Evidence map›Paper›PMID 33167951›Full record

ArticleBMC complementary medicine and therapies2020

Pharmacodynamics and pharmacokinetics of a new type of recombinant insulin Lisargine injection.

Jiangjie Lu, Yong Zeng, Xiulin Yi, Hongmei Zhang, Lin Zhu, Lixin Jiang, Jing Li, Wei Zhou, Hong Zhu, Aijun Xiong

Abstract readComparative Study
In one paragraph

Article in BMC complementary medicine and therapies, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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.

Jiangjie LuHefei Tianmai Biotechnology Development Co,. Ltd., Hefei, 230601, Anhui Province, China.
Yong ZengTIPR Drug Assessment Co., Ltd, Tianjin, 300452, China.
Xiulin YiTIPR Drug Assessment Co., Ltd, Tianjin, 300452, China.
Hongmei ZhangWuXi AppTec Co., Ltd (Headquarters), Shanghai, 200131, China.
Lin ZhuWuXi AppTec Co., Ltd (Suzhou), Suzhou, 215104, Jiangsu Province, China.
Lixin JiangHefei Tianmai Biotechnology Development Co,. Ltd., Hefei, 230601, Anhui Province, China.
Jing LiHefei Tianmai Biotechnology Development Co,. Ltd., Hefei, 230601, Anhui Province, China.
Wei ZhouHefei Tianmai Biotechnology Development Co,. Ltd., Hefei, 230601, Anhui Province, China.
Hong ZhuHefei Tianmai Biotechnology Development Co,. Ltd., Hefei, 230601, Anhui Province, China.
Aijun XiongHefei Tianmai Biotechnology Development Co,. Ltd., Hefei, 230601, Anhui Province, China. aijunx2020@tom.com.ORCID http://orcid.org/0000-0001-5940-1587

Funding

the National major new drug development project No. 2014ZX09101045003
6 · The paper itself

Abstract

backgroundRecombinant insulin Lisargine is a new type of insulin. In this study, we aimed to compare its pharmacodynamic (PD) and pharmacokinetic (PK) with Lantus.

methodsThe PD test was performed by exploring the effect of single administration on blood glucose of normal rats and STZ-induced diabetic rats, and the effect of multiple administrations on blood glucose of STZ-induced diabetic rats. Further PD tests include receptor affinity test, receptor autophosphorylation test and adipocyte glucose uptake test. Four IU and 8 IU per dog Lisargine was used for PK test, insulin was measured and area under curve (AUC) was calculated.

resultsWith single injection, Lisargine 1.5 IU/kg had significant hypoglycemic effects at 1 and 2 h, similar to that of Lantus. Lisargine 5 IU/kg and 10 IU/kg lowered the blood glucose of STZ-induced diabetic rats at 1, 2, 4 & 6 h significantly. With multiple injections, Lantus lowered blood glucose at 2, 4 & 6 h, Lisargine 2.5 IU/kg, 5 IU/kg, and 10 IU/kg lowered blood glucose at 2 & 4 h significantly, compared with vehicle. There was no difference for receptor affinity test, receptor autophosphorylation test and adipocyte glucose uptake test between Lisargine and Lantus. The PK of Lisargine and Lantus of healthy Beagle dogs was very similar.

conclusionsThis animal study demonstrated that PK and PD of Lisargine and Lantus were similar, suggesting the bioequivalence of these products.

Indexed as

AnimalsDiabetes Mellitus, ExperimentalDisease Models, AnimalDogsHypoglycemic AgentsInjectionsInsulinInsulin GlargineLysineMaleRatsRats, Sprague-DawleyStreptozocinHypoglycemic AgentsInsulinInsulin GlargineLysineStreptozocinLantusPharmacodynamicPharmacokineticRecombinant insulin Lisargine injection

Identifiers

PMID33167951
PMCPMC7653765

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Registered trials

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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.