LMC Diabetes and Endocrinology, Concord, Ontario, Canada.
Diabetes Clinical Research, Division of Endocrinology, Diabetes & Hypertension, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Diabetes Obes Metab. 2021 Nov;23(11):2572-2581. doi: 10.1111/dom.14504. Epub 2021 Aug 16.
To compare time in range (TIR) with use of insulin degludec U100 (degludec) versus insulin glargine U100 (glargine U100) in people with type 2 diabetes.
We conducted a randomized, crossover, multicentre trial comparing degludec and glargine U100 in basal insulin-treated adults with type 2 diabetes and ≥1 hypoglycaemia risk factor. There were two treatment periods, each with 16-week titration and 2-week maintenance phases (with evaluation of glucose using blinded professional continuous glucose monitoring). The once-weekly titration (target: 3.9-5.0 mmol/L) was based on pre-breakfast self-measured blood glucose. The primary endpoint was percentage of TIR (3.9─10.0 mmol/L). Secondary endpoints included overall and nocturnal percentage of time in tight glycaemic range (3.9-7.8 mmol/L), and mean glycated haemoglobin (HbA1c) and glucose levels.
At baseline, participants (n = 498) had a mean (SD) age of 62.8 (9.8) years, a diabetes duration of 15.1 (7.7) years and an HbA1c level of 59.6 (11.0) mmol/mol (7.6 [1.0]%). Noninferiority and superiority were confirmed for degludec versus glargine U100 for the primary endpoint, with a mean TIR of 72.1% for degludec versus 70.7% for glargine U100 (estimated treatment difference [ETD] 1.43% [95% confidence interval (CI): 0.12, 2.74; P = 0.03] or 20.6 min/d). Overall time in tight glycaemic range favoured degludec versus glargine U100 (ETD 1.5% [95% CI: 0.15, 2.89] or 21.9 min/d). Degludec also reduced nocturnal time below range (TBR; <3.9 mmol/L) compared with glargine U100 (ETD -0.88% [95% CI: -1.34, -0.42] or 12.7 min/night; post hoc) and significantly fewer nocturnal hypoglycaemic episodes of <3.0 mmol/L were observed.
Degludec, compared with glargine U100, provided more TIR and time in tight glycaemic range, and reduced nocturnal TBR in insulin-treated people with type 2 diabetes.
比较 2 型糖尿病患者使用胰岛素地特胰岛素 U100（地特胰岛素）和甘精胰岛素 U100（甘精胰岛素 U100）的时间在目标范围内（TIR）。
我们进行了一项随机、交叉、多中心试验，比较了基础胰岛素治疗的 2 型糖尿病且有≥1 个低血糖危险因素的成人中地特胰岛素和甘精胰岛素 U100 的疗效。有两个治疗期，每个治疗期都有 16 周的滴定和 2 周的维持阶段（使用盲法专业连续血糖监测评估血糖）。每周一次的滴定（目标：3.9-5.0mmol/L）基于早餐前自我测量的血糖。主要终点是 TIR（3.9-10.0mmol/L）的百分比。次要终点包括整体和夜间严格血糖范围内的时间百分比（3.9-7.8mmol/L），以及平均糖化血红蛋白（HbA1c）和血糖水平。
在基线时，参与者（n=498）的平均（SD）年龄为 62.8（9.8）岁，糖尿病病程为 15.1（7.7）年，HbA1c 水平为 59.6（11.0）mmol/mol（7.6[1.0]%）。与甘精胰岛素 U100 相比，地特胰岛素在主要终点方面具有非劣效性和优越性，地特胰岛素的 TIR 平均值为 72.1%，甘精胰岛素 U100 为 70.7%（估计治疗差异[ETD]为 1.43%[95%可信区间（CI）：0.12，2.74；P=0.03]或 20.6 分钟/天）。整体上，严格血糖范围内的时间有利于地特胰岛素优于甘精胰岛素 U100（ETD 1.5%[95% CI：0.15，2.89]或 21.9 分钟/天）。与甘精胰岛素 U100 相比，地特胰岛素还降低了夜间低于目标范围（TBR；<3.9mmol/L）的时间（ETD-0.88%[95% CI：-1.34，-0.42]或 12.7 分钟/夜；事后分析），夜间发生<3.0mmol/L 的低血糖事件也明显减少。
与甘精胰岛素 U100 相比，地特胰岛素可提供更多的 TIR 和严格血糖范围内的时间，并降低 2 型糖尿病患者的夜间 TBR。
