Raskin P, Klaff L, Bergenstal R, Hallé J P, Donley D, Mecca T
Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas 75930-8853, USA.
Diabetes Care. 2000 Nov;23(11):1666-71. doi: 10.2337/diacare.23.11.1666.
To determine the safety and efficacy of the long-acting insulin analog, insulin glargine, as a component of basal bolus therapy in patients with type 1 diabetes.
Patients with type 1 diabetes receiving basal-bolus insulin treatment with NPH human insulin and insulin lispro were randomized to receive insulin glargine (HOE 901), a long-acting basal insulin analog, once a day (n = 310) or NPH human insulin (n = 309) as basal treatment with continued bolus insulin lispro for 16 weeks in an open-label study NPH insulin patients maintained their prior schedule of administration once or twice a day, whereas insulin glargine patients received basal insulin once a day at bedtime.
Compared with all NPH insulin patients, insulin glargine patients had significant decreases in fasting blood glucose measured at home (means +/- SEM, -42.0 +/- 4.7 vs. -12.4 +/- 4.7 mg/dl [-2.33 +/- 0.26 vs. -0.69 +/- 0.26 mmol/l]; P = 0.0001). These differences were evident early and persisted throughout the study More patients in the insulin glargine group (29.6%) than in the NPH group (16.8%) reached a target fasting blood glucose of 119 mg/dl (< 6.6 mmol/l). However, there were no differences between the groups with respect to change in GHb. Insulin glargine treatment was also associated with a significant decrease in the variability of fasting blood glucose values (P = 0.0124). No differences in the occurrence of symptomatic hypoglycemia, including nocturnal hypoglycemia, were observed. Overall, adverse events were similar in the two treatment groups with the exception of injection site pain, which was more common in the insulin glargine group (6.1%) than in the NPH group (0.3%). Weight gain was 0.12 kg in insulin glargine patients and 0.54 kg in NPH insulin patients (P = 0.034).
Basal insulin therapy with insulin glargine once a day appears to be as safe and at least as effective as using NPH insulin once or twice a day in maintaining glycemic control in patients with type 1 diabetes receiving basal-bolus insulin treatment with insulin lispro.
确定长效胰岛素类似物甘精胰岛素作为基础-餐时胰岛素治疗方案的一部分，用于1型糖尿病患者的安全性和有效性。
接受中效人胰岛素和赖脯胰岛素基础-餐时胰岛素治疗的1型糖尿病患者，在一项开放标签研究中被随机分为两组，一组每天一次接受长效基础胰岛素类似物甘精胰岛素（HOE 901）治疗（n = 310），另一组接受中效人胰岛素治疗（n = 309），同时继续使用赖脯胰岛素进行餐时胰岛素治疗，为期16周。中效胰岛素组患者维持其之前每天一次或两次的给药方案，而甘精胰岛素组患者在睡前每天接受一次基础胰岛素治疗。
与所有中效胰岛素组患者相比，甘精胰岛素组患者在家中测量的空腹血糖显著降低（均值±标准误，-42.0±4.7 vs. -12.4±4.7 mg/dl [-2.33±0.26 vs. -0.69±0.26 mmol/l]；P = 0.0001）。这些差异在研究早期就很明显，并持续整个研究过程。甘精胰岛素组达到空腹血糖目标值119 mg/dl（< 6.6 mmol/l）的患者比例（29.6%）高于中效胰岛素组（16.8%）。然而，两组之间糖化血红蛋白的变化没有差异。甘精胰岛素治疗还与空腹血糖值的变异性显著降低相关（P = 0.0124）。在有症状低血糖（包括夜间低血糖）的发生方面未观察到组间差异。总体而言，除注射部位疼痛外，两个治疗组的不良事件相似，注射部位疼痛在甘精胰岛素组（6.1%）比中效胰岛素组（0.3%）更常见。甘精胰岛素组患者体重增加0.12 kg，中效胰岛素组患者体重增加0.54 kg（P = 0.034）。
对于接受赖脯胰岛素基础-餐时胰岛素治疗的1型糖尿病患者，每天一次使用甘精胰岛素进行基础胰岛素治疗，在维持血糖控制方面似乎与每天一次或两次使用中效胰岛素一样安全且至少同样有效。
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