Evidence map›Paper›PMID 40056372›Full record

Observational studyAdvances in therapy2025

Safety of iGlarLixi in Japanese People with Type 2 Diabetes: A Post-marketing Database Study.

Hideaki Kaneto, Makiko Hatanaka, Yukiko Morimoto, Yoko Takahashi, Yasuo Terauchi

Abstract readObservational Study
In one paragraph

Observational study in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

5 authors.

Hideaki KanetoDepartment of Diabetes, Endocrinology and Metabolism, Kawasaki Medical School, Kurashiki, Japan.ORCID http://orcid.org/0000-0001-7898-1943
Makiko HatanakaPost Authorization Regulatory Study, Medical Affairs, Sanofi K.K., Tokyo, Japan.
Yukiko MorimotoReal World Evidence Generation Partnering, Medical Affairs, Sanofi K.K., Tokyo, Japan.
Yoko TakahashiGeneral Medicine Medical, Sanofi K.K., Opera City Tower 3-20-2, Nishi-Shinjuku, Shinjuku-ku, Tokyo, 163-1488, Japan. Yoko.Takahashi@sanofi.com.ORCID http://orcid.org/0000-0003-2481-9574
Yasuo TerauchiDepartment of Endocrinology and Metabolism, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.ORCID http://orcid.org/0000-0002-8872-3697

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn this post-marketing study in Japan, the occurrence of hospital-treated hypoglycaemia and severe hyperglycaemia requiring inpatient treatment was evaluated in various cohorts of people with type 2 diabetes (T2D) newly switched to iGlarLixi, a titratable, once-daily, fixed-ratio combination of long-acting insulin glargine 100 U/mL (iGlar-100) and a glucagon-like peptide-1 receptor agonist (GLP-1 RA, lixisenatide).

methodsIn this retrospective, observational study, acute-care hospital data from adults with T2D were analysed from the Medical Data Vision database. In Cohort 1, the incidence rate of hospital-treated hypoglycaemia following newly prescribed iGlarLixi versus iGlar-100 was assessed. Cohort 2 was subdivided to evaluate the incidence rate of hospital-treated hypoglycaemia and severe hyperglycaemia requiring inpatient treatment in people switched to iGlarLixi from either a GLP-1 RA ± oral antidiabetic drugs (OADs) or OADs alone (Cohort 2A) or from a GLP-1 RA and long-acting insulin ± OADs or long-acting insulin ± OADs (Cohort 2B).

resultsOf the 438 people in the iGlarLixi group and 9295 people in the iGlar-100 group in Cohort 1, who had a median follow-up duration of 52 and 44 days, respectively, there were zero and 0.011 (95% CI 0.006-0.018) events per person-year of hospital-treated hypoglycaemia, respectively. Cohort 2A included 201 people each in the GLP-1 RA ± OADs and OADs alone groups, with a median follow-up duration of 76 and 101 days, respectively, and Cohort 2B included 255 people in the GLP-1 RA and long-acting insulin ± OADs group and 623 people in the long-acting insulin ± OADs group, with a median follow-up duration of 73 and 62 days, respectively; no cases of hospital-treated hypoglycaemia or severe hyperglycaemia requiring inpatient treatment were observed.

conclusionConsistent with clinical trials, this post-marketing database study observed that newly prescribed iGlarLixi has a low risk of serious hypoglycaemia or hyperglycaemia in Japanese people with T2D, irrespective of prior antidiabetic drug treatment.

Indexed as

Diabetes Mellitus, Type 2HypoglycemiaHypoglycemic AgentsInsulin GlarginePeptidesAdultAgedDatabases, FactualEast Asian PeopleFemaleGlucagon-Like Peptide-1 Receptor AgonistsGlucagon-Like Peptide-2 ReceptorHumansHyperglycemiaJapanMaleGlucagon-Like Peptide-1 Receptor AgonistsGlucagon-Like Peptide-2 ReceptorHypoglycemic AgentsInsulin GlarginelixisenatidePeptidesDatabase analysisHyperglycaemiaHypoglycaemiaIGlarLixiJapanPost-marketing surveillanceType 2 diabetes

Identifiers

PMID40056372
PMCPMC12006214

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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.