Evidence map›Paper›PMID 34453682›Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2021

Pancreatic Safety of Once-Weekly Dulaglutide in Chinese Patients with Type 2 Diabetes Mellitus: Subgroup Analysis by Potential Influencing Factors.

Yan Zhou, Jiankun Zhu, Haiya Wu, Yuying Deng, Qiuhe Ji

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01648582. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.1field-weighted citation impact, top 48% 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.

NCT01648582 phase3completed

The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Compared to Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Mellitus on Metformin and/or a Sulfonylurea

Ran2012Enrolled774Registered outcomes22Posted comparisons62ConditionsType 2 Diabetes MellitusArmsDulaglutide, Insulin glargine, Metformin, Sulfonylureas
Open the trial in the graph
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
  2. Review
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

5 authors at 2 institutions in 1 country.

Yan ZhouEndocrinology Department of Xi'an International Medical Center Hospital, 777 Xitai Road, Gaoxin District, Xi'an, 710100, Shaanxi Province, China.
Jiankun ZhuLilly Suzhou Pharmaceutical Co. Ltd., 19F, Centre T1, HKRI Taikoo, No. 288, Shimen No.1 Road, Jing'an District, Shanghai, 200041, China.
Haiya WuLilly Suzhou Pharmaceutical Co. Ltd., 19F, Centre T1, HKRI Taikoo, No. 288, Shimen No.1 Road, Jing'an District, Shanghai, 200041, China.
Yuying DengLilly Suzhou Pharmaceutical Co. Ltd., 19F, Centre T1, HKRI Taikoo, No. 288, Shimen No.1 Road, Jing'an District, Shanghai, 200041, China. deng_yu_ying@lilly.com.
Qiuhe JiEndocrinology Department of the First Affiliated Hospital (Xijing Hospital) of Air Force Medical University, 127 Changle West Road, Xincheng District, Xi'an, 710032, Shaanxi Province, China. qiuheji@hotmail.com.ORCID http://orcid.org/0000-0002-3010-5837
Shanghai Huayi Group (China) · CNXijing Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn the randomized, open-label, parallel-arm, active-controlled phase III AWARD-CHN2 trial, once-weekly dulaglutide plus concomitant oral antihyperglycemic medications (OAMs) improved HbA1c over 26 weeks compared with once-daily insulin glargine in patients with type 2 diabetes mellitus (T2DM). This post-hoc subgroup analysis of AWARD-CHN2 investigated the pancreatic safety of dulaglutide in Chinese patients with T2DM, stratified by potential influencing factors.

methodsChanges in pancreatic enzyme (pancreatic amylase, total amylase, and lipase) levels over 26 weeks were assessed and stratified by patient age (< 60, ≥ 60 years), sex (female, male), duration of diabetes (< 10, ≥ 10 years), baseline weight (< 70, ≥ 70 kg), BMI (< 25, ≥ 25 kg/m

resultsA total of 203 Chinese patients with T2DM were included in this post-hoc analysis. Pancreatic enzyme levels increased within the normal range from baseline to Week 26, and no pancreatitis events were confirmed by independent adjudication. Least-squares mean increase in pancreatic amylase (U/L) from baseline to Week 26 was comparable across all subgroups with no statistically (all P-values > 0.05) or clinically significant between-group differences for age (< 60 years: 5.34; ≥ 60 years: 6.71), sex (female: 5.85; male: 5.66), duration of diabetes (< 10 years: 6.15; ≥ 10 years: 4.85), weight (< 70 kg: 6.19; ≥ 70 kg: 5.39), BMI (< 25 kg/m

conclusionIn Chinese patients with T2DM receiving dulaglutide 1.5 mg in AWARD-CHN2, elevations of pancreatic enzymes over 26 weeks were within the normal range and were neither associated with pancreatitis nor baseline factors, which suggests the clinical use of dulaglutide in Chinese patients with T2DM is not associated with pancreatic safety issues. CLINICAL

trial registrationNCT01648582.

Indexed as

Chinese patientDulaglutidePancreatic safetySubgroup analysisType 2 diabetes

Identifiers

PMID34453682
PMCPMC8479006
OpenAlexW3193280482

What OpenQuestion holds

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LicenceCC BY-NC
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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.