Evidence mapPaperPMID 29799100Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2018

No QTc Prolongation with Semaglutide: A Thorough QT Study in Healthy Subjects.

Valentin Demmel, Anne Sandberg-Schaal, Jacob B Jacobsen, Georg Golor, Jonas Pettersson, Anne Flint

Registry-linked trialAbstract read
In one paragraph

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02064348. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 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.

NCT02064348 phase1completed

A Thorough QTc Evaluation of the Effect of Semaglutide on Cardiac Repolarisation in Healthy Subjects: A Randomised, Double-Blind,Placebo-Controlled, Three-Arm Parallel Trial With a Nested Cross-Over Design for Positive Control With Moxifloxacin Administration

Ran2014Enrolled168Registered outcomes2Posted comparisons0ConditionsDiabetes, HealthyArmsmoxifloxacin, Placebo, semaglutide
Open the trial in the graph
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. The expanding role of semaglutide: beyond glycemic control.Journal of diabetes and metabolic disorders · 2025
    Review
  4. Review
  5. Article
  6. Safety of Semaglutide.Frontiers in endocrinology · 2021 · on this map
    Review
  7. Review
  8. Population Pharmacokinetics of Semaglutide for Type 2 Diabetes.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2019
    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.

Valentin DemmelNabios GmbH, Munich, Germany. Valentin.Demmel@nabios.com.ORCID http://orcid.org/0000-0003-0392-7920
Anne Sandberg-SchaalClinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark.
Jacob B JacobsenBiostatistics, Novo Nordisk A/S, Søborg, Denmark.
Georg GolorEarly Phase Clinical Unit, PAREXEL International GmbH, Berlin, Germany.
Jonas PetterssonMedical and Science, Novo Nordisk A/S, Søborg, Denmark.
Anne FlintClinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSemaglutide is a glucagon-like peptide-1 (GLP-1) analog approved for the once-weekly treatment of type 2 diabetes. The objective of this 16-week, double-blind, single-center thorough QT study was to confirm that semaglutide treatment does not prolong cardiac repolarization versus placebo. Prolongation of the QT interval is a biomarker for ventricular tachyarrhythmia.

methodsIn a parallel design, 168 healthy subjects were randomized to the treatment or placebo arms, of whom 166 were treated with subcutaneous semaglutide (N = 83; escalated to a supratherapeutic dose of 1.5 mg) or placebo (N = 83). The subjects (60% males) had a mean age of 38.2 years and body mass index of 25.1 kg/m

resultsNo QTcI prolongation occurred with any semaglutide dose; the upper limits of two-sided 90% confidence intervals of the placebo-subtracted ΔQTcI were < 10 ms at all doses and time points. Exposure-response analysis showed no dependence of QTcI on semaglutide concentration. QT assay sensitivity was confirmed. The semaglutide safety profile was similar to that of other GLP-1 receptor agonists.

conclusionBased on investigations of QT/QTc, no concern with regard to ventricular arrhythmias was raised as semaglutide did not prolong the cardiac repolarization duration in healthy subjects.

trial registrationClinicalTrials.gov identifier: NCT 02064348.

fundingNovo Nordisk.

Indexed as

Cardiac repolarizationDrug safetyGLP-1 analogGLP-1 receptor agonistQT intervalSemaglutide

Identifiers

PMID29799100
PMCPMC6064589

What Socratic holds

Textmetadata
LicenceCC BY-NC
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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 Socratic graph.