Effect on glycemic control of exenatide (synthetic exendin-4) additive to existing metformin and/or sulfonylurea treatment in patients with type 2 diabetes

Effect on glycemic control of exenatide (synthetic exendin-4) additive to existing metformin and/or sulfonylurea treatment in patients with type 2 diabetes
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DOI:
10.2337/diacare.26.8.2370
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发表时间:
2003-08-01
期刊:
影响因子:
16.2
通讯作者:
Baron, AD
Baron, AD
中科院分区:
医学1区
文献类型:
--
作者:
Fineman, MS;Bicsak, TA;Baron, AD

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目的-AC 2993(合成exendin-4; exendin)是一种肽,可增强葡萄糖依赖性胰岛素分泌,抑制不适当升高的胰高血糖素分泌,并减缓胃排空。AC 2993还在体外和动物模型中促进P细胞增殖和新生。本研究检查了皮下注射AC 2993在目前用饮食和/或口服抗糖尿病药物(OAA)治疗的2型糖尿病患者中的活性和安全性。研究设计和方法-总共109名用饮食和磺酰脲和/或二甲双胍治疗的患者参加了盲法研究。患者被随机分配到三个皮下(SC)注射方案的AC 2993(0.08 μ g/kg)或安慰剂28 days.Results -所有三个AC 2993方案导致血清果糖胺相对于安慰剂显着降低(P小于或等于0.004)。平均降低范围为39至46 mumol/l。所有AC 2993组的HbA(1c)降低范围为0.7 - 1.1%(P ≤ 0.006)。研究结束时HbA(1c)
OBJECTIVE - AC2993 (synthetic exendin-4; exenatide) is a peptide that enhances glucose-dependent insulin secretion, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying. AC2993 also promotes P-cell proliferation and neogenesis in vitro and in animal models. This study examines the activity and safety of subcutaneously injected AC2993 in patients with type 2 diabetes currently treated With diet and/or oral antidiabetic agents (OAAs).RESEARCH DESIGN AND METHODS - A total of 109 patients treated with diet and a sulfonylurea and/or metformin were enrolled in a blinded study. Patients were randomly assigned to one of three subcutaneously (SC) injected regimens of AC2993 (0.08 mug/kg) or placebo for 28 days.RESULTS - All three AC2993 regimens led to significant reductions in serum fructosamine relative to placebo (P less than or equal to 0.004). Mean reductions ranged from 39 to 46 mumol/l. All AC2993 groups had reductions in HbA(1c) ranging from 0.7 to 1.1% (P less than or equal to 0.006). An end-of-study HbA(1c)