Background: We aimed to describe the safety and efficacy of insulin glargine in Chinese paediatric patients with\ntype 1 diabetes mellitus (T1DM). Neutral protamine Hagedorn (NPH) insulin was the reference therapy.\nMethods: This open-label, randomised, Phase III study was conducted at 10 sites in China. Children aged ââ?°Â¥6 to\n<18 years with T1DM were randomised (2:1) to insulin glargine or NPH insulin asbasal insulinfor a 24-week\ntreatment period. For all patients, insulin aspart was given as bolus insulin. The primary endpoint was absolute\nchange in glycated haemoglobin(HbA1c) from baseline to Week 24. Secondary endpoints included the percentage\nof patients reaching HbA1c <7.5% (<58.5 mmol/mol), and safety. The study was registered at clinicaltrials.gov\n(NCT01223131).\nResults: In total,196 patients were screened, and 162 were randomised (107 and 55 patients were randomised to\ninsulin glargine and NPH insulin, respectively). The mean Ã?± SD of absolute change in HbA1c wasââ?¬â??0.25 Ã?± 1.68% (ââ?¬â??2.69 Ã?±\n18.32 mmol/mol) in the insulin glargine group and ââ?¬â??0.54 Ã?± 1.67% (ââ?¬â??5.55 Ã?± 20.32 mmol/mol) in the NPH insulin group.\nAt Week 24, 18.7 and 21.6% of patients in the insulin glargine and NPH insulin groups achieved HbA1c <7.5% (<58.\n5 mmol/mol). Both treatments were generally well tolerated. A numerically lower rate of symptomatic hypoglycaemia\nper patient year was observed for insulin glargine versus NPH insulin (24.3 Ã?± 45.8 versus32.3 Ã?± 43.2); severe\nhypoglycaemia was rare (<2%).\nConclusions: Initiation of insulin glargine can aid Chinese paediatric patients with T1DM to safely reduce their HbA1c\nlevels.
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