Evidence map›Paper›PMID 30565096›Full record

Trial reportClinical pharmacokinetics2019

Safety and Pharmacokinetics of Single and Multiple Ascending Doses of the Novel Oral Human GLP-1 Analogue, Oral Semaglutide, in Healthy Subjects and Subjects with Type 2 Diabetes.

Charlotte Granhall, Morten Donsmark, Thalia M Blicher, Georg Golor, Flemming L Søndergaard, Mette Thomsen, Tine A Bækdal

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical pharmacokinetics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01686945. Cited by 74 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 6 pooled it
–field-weighted citation impact
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.

NCT01686945 phase1completed

Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects and Male Subjects With Type 2 Diabetes

Ran2012Enrolled107Registered outcomes7Posted comparisons0ConditionsDiabetes, Diabetes Mellitus, Type 2, HealthyArmsPlacebo, semaglutide
PMID 30566096other papers from this trial
Open the trial in the graph
NCT01037582 phase1completednot on this map

Investigation on Safety, Tolerability and Bioavailability of Oral NN9924 in Healthy Male Subjects

TypeinterventionalSponsorNovo Nordisk A/SRan2009 to 2010Enrolled155ConditionsDiabetes, Diabetes Mellitus, Type 2, HealthyArmsNN9924 (oral), placebo, NN9924 (s.c.), NN9924 (i.v.)
3 · Its place in the literature

Who cites it

74 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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

7 authors.

Charlotte GranhallNovo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.
Morten DonsmarkNovo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.
Thalia M BlicherNovo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.
Georg GolorEarly Phase Clinical Unit-Berlin, Parexel International GmbH, Klinikum Westend-Haus 18, Spandauer Damm 130, 14050, Berlin, Germany.
Flemming L SøndergaardNovo Nordisk A/S, Alfred Nobels Vej 27, 9220, Aalborg Ø, Denmark.
Mette ThomsenNovo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.
Tine A BækdalNovo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark. tabq@novonordisk.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOral semaglutide is a novel tablet containing the human glucagon-like peptide-1 (GLP‑1) analogue semaglutide, co-formulated with the absorption enhancer sodium N-(8-[2-hydroxybenzoyl] amino) caprylate (SNAC). The safety and pharmacokinetics of oral semaglutide were investigated in two randomised, double-blind, placebo-controlled trials.

methodsIn a single-dose, first-in-human trial, 135 healthy males received oral semaglutide (2-20 mg semaglutide co-formulated with 150-600 mg SNAC) or placebo with SNAC. In a 10-week, once-daily, multiple-dose trial, 84 healthy males received 20 or 40 mg oral semaglutide (with 300 mg SNAC), placebo, or placebo with SNAC, and 23 males with type 2 diabetes (T2D) received 40 mg oral semaglutide (with 300 mg SNAC), placebo, or placebo with SNAC.

resultsOral semaglutide was safe and well-tolerated in both trials. The majority of adverse events (AEs) were mild, with the most common AEs being gastrointestinal disorders. In the single-dose trial, semaglutide exposure was highest when co-formulated with 300 mg SNAC. In the multiple-dose trial, semaglutide exposure was approximately twofold higher with 40 versus 20 mg oral semaglutide in healthy males, in accordance with dose proportionality, and was similar between healthy males and males with T2D. The half-life of semaglutide was approximately 1 week in all groups.

conclusionThe safety profile of oral semaglutide was as expected for the GLP-1 receptor agonist drug class. Oral semaglutide co-formulated with 300 mg SNAC was chosen for further clinical development. The pharmacokinetic results supported that oral semaglutide is suitable for once-daily dosing. CLINICALTRIALS. GOV IDENTIFIERS: NCT01037582, NCT01686945.

Indexed as

Glucagon-Like PeptidesHypoglycemic AgentsAdministration, OralAdolescentAdultArea Under CurveDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDouble-Blind MethodGlucagon-Like Peptide 1Healthy VolunteersHumansMaleMetabolic Clearance RateMiddle AgedSemaglutideGlucagon-Like Peptide 1Glucagon-Like PeptidesHypoglycemic AgentsSemaglutide

Identifiers

PMID30565096

What OpenQuestion holds

Texttitle and abstract
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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.