Evidence mapPaperPMID 28932995Full record

Trial reportClinical drug investigation2017

Pharmacokinetics and Preliminary Pharmacodynamics of Single- and Multiple-dose Lyophilized Recombinant Glucagon-like Peptide-1 Receptor Agonist (rE-4) in Chinese Patients with Type 2 Diabetes Mellitus.

Yitong Wang, Bingfeng Xu, Lixia Zhu, Kun Lou, Yingli Chen, Xia Zhao, Qian Wang, Ling Xu, Xiaohui Guo, Linong Ji and 2 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical drug investigation, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01342042 (The Safety, Preliminary Pharmacodynamics and Pharmacokinetics Study of rExenatide-4 in Chinese T2DM), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 42% 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.

NCT01342042 phase2unknown statusnot on this map

The Safety, Preliminary Pharmacodynamics and Pharmacokinetics Study of rExenatide-4 in Chinese T2DM

TypeinterventionalSponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.Ran2011 to 2011Enrolled36ConditionsType 2 DiabetesArmsrExenatide-4
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Review
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

12 authors at 6 institutions in 1 country.

Yitong WangDepartment of Pharmacy, Peking University People's Hospital, No. 11 Xizhimen South Street, Xicheng District, Beijing, 100044, China.
Bingfeng XuJiangsu Key Laboratory of New Drug Research and Clinical Pharmacy, Xuzhou Medical College, Xuzhou, 221004, China.
Lixia ZhuClinical Medicine Department, CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd, Hebei, 050035, China.
Kun LouClinical Medicine Department, CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd, Hebei, 050035, China.
Yingli ChenDepartment of Endocrinology, Peking University People's Hospital, Beijing, 100044, China.
Xia ZhaoDepartment of Pharmacy, Peking University First Hospital, No. 8 XiShiKu Street, Xi Cheng District, Beijing, 100034, China.
Qian WangDepartment of Pharmacy, Peking University People's Hospital, No. 11 Xizhimen South Street, Xicheng District, Beijing, 100044, China.
Ling XuShanghai University of Chinese Medicine, Shanghai, 201203, China.
Xiaohui GuoDepartment of Endocrinology, Peking University First Hospital, Beijing, 100034, China.
Linong JiDepartment of Endocrinology, Peking University People's Hospital, Beijing, 100044, China.
Yimin CuiDepartment of Pharmacy, Peking University First Hospital, No. 8 XiShiKu Street, Xi Cheng District, Beijing, 100034, China. cuiymzy@126.com.
Yi FangDepartment of Pharmacy, Peking University People's Hospital, No. 11 Xizhimen South Street, Xicheng District, Beijing, 100044, China. phaseistudy@163.com.
Peking University People's Hospital · CNPeking University · CNShijiazhuang Yiling Pharmaceutical (China) · CNPeking University First Hospital · CNShanghai University · CNXuzhou Medical College · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesRecombinant glucagon-like peptide-1 receptor agonist (rE-4) is a glucagon-like peptide-1 receptor agonist, which has the same amino acid sequence to exenatide, except for the C-terminal deamidated. This study assessed the pharmacokinetics and preliminary pharmacodynamics of rE-4, following single and multiple subcutaneous injections in Chinese patients with type 2 diabetes mellitus (T2DM). DESIGN AND

methodsIn the randomized, open-label study, Chinese patients with T2DM (n = 36) were randomly assigned to three groups of rE-4 (n = 12), rE-4 with metformin (n = 12) and exenatide (n = 12, as the control group) for 12 weeks. rE-4 and exenatide were administered by subcutaneous injection in the abdomen, and metformin was given by oral administration. Patients received rE-4 or exenatide 5 μg twice a day for the first 4 weeks and adjusted the dose of rE-4 or exenatide to 10 μg twice a day at day 29 for the following 8 weeks, if their glycated albumin (GA) values were still greater than 17%. We evaluated pharmacokinetic parameters of rE-4 and exenatide, fasting plasma glucose (FPG), 2-h postprandial blood glucose (PG2 h), glycosylated hemoglobin (HbA1c) and body weight at designated time points.

resultsThirty-six patients were enrolled, and 29 subjects finished the study. rE-4 was absorbed quickly with a median peak-reaching time (t

conclusionsrE-4 twice a day has a pharmacokinetic profile similar to exenatide and rE-4 with metformin after single and multiple doses in Chinese patients with T2DM. Also, rE-4 could improve glycemic control effectively. CLINICALTRIALS. GOV IDENTIFIER: NCT01342042.

Indexed as

Glucagon-Like Peptide-1 Receptor AgonistsAdultAsian PeopleBlood GlucoseDiabetes Mellitus, Type 2ExenatideFemaleGlycated HemoglobinHalf-LifeHumansHypoglycemic AgentsInjections, SubcutaneousMaleMetforminMiddle AgedPeptidesBlood GlucoseExenatideGlucagon-Like Peptide-1 Receptor AgonistsGlycated HemoglobinHypoglycemic AgentsMetforminPeptidesVenoms

Identifiers

PMID28932995
OpenAlexW2755480685

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.