Evidence map›Paper›PMID 39170740›Full record

ArticleFrontiers in endocrinology2024

A comparative evaluation of bioequivalence of Gan & Lee glargine U300 and Toujeo

Xiaoli Li, Anshun He, Bingyan Liu, Rongfang Shan, Juan Zhu, Xiaoyue Li, Tian Xie, Yue Li, Mengmeng Chen, He Su and 11 more

Abstract readComparative StudyEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Article in Frontiers in endocrinology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

21 authors.

Xiaoli Li *Clinical Trial Center, The First Affiliated Hospital of Bengbu Medical University, Bengbu, China.
Anshun He *Gan & Lee Pharmaceuticals, Beijing, China.
Bingyan Liu *Clinical Trial Center, The First Affiliated Hospital of Bengbu Medical University, Bengbu, China.
Rongfang ShanSchool of Pharmacy, Bengbu Medical University, Bengbu, China.
Juan ZhuSchool of Pharmacy, Bengbu Medical University, Bengbu, China.
Xiaoyue LiClinical Trial Center, The First Affiliated Hospital of Bengbu Medical University, Bengbu, China.
Tian XieGan & Lee Pharmaceuticals, Beijing, China.
Yue LiGan & Lee Pharmaceuticals, Beijing, China.
Mengmeng ChenClinical Trial Center, The First Affiliated Hospital of Bengbu Medical University, Bengbu, China.
He SuClinical Trial Center, The First Affiliated Hospital of Bengbu Medical University, Bengbu, China.
Chaoyang ZhangClinical Trial Center, The First Affiliated Hospital of Bengbu Medical University, Bengbu, China.
Lufeng LiClinical Trial Center, The First Affiliated Hospital of Bengbu Medical University, Bengbu, China.
Dongmei ChengClinical Trial Center, The First Affiliated Hospital of Bengbu Medical University, Bengbu, China.
Juan ChenClinical Trial Center, The First Affiliated Hospital of Bengbu Medical University, Bengbu, China.
Ying WangSchool of Pharmacy, Bengbu Medical University, Bengbu, China.
Yue SuClinical Trial Center, The First Affiliated Hospital of Bengbu Medical University, Bengbu, China.
Yuanyuan XuSchool of Pharmacy, Bengbu Medical University, Bengbu, China.
Zhuoran LiGan & Lee Pharmaceuticals, Beijing, China.
Huan Zhou *Clinical Trial Center, The First Affiliated Hospital of Bengbu Medical University, Bengbu, China.
Wei Chen *Gan & Lee Pharmaceuticals, Beijing, China.
Yuanyuan Liu *Clinical Trial Center, The First Affiliated Hospital of Bengbu Medical University, Bengbu, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: To assess the bioequivalence between Gan & Lee (GL) glargine U300 and Toujeo Methods: A single-center, randomized, double-blind, single-dose, two-preparation, two-sequence, four-cycle repeated crossover design study was performed to compare GL glargine U300 and Toujeo Results: GL Glargine U300 demonstrated comparable PK parameters (AUC Conclusion: The PK, PD, and safety of GL glargine U300 were bioequivalent to that of Toujeo Clinical trial registration: https://www.chinadrugtrials.org.cn/, identifier CTR20212419.

Indexed as

Hypoglycemic AgentsInsulin GlargineTherapeutic EquivalencyAdultArea Under CurveBlood GlucoseChinaCross-Over StudiesDouble-Blind MethodHealthy VolunteersHumansMaleYoung AdultBlood GlucoseHypoglycemic AgentsInsulin Glarginebioequivalencebiosimilardiabetesinsulin glargine U300pharmacodynamicspharmacokinetics

Identifiers

PMID39170740
PMCPMC11337195

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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.