Linjawi Sultan, Lee Byung-Wan, Tabak Ömür, Lövdahl Susanna, Werther Shanti, Abusnana Salahedeen
Coffs Endocrine and Diabetes Service, Coffs Harbour, NSW, Australia.
Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.
Diabetes Ther. 2018 Feb;9(1):1-11. doi: 10.1007/s13300-017-0334-8. Epub 2017 Nov 11.
This 32-week, open-label, randomized, parallel-group, multinational trial aimed to compare the efficacy and safety of stepwise insulin intensification of biphasic insulin aspart 30 (BIAsp 30) relative to stepwise intensification of a basal-bolus regimen in insulin-naïve adults with type 2 diabetes (T2D) who continued pretrial treatment with metformin and sulfonylurea.
Adults with T2D were randomized into one of two treatment arms for 32 weeks: (1) BIAsp 30 once daily (OD), with the possibility of stepwise treatment intensification up to BIAsp 30 three times daily (TID); (2) insulin glargine OD, with the possibility of stepwise treatment intensification with insulin aspart up to TID. The primary endpoint was change from baseline in HbA after 32 weeks.
After 32 weeks, the estimated mean change in HbA from baseline was statistically significantly lower in the BIAsp 30 arm (- 1.18%) versus basal-bolus (- 1.36%) [estimated treatment difference 0.18%; 95% confidence interval (95% CI) 0.01; 0.36; p < 0.05]. The proportion of patients with HbA below 7.0% was statistically significantly lower with BIAsp 30 (42.9%) compared with basal-bolus (56.9%) (odds ratio 0.58; 95% CI 0.37; 0.89; p = 0.01). The overall rate of severe or blood glucose (BG)-confirmed hypoglycemic events was numerically lower for BIAsp 30 compared with basal-bolus, and a statistically significantly lower rate in nocturnal severe or BG-confirmed hypoglycemia in the BIAsp 30 arm relative to basal-bolus was observed: estimated rate ratio 0.32 (95% CI 0.13; 0.79), p = 0.0131. The proportion of patients with adverse events was similar in both treatment arms.
Insulin intensification with BIAsp 30 and basal-bolus showed an improvement in glycemic control; the change in HbA was statistically significantly lower for BIAsp 30 compared to basal-bolus. Basal-bolus treatment was accompanied by a numerically, and statistically significantly, higher rate of overall and nocturnal severe or BG-confirmed hypoglycemia, respectively, compared with BIAsp 30.
Novo Nordisk A/S.
ClinicalTrials.gov identifier, NCT02453685.
这项为期32周的开放标签、随机、平行组、多国试验旨在比较门冬胰岛素30（BIAsp 30）逐步强化胰岛素治疗与基础-餐时胰岛素强化治疗方案在初治2型糖尿病（T2D）成人患者中的疗效和安全性，这些患者继续接受二甲双胍和磺脲类药物的治疗前治疗。
T2D成人患者被随机分为两个治疗组之一，为期32周：（1）BIAsp 30每日一次（OD），可逐步强化治疗至BIAsp 30每日三次（TID）；（2）甘精胰岛素OD，可逐步强化治疗至门冬胰岛素每日三次。主要终点是32周后糖化血红蛋白（HbA）相对于基线的变化。
32周后，BIAsp 30组（-1.18%）相对于基础-餐时组（-1.36%），HbA相对于基线的估计平均变化在统计学上显著更低[估计治疗差异0.18%；95%置信区间（95%CI）0.01；0.36；p<0.05]。HbA低于7.0%的患者比例，BIAsp 30组（42.9%）与基础-餐时组（56.9%）相比在统计学上显著更低（比值比0.58；95%CI 0.37；0.89；p=0.01）。BIAsp 30组严重或血糖（BG）确诊的低血糖事件总体发生率在数值上低于基础-餐时组，并且观察到BIAsp 30组夜间严重或BG确诊的低血糖发生率相对于基础-餐时组在统计学上显著更低：估计发生率比值0.32（95%CI 0.13；0.79），p=0.0131。两个治疗组不良事件患者比例相似。
BIAsp 30和基础-餐时胰岛素强化治疗均显示血糖控制有所改善；与基础-餐时组相比，BIAsp 30组HbA的变化在统计学上显著更低。与BIAsp 30组相比，基础-餐时治疗总体和夜间严重或BG确诊的低血糖发生率分别在数值上和统计学上显著更高。
诺和诺德公司。
ClinicalTrials.gov标识符，NCT02453685。
