Zafar Mohammad Ishraq, Ai Xinquan, Shafqat Raja Adeel, Gao Feng
Department of Endocrinology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People's Republic of China.
Zhijiang Petrochemical Hospital, Zhijiang, People's Republic of China.
Ther Clin Risk Manag. 2014 Dec 19;11:27-32. doi: 10.2147/TCRM.S75602. eCollection 2015.
Humalog Mix 75/25 insulin analog is widely used in the People's Republic of China to treat type 2 diabetes mellitus, but the Humalog Mix 50/50 analog is not as yet widely used or assessed. The purpose of this 12-week, parallel-group, randomized, treat-to-target study was to evaluate the difference in clinical efficacy, safety, and outcome of treatment between Humalog Mix 50/50 and Humalog Mix 75/25 analogs in Chinese patients with type 2 diabetes mellitus. In total, 146 insulin-naïve patients with type 2 diabetes mellitus and aged 18-75 years were randomized and treated twice a day with either Humalog Mix 50/50 (group A) or Humalog Mix 75/25 (group B). We monitored levels of fasting blood glucose, 2-hour postprandial blood glucose, and glycosylated hemoglobin (HbA1c) in patients in both groups prior to and 3 months post treatment, the average time to achieve target blood glucose level, and frequency of hypoglycemic episodes during treatment. We found that group A showed better glycemic control as per fasting blood glucose and 2-hour postprandial blood glucose than group B. Moreover, HbA1c levels in group A (5.5%±1.4%) were lower by 1.0%±0.1% (P<0.05) compared with those in group B (6.5%±1.5%). The time to achieve glucose control was shorter (P<0.05) in group A (12.6±3.6 days) than in group B (22.3±4.7 days). Regarding safety, no significant adverse events or severe hypoglycemia on treatment was observed in either group. Additionally, the 1:1 ratio of Humalog Mix 50/50 showed a trend towards fewer episodes of nocturnal hypoglycemia. Thus, compared with Humalog Mix 75/25, the high-proportion premix insulin analog, Humalog Mix 50/50 showed better glycemic control, achieved target blood glucose levels more rapidly and without an increase in hypoglycemic episodes in Chinese type 2 diabetic individuals and is recommended for use in clinical practice.
优泌乐 75/25 胰岛素类似物在中国被广泛用于治疗 2 型糖尿病，但优泌乐 50/50 类似物尚未得到广泛应用或评估。这项为期 12 周的平行组、随机、达标治疗研究的目的是评估优泌乐 50/50 和优泌乐 75/25 类似物在中国 2 型糖尿病患者中的临床疗效、安全性及治疗结局的差异。共有 146 例年龄在 18 - 75 岁、既往未使用过胰岛素的 2 型糖尿病患者被随机分组，分别接受优泌乐 50/50（A 组）或优泌乐 75/25（B 组）每日两次的治疗。我们监测了两组患者治疗前及治疗后 3 个月的空腹血糖、餐后 2 小时血糖及糖化血红蛋白（HbA1c）水平、达到目标血糖水平的平均时间以及治疗期间低血糖发作的频率。我们发现，A 组在空腹血糖和餐后 2 小时血糖方面的血糖控制情况优于 B 组。此外，A 组的 HbA1c 水平（5.5%±1.4%）比 B 组（6.5%±1.5%）低 1.0%±0.1%（P<0.05）。A 组达到血糖控制的时间（12.6±3.6 天）比 B 组（22.3±4.7 天）短（P<0.05）。在安全性方面，两组均未观察到显著的不良事件或治疗期间的严重低血糖。此外，优泌乐 50/50 的 1:1 比例显示夜间低血糖发作次数有减少的趋势。因此，与优泌乐 75/25 相比，高比例预混胰岛素类似物优泌乐 50/50 在 Chinese 2 型糖尿病患者中显示出更好的血糖控制效果，能更快达到目标血糖水平且不增加低血糖发作次数，推荐用于临床实践。 （注：原文中“Chinese”表述有误，结合语境这里应是“中国的”意思，英文为“Chinese”，但中文译文里不应保留错误表述，可改为“中国的”）
