Evidence map›Paper›PMID 31530667›Full record

Trial reportDiabetes care2019

Efficacy, Safety, and Tolerability of Oral Semaglutide Versus Placebo Added to Insulin With or Without Metformin in Patients With Type 2 Diabetes: The PIONEER 8 Trial.

Bernard Zinman, Vanita R Aroda, John B Buse, Bertrand Cariou, Stewart B Harris, Søren Tetens Hoff, Karen Boje Pedersen, Mads Jeppe Tarp-Johansen, Eiichi Araki, PIONEER 8 Investigators

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes care, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT03021187. Cited by 137 papers, 19 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
137citing papers in PubMed, 19 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.

NCT03021187 phase3completed

Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Insulin. A 52-week, Randomised, Double-blind, Placebo-controlled Trial (PIONEER 8 - Insulin add-on)

Ran2017Enrolled731Registered outcomes37Posted comparisons18ConditionsDiabetes, Diabetes Mellitus, Type 2ArmsPlacebo, semaglutide
Open the trial in the graph
3 · Its place in the literature

Who cites it

137 citing papers in PubMed, 19 syntheses or guidelines pooled it.

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77 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

10 authors.

Bernard ZinmanLunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada zinman@lunenfeld.ca.ORCID 0000-0002-0041-1876
Vanita R ArodaDivision of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.ORCID 0000-0002-7706-4585
John B BuseDivision of Endocrinology and Metabolism, University of North Carolina School of Medicine, Chapel Hill, NC.
Bertrand CariouDepartment of Endocrinology, L'Institut du Thorax, CIC INSERM 1413, CHU Nantes, Université de Nantes, Nantes, France.ORCID 0000-0002-1580-8040
Stewart B HarrisDepartment of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.ORCID 0000-0002-8282-5449
Søren Tetens HoffNovo Nordisk A/S, Søborg, Denmark.
Karen Boje PedersenNovo Nordisk A/S, Søborg, Denmark.
Mads Jeppe Tarp-JohansenNovo Nordisk A/S, Søborg, Denmark.
Eiichi Araki
PIONEER 8 Investigators

Funding

Continuation of the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) StudyU01DK098246 · NIDDK · GEORGE WASHINGTON UNIVERSITY · PI Heidi Krause-Steinrauf, JOHN M LACHIN · 2021 to 2022
$21.0M
RADIANT Clinic and Data Coordinating CenterU54DK118612 · NIDDK · UNIVERSITY OF CHICAGO · 2022 to 2025
$8.2M
NCATS NIH HHS UL1 TR002489NIDDK NIH HHS U01 DK098246NIDDK NIH HHS U54 DK118612NIDDK NIH HHS UC4 DK108612
6 · The paper itself

Abstract

objectiveTo investigate the efficacy, safety, and tolerability of oral semaglutide added to insulin with or without metformin. RESEARCH DESIGN AND

methodsPatients with type 2 diabetes uncontrolled on insulin with or without metformin were randomized to oral semaglutide 3 mg (

resultsOral semaglutide was superior to placebo in reducing HbA

conclusionsOral semaglutide was superior to placebo in reducing HbA

Indexed as

AdultBody WeightDiabetes Mellitus, Type 2Double-Blind MethodDrug Therapy, CombinationFemaleGlucagon-Like PeptidesGlycated HemoglobinHumansHypoglycemic AgentsInsulinMaleMetforminMiddle AgedNauseaSemaglutideGlucagon-Like PeptidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulinMetforminSemaglutide

Identifiers

PMID31530667
PMCPMC7364672

What Socratic 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 Socratic graph.