Pramlintide as an adjunct to insulin therapy improves long-term glycemic and weight control in patients with type 2 diabetes - A 1-year randomized controlled trial
Pramlintide as an adjunct to insulin therapy improves long-term glycemic and weight control in patients with type 2 diabetes - A 1-year randomized controlled trial
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DOI：
10.2337/diacare.26.3.784
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发表时间：
2003-03-01
期刊：
影响因子：
16.2
通讯作者：
Kolterman, OG
中科院分区：
文献类型：
--
作者：
Hollander, PA;Levy, P;Kolterman, OG
目的：在2型糖尿病患者中，餐时用胰淀粉酶类似物普兰林肽替代胰淀粉酶，作为餐时胰岛素替代的辅助药物，可减少餐后血糖漂移。本研究的目的是评估普兰林肽在该患者群体中的长期疗效和安全性。研究设计和方法：在一项为期52周的双盲、安慰剂对照、平行组、多中心研究中，656例2型糖尿病患者(年龄7+/-10岁，糖尿病病程12+/-7年，BMI 34.0+/-7.0 kg/m（2), HbA(1c) 9.1+/-1.2%，平均+/-SD）接受胰岛素治疗（单独或联合磺脲类药物和/或二甲双胍），随机接受额外的餐前皮下注射安慰剂或普兰林肽（60杯TID， 90杯BID或120杯BID）。结果：普兰林肽120杯BID治疗导致HbA（1c）从基线持续降低（在26周和52周分别为-0.68和-0.62%），显著高于安慰剂组(P
Objective-Mealtime amylin replacement with the human amylin analog pramlintide, as an adjunct to mealtime insulin replacement, reduces postprandial glucose excursions in patients with type 2 diabetes. The aim of the present study was to assess the long-term efficacy and safety of pramlintide in this patient population.Research Design and Methods-In a 52-week, double-blind, placebo-controlled, parallel-group, multicenter study, 656 patients with type 2 diabetes (age 7+/-10 years, diabetes duration 12+/-7 years, BMI 34.0+/-7.0 kg/m(2), HbA(1c) 9.1+/-1.2%, mean+/-SD) treated with insulin (alone or in combination with sulfonylureas and/or metformin) were randomized to receive additional preprandial subcutaneous injections of either placebo or pramlintide (60 mug TID, 90 mug BID, or 120 mug BID).Results-Treatment with pramlintide 120 mug BID led to a sustained reduction from baseline in HbA(1c) (-0.68 and -0.62% at weeks 26 and 52, respectively), which was significantly greater than that seen with placebo (P