Comparison of Insulin Detemir and Insulin Glargine in a Basal-Bolus Regimen, With Insulin Aspart as the Mealtime Insulin, in Patients With Type 1 Diabetes: A 52-Week, Multinational, Randomized, Open-Label, Parallel-Group, Treat-to-Target Noninferiority Trial
Comparison of Insulin Detemir and Insulin Glargine in a Basal-Bolus Regimen, With Insulin Aspart as the Mealtime Insulin, in Patients With Type 1 Diabetes: A 52-Week, Multinational, Randomized, Open-Label, Parallel-Group, Treat-to-Target Noninferiority Trial
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DOI：
10.1016/j.clinthera.2009.10.006
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发表时间：
2009-10-01
影响因子：
3.2
通讯作者：
Bode, Bruce
中科院分区：
文献类型：
--
作者：
Heller, Simon;Koenen, Christoph;Bode, Bruce
目的：主要研究目的是确定地特胰岛素（地特胰岛素）是否非劣效于甘精胰岛素在基础-餐时胰岛素方案中，以甘精胰岛素作为基础胰岛素，门冬胰岛素作为餐时胰岛素，在52周结束时对I型糖尿病（T1 DM）患者进行血糖控制。这项多国、开放标签、平行组、达标治疗、非劣效性试验招募了年龄≥ 18岁且患有T1 DM至少12个月的患者，已接受基础-餐时胰岛素方案至少3个月，并具有糖化血红蛋白（HbA（1c））值
Objective: The primary study objective was to determine whether insulin detemir (detemir) was noninferior to insulin glargine (glargine) as the basal insulin in a basal-bolus regimen, with insulin aspart as the mealtime insulin, in terms of glycemic control at the end of 52 weeks in patients with type I diabetes mellitus (T1DM).Methods: This multinational, open-label, parallel-group, treat-to-target, noninferiority trial enrolled patients aged >= 18 years who had had T1DM for at least 12 months, had been taking a basal-bolus insulin regimen for at least 3 months, and had a glycosylated hemoglobin (HbA(1c)) value