Evidence map›Paper›PMID 31396983›Full record

ArticleBritish journal of clinical pharmacology2019

Polyethylene glycol loxenatide (PEX168) in subjects with renal impairment: A pharmacokinetic study.

Jianwen Wang, Jie Huang, Wei Li, Shiqi Tang, Jian Sun, Xianming Zhang, Jun Liu, Bin Yi, Jishi Liu, Xingfei Zhang and 5 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in British journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02467790 (Kinetic Study of Human Pharmacokinetics in Normal Renal Function, and Renal Insufficiency Subject of Polyethylene Glycol Loxenatide), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.8field-weighted citation impact, top 25% 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.

NCT02467790 phase1unknown statusnot on this map

Kinetic Study of Human Pharmacokinetics in Normal Renal Function, and Renal Insufficiency Subject of Polyethylene Glycol Loxenatide (PEX168)(Open, Non-randomized, Parallel-group)

TypeinterventionalSponsorJiangsu Hansoh Pharmaceutical Co., Ltd.Ran2015 to 2016Enrolled24ConditionsType 2 Diabetes MellitusArmsPEX168
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 15 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Article
  6. 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

15 authors at 1 institution in 1 country.

Jianwen WangDepartment of Nephrology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.
Jie HuangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.
Wei LiDepartment of Nephrology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.
Shiqi TangDepartment of Nephrology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.
Jian SunDepartment of Nephrology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.
Xianming ZhangDepartment of Nephrology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.
Jun LiuDepartment of Nephrology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.
Bin YiDepartment of Nephrology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.
Jishi LiuDepartment of Nephrology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.
Xingfei ZhangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.
Qian YangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.
Xiaoyan YangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.
Shuang YangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.
Guoping YangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.ORCID 0000-0001-5930-586X
Hao ZhangDepartment of Nephrology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.ORCID 0000-0002-2049-3485
Central South University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsType 2 diabetes mellitus (T2DM) is commonly complicated by renal impairment. Polyethylene glycol loxenatide (PEX168) is a novel long-acting glucagon-like peptide-1 receptor agonist for T2DM. PEX168 pharmacokinetics was studied to identify requirements for dose-modification in T2DM complicated by renal impairment.

methodsThis was a single-centre, open-labelled, parallel-group, single-dose, phase I clinical trial of patients with mild and moderate renal impairment, and with or without T2DM. Age-, sex- and body mass index-matched subjects with normal renal function, and with or without T2DM were recruited as controls. Subjects received a single abdominal subcutaneous injection of PEX168 200 μg. Pharmacokinetic samples were taken at 0, 24, 48, 72, 96, 120, 144, 216, 312, 480, 648 and 720 hours.

resultsTwenty-three patients were included in the pharmacokinetics analysis. Vz/F and CL/F were lower in the moderate impairment group than in the other groups. The mean t

conclusionA single dose of 200 μg of PEX168 was in general well tolerated in patients with renal impairment. The in vivo clearance rate of PEX168 in patients with moderate renal impairment is slower than in patients with mild renal impairment and normal renal function and dose adjustment might be required (ClinicalTrials.org #NCT02467790).

Indexed as

Glucagon-Like Peptide-1 Receptor AgonistsAdultArea Under CurveDiabetes Mellitus, Type 2Diabetic NephropathiesDose-Response Relationship, DrugDrug-Related Side Effects and Adverse ReactionsFemaleHumansHypoglycemic AgentsKidneyMaleMiddle AgedPeptidesPolyethylene GlycolsGlucagon-Like Peptide-1 Receptor AgonistsHypoglycemic AgentsPeptidespolyethylene glycol loxenatidePolyethylene Glycolschronic kidney diseasepharmacokineticsphase I trialpolyethylene glycol loxenatidetype 2 diabetes mellitus

Identifiers

PMID31396983
PMCPMC6955414
OpenAlexW2973017910

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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.