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Safety and effectiveness of bolus insulin aspart in people with type 2 diabetes: a1chieve sub-analysis.

机译:推注胰岛素门冬胰岛素在2型糖尿病患者中的安全性和有效性:实现亚分析。

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INTRODUCTION: This sub-analysis evaluated clinical safety and effectiveness ofbolus insulin aspart [with/without oral glucose-lowering drugs (OGLDs)] as theonly insulin therapy.METHODS: A1chieve was an international, multicenter, prospective, open-label,non-interventional, observational, 24-week study in people with type 2 diabetesmellitus starting/switching to biphasic insulin aspart 30, insulin detemir orinsulin aspart treatment (alone/in combination) in routine clinical practice.This sub-analysis evaluated clinical safety and effectiveness of bolus insulinaspart (+-OGLDs) as the only insulin therapy. Data were analyzed for all patients,insulin-experienced and insulin-naive sub-groups, and sub-groups defined by thenumber of OGLDs prescribed at baseline (no OGLDs, one OGLD or >=two OGLDs). Safetyand effectiveness endpoints were assessed at baseline and following 24?weeks'therapy.RESULTS: In total, 2,026 patients were included (insulin-experienced, n?=?561;insulin-naive, n?=?1,465) in this sub-analysis. Significant improvements frombaseline after 24?weeks' treatment with insulin aspart?+-?OGLDs were observedacross all sub-groups for: glycated hemoglobin (range of means across sub-groups -1.6 to -2.4%; p?
机译:简介:本子分析评估了门冬胰岛素(有/无口服降糖药(OGLDs))作为唯一的胰岛素治疗的临床安全性和有效性。方法:A1chieve是国际,多中心,前瞻性,开放标签,非介入治疗,观察性,为期24周的2型糖尿病患者在常规临床实践中开始/转换为双相门冬胰岛素30,地特米尔或门冬胰岛素治疗(单独/联合使用)的评估。该子分析评估了门冬胰岛素的安全性和有效性(+ -OGLDs)作为唯一的胰岛素疗法。分析了所有患者,有胰岛素经验和未使用胰岛素的亚组以及由基线规定的OGLD数量(无OGLD,一个OGLD或> =两个OGLD)定义的亚组的数据。在基线和治疗24周后评估安全性和有效性终点。结果:本子分析共纳入2,026例患者(有胰岛素经验的患者,n?=?561;未经胰岛素治疗的患者,n?=?1,465)。 。糖化血红蛋白在所有亚组中均观察到:在天冬胰岛素治疗24周后,门冬胰岛素+α-OGLDs与基线相比有显着改善(糖基血红蛋白的平均值范围为-1.6至-2.4%;所有比较的p <0.001) ),空腹血浆葡萄糖(-2.5至-3.8?mmol / l;所有比较的p 0.001),早餐后餐后葡萄糖(-3.4至-5.8?mmol / l; p 0.001所有比较),以及与健康相关的生活质量(HRQoL;所有比较p 0.001)。 24周后报告低血糖事件的患者比例显着降低(未接受胰岛素的队列:7.9-2.8%; p <0.001);经历过胰岛素的队列:23.2-7.8%; p <0.001。在第24周没有重大低血糖事件的报道。夜间低血糖的风险<0.6事件/人年。结论:2型糖尿病和血糖控制不佳的人中,门冬胰岛素+-αOGLDs可显着改善血糖控制和HRQoL,而不会增加低血糖风险。

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