Battelino Tadej, Bosnyak Zsolt, Danne Thomas, Mukherjee Bhaswati, Edelman Steve, Pilorget Valerie, Choudhary Pratik, Renard Eric, Bergenstal Richard
UMC-University Children's Hospital, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
Sanofi S.A., Paris, France.
Diabetes Ther. 2020 Apr;11(4):1017-1027. doi: 10.1007/s13300-020-00781-6. Epub 2020 Feb 25.
Suboptimal glycaemic control among people with type 1 diabetes (T1D) is known to lead to long-term micro- and macrovascular complications and, unfortunately, it is still prevalent even in the most affluent societies. Although glycated haemoglobin monitoring is considered to be the gold standard for assessing glycaemic control, such monitoring is unable to reliably measure acute glycaemic excursions. Continuous glucose monitoring (CGM) has been shown to improve glucose control and reduce the incidence of hypoglycaemia, and also allow a more complete assessment of overall glycaemic control and hyper- and hypoglycaemic excursions. The use of CGM has led to time-in-range, which is the time that a patient is within the glycaemic range of 70 to 180 mg/dL, to be adopted as a treatment target. To date, only limited data comparing the second-generation insulins glargine 300 U/mL (Gla-300) and degludec 100 U/mL (IDeg-100) in people with T1D are available, and there is no CGM literature on comparisons of the use of CGM results to assess primary, secondary and tertiary endpoints. The aim of the InRange study was to address this unmet need.
InRange is a multicentre, randomised, active-controlled, parallel-group, 12-week, open-label, phase 4, comparative study. Adults with T1D will be randomised to receive once-daily Gla-300 or IDeg-100 by subcutaneous injection in the morning. Following an 8-week titration period, CGM data will be collected over 20 consecutive days.
The primary objective is to demonstrate that Gla-300 is noninferior to IDeg-100 in terms of glycaemic control [time-in-range ≥ 70 to ≤ 180 mg/dL (≥ 3.9 to ≤ 10 mmol/L)] and variability, as assessed using CGM, in adults with T1D. The results are expected to help confirm the utility of CGM in clinical practice in this population and provide insight into its application as an outcome measure in clinical practice.
NCT04075513.
1型糖尿病（T1D）患者血糖控制不佳会导致长期微血管和大血管并发症，不幸的是，即便在最富裕的社会中，这一情况仍很普遍。尽管糖化血红蛋白监测被认为是评估血糖控制的金标准，但这种监测无法可靠地测量急性血糖波动。连续血糖监测（CGM）已被证明可改善血糖控制并降低低血糖发生率，还能更全面地评估整体血糖控制以及高血糖和低血糖波动情况。CGM的应用使得血糖处于70至180mg/dL（3.9至10mmol/L）范围内的时间（即血糖达标时间）成为一个治疗目标。迄今为止，关于1型糖尿病患者中第二代胰岛素甘精胰岛素300U/mL（Gla - 300）和德谷胰岛素100U/mL（IDeg - 100）对比的数据有限，且尚无关于使用CGM结果评估一级、二级和三级终点的比较的文献。InRange研究的目的就是满足这一未被满足的需求。
InRange是一项多中心、随机、活性对照、平行组、为期12周的开放标签4期比较研究。成年1型糖尿病患者将被随机分组，于早晨皮下注射每日一次的Gla - 300或IDeg - 100。经过8周的滴定期后，将连续20天收集CGM数据。
主要目标是证明在1型糖尿病成年患者中，就血糖控制[血糖达标时间≥70至≤180mg/dL（≥3.9至≤10mmol/L）]和变异性而言，Gla - 300不劣于IDeg - 100，这是通过CGM评估得出的。预期结果将有助于证实CGM在该人群临床实践中的效用，并深入了解其作为临床实践中一项结局指标的应用情况。
NCT04075513。
