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

نویسندگان

  • 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
چکیده

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.

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Cost-effectiveness of insulin analogues for diabetes mellitus.

BACKGROUND Insulin analogues may be associated with fewer episodes of hypoglycemia than conventional insulins. However, they are costly alternatives. We compared the cost-effectiveness of insulin analogues and conventional insulins used to treat type 1 and type 2 diabetes mellitus in adults. METHODS We conducted a cost-effectiveness evaluation of insulin analogues versus conventional insulins...

متن کامل

Quality of Life in Type 2 Diabetes Mellitus Patients Requiring Insulin Treatment in Buenos Aires, Argentina: A Cross-Sectional Study

Background Decision-makers have begun to recognize Health-Related Quality of Life (HRQoL) as an important and measurable outcome of healthcare interventions; and HRQoL data is increasingly being used by policy-makers to prioritize health resources. Our objective was to measure HRQoL in a group of Type 2 Diabetes Mellitus (T2DM) patients receiving insulin treatment in Buenos Aires, Argentina.   ...

متن کامل

Efficacy and safety of insulin lispro protamine suspension as basal supplementation in patients with type 2 diabetes.

The three currently marketed long-acting insulin analogs, glargine, detemir and insulin lispro protamine suspension (ILPS), represent the most significant advances in basal insulin supplementation since the 1940s and 1950s and the introduction of the intermediate-acting NPH (neutral protamine Hagedorn) insulin. As injection of NPH insulin lacks chronic maintenance of a steady-state low-level ba...

متن کامل

Safety of Insulin Glargine in Pregnancy

In order to improve the control of diabetes, insulin analogs with duration of action longer or shorter than traditional insulins, (regular and neutral protamine Hagedorn) have been developed and have shown to provide better glucose control and also decrease the rate of hypoglycemia in patients with diabetes [1-3]. Strict control of hyperglycemia is essential to reduce adverse maternal and fetal...

متن کامل

Real-world outcomes of US employees with type 2 diabetes mellitus treated with insulin glargine or neutral protamine Hagedorn insulin: a comparative retrospective database study

OBJECTIVES To compare real-world outcomes of initiating insulin glargine (GLA) versus neutral protamine Hagedorn (NPH) insulin among employees with type 2 diabetes mellitus (T2DM) who had both employer-sponsored health insurance and short-tem-disability coverages. DESIGN Retrospective cohort study. SETTING MarketScan Commercial Claims and Encounters/Health and Productivity Management Databa...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:

دوره 16  شماره 

صفحات  -

تاریخ انتشار 2016