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.

Keywords: Chinese paediatric patients; Insulin glargine; NPH insulin; Type 1 diabetes mellitus.

Figures

Fig. 1

Patient flow diagram.*Patients could be excluded for more than one reason.†Serum creatinine > 177 μmol/l (2.0 mg/dl); serum alanine amino transferase or aspartate amino transferase > 3 times upper limit of normal for the patient’s age and gender; haemoglobin <10 g/dl (100 g/l) and/or neutrophils < 1500/mm3 (1.5 × 109/l) and/or platelets < 100,000/mm3 (100 × 109/l).cThreepatients had no post-baseline HbA1c assessment and were not included in the HbA1c analysis

Fig. 2

Variation in study variables over the 24-week study window for the mITT population. a Mean HbA1c (%). The analysis excluded measurements obtained >14 days after treatment cessation and for Week 24 (LOCF), the analysis included measurements obtained ≤14 days after the last dose of study medication. b Mean fasting blood glucose (mmol/l). The analysis excluded measurements obtained >1 day after treatment cessation. c Mean nocturnal blood glucose (mmol/l). The analysis excluded measurements obtained >1 day after treatment cessation. d Mean eight-point SMBG (mmol/l). Error bars represent the standard deviation. LOCF, last observation carried forward; SMBG, self-measured blood glucose