A 1-year, prospective, observational study of Japanese outpatients with type 1 and type 2 diabetes switching from insulin glargine or detemir to insulin degludec in basal-bolus insulin therapy (Kumamoto Insulin Degludec Observational study).
A 1-year, prospective, observational study of Japanese outpatients with type 1 and type 2 diabetes switching from insulin glargine or detemir to insulin degludec in basal-bolus insulin therapy (Kumamoto Insulin Degludec Observational study).
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DOI：
10.1111/jdi.12496
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发表时间：
2016-09
影响因子：
3.2
通讯作者：
Kumamoto Insulin Degludec Observational (KIDUNA) Study Group
中科院分区：
文献类型：
--
作者：
Shimoda S;Sato M;Sekigami T;Motoshima H;Yoshimura R;Fukuda K;Matsuo Y;Noda H;Okubo M;Ichimori S;Fujisawa K;Fukunaga M;Araki E;Kumamoto Insulin Degludec Observational (KIDUNA) Study Group
本前瞻性观察性研究的目的是评估日本1型或2型糖尿病患者在常规临床实践中将去糖葡糖苷胰岛素作为基础灌注治疗的一部分的长期疗效和安全性。在本研究中，93例1型糖尿病患者和135例使用甘精胰岛素或地特米尔治疗的2型糖尿病患者从基础胰岛素切换到degludec胰岛素。主要终点是3、6和12个月时糖化血红蛋白（HbA1c）较基线的变化。次要终点是体重指数、胰岛素剂量、低血糖发生频率和不良事件的变化。在3、6和12个月时，1型糖尿病患者的HbA1c水平分别显著降低0.4、0.4和0.3%，2型糖尿病患者的HbA1c水平分别显著降低0.5、0.5和0.3%。1型糖尿病患者体质量指数显著升高（P < 0.05）， 2型糖尿病患者体质量指数无明显变化。转换后3个月基础胰岛素剂量显著降低（P < 0.05）， 1型糖尿病和2型糖尿病患者在12个月时恢复基线剂量。1型糖尿病和2型糖尿病患者发生总低血糖和夜间低血糖的频率均显著降低（P < 0.05）。多元回归分析结果显示，基线HbA1c是HbA1c随切换百分比变化的显著自变量。在1型糖尿病和2型糖尿病患者中，从甘精胰岛素或地特胰岛素切换到降葡萄糖胰岛素可改善血糖控制，显著降低低血糖。
The aim of the present prospective observational study was to assess long‐term efficacy and safety of insulin degludec as a part of a basal–bolus therapy for Japanese patients with type 1 or type 2 diabetes in routine clinical practice. In the present study, 93 type 1 diabetes patients and 135 type 2 diabetes patients treated with insulin glargine or detemir were switched from their basal insulin to insulin degludec. The primary end‐points were the changes in glycated hemoglobin (HbA1c) from baseline at 3, 6 and 12 months. The secondary end‐points were changes in body mass index, insulin dose, frequency of hypoglycemia and adverse events. HbA1c levels from baseline were significantly reduced at 3, 6, and 12 months by 0.4, 0.4 and 0.3% in type 1 diabetes patients, respectively, and by 0.5, 0.5 and 0.3% in type 2 diabetes patients, respectively. Body mass index in type 1 diabetes patients increased significantly (P < 0.05), whereas that in type 2 diabetes patients did not change. Basal insulin dose decreased significantly at 3 months after switching (P < 0.05), and returned baseline dose at 12 months in type 1 diabetes and type 2 diabetes patients. The frequency of both total and nocturnal hypoglycemia decreased significantly in type 1 diabetes and type 2 diabetes patients (P < 0.05). The result of multiple regression analysis showed that baseline HbA1c was a significant independent variable of the percentage change in HbA1c with switching. In both type 1 diabetes and type 2 diabetes patients, switching from insulin glargine or insulin detemir to insulin degludec led to improvement of glycemic control with a significant reduction of hypoglycemia.
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DOI：
10.1210/jc.2012-3249
发表时间：
2013-03
期刊：
The Journal of clinical endocrinology and metabolism
影响因子：
--
作者：
Mathieu C;Hollander P;Miranda-Palma B;Cooper J;Franek E;Russell-Jones D;Larsen J;Tamer SC;Bain SC;NN1250-3770 (BEGIN: Flex T1) Trial Investigators
通讯作者：
NN1250-3770 (BEGIN: Flex T1) Trial Investigators
影响因子：
3.5
作者：
Bode, B. W.;Buse, J. B.;Heller, S. R.
通讯作者：
Heller, S. R.
影响因子：
3.8
作者：
Kusunoki, Yoshiki;Katsuno, Tomoyuki;Namba, Mitsuyoshi
通讯作者：
Namba, Mitsuyoshi
影响因子：
5.8
作者：
Heise, T.;Nosek, L.;Haahr, H.
通讯作者：
Haahr, H.
影响因子：
3
作者：
Nakae, Rie;Kusunoki, Yoshiki;Namba, Mitsuyoshi
通讯作者：
Namba, Mitsuyoshi