Evidence map›Paper›PMID 27887605›Full record

Trial reportBMC endocrine disorders2016

A randomised, open-labelstudy of insulin glargine or neutral protamine Hagedorn insulin in Chinese paediatric patients with type 1 diabetes mellitus.

Min Liu, Zhiguang Zhou, Jinhua Yan, Pin Li, Wenhui Song, Junfen Fu, Xiaobo Chen, Weigang Zhao, Li Xi, Xiaoping Luo and 3 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC endocrine disorders, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 32% 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.

NCT01223131 phase3completednot on this map

A 24-week, Randomized, Open-label, Parallel Group, Multicenter Comparison of Lantus® (Insulin Glargine) Given Once Daily Versus Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diabetes Mellitus Aged at Least 6 Years to Less Than 18 Years

TypeinterventionalSponsorSanofiRan2011 to 2014Enrolled162ConditionsType 1 Diabetes MellitusArmsInsulin glargine (HOE901), NPH insulin
NCT05709938 phase4completednot on this mapstarted 2019, after this paper: background citation

Comparison of Insulin Glargine Mixed With Regular Insulin Versus the Standard Neutral Protamine Hagedorn (NPH) and Regular Insulin in the Treatment of Type 1 Diabetes Mellitus

TypeinterventionalSponsorKing Edward Medical UniversityRan2019 to 2021Enrolled68ConditionsTo Assess the Glycemic Control of Insulin Glargine in Combination With Regular Insulin in Type 1 Diabetes in ChildrenArmsGlargine and regular insulin versus NPH and regular insulin
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. 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

13 authors at 12 institutions in 1 country.

Min LiuBeijing Children's Hospital, Capital Medical University, No.56 South Lishi Road, Xicheng District, Beijing, China.
Zhiguang ZhouThe Second Xiangya Hospital of Central South University, Changsha, China.
Jinhua YanThe Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
Pin LiChildren's Hospital of Shanghai, Shanghai Jiaotong University, Shanghai, China.
Wenhui SongChildren's Hospital of Shanxi Province, Taiyuan, China.
Junfen FuThe Children's Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Xiaobo ChenCapital Institute of Pediatrics, Beijing, China.
Weigang ZhaoPeking Union Medical College Hospital, Beijing, China.
Li XiChildren's Hospital Affiliated to Fudan University, Shanghai, China.
Xiaoping LuoTongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, China.
Liang ShaSanofi (China) Investment Co., Ltd., Shanghai, China.
Xueyuan DengSanofi (China) Investment Co., Ltd., Shanghai, China.
Chunxiu GongBeijing Children's Hospital, Capital Medical University, No.56 South Lishi Road, Xicheng District, Beijing, China. chunxiugong@163.com.
Sanofi (China) · CNBeijing Children’s Hospital · CNCapital Institute of Pediatrics · CNCapital Medical University · CNChildren's Hospital of Fudan University · CNChildren's Hospital of Zhejiang University · CNHuazhong University of Science and Technology · CNPeking Union Medical College Hospital · CNSecond Xiangya Hospital of Central South University · CNShanghai Children's Hospital · CNShanxi Provincial Children's Hospital · CNThird Affiliated Hospital of Sun Yat-sen University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe aimed to describe the safety and efficacy of insulin glargine in Chinese paediatric patients with type 1 diabetes mellitus (T1DM). Neutral protamine Hagedorn (NPH) insulin was the reference therapy.

methodsThis open-label, randomised, Phase III study was conducted at 10 sites in China. Children aged ≥6 to <18 years with T1DM were randomised (2:1) to insulin glargine or NPH insulin asbasal insulinfor a 24-week treatment period. For all patients, insulin aspart was given as bolus insulin. The primary endpoint was absolute change in glycated haemoglobin(HbA1c) from baseline to Week 24. Secondary endpoints included the percentage of patients reaching HbA1c <7.5% (<58.5 mmol/mol), and safety. The study was registered at clinicaltrials.gov (NCT01223131).

resultsIn total,196 patients were screened, and 162 were randomised (107 and 55 patients were randomised to insulin glargine and NPH insulin, respectively). The mean ± SD of absolute change in HbA1c was-0.25 ± 1.68% (-2.69 ± 18.32 mmol/mol) in the insulin glargine group and -0.54 ± 1.67% (-5.55 ± 20.32 mmol/mol) in the NPH insulin group. At Week 24, 18.7 and 21.6% of patients in the insulin glargine and NPH insulin groups achieved HbA1c <7.5% (<58.5 mmol/mol). Both treatments were generally well tolerated. A numerically lower rate of symptomatic hypoglycaemia per patient year was observed for insulin glargine versus NPH insulin (24.3 ± 45.8 versus32.3 ± 43.2); severe hypoglycaemia was rare (<2%).

conclusionsInitiation of insulin glargine can aid Chinese paediatric patients with T1DM to safely reduce their HbA1c levels.

Indexed as

AdolescentBlood GlucoseChildChinaDiabetes Mellitus, Type 1FemaleGlycated HemoglobinHumansHypoglycemic AgentsInsulin GlargineInsulin, IsophaneMaleTreatment OutcomeBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulin GlargineInsulin, IsophaneChinese paediatric patientsInsulin glargineNPH insulinType 1 diabetes mellitus

Identifiers

PMID27887605
PMCPMC5124261
OpenAlexW2554064951

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.