Evidence map›Paper›PMID 32333876›Full record

Trial reportThe lancet. Diabetes & endocrinology2020

Safety and efficacy of oral semaglutide versus dulaglutide in Japanese patients with type 2 diabetes (PIONEER 10): an open-label, randomised, active-controlled, phase 3a trial.

Daisuke Yabe, Jiro Nakamura, Hideaki Kaneto, Srikanth Deenadayalan, Andrea Navarria, Mette Gislum, Nobuya Inagaki, PIONEER 10 Investigators

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The lancet. Diabetes & endocrinology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT03015220. Cited by 110 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
110citing papers in PubMed, 12 pooled it
14.2field-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.

NCT03015220 phase3completed

Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD in Japanese Subjects With Type 2 Diabetes

Ran2017Enrolled458Registered outcomes33Posted comparisons6ConditionsDiabetes, Diabetes Mellitus, Type 2ArmsDulaglutide, semaglutide
PMID 33460016other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

110 citing papers in PubMed, 12 syntheses or guidelines pooled it, 193 citations in OpenAlex.

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50 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

8 authors at 5 institutions in 2 countries.

Daisuke YabeDepartment of Diabetes and Endocrinology, Gifu University Graduate School of Medicine, Gifu, Japan. Electronic address: ydaisuke-kyoto@umin.ac.jp.
Jiro NakamuraDivision of Diabetes, Department of Internal Medicine, Aichi Medical University School of Medicine, Aichi, Japan.
Hideaki KanetoDepartment of Diabetes, Endocrinology and Metabolism, Kawasaki Medical School, Kurashiki, Japan.
Srikanth DeenadayalanNovo Nordisk, Søborg, Denmark.
Andrea NavarriaNovo Nordisk, Søborg, Denmark.
Mette GislumNovo Nordisk, Søborg, Denmark.
Nobuya InagakiDepartment of Diabetes, Endocrinology and Nutrition, Kyoto University Graduate School of Medicine, Kyoto, Japan.
PIONEER 10 Investigators
Kyoto University · JPNovo Nordisk (Denmark) · DKAichi Medical University · JPGifu University · JPKawasaki Medical School · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNew glucose-lowering medications need to be investigated in east Asian populations, as the clinical characteristics of type 2 diabetes differ between western and east Asian patients. The PIONEER 10 study aimed to evaluate the safety and efficacy of oral semaglutide versus dulaglutide in Japanese patients with type 2 diabetes.

methodsPIONEER 10 was an open-label, randomised, active-controlled, phase 3a trial done at 36 sites (clinics and university hospitals) in Japan. Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication. The primary endpoint was the number of treatment-emergent adverse events over 57 weeks. Supportive secondary endpoints (not controlled for multiplicity) included mean change from baseline in HbA

findingsBetween Jan 10, and May 30, 2017, 492 patients were screened and 458 were randomly assigned to oral semaglutide 3 mg (n=131), 7 mg (n=132), or 14 mg (n=130), or dulaglutide 0·75 mg (n=65). 448 (98%) patients completed the trial. Adverse events occurred in 101 (77%) of 131 patients with oral semaglutide 3 mg, 106 (80%) of 132 with oral semaglutide 7 mg, 111 (85%) of 130 with oral semaglutide 14 mg, and 53 (82%) of 65 with dulaglutide. The most common adverse events were infections and gastrointestinal events. Gastrointestinal adverse events (mostly mild and transient constipation and nausea) occurred in a dose-dependent manner with oral semaglutide. Adverse events led to premature treatment discontinuation in four (3%) of 131 patients receiving oral semaglutide 3 mg, eight (6%) of 132 receiving oral semaglutide 7 mg, eight (6%) of 130 receiving oral semaglutide 14 mg, and two (3%) of 65 receiving dulaglutide. No deaths or severe hypoglycaemic events were reported. Based on the treatment policy estimand (ie, regardless of study drug discontinuation or rescue medication use), estimated mean reductions in HbA

interpretationOral semaglutide was well tolerated in Japanese patients with type 2 diabetes. Once-daily oral semaglutide significantly reduced HbA

fundingNovo Nordisk.

Indexed as

Administration, OralAdultAgedDiabetes Mellitus, Type 2FemaleGlucagon-Like PeptidesGlycated HemoglobinHumansHypoglycemic AgentsImmunoglobulin Fc FragmentsMaleMiddle AgedRecombinant Fusion ProteinsSemaglutidedulaglutideGlucagon-Like PeptidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsImmunoglobulin Fc FragmentsRecombinant Fusion ProteinsSemaglutide

Identifiers

PMID32333876
OpenAlexW3018053472

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.