Evidence map›Paper›PMID 29708650›Full record

Trial reportDiabetes, obesity & metabolism2018

Efficacy and safety of dulaglutide monotherapy compared with glimepiride in East-Asian patients with type 2 diabetes in a multicentre, double-blind, randomized, parallel-arm, active comparator, phase III trial.

Yu Hong Chen, Chien-Ning Huang, Young Min Cho, Pengfei Li, Liqun Gu, Feng Wang, Jun Yang, Wei Qing Wang

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 4 pooled it
2.6field-weighted citation impact, top 9% 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

22 citing papers in PubMed, 4 syntheses or guidelines pooled it, 40 citations in OpenAlex.

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  15. Study Design and Baseline Characteristics of Patients with T2DM in the Post-marketing Safety Study of Dulaglutide in China (TRUST-CHN).Diabetes therapy : research, treatment and education of diabetes and related disorders · 2022
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  20. Efficacy and Safety of Dulaglutide by Baseline HbA1c in Chinese Patients with Type 2 Diabetes: A Post Hoc Analysis.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020
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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 4 countries.

Yu Hong ChenRuijin Hospital, Shanghai Jiao Tong University, Shanghai, China.
Chien-Ning HuangChung Shan Medical University Hospital, Taichung City, Taiwan.
Young Min ChoSeoul National University College of Medicine, Seoul, South Korea.
Pengfei LiTakeda Development Center Asia, Shanghai, China.
Liqun GuLilly Suzhou Pharmaceutical Co. Ltd, Shanghai, China.
Feng WangLilly Suzhou Pharmaceutical Co. Ltd, Shanghai, China.
Jun YangLilly Suzhou Pharmaceutical Co. Ltd, Shanghai, China.ORCID http://orcid.org/0000-0002-4987-4820
Wei Qing WangRuijin Hospital, Shanghai Jiao Tong University, Shanghai, China.
Lilly (China) · CNShanghai Jiao Tong University · CNChung Shan Medical University Hospital · TWSeoul National University · KRTakeda (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo compare the efficacy and safety of once-weekly glucagon-like peptide-1 receptor agonist dulaglutide 1.5 and 0.75 mg with glimepiride in East-Asian patients with type 2 diabetes (T2D). MATERIALS AND

methodsIn this phase III, multinational, multicentre, double-blind, randomized, parallel-arm, 26-week study, patients with inadequate glycaemic control were randomized 1:1:1 to once-weekly dulaglutide 1.5 or 0.75 mg or daily glimepiride (1-3 mg/d). The primary endpoint was assessment of the non-inferiority of dulaglutide (1.5 mg), as measured by change in glycated haemoglobin (HbA1c), compared with glimepiride using a 0.4% non-inferiority margin.

resultsA total of 737 patients were randomized (dulaglutide 1.5 mg, n = 244; dulaglutide 0.75 mg, n = 248; glimepiride, n = 245). At week 26, both doses of dulaglutide were non-inferior and also superior to glimepiride for HbA1c reduction from baseline with a least squares mean difference of -6.34 mmol/mol (95% confidence interval [CI] -8.31, -4.26) or -0.58% (95% CI -0.76, -0.39) for dulaglutide 1.5 mg and -3.50 mmol/mol (95% CI -5.47, -1.42) or -0.32% (95% CI -0.50, -0.13) for dulaglutide 0.75 mg (P < .001). A greater proportion of patients in the dulaglutide 1.5 mg group achieved the HbA1c target of <53 mmol/mol (<7.0%) compared with the glimepiride group (74.1% vs 57.4%; P < .001). The mean body weight decreased (P < .005) and total hypoglycaemia rates were lower (P < .001) in the dulaglutide groups compared with the glimepiride group. The most common drug-related adverse events in both dulaglutide groups (≥5% of patients) included diarrhoea, nausea, increased lipase, decreased appetite, abdominal distension and vomiting.

conclusionsDulaglutide (both doses) demonstrated superior glycaemic control vs glimepiride, with a favourable tolerability and safety profile in East-Asian patients with T2D.

Indexed as

AgedAsia, EasternBlood GlucoseDiabetes Mellitus, Type 2Double-Blind MethodFemaleGlucagon-Like PeptidesGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsImmunoglobulin Fc FragmentsMaleMiddle AgedRecombinant Fusion ProteinsSulfonylurea CompoundsBlood GlucosedulaglutideglimepirideGlucagon-Like PeptidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsImmunoglobulin Fc FragmentsRecombinant Fusion ProteinsSulfonylurea Compoundsdulaglutideglimepirideglucagon-like peptide-1 receptor agonistHbA1ctype 2 diabetes

Identifiers

PMID29708650
PMCPMC6099453
OpenAlexW2799375839

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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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.