Evidence map›Paper›PMID 32219675›Full record

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

Efficacy and Safety of Dulaglutide Monotherapy Compared to Glimepiride in Oral Antihyperglycemic Medication-Naïve Chinese patients with Type 2 Diabetes: A Post Hoc Analysis of AWARD-CHN1.

Yi Ming Li, Li Hui Zhang, Xue Jun Li, Bin Zhang, Jia Ning Hou, Nan Wei Tong

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
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 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 36% 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
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. 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

6 authors at 5 institutions in 1 country.

Yi Ming LiDepartment of Endocrinology, Huashan Hospital, Fudan University, Shanghai, 200040, China.
Li Hui ZhangDepartment of Endocrinology, The Second Hospital of Hebei Medical University, Hebei, 050000, China.
Xue Jun LiDepartment of Endocrinology and Diabetes, Xiamen Diabetes Institute, The First Affiliated Hospital of Xiamen University, Xiamen, 361000, China.
Bin ZhangLilly Suzhou Pharmaceutical Co., Ltd Shanghai Branch, No. 288 Shimen No.1 Road, Jingan District, Shanghai, 200041, China.
Jia Ning HouLilly Suzhou Pharmaceutical Co., Ltd Shanghai Branch, No. 288 Shimen No.1 Road, Jingan District, Shanghai, 200041, China. hou_jia_ning@lilly.com.
Nan Wei TongDivision of Endocrinology and Metabolism, West China Hospital of Sichuan University, Sichuan, 610041, China. tongnw@scu.edu.cn.
Lilly (China) · CNFirst Affiliated Hospital of Xiamen University · CNFudan University · CNHebei Medical University · CNWest China Hospital of Sichuan University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionGlucagon-like peptide (GLP)-1 receptor agonists are glucose-lowering agents associated with weight loss, cardiovascular benefits, and low hypoglycemic risk and are recommended by recent guidelines as first-line therapy for some patients with type 2 diabetes (T2D). This post hoc analysis of the AWARD-CHN1 study compared the efficacy and safety of once-weekly dulaglutide with glimepiride in oral antihyperglycemic medication (OAM)-naïve Chinese patients with T2D.

methodsAWARD-CHN1 was a phase 3, double-blind study with 737 patients randomized 1:1:1 to once-weekly dulaglutide (1.5 or 0.75 mg) or glimepiride (1-3 mg/day). This is a post hoc analysis of AWARD-CHN1 based on mixed-model repeated measures using a modified intent-to-treat analysis set with only the OAM-naïve Chinese population.

resultsThere were 264 OAM-naïve Chinese patients included in this analysis (dulaglutide 1.5 mg, n = 87; dulaglutide 0.75 mg, n = 90; glimepiride, n = 87). A greater glycated hemoglobin (HbA1c) reduction from baseline was observed with dulaglutide 1.5 mg and 0.75 mg compared to glimepiride (- 2.02% and - 1.84% vs - 1.37%, respectively; both P < 0.001). Significantly more patients in dulaglutide 1.5 mg and 0.75 mg groups achieved HbA1c targets < 7.0% compared to glimepiride (86.2% and 81.1% vs 65.5%; P = 0.002 and P = 0.026, respectively). Beta cell function was significantly increased for dulaglutide groups compared to glimepiride. Mean body weight was significantly reduced for dulaglutide 1.5 mg and 0.75 mg compared to glimepiride (- 1.40 kg and - 0.96 kg vs + 0.73 kg, respectively; both P < 0.001). Through 26 weeks, 7.9%, 4.2%, and 18.2% of patients reported hypoglycemia, and 40.4%, 23.2%, and 8.0% of patients reported at least one gastrointestinal treatment emergent adverse event, in dulaglutide 1.5 mg, 0.75 mg, and glimepiride groups, respectively.

conclusionsIn this post hoc analysis, dulaglutide was effective in reducing both HbA1c and weight with favorable tolerability and safety profile, which is consistent with results seen in larger international dulaglutide monotherapy studies.

trial registrationClinicalTrials.gov NCT01644500.

Indexed as

ChinaDulaglutideGlimepirideType 2 diabetes

Identifiers

PMID32219675
PMCPMC7192982
OpenAlexW3013718006

What Socratic holds

Textmetadata
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 Socratic graph.