Trial reportNature medicine2022

Dorzagliatin add-on therapy to metformin in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 3 trial.

Wenying Yang, Dalong Zhu, Shenglian Gan, Xiaolin Dong, Junping Su, Wenhui Li, Hongwei Jiang, Wenjuan Zhao, Minxiu Yao, Weihong Song and 67 more

2 registry-linked trialsOpen access · hybridFull text readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Nature medicine, 2022. The graph read 1 number from its abstract, feeding 1 cell of the map: it supports the treatment in 1. It is linked to 2 registered trials, which are not on this map. Cited by 39 papers, 3 of them syntheses that pooled it.

1number the graph read from it
1cell of the map it votes in
39citing papers in PubMed, 3 pooled it
15.5field-weighted citation impact, top 1% 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.

← favours the treatmentfavours the comparator →
-0.790 · no effect
Glycemic controlfavours the treatment · against placebo · t2dfeeds one cell of the map
Δ -0.66-0.79 to -0.53P < 0.0001
At week 24, the least-squares mean change from baseline in HbA1c (95% confidence interval (CI)) was -1.02% (-1.11, -0.93) in the dorzagliatin group and -0.36% (-0.45, -0.26) in the placebo group (estimated treatment difference, -0.66%; 95% CI: -0.79, -0.53; P < 0.0001).

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

Other glucose-lowering×glycemic control

SupportsOpen on the map →What to test next →

8 readable studies in this cell: 4 favour the treatment, 0 find no difference, 4 favour the comparator.

Belief with this paper
0.50contested · 3 families support, 1 contradict · against placebo
Without it
0.50This paper does not move the number.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2022
Δ -0.66-0.79 to -0.53
NCT017093055,570 enrolled · 2012
Δ 0.190.02 to 0.36
NCT050350821,018 enrolled · 2021
Δ -0.24-0.44 to -0.04
placebo-subtracted decrease -0.44
4 · 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.

NCT03141073 phase3completednot on this map

A 24-week Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HMS5552 add-on to Metformin With Additional 28-week Open-label Treatment to Evaluate the Safety in T2DM Subjects

TypeinterventionalSponsorHua Medicine LimitedRan2017 to 2021Enrolled767ConditionsDiabetes Mellitus, Type 2ArmsHMS5552, Placebo
NCT06222476 naunknown statusnot on this mapstarted 2024, after this paper: background citation

A Multicentric, Prospective, Randomized Study Evaluating the Improvement of Renal Function Outcomes With Dorzagliatin in Patients With Type 2 Diabetes Mellitus With Early Kidney Injury.

TypeinterventionalSponsorYan BiRan2024 to 2026Enrolled106ConditionsDiabetic Nephropathy Type 2ArmsDorzagliatin, Gliclazide
5 · Its place in the literature

Who cites it

39 citing papers in PubMed, 3 syntheses or guidelines pooled it, 76 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Contrasting Effects of Chronic Glucokinase Activation and Inhibition on Pancreatic Beta-Cell Function.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2026
    Article
  7. Review
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6 · The record

Corrections and comments

7 · Who and what money

Authors and funding

77 authors at 20 institutions in 1 country.

Wenying YangChina-Japan Friendship Hospital, Beijing, China.ORCID http://orcid.org/0000-0002-7997-9404
Dalong ZhuAffiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China. zhudalong@nju.edu.cn.ORCID http://orcid.org/0000-0002-1064-1261
Shenglian GanThe First People's Hospital of Changde City, Changde, China.
Xiaolin DongJinan Central Hospital Affiliated to Shandong First Medical University, Jinan, China.
Junping SuCangzhou People's Hospital, Cangzhou, China.
Wenhui LiPeking Union Medical College Hospital, Beijing, China.
Hongwei JiangThe First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, Luoyang, China.
Wenjuan ZhaoThe Affiliated Hospital of Qingdao University, Qingdao, China.
Minxiu YaoQingdao Central Hospital, Qingdao, China.
Weihong SongChenzhou First People's Hospital, Chenzhou, China.
Yibing LuThe Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Xiuzhen ZhangTongji Hospital of Tongji University, Shanghai, China.
Huifang LiThe First Affiliated Hospital of Kunming Medical University, Kunming, China.
Guixia WangThe First Bethune Hospital of Jilin University, Changchun, China.
Wei QiuHuzhou Central Hospital, Huzhou, China.
Guoyue YuanThe Affiliated Hospital of Jiangsu University, Zhenjiang, China.
Jianhua MaNanjing First Hospital, Nanjing, China.
Wei LiThe Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Ziling LiInner Mongolia Baogang Hospital, Baotou, China.
Xiaoyue WangThe First People's Hospital of Yue Yang, Yueyang, China.
Jiao'e ZengJingzhou Hospital Affiliated to Yangtze University, Jingzhou, China.
Zhou YangJiangxi Pingxiang People's Hospital, Pingxiang, China.
Jingdong LiuJiangxi Provincial People's Hospital, Nanchang, China.
Yongqian LiangThe First People's Hospital of Shunde, Foshan, China.
Song LuChongqing General Hospital, Chongqing, China.
Huili ZhangQinghai University Affiliated Hospital, Xining, China.
Hui LiuLuoyang Central Hospital, Luoyang, China.
Ping LiuGeneral Hospital of Ningxia Medical University, Yinchuan, China.
Kuanlu FanThe General Hospital of Xuzhou City Mining Group, Xuzhou, China.
Xiaozhen JiangShanghai Pudong New Area People's Hospital, Shanghai, China.
Yufeng LiBeijing Friendship Hospital Pinggu Campus, Capital Medical University, Beijing, China.
Qing SuXinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Tao NingBaotou Central Hospital, Baotou, China.
Huiwen TanWest China Hospital of Sichuan University, Chengdu, China.
Zhenmei AnWest China Hospital of Sichuan University, Chengdu, China.
Zhaoshun JiangThe 960th Hospital of the PLA Joint Logistics Support Force, Jinan, China.
Lijun LiuYiyang Central Hospital, Yiyang, China.
Zunhai ZhouYangpu Hospital, Tongji University, Shanghai, China.
Qiu ZhangThe First Affiliated Hospital of Anhui Medical University, Hefei, China.
Xuefeng LiTaihe Hospital, Hubei University of Medicine, Shiyan, China.
Zhongyan ShanThe First Hospital of China Medical University, Shenyang, China.
Yaoming XueSouthern Medical University Nanfang Hospital, Guangzhou, China.
Hong MaoThe Central Hospital of Wuhan, Wuhan, China.
Lixin ShiThe Affiliated Hospital of Guizhou Medical University, Guiyang, China.
Shandong YeAnhui Provincial Hospital, Hefei, China.
Xiaomei ZhangThe First Affiliated Hospital of Bengbu Medical College, Bengbu, China.
Jiao SunHuadong Hospital Affiliated to Fudan University, Shanghai, China.
Ping LiAffiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China.
Tao YangJiangsu Province Hospital, Nanjing, China.ORCID http://orcid.org/0000-0001-6375-3622
Feng LiJining No. 1 People's Hospital, Jining, China.
Jingna LinTianjin People's Hospital, Tianjin, China.
Zhinong ZhangThe First Hospital of Qiqihar, Qiqihar, China.
Ying ZhaoJilin Central General Hospital, Jilin, China.
Ruonan LiThird People's Hospital of Yunnan Province, Kunming, China.
Xiaohui GuoPeking University First Hospital, Beijing, China.
Qi YaoNingbo First Hospital, Ningbo, China.
Weiping LuThe Affiliated Huai'an No. 1 People's Hospital of Nanjing Medical University, Huai'an, China.
Shen QuShanghai Tenth People's Hospital, Shanghai, China.
Hongmei LiEmergency General Hospital, Beijing, China.
Liling TanThe First Affiliated Hospital of Hainan Medical University, Haikou, China.
Wenbo WangPeking University Shougang Hospital, Beijing, China.
Yongli YaoQinghai Provincial People's Hospital, Xining, China.
Daoxiong ChenHainan General Hospital, Haikou, China.
Yulan LiLiuzhou People's Hospital, Liuzhou, China.
Jialin GaoYijishan Hospital, The First Affiliated Hospital of Wannan Medical University, Wuhu, China.
Wen HuThe Second People's Hospital of Huai'an, Huai'an, China.
Xiaoqiang FeiJiangsu Taizhou People's Hospital, Taizhou, China.
Tianfeng WuZhejiang Hospital, Hangzhou, China.
Song DongAerospace Center Hospital, Beijing, China.
Wenlong JinYanbian University Hospital, Yanji, China.
Chenzhong LiThe Third Affiliated Hospital of Southern Medical University, Guangzhou, China.
Dong ZhaoBeijing Luhe Hospital Affiliated to Capital Medical University, Beijing, China.
Bo FengShanghai East Hospital, Tongji University, Shanghai, China.
Yu ZhaoHua Medicine (Shanghai) Ltd., Shanghai, China.ORCID http://orcid.org/0000-0001-5245-4379
Yi ZhangHua Medicine (Shanghai) Ltd., Shanghai, China.
Xiaoying LiZhongshan Hospital, Fudan University, Shanghai, China. xiaoying_li@hotmail.com.ORCID http://orcid.org/0000-0003-2243-3336
Li ChenHua Medicine (Shanghai) Ltd., Shanghai, China. lichen@huamedicine.com.ORCID http://orcid.org/0000-0002-6192-3752
Xuzhou Medical College · CNCapital Medical University · CNHua Medicine (China) · CNHubei University of Medicine · CNJilin City Central Hospital · CNKunming Medical University · CNNanjing Drum Tower Hospital · CNQingdao University · CNSichuan University · CNTongji University · CNAerospace Center Hospital · CNAnhui Medical University · CNAnhui Provincial Hospital · CNBaogang Group (China) · CNBaotou Central Hospital · CNBeijing Luhe Hospital Affiliated to Capital Medical University · CNCentral Hospital of Wuhan · CNChenzhou First People's Hospital · CNChina-Japan Friendship Hospital · CNFirst Affiliated Hospital of Henan University of Science and Technology · CN

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

Metformin, the first-line therapy for type 2 diabetes (T2D), decreases hepatic glucose production and reduces fasting plasma glucose levels. Dorzagliatin, a dual-acting orally bioavailable glucokinase activator targeting both the pancreas and liver glucokinase, decreases postprandial glucose in patients with T2D. In this randomized, double-blind, placebo-controlled phase 3 trial, the efficacy and safety of dorzagliatin as an add-on therapy to metformin were assessed in patients with T2D who had inadequate glycemic control using metformin alone. Eligible patients with T2D (n = 767) were randomly assigned to receive dorzagliatin or placebo (1:1 ratio) as an add-on to metformin (1,500 mg per day) for 24 weeks of double-blind treatment, followed by 28 weeks of open-label treatment with dorzagliatin for all patients. The primary efficacy endpoint was the change in glycated hemoglobin (HbA1c) levels from baseline to week 24, and safety was assessed throughout the trial. At week 24, the least-squares mean change from baseline in HbA1c (95% confidence interval (CI)) was -1.02% (-1.11, -0.93) in the dorzagliatin group and -0.36% (-0.45, -0.26) in the placebo group (estimated treatment difference, -0.66%; 95% CI: -0.79, -0.53; P < 0.0001). The incidence of adverse events was similar between groups. There were no severe hypoglycemia events or drug-related serious adverse events in the dorzagliatin and metformin combined therapy group. In patients with T2D who experienced inadequate glycemic control with metformin alone, dorzagliatin resulted in effective glycemic control with good tolerability and safety profile ( NCT03141073 ).

Indexed as

Diabetes Mellitus, Type 2MetforminBlood GlucoseDouble-Blind MethodDrug Therapy, CombinationGlucokinaseGlycated HemoglobinHumansHypoglycemic AgentsPyrazolesTreatment OutcomeBlood GlucoseDorzagliatinGlucokinaseGlycated HemoglobinHypoglycemic AgentsMetforminPyrazoles

Identifiers

PMID35551292
PMCPMC9117147
OpenAlexW4280562645

What Socratic holds

Textfull text, public
LicenceCC BY
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.