The treat-to-target trial - Randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients
The treat-to-target trial - Randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients
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DOI：
10.2337/diacare.26.11.3080
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发表时间：
2003-11-01
期刊：
影响因子：
16.2
通讯作者：
Gerich, J
中科院分区：
文献类型：
--
作者：
Riddle, MC;Rosenstock, J;Gerich, J
目的：比较甘精胰岛素和人NPH胰岛素在2型糖尿病口服治疗中达到7%HBA(1c)的能力和相关的低血糖风险。研究设计和方法：在一项随机、开放、平行、24周的多中心试验中，756名血糖控制不佳的超重男性和女性(HbA(1c)和GT；7.5%)继续服用研究前口服药物，每天睡前服用一次甘精胰岛素或NPH，用一种简单的算法寻找空腹血糖小于或等于100 mg/dl(5.5 mmol/L)的目标。观察指标为空腹血糖、糖化血红蛋白(1c)、低血糖以及糖化血红蛋白(1c)低于或等于7%且无夜间低血糖记录的患者。结果：终点的平均空腹血糖与甘精和非精氨酸相似(117vs.120 mg/dl[6.5vs.6.7 mmol/L])，糖化血红蛋白(1c)(6.96%vs.6.97%)。大多数患者(接近60%)每种胰岛素类型的HBA(1c)小于或等于7%。然而，在没有记录的夜间低血糖(小于或等于72 mg/dl[4.0 mmol/L])的患者中，有近25%的患者在服用甘精素后达到这一水平(33.2vs.26.7%，P<；0.05)。此外，服用甘精胰岛素后，其他类型的症状性低血糖的发生率降低了21-48%。结论在口服治疗的基础上系统滴定基础胰岛素，可以安全地使大多数超重的2型糖尿病患者口服HBA(1c)在7.5%-10.0%之间，达到7%的HBA(1c)。只有特工一人。在这一过程中，甘精油引起的夜间低血糖明显低于NPH，从而减少了启动胰岛素的主要障碍。这一简单的方案可能有助于在常规医疗实践中更早、更有效地使用胰岛素，提高糖尿病治疗的推荐标准。
OBJECTIVE - To compare the abilities and associated hypoglycemia risks of insulin glargine and human NPH insulin added to oral therapy of type 2 diabetes to achieve 7% HbA(1c).RESEARCH DESIGN AND METHODS - In a randomized, open-label, parallel, 24-week multicenter trial, 756 over-weight men and women with inadequate glycemic control (HbA(1c) > 7.5%) on one or two oral agents continued prestudy oral agents and received bedtime glargine or NPH once daily, titrated using a simple algorithm seeking a target fasting plasma glucose (FPG) less than or equal to 100 mg/dl (5.5 mmol/l). Outcome measures were,FPG, HbA(1c), hypoglycemia, and percentage of patients reaching HbA(1c) less than or equal to 7% without documented nocturnal hypoglycemia.RESULTS - Mean FPG at end point was similar with glargine and NPH (117 vs. 120 mg/dl [6.5 vs. 6.7 mmol/l]), as was HbA(1c) (6.96 vs. 6.97%). A majority of patients (similar to60%) attained HbA(1c) less than or equal to 7% with each insulin type. However, nearly 25% more patients attained this without documented nocturnal hypoglycemia (less than or equal to 72 mg/dl [4.0 mmol/l]) with glargine (33.2 vs. 26.7%, P < 0.05). Moreover, rates of other categories of symptomatic hypoglycemia were 21-48% lower with glargine.CONCLUSIONS - Systematically titrating bedtime basal insulin added to oral therapy can safely achieve 7% HbA(1c) in a majority of overweight patients with type 2 diabetes with HbA(1c) between 7.5 and 10.0% on oral. agents alone. In doing this, glargine causes significantly less nocturnal hypoglycemia than NPH, thus reducing a leading barrier to initiating insulin. This simple regimen may facilitate earlier and effective insulin use in routine medical practice, improving achievement of recommended standards of diabetes care.