Evidence map›Paper›PMID 39434431›Full record

Trial reportDiabetes, obesity & metabolism2025

Efficacy and safety of cofrogliptin once every 2 weeks in Chinese patients with type 2 diabetes: A randomized, double-blind, placebo-controlled, phase 3 trial.

Leili Gao, Fang Bian, Tianrong Pan, Hongwei Jiang, Bo Feng, Chengxia Jiang, Jia Sun, Jianzhong Xiao, Pangke Yan, Linong Ji

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04556851 (A Multicentre, Randomised, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of HSK7653 as Monotherapy in Chinese Patients With Type 2 Diabetes), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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.

NCT04556851 phase3completednot on this map

A Multicentre, Randomised, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of HSK7653 as Monotherapy in Chinese Patients With Type 2 Diabetes

TypeinterventionalSponsorSichuan Haisco Pharmaceutical Group Co., LtdRan2020 to 2022Enrolled476ConditionsDiabetes Mellitus, Type 2ArmsHSK7653 10 mg Q2W, HSK7653 25 mg Q2W, Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. 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

10 authors.

Leili GaoDepartment of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.ORCID 0000-0003-4928-9418
Fang BianDepartment of Endocrinology, Cangzhou People's Hospital, Cangzhou, China.
Tianrong PanDepartment of Endocrinology, The Second Affiliated Hospital of Anhui Medical University Hefei, Hefei, China.ORCID 0000-0002-4293-4579
Hongwei JiangDepartment of Endocrinology, The First Affiliated Hospital and College of Clinical Medicine of Henan University of Science and Technology, Luoyang, China.
Bo FengDepartment of Endocrinology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.
Chengxia JiangDepartment of Endocrinology, The Second People's Hospital of Yibin, Yibin, China.
Jia SunDepartment of Endocrinology and Metabolism, Zhujiang Hospital, Southern Medical University, Guangzhou, China.ORCID 0000-0001-9617-5865
Jianzhong XiaoDepartment of Endocrinology, Beijing Tsinghua Changgung Hospital, Beijing, China.
Pangke YanHaisco Pharmaceutical Group Co. Ltd., Chengdu, China.
Linong JiDepartment of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.ORCID 0000-0003-1305-1598

Funding

Haisco Pharmaceutical Group Co. Ltd
6 · The paper itself

Abstract

aimWe conducted a multicentre, randomized phase 3 trial in China to evaluate the efficacy and safety of cofrogliptin (HSK7653), a novel long-acting dipeptidyl peptidase-4 inhibitor, in patients with drug-naïve type 2 diabetes (T2D). MATERIALS AND

methodsPatients with inadequately controlled T2D were randomly assigned (1:1:1) to cofrogliptin 10 mg, cofrogliptin 25 mg or placebo, taken orally once every 2 weeks for a 24-week double-blind period. Eligible patients then received cofrogliptin 25 mg in a 28-week open-label extension. The primary endpoint was the change in glycated haemoglobin (HbA

resultsIn total, 475 patients (median age: 54.0 years) were randomized and received at least one dose of cofrogliptin 10 mg (n = 158), cofrogliptin 25 mg (n = 158) or placebo (n = 159); 401 patients entered the open-label extension. At week 24, the least-squares (LS) mean difference (95% confidence interval [CI]) in HbA

conclusionsCofrogliptin provided glycaemic control over 52 weeks and was generally well tolerated in patients with T2D. CLINICAL

trial registrationRegistered on Clinicaltrials.gov with the registration number NCT04556851 (https://clinicaltrials.gov/study/NCT04556851).

Indexed as

Diabetes Mellitus, Type 2Glycated HemoglobinAdultAgedBlood GlucoseChinaDipeptidyl-Peptidase IV InhibitorsDouble-Blind MethodDrug Administration ScheduleEast Asian PeopleFemaleHumansHypoglycemiaHypoglycemic AgentsMaleMiddle AgedBlood GlucoseDipeptidyl-Peptidase IV InhibitorsGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic Agentscofrogliptinglycated haemoglobinlong‐acting DPP4‐inhibitorrandomized controlled trialtype 2 diabetes

Identifiers

PMID39434431
PMCPMC11618291

What Socratic 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 Socratic graph.