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

• DOI: 10.1186/s12902-016-0146-2
• Publication Date: 2016-11-25T22:25:12Z
• Authors: Min Liu; Zhiguang Zhou; Jinhua Yan; Pin Li; Wenhui Song; Junfen Fu; Xiaobo Chen; Weigang Zhao; Li Xi; Xiaoping Luo; Liang Sha; Xueyuan Deng; Chunxiu Gong
• Keywords: NPH insulin; Clinical endpoint; Insulin aspart

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) was reference therapy. This open-label, randomised, Phase III study conducted at 10 sites China. Children aged ≥6 <18 years T1DM were randomised (2:1) or NPH asbasal insulinfor a 24-week treatment period. For all patients, aspart given as bolus insulin. The primary endpoint absolute change glycated haemoglobin(HbA1c) from baseline Week 24. Secondary endpoints included percentage reaching HbA1c <7.5% (<58.5 mmol/mol), safety. registered clinicaltrials.gov (NCT01223131). In total,196 screened, 162 (107 55 insulin, respectively). mean ± SD was–0.25 1.68% (–2.69 18.32 mmol/mol) group –0.54 1.67% (–5.55 20.32 group. At 24, 18.7 21.6% groups achieved mmol/mol). Both treatments generally well tolerated. A numerically lower rate symptomatic hypoglycaemia per patient year observed for versus (24.3 45.8 versus32.3 43.2); severe rare (<2%). Initiation can aid safely reduce their levels.