Evidence map›Paper›PMID 28205322›Full record

Trial reportDiabetes, obesity & metabolism2017

Efficacy and safety of autoinjected exenatide once-weekly suspension versus sitagliptin or placebo with metformin in patients with type 2 diabetes: The DURATION-NEO-2 randomized clinical study.

Kishore M Gadde, Marion L Vetter, Nayyar Iqbal, Elise Hardy, Peter Öhman, DURATION-NEO-2 study investigators

Erratum issuedOpen access · bronzeAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 25 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 8 pooled it
4.3field-weighted citation impact, top 5% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 8 syntheses or guidelines pooled it, 56 citations in OpenAlex.

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  19. Autoinjector - A smart device for emergency cum personal therapy.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2021
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 1 country.

Kishore M GaddePennington Biomedical Research Center, Louisiana State University, Baton Rouge, Louisiana.ORCID 0000-0002-1856-5574
Marion L VetterBristol-Myers Squibb, Princeton, New Jersey.
Nayyar IqbalAstraZeneca, Gaithersburg, Maryland.
Elise HardyAstraZeneca, Gaithersburg, Maryland.
Peter ÖhmanAstraZeneca, Gaithersburg, Maryland.
DURATION-NEO-2 study investigators
AstraZeneca (United States) · USBristol-Myers Squibb (United States) · USPennington Biomedical Research Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsGlucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors treat type 2 diabetes through incretin-signaling pathways. This study compared the efficacy and safety of the glucagon-like peptide-1 receptor agonist exenatide once-weekly (Miglyol) suspension for autoinjection (QWS-AI) with the dipeptidyl peptidase-4 inhibitor sitagliptin or placebo. MATERIALS AND

methodsIn this open-label, multicentre study of patients with type 2 diabetes who had suboptimal glycaemic control on metformin monotherapy, 365 patients were randomized to receive exenatide 2.0 mg QWS-AI, sitagliptin 100 mg once daily or oral placebo (3:2:1 ratio). The primary endpoint was change in glycated hemoglobin (HbA1c) from baseline to 28 weeks.

resultsAt 28 weeks, exenatide QWS-AI significantly reduced HbA1c from baseline compared to sitagliptin (-1.13% vs -0.75% [baseline values, 8.42% and 8.50%, respectively]; P  = .02) and placebo (-0.40% [baseline value, 8.50%]; P = .001). More exenatide QWS-AI-treated patients achieved HbA1c <7.0% than did sitagliptin- or placebo-treated patients (43.1% vs 32.0% and 24.6%; both P  < .05). Exenatide QWS-AI and sitagliptin reduced fasting plasma glucose from baseline to 28 weeks (-21.3 and -11.3 mg/dL) vs placebo (+9.6 mg/dL), with no significant difference between the 2 active treatments. Body weight decreased with both active treatments (-1.12 and -1.19 kg), but not with placebo (+0.15 kg). No improvement in blood pressure was observed in any group. The most common adverse events with exenatide QWS-AI were gastrointestinal events and injection-site reactions.

conclusionsThis study demonstrated that exenatide QWS-AI reduced HbA1c more than sitagliptin or placebo and was well tolerated.

Indexed as

Cardiovascular DiseasesCohort StudiesDiabetes Mellitus, Type 2Diabetic AngiopathiesDiabetic CardiomyopathiesDrug Therapy, CombinationExcipientsExenatideFemaleGlycated HemoglobinHumansHyperglycemiaHypoglycemic AgentsIncidenceIncretinsInjections, JetExcipientsExenatideGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsIncretinsMetforminmiglyol 812PeptidesSitagliptin PhosphateTriglyceridesVenomsautoinjectorexenatideonce weeklysitagliptinsuspensiontype 2 diabetes

Identifiers

PMID28205322
PMCPMC5485171
OpenAlexW2588441560

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.