title: A randomised, open-labelstudy of insulin glargine or neutral protamine Hagedorn insulin in Chinese paediatric patients with type 1 diabetes mellitus.
abstract: BACKGROUND
  We 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.
  
  
  METHODS
  This 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).
  
  
  RESULTS
  In 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%).
  
  
  CONCLUSIONS
  Initiation of insulin glargine can aid Chinese paediatric patients with T1DM to safely reduce their HbA1c levels.
authors.affiliation: Beijing Children's Hospital, Capital Medical University, No.56 South Lishi Road, Xicheng District, Beijing, China.
authors.forename: Min
authors.initials: M
authors.lastname: Liu
authors.affiliation: The Second Xiangya Hospital of Central South University, Changsha, China.
authors.forename: Zhiguang
authors.initials: Z
authors.lastname: Zhou
authors.affiliation: The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
authors.forename: Jinhua
authors.initials: J
authors.lastname: Yan
authors.affiliation: Children's Hospital of Shanghai, Shanghai Jiaotong University, Shanghai, China.
authors.forename: Pin
authors.initials: P
authors.lastname: Li
authors.affiliation: Children's Hospital of Shanxi Province, Taiyuan, China.
authors.forename: Wenhui
authors.initials: W
authors.lastname: Song
authors.affiliation: The Children's Hospital, Zhejiang University School of Medicine, Hangzhou, China.
authors.forename: Junfen
authors.initials: J
authors.lastname: Fu
authors.affiliation: Capital Institute of Pediatrics, Beijing, China.
authors.forename: Xiaobo
authors.initials: X
authors.lastname: Chen
authors.affiliation: Peking Union Medical College Hospital, Beijing, China.
authors.forename: Weigang
authors.initials: W
authors.lastname: Zhao
authors.affiliation: Children's Hospital Affiliated to Fudan University, Shanghai, China.
authors.forename: Li
authors.initials: L
authors.lastname: Xi
authors.affiliation: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, China.
authors.forename: Xiaoping
authors.initials: X
authors.lastname: Luo
authors.affiliation: Sanofi (China) Investment Co., Ltd., Shanghai, China.
authors.forename: Liang
authors.initials: L
authors.lastname: Sha
authors.affiliation: Sanofi (China) Investment Co., Ltd., Shanghai, China.
authors.forename: Xueyuan
authors.initials: X
authors.lastname: Deng
authors.affiliation: Beijing Children's Hospital, Capital Medical University, No.56 South Lishi Road, Xicheng District, Beijing, China. chunxiugong@163.com.
authors.forename: Chunxiu
authors.initials: C
authors.lastname: Gong
mesh_terms: D000293:Adolescent; D001786:Blood Glucose; D002648:Child; D002681:China; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism*; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000069036:Insulin Glargine / Q000009:adverse effects / Q000627:therapeutic use*; D007336:Insulin, Isophane / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069036:Insulin Glargine; D007336:Insulin, Isophane; C517652:hemoglobin A1c protein, human
keywords: Chinese paediatric patients; Insulin glargine; NPH insulin; Type 1 diabetes mellitus