Lau Ip Tim, Lee Ka Fai, So Wing Yee, Tan Kathryn, Yeung Vincent Tok Fai
Department of Medicine, Tseung Kwan O Hospital.
Department of Medicine and Geriatrics, Kwong Wah Hospital.
Diabetes Metab Syndr Obes. 2017 Jun 30;10:273-284. doi: 10.2147/DMSO.S131358. eCollection 2017.
To review published clinical studies on the efficacy and safety of new insulin glargine 300 units/mL (Gla-300), a new long-acting insulin analog, for the treatment of type 1 and type 2 diabetes mellitus (T1DM, T2DM).
Data sources comprised primary research articles on Gla-300, including pharmacodynamic, pharmacokinetic, and clinical studies.
In pharmacodynamic and pharmacokinetic studies, Gla-300 showed a flatter time-action profile and longer duration of action than Gla-100. Noninferiority of Gla-300 versus Gla-100 for lowering of glycated hemoglobin was demonstrated in Phase III clinical studies covering a range of T1DM and T2DM patient populations. Over 6-12 months of follow-up, Gla-300 consistently showed comparable glycemic efficacy with less hypoglycemia vs Gla-100, even during the first 8 weeks of treatment. Although titrated insulin doses were 11%-17% higher with Gla-300 vs Gla-100, changes in body weight were similar or favored Gla-300.
Clinical studies provide evidence that the pharmacodynamic and pharmacokinetic properties of Gla-300 may translate into clinical benefits in both T1DM and T2DM. Gla-300 may provide a new option for people initiating basal insulin, those requiring higher basal insulin doses, those with T1DM, and those who may be at increased risk for hypoglycemia, such as people with chronic kidney disease, the elderly, and those with cardiovascular comorbidities.
综述已发表的关于新型长效胰岛素类似物甘精胰岛素300单位/毫升（Gla-300）治疗1型和2型糖尿病（T1DM、T2DM）的疗效和安全性的临床研究。
数据来源包括关于Gla-300的主要研究文章，涵盖药效学、药代动力学和临床研究。
在药效学和药代动力学研究中，Gla-300显示出比Gla-100更平稳的时间-作用曲线和更长的作用持续时间。在涵盖一系列T1DM和T2DM患者群体的III期临床研究中，证实了Gla-300在降低糖化血红蛋白方面不劣于Gla-100。在6至12个月的随访中，Gla-300始终显示出与Gla-100相当的血糖疗效，且低血糖发生率更低，即使在治疗的前8周也是如此。尽管Gla-300的胰岛素滴定剂量比Gla-100高11%-17%，但体重变化相似或更有利于Gla-300。
临床研究提供了证据，表明Gla-300的药效学和药代动力学特性可能转化为T1DM和T2DM的临床益处。Gla-300可能为开始使用基础胰岛素的人群、需要更高基础胰岛素剂量的人群、T1DM患者以及低血糖风险可能增加的人群（如慢性肾脏病患者、老年人和有心血管合并症的患者）提供新的选择。
