Oxford Centre for Diabetes, Endocrinology and Metabolism and NIHR Oxford Biomedical Research Centre, Oxford, UK.
Diabetes Care. 2013 Sep;36(9):2536-42. doi: 10.2337/dc12-2329. Epub 2013 May 28.
The 200 units/mL formulation of insulin degludec (IDeg 200 units/mL) contains equal units of insulin in half the volume compared with the 100 units/mL formulation. We compared the efficacy and safety of IDeg 200 units/mL once daily with 100 units/mL insulin glargine (IGlar) in insulin-naïve subjects with type 2 diabetes (T2DM) inadequately controlled with oral antidiabetic drugs.
In this 26-week, open-label, treat-to-target trial, subjects (n = 457; mean HbA1c 8.3% [67 mmol/mol], BMI 32.4 kg/m(2), and fasting plasma glucose [FPG] 9.6 mmol/L [173.2 mg/dL]) were randomized to IDeg 200 units/mL or IGlar, both given once daily in combination with metformin with or without a dipeptidyl peptidase-4 inhibitor. Basal insulin was initiated at 10 units/day and titrated weekly to an FPG target of <5 mmol/L (<90 mg/dL) according to mean prebreakfast self-measured blood glucose values from the preceding 3 days.
By 26 weeks, IDeg reduced HbA1c by 1.30% and was not inferior to IGlar. Mean observed FPG reductions were significantly greater with IDeg than IGlar (-3.7 vs. -3.4 mmol/L [-67 vs. -61 mg/dL]; estimated treatment difference: -0.42 [95% CI -0.78 to -0.06], P = 0.02). Despite this difference, rates of overall confirmed hypoglycemia were not higher with IDeg than with IGlar (1.22 and 1.42 episodes/patient-year, respectively), as were rates of nocturnal confirmed hypoglycemia (0.18 and 0.28 episodes/patient-year, respectively). Mean daily basal insulin dose was significantly lower by 11% with IDeg 200 units/mL compared with IGlar. IDeg was well-tolerated, and the rate of treatment-emergent adverse events was similar across groups.
In this treat-to-target trial in insulin-naïve patients with T2DM, IDeg 200 units/mL improved glycemic control similarly to IGlar with a low risk of hypoglycemia.
德谷胰岛素 200 单位/毫升（IDeg 200 单位/毫升）制剂的胰岛素含量与 100 单位/毫升制剂相同，但体积减半。我们比较了每日一次注射德谷胰岛素 200 单位/毫升与每日一次注射甘精胰岛素 100 单位/毫升（IGlar）在口服降糖药治疗控制不佳的 2 型糖尿病（T2DM）患者中的疗效和安全性。
在这项为期 26 周、开放标签、以目标为导向的试验中，共纳入 457 例受试者（平均 HbA1c 8.3%[67mmol/mol]，BMI 32.4kg/m²，空腹血糖[FPG]9.6mmol/L[173.2mg/dL]），按 1:1 随机分为 IDeg 200 单位/毫升组或 IGlar 组，两组均联合二甲双胍治疗，部分患者加用二肽基肽酶-4 抑制剂。起始基础胰岛素剂量为 10 单位/天，根据前 3 天的平均早餐前自我监测血糖值每周调整 1 次剂量，使 FPG 目标值达到＜5mmol/L（＜90mg/dL）。
治疗 26 周后，IDeg 降低 HbA1c 1.30%，与 IGlar 相当。IDeg 组较 IGlar 组平均观察到的 FPG 降低更显著（-3.7 比-3.4mmol/L[-67 比-61mg/dL]；估计治疗差值：-0.42[95%CI-0.78 至-0.06]，P=0.02）。尽管存在这一差异，但 IDeg 组与 IGlar 组总体确证性低血糖发生率（分别为 1.22 和 1.42 次/患者年）或夜间确证性低血糖发生率（分别为 0.18 和 0.28 次/患者年）无差异。与 IGlar 相比，IDeg 200 单位/毫升的基础胰岛素日剂量显著降低 11%。IDeg 耐受性良好，各组间治疗期间出现的不良事件发生率相似。
在这项针对胰岛素初治的 T2DM 患者的以目标为导向的试验中，IDeg 200 单位/毫升改善血糖控制的疗效与 IGlar 相当，低血糖风险较低。
