1 Peking University First Hospital , Beijing, China .
2 Peking University People's Hospital , Beijing, China .
Diabetes Technol Ther. 2017 Nov;19(11):675-684. doi: 10.1089/dia.2017.0111. Epub 2017 Nov 1.
The Observational Registry of Basal Insulin Treatment (ORBIT) study evaluated the safety of basal insulin (BI) in real-world settings in China.
We analyzed 9002 patients with type 2 diabetes (T2D) inadequately controlled with oral hypoglycemic agents from 8 geographic regions and 2 hospital tiers in China who initiated and maintained BI treatment. Body weight and hypoglycemic episodes were recorded at baseline and 3 and 6 months. Serious adverse events (SAEs) were recorded at 3 and 6 months.
Age, gender, inpatient/outpatient status, body mass index, glycated hemoglobin (HbA1c) at baseline and at the end of study, T2D duration, microvascular complications, BI type, combination with insulin secretagogues, self-monitoring of blood glucose frequency, and insulin dosage, all predicted hypoglycemia. BI use generally did not induce significant weight gain (0.02 kg); weight gain with insulin detemir (-0.30 kg) was less than that with neutral protamine Hagedorn (NPH) insulin (0.20 kg) or insulin glargine (0.05 kg). Overall, general hypoglycemia incidence (5.6% vs. 7.7%) and annual event rate (1.6 vs. 1.8) were similar before and after BI initiation, whereas a slight decrease was noted in severe hypoglycemia incidence (0.6%-0.3%) and frequency (0.05-0.03 events/patient-year). The general hypoglycemia rate was lowest with insulin glargine, whereas there was no significant difference in severe hypoglycemia among the three BI groups. Overall, 3.5% of patients had at least one SAE during the study. Most SAEs were found to be unrelated to BI treatment.
Real-world BI use, particularly insulin detemir and glargine, was associated with only slight weight gain and low hypoglycemia risk in patients with T2D in China.
观察性基础胰岛素治疗注册研究（ORBIT）评估了基础胰岛素（BI）在真实环境下在中国的安全性。
我们分析了来自中国 8 个地理区域和 2 个医院级别的 9002 例口服降糖药控制不佳的 2 型糖尿病（T2D）患者，他们开始并维持 BI 治疗。体重和低血糖发作在基线和 3 个月和 6 个月时记录。严重不良事件（SAE）在 3 个月和 6 个月时记录。
年龄、性别、住院/门诊状态、体重指数、糖化血红蛋白（HbA1c）在基线和研究结束时、T2D 病程、微血管并发症、BI 类型、与胰岛素促分泌剂联合使用、自我监测血糖的频率和胰岛素剂量均预测低血糖。BI 一般不会引起明显的体重增加（0.02kg）；与中性鱼精蛋白锌胰岛素（NPH）胰岛素（0.20kg）或甘精胰岛素（0.05kg）相比，使用胰岛素地特胰岛素（0.30kg）引起的体重增加更少。总体而言，BI 起始前后一般低血糖发生率（5.6%比 7.7%）和年事件发生率（1.6 比 1.8）相似，严重低血糖发生率（0.6%-0.3%）和频率（0.05-0.03 次/患者年）略有下降。甘精胰岛素的一般低血糖发生率最低，而三种 BI 组之间严重低血糖无显著差异。总体而言，研究期间 3.5%的患者至少发生一次 SAE。大多数 SAE 被认为与 BI 治疗无关。
在真实世界中，BI 的使用，特别是地特胰岛素和甘精胰岛素，与中国 T2D 患者的体重增加轻微和低血糖风险低有关。
