Evidence map›Paper›PMID 31189517›Full record

Trial reportThe lancet. Diabetes & endocrinology2019

Efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment (PIONEER 5): a placebo-controlled, randomised, phase 3a trial.

Ofri Mosenzon, Thalia Marie Blicher, Signe Rosenlund, Jan W Eriksson, Simon Heller, Ole Holm Hels, Richard Pratley, Thozhukat Sathyapalan, Cyrus Desouza, PIONEER 5 Investigators

Erratum issued Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The lancet. Diabetes & endocrinology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It reports registered trial NCT02827708. Cited by 175 papers, 21 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
175citing papers in PubMed, 21 pooled it
24.1field-weighted citation impact, top 1% 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.

NCT02827708 phase3completed

Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes and Moderate Renal Impairment

Ran2016Enrolled324Registered outcomes40Posted comparisons6ConditionsDiabetes, Diabetes Mellitus, Type 2ArmsPlacebo, semaglutide
Open the trial in the graph
3 · Its place in the literature

Who cites it

175 citing papers in PubMed, 21 syntheses or guidelines pooled it, 329 citations in OpenAlex.

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115 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 8 institutions in 5 countries.

Ofri MosenzonDiabetes Unit, Division of Internal Medicine, Hadassah Hebrew University Hospital, Jerusalem, Israel. Electronic address: ofrim@hadassah.org.il.
Thalia Marie BlicherNovo Nordisk A/S, Søborg, Denmark.
Signe RosenlundNovo Nordisk A/S, Søborg, Denmark.
Jan W ErikssonClinical Diabetology and Metabolism, Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
Simon HellerAcademic Unit of Diabetes, Endocrinology and Metabolism, Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK.
Ole Holm HelsNovo Nordisk A/S, Søborg, Denmark.
Richard PratleyAdventHealth Translational Research Institute for Metabolism and Diabetes, Orlando, FL, USA.
Thozhukat SathyapalanAcademic Diabetes, Endocrinology and Metabolism Research Group, Hull York Medical School, University of Hull, Hull, UK.
Cyrus DesouzaDivision of Diabetes, Endocrinology, and Metabolism, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, USA.
PIONEER 5 Investigators
University of Nebraska Medical Center · USHull York Medical School · GBUppsala University · SEUniversity of Hull · GBUniversity of Sheffield · GBHebrew University of Jerusalem · ILTranslational Research Institute for Metabolism and Diabetes · USNovo Nordisk (Denmark) · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOral semaglutide is the first oral glucagon-like peptide-1 (GLP-1) receptor agonist for glycaemic control in patients with type 2 diabetes. Type 2 diabetes is commonly associated with renal impairment, restricting treatment options. We aimed to investigate the efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment.

methodsThis randomised, double-blind, phase 3a trial was undertaken at 88 sites in eight countries. Patients aged 18 years and older, with type 2 diabetes, an estimated glomerular filtration rate of 30-59 mL/min per 1·73 m

findingsBetween Sept 20, 2016, and Sept 29, 2017, of 721 patients screened, 324 were eligible and randomly assigned to oral semaglutide (n=163) or placebo (n=161). Mean age at baseline was 70 years (SD 8), and 168 (52%) of participants were female. 133 (82%) participants in the oral semaglutide group and 141 (88%) in the placebo group completed 26 weeks on treatment. At 26 weeks, oral semaglutide was superior to placebo in decreasing HbA

interpretationOral semaglutide was effective in patients with type 2 diabetes and moderate renal impairment, potentially providing a new treatment option for this population. Safety, including renal safety, was consistent with the GLP-1 receptor agonist class.

fundingNovo Nordisk A/S.

Indexed as

Diabetic NephropathiesAdministration, OralAgedDiabetes Mellitus, Type 2Double-Blind MethodFemaleGlucagon-Like Peptide-1 Receptor AgonistsGlucagon-Like PeptidesHumansMaleMiddle AgedRenal InsufficiencySemaglutideTreatment OutcomeGlucagon-Like Peptide-1 Receptor AgonistsGlucagon-Like PeptidesSemaglutide

Identifiers

PMID31189517
OpenAlexW2948370538

What OpenQuestion holds

Texttitle and abstract
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.