Evidence map›Paper›PMID 31758850›Full record

Trial reportJournal of diabetes investigation2020

Achieving the composite end-point of glycated hemoglobin <7.0% without weight gain or hypoglycemia with once-weekly dulaglutide in Chinese patients with type 2 diabetes: A post-hoc analysis.

Xinhua Xiao, Changjiang Wang, Xiaoyang Lai, Bin Zhang, Liqun Gu, Jianing Hou, Zhiguang Zhou

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of diabetes investigation, 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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-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
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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
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3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. 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

7 authors at 6 institutions in 2 countries.

Xinhua XiaoDepartment of Endocrinology, Key Laboratory of Endocrinology, National Health Commission, Chinese Academy of Medical Science, Peking Union Medical College Hospital, Beijing, China.
Changjiang WangThe First Hospital of Anhui Medical University, Hefei, China.
Xiaoyang LaiThe Second Affiliated Hospital of Nanchang University, Nanchang, China.
Bin ZhangLilly Suzhou Pharmaceutical Co. Ltd., Shanghai, China.
Liqun GuLilly Suzhou Pharmaceutical Co. Ltd., Shanghai, China.
Jianing HouClinical Research Physician, Diabetes Therapeutic Area, Eli Lilly and Company, Lilly Suzhou Pharmaceutical Co. Ltd, Shanghai, China.ORCID https://orcid.org/0000-0002-6001-7897
Zhiguang ZhouInstitute of Metabolism and Endocrinology, Key Laboratory of Diabetes Immunology, Ministry of Education, National Clinical Research Center for Metabolic Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.
Lilly (China) · CNAnhui Medical University · CNCentral South University · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNEli Lilly (United States) · USNanchang University · CN

Funding

Eli Lilly and Company
6 · The paper itself

Abstract

AIMS/

introductionTo assess the effect of dulaglutide (DU) 1.5/0.75 mg in comparison with glimepiride (GLIM) or insulin glargine (GLAR) on the composite end-point in Chinese type 2 diabetes patients. MATERIALS AND

methodsPost-hoc analyses of two randomized phase III trials (NCT01644500 and NCT01648582) were carried out using Fisher's exact test. The primary composite end-point was the number of patients reaching glycated hemoglobin (HbA1c) <7.0%, without weight gain and hypoglycemia. Secondary composite end-points included the number of patients reaching HbA1c <7.0% without weight gain and HbA1c <7.0% without hypoglycemia.

resultsData of 1,147 Chinese type 2 diabetes patients were analyzed (NCT01644500 = 556; NCT01648582 = 591). In each analyzed trial, 40-48% of patients received DU (1.5 mg), 30-39% of patients received DU (0.75 mg) and 15-20% of patients on active comparators (GLIM/GLAR) reached the primary composite end-point at week 26 (P < 0.001 for DU vs GLIM/GLAR). At 52 weeks, 26% of patients that received DU (1.5 mg), 23% of patients that received DU (0.75 mg) and 7% of patients that received GLAR attained the primary composite end-point (P < 0.001 for DU vs GLAR). A similar trend of results was found for secondary composite end-points.

conclusionsDulaglutide is found to be an effective therapeutic alternative for Chinese type 2 diabetes patients. Compared with GLIM/GLAR, significantly greater proportions of patients on DU attained the HbA1c target of <7.0% without weight gain or hypoglycemia.

Indexed as

Asian PeopleChinaDiabetes Mellitus, Type 2Endpoint DeterminationFemaleGlucagon-Like PeptidesGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsImmunoglobulin Fc FragmentsMaleMiddle AgedRecombinant Fusion ProteinsWeight GaindulaglutideGlucagon-Like PeptidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsImmunoglobulin Fc FragmentsRecombinant Fusion ProteinsComposite end-pointDulaglutideType 2 diabetes

Identifiers

PMID31758850
PMCPMC7232276
OpenAlexW2990683410

What OpenQuestion holds

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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.