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首页> 外文期刊>Pediatric diabetes. >The rate of hyperglycemia and ketosis with insulin degludec‐based treatment compared with insulin detemir in pediatric patients with type 1 diabetes: An analysis of data from two randomized trials
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The rate of hyperglycemia and ketosis with insulin degludec‐based treatment compared with insulin detemir in pediatric patients with type 1 diabetes: An analysis of data from two randomized trials

机译：基于胰岛素Degludec治疗的高血糖和刺激率与1型糖尿病患者的胰岛素Devemir相比：两种随机试验中的数据分析

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Background Historically, data on the rate of hyperglycemia and ketosis have not been collected in clinical trials. However, it is clinically important to assess the rate of these events in children with type 1 diabetes (T1D). This question was addressed in two pediatric trials using insulin degludec (degludec). Objective To assess the rate of hyperglycemia and ketosis in two‐phase 3b trials investigating degludec (Study 1) and degludec with insulin aspart (IDegAsp [Study 2]) vs insulin detemir (IDet). Subjects Patients (aged 1‐17 years inclusive) with T1D treated with insulin for ≥3 months. Methods Study 1: patients were randomized to degludec once daily (OD) or IDet OD/twice daily (BID) for 26 weeks, followed by a 26‐week extension phase. Study 2: patients were randomized to IDegAsp OD or IDet OD/BID for 16 weeks. Bolus mealtime IAsp was included in both studies. In Study 1, hyperglycemia was recorded if plasma glucose (PG) was 11.1 mmol/L, with ketone measurement required with significant hyperglycemia (14.0 mmol/L). In Study 2, hyperglycemia was recorded with PG 14.0 mmol/L where the subject looked/felt ill, with ketone measurement also required in these hyperglycemic patients. In this post hoc analysis, the hyperglycemia threshold was 14.0 mmol/L for uniformity. Results Despite similar rates of hyperglycemia with degludec/IDegAsp compared with IDet, the rates of ketosis were lower with degludec/IDegAsp. Conclusions These trials, the first to systematically collect data on ketosis in pediatric patients with T1D, demonstrate the potential of degludec/IDegAsp to reduce rates of metabolic decompensation, compared with IDet.
机译：背景技术历史上，临床试验中未收集有关高血糖和刺激率的数据。然而，在临床上是评估1型糖尿病（T1D）的儿童中这些事件的速率。使用胰岛素Degludec（Degleudec）的两项儿科试验在两个儿科试验中解决了这个问题。目的评估两期3B试验中的高血糖和酮症的速率调查Degludec（研究1）和胰岛素Aspart（IDEGASP [研究2]）与胰岛素DECIMIR（IDET）进行DELLUDEC。受试者患者（1-17岁，包容为1-17岁），T1D用胰岛素治疗≥3个月。方法研究1：患者每天一次（OD）或IDET OD /每日两次（BID）随机转移到26周，其次是26周的延伸阶段。研究2：患者随机转移到IDEGASP OD或IDET OD /出价16周。两个研究中包含了推注膳食IASP。在研究1中，如果血浆葡萄糖（PG）为11.1mmol / L，则记录高血糖血症，其中酮测量需要显着的高血糖（＆ 14.0mmol / L）。在研究2中，用PG＆ 14.0 mmol / L记录高血糖，其中受试者看起来/感觉不适，在这些高血糖患者中也需要酮测量。在这种情况下，高血糖阈值为14.0 mmol / L，用于均匀性。结果尽管与IDEEC / IDEGASP的高血糖/ ideGASP相比具有类似的高血糖率，但酮化率较低，DELLUDEC / IDEGASP较低。结论这些试验，第一个系统地收集关于T1D的儿科患者酮症的数据，证明了Degledec / IDEGASP的潜力，以降低代谢解组的率，与IEE相比。

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