Evidence map›Paper›PMID 39691971›Full record

Trial reportDiabetes, obesity & metabolism2025

Efficacy and safety of switching to insulin glargine 300 U/mL in people with type 2 diabetes uncontrolled on basal insulin in China: A post hoc subpopulation analysis of the INITIATION study.

Liming Chen, Hailong Wan, Jie Han, Caixian Yang, Hailin Shao, Jialin Li, Wensheng Yan, Jianzhong Xiao, Yadong Sun, Min Li and 3 more

Abstract readClinical Trial, Phase IVMulticenter Study
In one paragraph

Trial report in Diabetes, obesity & metabolism, 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. Trial
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

13 authors.

Liming ChenNHC Key Laboratory of Hormones and Development, Tianjin Key Laboratory of Metabolic Diseases, Chu Hsien-I Memorial Hospital and Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China.ORCID 0000-0002-5682-2340
Hailong WanDepartment of Endocrinology, Panjin Central Hospital, Panjin, China.
Jie HanDepartment of Endocrinology, Hebei PetroChina Central Hospital, Langfang, China.
Caixian YangThe Sixth Affiliated Hospital of Guangzhou Medical University, Qingyuan People's Hospital, Qingyuan, China.
Hailin ShaoDepartment of Endocrinology, Tianjin 4th Center Hospital Affiliated to Nankai University, Tianjin, China.
Jialin LiDepartment of Endocrinology and Metabolism, The First Affiliated Hospital of Ningbo University, Ningbo, China.
Wensheng YanDepartment of Endocrinology, Huadu District People's Hospital of Guangzhou, Guangzhou, China.
Jianzhong XiaoBeijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.
Yadong SunDepartment of Endocrinology, Jilin Province People's Hospital, Changchun, China.
Min LiSanofi Investment Co., Ltd., Beijing, China.
Yanfang HanSanofi Investment Co., Ltd., Beijing, China.
Lei KangSanofi Investment Co., Ltd., Beijing, China.
Minlu ZhangSanofi Investment Co., Ltd., Shanghai, China.

Funding

Sanofi China Investment Company
6 · The paper itself

Abstract

aimsTo evaluate the efficacy and safety of insulin glargine 300 U/mL (Gla-300) in people with uncontrolled type 2 diabetes (T2D) switching from another basal insulin (BI). MATERIALS AND

methodsINITIATION was an interventional, single-arm, phase IV study conducted in China. In this post hoc subpopulation analysis, the efficacy and safety of switching to Gla-300 was investigated in individuals with uncontrolled T2D (HbA1c 7.5%-11.0% [58-97 mmol/mol]) with previous BI. The primary endpoint was HbA1c change at week 24. Other measures of glycaemia, hypoglycaemia, insulin dose and weight change were assessed.

resultsThree hundred and two participants switched to Gla-300 from another BI, including 232 from insulin glargine 100 U/mL (Gla-100) and 55 from insulin degludec (IDeg). At week 24, the mean ± standard error (SE) HbA1c change from baseline was -0.87% ± 0.06% (-9.5 ± 0.7 mmol/mol; p <0.001). Significant reductions in fasting plasma glucose (least-squares mean [LSM] change -1.13 mmol/L) and fasting self-measured blood glucose (LSM change -1.36 mmol/L) were also observed (both p <0.001). The mean daily BI dose increased from 18.86 U (0.27 U/kg) at baseline to 28.83 U (0.41 U/kg) at week 24. During the 24-week treatment period, the incidence of any hypoglycaemia was 43.8% for all hypoglycaemia and 15.1% for nocturnal hypoglycaemia; the incidence of severe hypoglycaemia was low (0.7%). Minimal body weight change was documented.

conclusionsGla-300 improved glycaemic control with a relatively low hypoglycaemia risk and minimal weight gain in Chinese people with T2D uncontrolled on previous BI.

Indexed as

Diabetes Mellitus, Type 2Drug SubstitutionHypoglycemic AgentsInsulin GlargineInsulin, Long-ActingAdultAgedBlood GlucoseChinaFemaleGlycated HemoglobinGlycemic ControlHumansHypoglycemiaMaleMiddle AgedBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulin GlargineInsulin, Long-Actingbasal insulininsulin glarginephase IV studytype 2 diabetes

Identifiers

PMID39691971
PMCPMC11802391

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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.