Insulin degludec/insulin aspart versus biphasic insulin aspart 30 twice daily in insulin‐experienced Japanese subjects with uncontrolled type 2 diabetes: Subgroup analysis of a Pan‐Asian, treat‐to‐target Phase 3 Trial

• Published in: Journal of diabetes Vol. 9; no. 3; pp. 243 - 247
• Main Authors: Taneda, Shinji, Hyllested‐Winge, Jacob, Gall, Mari‐Anne, Kaneko, Shizuka, Hirao, Koichi
• Format: Journal Article
• Language: English
• Published: Australia 01.03.2017
• Subjects: Aged; Asian Continental Ancestry Group; Biphasic Insulins - adverse effects; Biphasic Insulins - therapeutic use; Blood Glucose - metabolism; Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - drug therapy; Diabetes Mellitus, Type 2 - ethnology; Diabetic Retinopathy - chemically induced; Drug Administration Schedule; Drug Therapy, Combination; Female; Glycated Hemoglobin A - metabolism; glycemic control; Humans; Hypertension - chemically induced; Hypoglycemic Agents - adverse effects; Hypoglycemic Agents - therapeutic use; Insulin Aspart - adverse effects; Insulin Aspart - therapeutic use; insulin degludec/insulin aspart; Insulin, Isophane - adverse effects; Insulin, Isophane - therapeutic use; Insulin, Long-Acting - adverse effects; Insulin, Long-Acting - therapeutic use; Male; Metformin - adverse effects; Metformin - therapeutic use; Middle Aged; Nasopharyngitis - chemically induced; nocturnal hypoglycemia; Treatment Outcome; 血糖控制,德谷胰岛素/门冬胰岛素,夜间低血糖; insulin degludec/insulin aspart; nocturnal hypoglycemia; glycemic control; 血糖控制,德谷胰岛素/门冬胰岛素,夜间低血糖
• ISSN: 1753-0393; 1753-0407
• DOI: 10.1111/1753-0407.12407

Background The present study was a subgroup analysis of a Pan‐Asian Phase 3 open‐label randomized treat‐to‐target trial evaluating insulin degludec/insulin aspart (IDegAsp) and biphasic insulin aspart 30 (BIAsp 30) in Japanese subjects with type 2 diabetes inadequately controlled on insulin. Methods Eligible subjects (n = 178) were randomized (2: 1) to twice‐daily (b.i.d.) IDegAsp or BIAsp 30 with or without metformin for 26 weeks, titrated to a blood glucose target of between 3.9 and <5.0 mmol/L. Changes in HbA1c, the proportion of responders reaching the HbA1c target, and changes in fasting plasma glucose, nine‐point self‐monitored plasma glucose profiles, and body weight were assessed. Results At 26 weeks, the decrease in HbA1c was similar in both groups. Fasting plasma glucose was lower with IDegAsp than BIAsp 30 (estimated treatment difference −1.50 mmol/L; 95 % confidence interval [CI] −1.98, −1.01). Overall confirmed hypoglycemia rates were similar; the nocturnal confirmed hypoglycemia rate was lower with IDegAsp than BIAsp 30 (estimated rate ratio 0.44; 95 % CI 0.20, 0.99). No severe hypoglycemic episodes were reported. Conclusions The results indicate that IDegAsp b.i.d. improves glycemic control and, compared with BIAsp 30, lowers the rate of nocturnal confirmed hypoglycemia. 背景: 当前这项研究是一项在既往使用胰岛素治疗控制不佳的日本2型糖尿病受试者中进行的旨在评估德谷胰岛素/门冬胰岛素(IDegAsp)与双相门冬胰岛素30(BIAsp 30)的随机、开放标签、泛亚达标治疗3期试验的亚组分析。 方法: 入选的受试者(n = 178) 被随机(2: 1)分配到每日2次(b.i.d.)注射IDegAsp组或者BIAsp 30组,联用或者不联用二甲双胍,共治疗了26周,逐渐滴定胰岛素的剂量直到血糖达到3.9至 < 5.0 mmol/L之间的目标值。对HbA1c的变化、达到HbA1c目标值的患者比例、空腹血糖、9点自我监测血糖谱以及体重的变化进行了评估。 结果: 在第26周时,两组患者的HbA1c下降情况相似。IDegAsp组与BIAsp30组相比空腹血糖更低(估计治疗差异为‐1.50 mmol/L;95%可信区间[CI] ‐1.98,‐1.01)。两组患者总的经过证实的低血糖发生率相似;IDegAsp组与BIAsp30组相比夜间低血糖的发生率更低(估计发生率的比值为0.44;95% CI为0.20,0.99)。没有严重低血糖事件报告。 结论: 研究结果表明,与BIAsp30相比,IDegAsp b.i.d.能够明显改善血糖控制,减少经过证实的夜间低血糖发生率。 Change in observed mean (a) HbA1c levels and (b) fasting plasma glucose (FPG) levels over 26 weeks' treatment with insulin degludec/insulin aspart (IDegAsp) b.i.d. and biphasic insulin aspart 30/70 (BIAsp 30) b.i.d. The gray horizontal line indicates the responder endpoint (7.0 %). Graphs show mean ± SE data, whereas values above symbol are presented as the mean ± SD. SE, standard error; SD, standard deviation.