Evidence map›Paper›PMID 37414069›Full record

Trial reportThe lancet. Diabetes & endocrinology2023

Safety and effectiveness of metformin plus lifestyle intervention compared with lifestyle intervention alone in preventing progression to diabetes in a Chinese population with impaired glucose regulation: a multicentre, open-label, randomised controlled trial.

Lihui Zhang, Yunliang Zhang, Sheng'ai Shen, Xueying Wang, Luling Dong, Qiuyun Li, Weidong Ren, Yufeng Li, Jianling Bai, Qiuhong Gong and 17 more

Erratum issued Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The lancet. Diabetes & endocrinology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT07452913 (Comparative Efficacy and Safety of Metformin-Empagliflozin-Sitagliptin vs. Metformin-Empagliflozin-Linagliptin as Initial Triple Therapy in Type 2 Diabetes Mellitus), which is not on this map. Cited by 45 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 3 pooled it
11.8field-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.

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.

NCT07452913 phase4enrolling by invitationstarted 2026, after this paper: background citation

Comparative Efficacy and Safety of Metformin-Empagliflozin-Sitagliptin vs. Metformin-Empagliflozin-Linagliptin as Initial Triple Therapy in Type 2 Diabetes Mellitus

Ran2026Enrolled110Registered outcomes5Posted comparisons0ConditionsType 2 Diabetes MellitusArmsMetformin + Empagliflozin + Linagliptin, Metformin+ Empagliflozin + Sitagliptin
PMID 37294638PMID 39596449PMID 39353925PMID 39096426PMID 39030553PMID 38423026PMID 39723311PMID 35307801PMID 11953758other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 3 syntheses or guidelines pooled it, 77 citations in OpenAlex.

  1. Pooled it
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  3. Pooled it
  4. Trial
  5. Trial
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  9. Article
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  11. Glucagon-Like Peptide-1 Receptor Agonists: Their Potential Role in Prediabetes.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2026
    Review
  12. Article
  13. Article
  14. Review
  15. Metformin Beyond Glycemic Control: Cardiovascular Protection and Diabetes Prevention.Journal of cardiovascular development and disease · 2026
    Review
  16. Review
  17. Article
  18. Meta-Analysis of the Effect of Metformin on the Progression of Different Types of Prediabetes Mellitus.Diabetes, metabolic syndrome and obesity : targets and therapy · 2026
    Review
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors at 17 institutions in 1 country.

Lihui ZhangDepartment of Endocrinology and Metabolism, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.
Yunliang ZhangDepartment of Endocrinology and Metabolism, Baoding First Central Hospital, Baoding, Hebei, China.
Sheng'ai ShenDepartment of Endocrinology and Metabolism, Yanji Hospital, Yanji, Yanbian Korean Autonomous Prefecture, Jilin, China.
Xueying WangDepartment of Endocrinology and Metabolism, Jinzhou Central Hospital, Jinzhou, Liaoning, China.
Luling DongDepartment of Endocrinology and Metabolism, Zhangjiakou First Hospital, Zhangjiakou, Hebei, China.
Qiuyun LiDepartment of Endocrinology and Metabolism, Kailuan General Hospital, Tangshan, Hebei, China.
Weidong RenDepartment of Endocrinology and Metabolism, First Affiliated Hospital of Hebei North University, Zhangjiakou, Hebei, China.
Yufeng LiDepartment of Endocrinology and Metabolism, Beijing Pinggu Hospital, Beijing, China.
Jianling BaiDepartment of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu, China.
Qiuhong GongDepartment of Endocrinology, Fuwai Hospital and Chinese Academy of Medical Sciences, Beijing, China.
Hongyu KuangDepartment of Endocrinology and Metabolism, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China.
Lin QiDepartment of Endocrinology and Metabolism, Beijing Yanhua Hospital, Beijing, China.
Qiang LuDepartment of Endocrinology, First Hospital of Qinhuangdao, Qinhuangdao, Hebei, China.
Wenli ChengDepartment of Hypertension, Beijing Anzhen Hospital, Beijing, China.
Yanjie LiuDepartment of Endocrinology and Hematology, Affiliated Hospital of Jilin Medical University, Jilin city, Jilin, China.
Shuang YanDepartment of Endocrinology and Metabolism, Fourth Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China.
Donghong WuDepartment of Endocrinology, Harbin The First Hospital, Harbin, Heilongjiang, China.
Hui FangDepartment of Endocrinology, Tangshan Gongren Hospital, Tangshan, Hebei, China.
Fang HouCommunity Health Service Center, Jiefang Road, Tanggu Street, Binhai New Area, Tianjin, China.
Yingju WangDepartment of Endocrinology, Beijing Miyun District Hospital, Beijing, China.
Zhixia YangDepartment of Endocrinology, The People's Hospital of Langfang, Langfang, Hebei, China.
Xu LianDepartment of Endocrinology and Metabolism, Hongqi Hospital, Mudanjiang Medical University, Mudanjiang, Heilongjiang, China.
Jianling DuDepartment of Endocrinology, The First affiliated hospital of Dalian Medical University, Dalian, Liaoning, China.
Ningling SunDepartment of Hypertension, Peking University People's Hospital, Beijing, China. Electronic address: sunnl@263.net.
Linong JiDepartment of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China. Electronic address: jiln@bjmu.edu.cn.
Guangwei LiDepartment of Endocrinology, Fuwai Hospital and Chinese Academy of Medical Sciences, Beijing, China. Electronic address: guangwei_li45@126.com.
China Diabetes Prevention Program Study Group
Harbin Medical University · CNBeijing Anzhen Hospital · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNJinzhou Central Hospital · CNDalian Medical University · CNHebei North University · CNPeking University · CNBaoding People's Hospital · CNHebei Medical University · CNKailuan General Hospital · CNFirst Hospital of Qinhuangdao · CNJilin Medical University · CNMudanjiang Medical University · CNNanjing Medical University · CNThe First Hospital of Kunming · CNYanbian University Hospital · CNTangshan Gongren Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundImpaired glucose regulation (defined as either impaired glucose tolerance or impaired fasting glucose) is an important risk factor for the development of diabetes. We aimed to evaluate the safety and effectiveness of metformin plus lifestyle intervention compared with lifestyle intervention alone in preventing diabetes in Chinese participants with impaired glucose regulation.

methodsWe did a multicentre, open-label, randomised controlled trial at 43 endocrinology departments in general hospitals across China. Eligible participants were individuals with impaired glucose regulation (ie, impaired glucose tolerance or impaired fasting glucose, or both), men or women aged 18-70 years with a BMI of 21-32 kg/m

findingsBetween April, 2017, and June, 2019, 3881 individuals were assessed for eligibility, of which 1678 (43·2%) participants were randomly assigned to either the metformin plus lifestyle intervention group (n=831) or the lifestyle intervention alone group (n=847) and received the allocated intervention at least once. During a median follow-up of 2·03 years, the incidence rate of diabetes was 17·27 (95% CI 15·19-19·56) per 100 person-years in the metformin plus lifestyle intervention group and 19·83 (17·67-22·18) per 100 person-years in the lifestyle intervention alone group. The metformin plus lifestyle intervention group showed a 17% lower risk of developing diabetes than the lifestyle intervention alone group (HR 0·83 [95% CI 0·70-0·99]; log-rank p=0·043). A higher proportion of participants in the metformin plus lifestyle intervention group reported adverse events than in the lifestyle intervention alone group, primarily due to more gastrointestinal adverse events. The percentage of participants reporting a serious adverse event was similar in both groups.

interpretationMetformin plus lifestyle intervention further reduced the risk of developing diabetes than lifestyle intervention alone in Chinese people with impaired glucose regulation, showing additional benefits of combined intervention in preventing progression to diabetes without new safety concerns.

fundingMerck Serono China, an affiliate of Merck KGaA, Darmstadt, Germany. TRANSLATION: For the Chinese translation of the abstract see Supplementary Materials section.

Indexed as

Diabetes Mellitus, Type 2Glucose IntoleranceMetforminPrediabetic StateAdolescentAdultAgedEast Asian PeopleFemaleGlucoseHealth BehaviorHumansLife StyleMaleMiddle AgedTreatment OutcomeGlucoseMetformin

Identifiers

PMID37414069
OpenAlexW4382930337

What Socratic holds

Texttitle and abstract
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.