematic Review.Drug design, development and therapy · 2024
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  9. Semaglutide Added to Basal Insulin in Type 2 Diabetes (SUSTAIN 5): A Randomized, Controlled Trial.The Journal of clinical endocrinology and metabolism · 2018 · on this map
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14 more citing papers are in PubMed but not listed here.

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 2 institutions in 2 countries.

Christoph KapitzaProfil, Neuss, Germany.
Leszek Nosek
Lene Jensen
Helle Hartvig
Christine B Jensen
Anne Flint
Novo Nordisk (Denmark) · DKProfil Institute for Metabolic Research · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The effect of semaglutide, a once-weekly human glucagon-like peptide-1 (GLP-1) analog in development for type 2 diabetes (T2D), on the bioavailability of a combined oral contraceptive was investigated. Postmenopausal women with T2D (n = 43) on diet/exercise ± metformin received ethinylestradiol (0.03 mg)/levonorgestrel (0.15 mg) once daily for 8 days before (semaglutide-free) and during (steady-state 1.0 mg) semaglutide treatment (subcutaneous once weekly; dose escalation: 0.25 mg 4 weeks; 0.5 mg 4 weeks; 1.0 mg 5 weeks). Bioequivalence of oral contraceptives was established if 90%CI for the ratio of pharmacokinetic parameters during semaglutide steady-state and semaglutide-free periods was within prespecified limits (0.80-1.25). The bioequivalence criterion was met for ethinylestradiol area under the curve (AUC0-24 h ) for semaglutide steady-state/semaglutide-free; 1.11 (1.06-1.15). AUC0-24 h was 20% higher for levonorgestrel at semaglutide steady-state vs. semaglutide-free (1.20 [1.15-1.26]). Cmax was within bioequivalence criterion for both contraceptives. Reductions (mean ± SD) in HbA1c (-1.1 ± 0.6%) and weight (-4.3 ± 3.1 kg) were observed. Semaglutide pharmacokinetics were compatible with once-weekly dosing; the semaglutide dose and dose-escalation regimen were well tolerated. Adverse events, mainly gastrointestinal, were mild to moderate in severity. Asymptomatic increases in mean amylase and lipase were observed. Three subjects had elevated alanine aminotransferase levels ≥3x the upper limit of normal during semaglutide/oral contraceptive coadministration, which were reported as adverse events, but resolved during follow-up. Semaglutide did not reduce the bioavailability of ethinylestradiol and levonorgestrel.

Indexed as

AgedArea Under CurveBlood GlucoseContraceptives, Oral, CombinedDrug CombinationsDrug InteractionsEthinyl EstradiolFemaleGlucagon-Like PeptidesGlycated HemoglobinHalf-LifeHumansHypoglycemic AgentsLevonorgestrelMetabolic Clearance RateMiddle AgedBlood GlucoseContraceptives, Oral, CombinedDrug CombinationsEthinyl Estradiolethinyl estradiol, levonorgestrel drug combinationGlucagon-Like PeptidesGlycated HemoglobinHypoglycemic AgentsLevonorgestrelSemaglutideethinylestradiolGLP-1levonorgestrelonce weeklysemaglutidetype 2 diabetes

Identifiers

PMID25475122
PMCPMC4418331
OpenAlexW2054088567

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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 OpenQuestion graph.