甘精胰岛素治疗2型糖尿病有效性及安全性的多中心临床研究

Efficacy and safety of glargine in the treatment of type 2 diabetes： a multi-center, open-labeled and self-controlled clinical study

目的观察对于尚未使用胰岛素治疗血糖控制不佳的2型糖尿病患者，启动甘精胰岛素治疗的有效性、安全性和可行性。方法为多中心、开放性、自身对照的临床观察性研究，共22个研究中心565例2型糖尿病患者参与。患者在0～3种口服降糖药治疗的基础上联合应用甘精胰岛素治疗12周后，评价甘精胰岛素治疗的有效性和安全性。结果受试者平均糖化血红蛋白（Hb）A1C由基线时的8．0％±0．99％下降至6．3％±0．64％（P〈0．01）。以HbA1c〈6．5％以及〈7．0％为目标值，达标率分别为66．55％和87．61％。患者全天7点血糖包括3餐前血糖、3餐后血糖及睡前血糖均得到明显改善。治疗期间有92例（16．3％）受试者发生低血糖事件129次，均为一般性低血糖，发生率为0．91次／（患者·年）。体重及体重指数均有所下降；无肝、肾功能损伤，其他不良反应轻微。结论对于经单纯生活方式干预或口服降糖药治疗血糖控制不佳的2型糖尿病患者，早期启动甘精胰岛素作为胰岛素的起始治疗用药，可使大多数患者安全、有效地达标。

Objective To investigate the efficacy and safety of glargine in the treatment of type 2 diabetic patients. Methods 565 type 2 diabetic patients with inadequate glycemic control by 0-3 kinds of oral hypoglycemic drugs were included in this muhi-center, open-labeled and self-controlled clinical study. Glargine was added to these patients for 12 weeks. The efficacy and safety of glargine were investigated. Results After treatment by gargine for 12 weeks, HbA1 c of these patients decreased from 8.0% ± 0.99% to 6.3%±0.64% （P 〈0.01 ） ,and 66.55% patients obtained the target of HbAlc 〈 6.5% ,87.61% obtained the target of HbA1 c 〈 7.0% o The blood glucose profile,including fasting blood glucose and postprandial blood glucose ,was improved significantly. During treatment period, 92 patients （ 16.3% ） experienced with 239 times of hypoglycemia, and no serious hypoglycemia was evident. Conclusion Glargine is efficient and safe as initial insulin in the treatment of type 2 diabetic patients who are poorly controlled by life style intervention or oral hypoglyeemic agents.