Evidence mapPaperPMID 32621083Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2020

Evaluation of Characteristics of Gastrointestinal Adverse Events with Once-Weekly Dulaglutide Treatment in Chinese Patients with Type 2 Diabetes: A Post Hoc Pooled Analysis of Two Randomized Trials.

Lixin Guo, Bin Zhang, Jianing Hou, Zhiguang Zhou

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01644500. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.4field-weighted citation impact, top 35% 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.

NCT01644500 phase3completed

The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Monotherapy Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus

Ran2012Enrolled737Registered outcomes21Posted comparisons46ConditionsType 2 Diabetes MellitusArmsDulaglutide, Glimepiride, Placebo as Capsules, Placebo as SC Injection
Open the trial in the graph
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

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. ANDREW: A Multicenter, Prospective, Observational Study in Patients with Type 2 Diabetes on Persistent Treatment with Dulaglutide.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020
    Article
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

4 authors at 3 institutions in 3 countries.

Lixin GuoDepartment of Endocrinology, Beijing Hospital, National Center of Gerontology, No.1, Dahua Road, Dongcheng District, Beijing, 100730, China.
Bin ZhangLilly Suzhou Pharmaceutical Co., Ltd, 19F, Tower 1 HKRI, Taikoo Hui, No. 288, Shi Men No. 1 Rd, Shanghai, 200041, China.
Jianing HouLilly Suzhou Pharmaceutical Co., Ltd, 19F, Tower 1 HKRI, Taikoo Hui, No. 288, Shi Men No. 1 Rd, Shanghai, 200041, China. hou_jia_ning@lilly.com.ORCID http://orcid.org/0000-0002-7210-0110
Zhiguang ZhouDepartment of Metabolism and Endocrinology, The Second Xiangya Hospital, Central South University, 139 Renmin Road, Changsha, 410011, Hunan, China. zhouzhiguang@csu.edu.cn.
Beijing Hospital · CNCentral South University · CNEli Lilly (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionGastrointestinal (GI) events are a common side effect of glucagon-like peptide 1 (GLP-1) receptor agonists (RA) class. This post hoc analysis assessed the characteristics of GI adverse events in Chinese patients with type 2 diabetes (T2D) who were treated with once-weekly dulaglutide from two randomized clinical trials.

methodsChinese patients with T2D, treated with once-weekly dulaglutide (1.5 mg and 0.75 mg) from two phase III multicenter trials (AWARD-CHN1 and AWARD-CHN2) were included. Descriptive statistics were used to present the data. The characteristics (incidence, severity, onset, duration, and time of occurrence) of GI adverse events reported through 26 weeks in a Chinese subpopulation from the two trials were investigated.

resultsA total of 787 Chinese patients with T2D were included in this analysis. Up to week 26, 225 patients (28.6%) reported at least one GI treatment-emergent adverse event (TEAE). The most frequently reported GI TEAEs were diarrhea (13.1%), nausea (6.6%), abdominal distension (6.4%), and vomiting (3.0%), with most being categorized as mild to moderate in severity in proportions of 92%, 88%, 94%, and 83%, respectively. A total of 12 patients (1.5%) discontinued the dulaglutide treatment as a result of GI TEAEs. The median duration of the first reported GI TEAEs was 4.0, 5.0, 12.5, and 4.0 days for diarrhea, nausea, abdominal distension, and vomiting, respectively. The incidence of GI TEAEs was more frequent during the first 2 weeks of dulaglutide treatment; however, the incidence declined rapidly after 2 weeks and remained low until week 26.

conclusionsMost of the GI TEAEs associated with once-weekly dulaglutide (1.5 mg and 0.75 mg) were mild to moderate in severity. The incidence of GI TEAEs was more pronounced during the first 2 weeks of dulaglutide treatment but declined rapidly as treatment continued, and was low at week 26, indicating that dulaglutide was well tolerated in Chinese patients with T2D.

trial registrationNCT01648582 and NCT01644500.

Indexed as

Chinese patientsDulaglutideGastrointestinal adverse eventsPooled analysisPost hoc analysisType 2 diabetes

Identifiers

PMID32621083
PMCPMC7376772
OpenAlexW3038415136

What Socratic holds

Textmetadata
LicenceCC BY-NC
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.