AIM To evaluate the effectiveness and safety of initiating basal insulin-supported oral therapy (BOT) with insulin glargine 300 U/mL (Gla-300) in patients with type 2 diabetes inadequately controlled on oral antidiabetic drugs (OADs). MATERIALS AND METHODS This non-interventional, multi-centre, prospective 52-week study, conducted in Germany and Switzerland, documented patients with type 2 diabetes with an HbA1c of between 7.5% and 10.0%, currently treated with OADs, after the physician had decided to start a BOT regimen with Gla-300. The primary endpoint was the rate of achievement of the individualized predefined HbA1c target. RESULTS Of 1748 patients included, 1153 comprised the full analysis set, of whom 721 completed documentation of 12 months of Gla-300 treatment. Twelve months after starting Gla-300, 49.9% achieved their individualized HbA1c target, and 61.1% achieved either their HbA1c target or a fasting plasma glucose (FPG) of ≤110 mg/dL. Mean HbA1c decreased by -1.22% ± 1.05% to 7.28% ± 0.92% and mean FPG by -51.5 (±48.63) mg/dl to 132.9 ± 33.0 mg/dL. Median duration of HbA1c target achievement was 341 days and probability to remain on target after 6 months was 81%. Hypoglycaemia incidence and rates remained low after 12 months of Gla-300 treatment; no severe or severe nocturnal hypoglycaemia was observed. Body weight remained unchanged. CONCLUSIONS Starting a BOT regimen with Gla-300 allowed about 60% of 721 German and Swiss patients with inadequately controlled type 2 diabetes to achieve glycaemic control within 12 months in daily clinical practice. Glycaemic control was achieved without weight gain or increased risk of nocturnal or severe hypoglycaemia.

中文翻译：

---

在现实世界中口服治疗失败后，未使用过胰岛素的2型糖尿病患者中，甘精胰岛素300 U / mL的有效性和安全性。

目的评估在口服抗糖尿病药物（OADs）控制不佳的2型糖尿病患者中，以甘精胰岛素300 U / mL（Gla-300）开始基础胰岛素支持的口服治疗（BOT）的有效性和安全性。材料和方法在德国和瑞士进行的这项非干预性，多中心，前瞻性的52周研究记录了2型糖尿病患者中HbA1c在7.5％至10.0％之间的情况，目前，在医生对其进行了OAD治疗后决定从Gla-300开始BOT养生。主要终点是个体化预定义HbA1c目标的实现率。结果包括1748例患者，其中1153例患者包含完整的分析集，其中721例患者完成了12个月的Gla-300治疗记录。在开始使用Gla-300的12个月后，即49岁。9％的患者达到了其各自的HbA1c目标，61.1％的患者达到了其HbA1c目标或空腹血糖（FPG）≤110 mg / dL。平均HbA1c下降-1.22％±1.05％至7.28％±0.92％，平均FPG下降-51.5（±48.63）mg / dl至132.9±33.0 mg / dL。HbA1c达到目标的中位时间为341天，六个月后仍保持在目标上的可能性为81％。Gla-300治疗12个月后，低血糖发生率和发生率仍然较低；没有观察到严重或严重的夜间低血糖症。体重保持不变。结论从Gla-300开始BOT方案可以使721位德国和瑞士2型糖尿病控制不佳的患者中的60％在日常临床实践中在12个月内实现血糖控制。