Wangnoo Subhash K, Chowdhury Subhankar, Rao P V
J Assoc Physicians India. 2014 Jan;62(1 Suppl):21-6.
Insulin degludec is a new-generation basal insulin with an ultra-long duration of action. The insulin degludec and insulin degludec/insulin aspart clinical trial programme was truly global, involving 40 different countries and encompassing a multitude of ethnic populations. It is the largest insulin development clinical trial programme on record--with more than 11,000 patients included worldwide. It includes two main components: BEGIN (insulin degludec studied across the spectrum of diabetes) and BOOST (insulin degludec in a fixed-dose combination with insulin aspart). In clinical trials (phase 2 and phase 3a), insulin degludec achieved similar glycaemic control to that seen with insulin glargine in patients with type 1 or 2 diabetes, but with a lower risk of nocturnal hypoglycaemia. In addition, trials examining a flexible dosing regimen of insulin degludec in patients with type 1 or 2 diabetes show the potential for adjusting the injection time, without compromising glycaemic control or safety. A 200 U/mL formulation of insulin degludec is also available for use in patients who require large volumes of basal insulin. Subcutaneous insulin degludec is generally well tolerated in patients with type 1 or 2 diabetes and represents a useful advance in the treatment of type 1 or 2 diabetes.
德谷胰岛素是一种作用持续时间超长效的新一代基础胰岛素。德谷胰岛素及德谷胰岛素/门冬胰岛素的临床试验项目是真正全球性的，涉及40个不同国家，涵盖众多种族人群。它是有记录以来规模最大的胰岛素研发临床试验项目——全球纳入了超过11000名患者。它包括两个主要部分：BEGIN（在整个糖尿病范围内研究德谷胰岛素）和BOOST（德谷胰岛素与门冬胰岛素的固定剂量复方制剂）。在临床试验（2期和3a期）中，德谷胰岛素在1型或2型糖尿病患者中实现了与甘精胰岛素相似的血糖控制，但夜间低血糖风险较低。此外，对1型或2型糖尿病患者中德谷胰岛素灵活给药方案的试验表明，在不影响血糖控制或安全性的情况下，有调整注射时间的潜力。一种200 U/mL的德谷胰岛素制剂也可供需要大量基础胰岛素的患者使用。皮下注射德谷胰岛素在1型或2型糖尿病患者中一般耐受性良好，是1型或2型糖尿病治疗方面的一项有益进展。
