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首页> 外文期刊>The Journal of pharmacy technology: jPT : official publication of the Association of Pharmacy Technicians >U300 Insulin Glargine: A Novel Basal Insulin for Type I and Type 2 Diabetes
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U300 Insulin Glargine: A Novel Basal Insulin for Type I and Type 2 Diabetes

机译：U300胰岛素甘精胰岛素：适用于I型和2型糖尿病的新型基础胰岛素

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Objective: To review clinical efficacy and safety of insulin glargine 300 units/mL (Gla-300), a novel high-concentration basal insulin. Data Sources: A MEDLINE search was performed to identify relevant articles published I960 through February 2015 using the search term glargine 300. Published ^w>s from conference proceedings of the American Diabetes Association 74th Scientific Sessions were identified. Study Selection and Data Extraction: Human studies that evaluated pharmacokinetics, efficacy, or safety of Gla-300 were included. Data Synthesis: Six trials investigated efficacy and safety of Gla-300; 3 of 6 trials were available in ^w> form only. The EDITION group of trials compared Gla-300 to insulin glargine 100 units/mL (Gla-100) in several populations. These included subjects with type I diabetes continuing mealtime insulin and subjects with type 2 diabetes on basal and mealtime insulin, basal insulin and oral antidiabetic drugs (OADs), and with no prior insulin use. Three studies were multinational including 2 studies exclusive to Japanese participants. Each clinical trial was an open-label, multicenter, randomized study with 6 to 12 months of follow-up. Gla-300 demonstrated similar reductions in HbA compared to Gla-100. Basal insulin requirements increased by 11% to 17% with Gla-300 without excessive weight gain. Rates of overall hypoglycemia were similar with Gla-300 compared to Gla-100; however, 16% to 38% less nocturnal hypoglycemia was observed in type 2 clinical trials. Conclusions: Gla-300 in combination with mealtime insulin or OADs has shown comparable glycemic control with higher insulin dose requirements versus Gla-100, and may induce less hypoglycemia in patients with type 2 diabetes.
机译：目的：综述新型高浓度基础胰岛素甘精胰岛素300单位/ mL（Gla-300）的临床疗效和安全性。数据来源：进行MEDLINE搜索，以使用搜索词glargine 300识别出I960年至2015年2月发表的相关文章。确定了来自美国糖尿病协会第74届科学会议会议记录的已发表论文。研究选择和数据提取：包括评估Gla-300的药代动力学，功效或安全性的人体研究。数据综合：六项试验研究了Gla-300的功效和安全性。 6个试验中的3个仅以^ w>形式提供。版本组的试验在多个人群中比较了Gla-300与甘精胰岛素100单位/ mL（Gla-100）。这些对象包括患有I型糖尿病的持续进餐胰岛素的受试者和患有2型糖尿病的基础和进餐胰岛素，基础胰岛素和口服抗糖尿病药（OAD），并且以前没有使用胰岛素的受试者。三项研究属于跨国研究，其中两项研究仅针对日本参与者。每个临床试验都是一项开放标签，多中心，随机研究，随访6至12个月。与Gla-100相比，Gla-300的HbA减少量相似。 Gla-300可使基础胰岛素需求增加11％至17％，而不会增加体重。与Gla-100相比，Gla-300的总体低血糖发生率相似。但是，在2型临床试验中，夜间低血糖症的发生率降低了16％至38％。结论：Gla-300与餐前胰岛素或OADs的结合已显示出与Gla-100相比可比的血糖控制和更高的胰岛素剂量需求，并且可能在2型糖尿病患者中引起较少的低血糖症。

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