Medical University of Gdańsk, Department of Hypertension and Diabetology, Debinki 7, 80-211 Gdansk, Poland.
Expert Opin Drug Saf. 2013 Mar;12(2):137-44. doi: 10.1517/14740338.2013.761971. Epub 2013 Jan 7.
Type 2 diabetes mellitus is characterized by hyperglycaemia. Incidence and progression of microvascular complications have been shown to undergo reduction with lowered glucose levels.
This is an open-label, non-randomized, non-interventional, observational study of safety and efficacy of BiAsp 30, enrolling 2223 patients with type 2 diabetes mellitus. Patients previously treated with oral antidiabetic drugs and/or human insulin were recruited, provided they had been hospitalized for at least 3 days. Data were collected during a single multi-stage visit lasting up to 6 days, during the patient's hospitalization period. A mild hypoglycaemic episode was defined as blood glucose measurement < 56 mg/dL (3.1 mmol/L). A severe hypoglycaemia was hypoglycaemic episode requiring assistance of another person.
The total number of hypoglycaemic episodes decreased over time of follow-up. The intensity of severe hypoglycaemic episodes decreased by almost a third from day to day (IRR = 0.64, 95%, p < 0.001). However, intensity of mild hypoglycaemic episodes was the same over the subsequent days of follow-up (IRR = 0.97, p > 0.1). Mean blood glucose concentration decreased from 202.0 mg/dL to 157.8 mg/dL after 3 days and to 138.3 mg/dL after 6 days (p < 0.001).
This study highlights the safety, efficacy and ease of initiation of insulin BiAsp 30 therapy for treatment of type 2 diabetes mellitus.
2 型糖尿病的特征是高血糖。已经表明，降低血糖水平可以减少微血管并发症的发生和进展。
这是一项针对安全性和疗效的开放标签、非随机、非干预性、观察性研究，共纳入 2223 例 2 型糖尿病患者。入组患者之前接受过口服降糖药和/或人胰岛素治疗，前提是他们至少住院 3 天。数据在单次多阶段就诊期间收集，持续长达 6 天，在此期间患者住院。轻度低血糖发作定义为血糖测量值<56mg/dL（3.1mmol/L）。严重低血糖是指需要他人协助的低血糖发作。
随着随访时间的延长，低血糖发作的总次数逐渐减少。严重低血糖发作的强度每天下降近三分之一（IRR=0.64，95%，p<0.001）。然而，随后几天的轻度低血糖发作强度相同（IRR=0.97，p>0.1）。治疗 3 天后，平均血糖浓度从 202.0mg/dL 降至 157.8mg/dL，治疗 6 天后降至 138.3mg/dL（p<0.001）。
这项研究强调了胰岛素 BiAsp 30 治疗 2 型糖尿病的安全性、疗效和起始治疗的便利性。
