Long-term efficacy and safety of insulin detemir compared to Neutral Protamine Hagedorn insulin in patients with Type 1 diabetes using a treat-to-target basal-bolus regimen with insulin aspart at meals: a 2-year, randomized, controlled trial.
Long-term efficacy and safety of insulin detemir compared to Neutral Protamine Hagedorn insulin in patients with Type 1 diabetes using a treat-to-target basal-bolus regimen with insulin aspart at meals: a 2-year, randomized, controlled trial.
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与中性鱼精蛋白哈格多恩胰岛素相比，地特胰岛素在 1 型糖尿病患者中的长期疗效和安全性采用门冬胰岛素治疗目标基础推注方案：一项为期 2 年的随机对照试验。
DOI：
10.1111/j.1464-5491.2007.02407.x
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发表时间：
2008-04
期刊：
影响因子：
--
通讯作者：
Philotheou A
中科院分区：
文献类型：
--
作者：
Bartley PC;Bogoev M;Larsen J;Philotheou A
这项为期24个月、多国、开放标签、平行组试验采用达标治疗概念，研究了地特胰岛素和中性鱼精蛋白哈格多恩胰岛素联合餐时门冬胰岛素治疗1型糖尿病患者的长期疗效和安全性。患者以2：1的比例随机分配至地特（n = 331）或NPH（n = 166）组。每日（晚上）开始一次基础胰岛素治疗，并根据自测血糖（PG）水平进行个体滴定，目标是早餐前和晚餐前目标≤ 6.0 mmol/l。可根据预先定义的标准添加第二次基础早晨剂量。24个月后，与NPH相比，地特胰岛素实现了糖化血红蛋白（HbA 1c）的优效性（地特胰岛素为7.36%，NPH为7.58%，平均差异为-0.22%）[95%置信区间（CI）为-0.41至-0.03%]，分别降低了0.94%和0.72%。地特米组的空腹PG（FPGlab）也较低（地特米8.35 mmol/l，NPH 9.43 mmol/l; P = 0.019）。在治疗的最后一个月内，22%的地特治疗患者在未发生经证实的低血糖的情况下达到HbA 1c ≤ 7.0%，而NPH组为13%（P = 0.019）。地特胰岛素组严重低血糖和夜间低血糖的风险分别比NPH组低69%和46%（P < 0.001）;地特胰岛素组患者体重增加较少（地特胰岛素1.7 kg，NPH 2.7 kg; P = 0.024）。两组的总体安全性特征相似，地特米治疗未导致任何意外结果。在降低HbA 1c方面，胰岛素类似物地特胰岛素+门冬胰岛素长期治疗优于NPH +门冬胰岛素上级治疗，并具有更少的严重低血糖和夜间低血糖以及更少的体重增加的额外获益。糖尿病Med.25，442-449（2008）
This 24-month, multi-national, open-label, parallel group trial investigated the long-term efficacy and safety of insulin detemir and Neutral Protamine Hagedorn insulin in combination with mealtime insulin aspart in patients with Type 1 diabetes using a treat-to-target concept. Patients were randomized 2 : 1 to detemir (n = 331) or NPH (n = 166) groups. Basal insulin was initiated once daily (evening) and titrated individually based on self-measured plasma glucose (PG) levels, aiming for pre-breakfast and pre-dinner targets ≤ 6.0 mmol/l. A second basal morning dose could be added according to pre-defined criteria. After 24 months, superiority of glycated haemoglobin (HbA1c) was achieved with detemir compared to NPH (detemir 7.36%, NPH 7.58%, mean difference −0.22% points) [95% confidence interval (CI) −0.41 to −0.03%], with reductions of 0.94% and 0.72% points, respectively. Fasting PG (FPGlab) was also lower with detemir (detemir 8.35 mmol/l, NPH 9.43 mmol/l; P = 0.019). Twenty-two per cent of patients treated with detemir reached an HbA1c ≤ 7.0% in the absence of confirmed hypoglycaemia during the last month of treatment vs. 13% on NPH (P = 0.019). Risk of major and nocturnal hypoglycaemia was 69% and 46% lower with detemir than with NPH (P < 0.001), respectively; patients treated with detemir gained less weight (detemir 1.7 kg, NPH 2.7 kg; P = 0.024). The overall safety profile was similar in the two groups and treatment with detemir did not result in any unexpected findings. Long-term treatment with the insulin analogues detemir + aspart was superior to NPH + aspart in reducing HbA1c, with added benefits of less major and nocturnal hypoglycaemia and less weight gain. Diabet. Med. 25, 442–449 (2008)
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影响因子：
1.1
作者：
Morikawa, T;Yoshida, M
通讯作者：
Yoshida, M
影响因子：
5.9
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影响因子：
7.7
作者：
Heise, T;Nosek, L;Draeger, E
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影响因子：
8.2
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Hermansen, K;Fontaine, P;Gall, MA
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Gall, MA
影响因子：
16.2
作者：
Home, P;Bartley, P;Draeger, E
通讯作者：
Draeger, E