在 24 周的时间内，接受艾塞那肽治疗的血糖控制不佳的 2 型糖尿病患者的血糖控制得到改善和体重减轻：一项在日本患者中进行的为期 24 周的双盲、随机、3 期研究。

Improved glycemic control and reduced bodyweight with exenatide: A double-blind, randomized, phase 3 study in Japanese patients with suboptimally controlled type 2 diabetes over 24 weeks.

机构信息

Department of Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo.

Division of Diabetes and Metabolism, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya Hyogo.

出版信息

J Diabetes Investig. 2011 Jun 5;2(3):210-7. doi: 10.1111/j.2040-1124.2010.00084.x.

UNLABELLED

Aims/Introduction: To evaluate the efficacy and safety of the glucagon-like peptide-1 receptor agonist, exenatide, in Japanese patients with type 2 diabetes mellitus suboptimally controlled despite therapeutic doses of a sulfonylurea alone or combined with a biguanide or thiazolidinedione.

MATERIALS AND METHODS

Patients were randomized to a placebo or exenatide, either 5 or 10 μg, given subcutaneously b.i.d. in addition to oral therapy. Patients randomized to 10 μg exenatide received 5 μg b.i.d. for the first 4 weeks, followed by 10 μg b.i.d. for the last 20 weeks.

RESULTS

A total of 179 patients received the study drug and composed the full analysis set (n = 35, placebo; n = 72, exenatide 5 μg; n = 72, exenatide 10 μg; 68% male; 58 ± 10 years; body mass index 25.5 ± 4.1 kg/m(2); HbA1c 8.2 ± 0.9%; means ± standard deviations). Baseline to end-point (least-squares means ± standard errors) HbA1c changes (%) were -0.28 ± 0.15 (placebo), -1.34 ± 0.11 (exenatide 5 μg) and -1.62 ± 0.11 (exenatide 10 μg) (both P < 0.001, exenatide vs placebo). Baseline to end-point bodyweight changes (kg) were -0.47 ± 0.39 (placebo), -0.39 ± 0.28 (exenatide 5 μg) and -1.54 ± 0.27 (exenatide 10 μg; P = 0.026, exenatide 10 μg vs placebo). Nausea, generally mild to moderate, was reported in 8.6% (placebo), 25.0% (exenatide 5 μg) and 36.1% (exenatide 10 μg) of patients. Mild to moderate hypoglycemia was reported in 22.9% (placebo), 51.4% (exenatide 5 μg) and 58.3% (exenatide 10 μg) of patients.

CONCLUSIONS

Over 24 weeks, exenatide vs the placebo improved glycemic control, reduced bodyweight (10 μg) and was well tolerated in Japanese patients with type 2 diabetes mellitus suboptimally controlled, despite oral therapy including a sulfonylurea. This trial was registered with ClinicalTrials.gov (no. NCT00577824). (J Diabetes Invest, doi: 10.1111/j.2040-1124.2010.00084.x, 2011).

目的/引言：评估胰高血糖素样肽-1 受体激动剂艾塞那肽在日本 2 型糖尿病患者中的疗效和安全性，这些患者尽管接受了磺酰脲类药物单独或联合二甲双胍或噻唑烷二酮类药物的治疗剂量，但血糖控制仍不理想。

材料和方法

患者被随机分配至安慰剂或艾塞那肽组，每日两次皮下注射 5μg 或 10μg，同时接受口服治疗。随机接受 10μg 艾塞那肽的患者在前 4 周接受每日两次 5μg，之后的 20 周接受每日两次 10μg。

结果

共有 179 名患者接受了研究药物治疗，构成了全分析集（n=35，安慰剂；n=72，艾塞那肽 5μg；n=72，艾塞那肽 10μg；68%为男性；58±10 岁；体重指数 25.5±4.1kg/m²；糖化血红蛋白 8.2±0.9%；均数±标准差）。从基线到终点（最小二乘均数±标准差）糖化血红蛋白变化（%）为-0.28±0.15（安慰剂）、-1.34±0.11（艾塞那肽 5μg）和-1.62±0.11（艾塞那肽 10μg）（均 P<0.001，艾塞那肽与安慰剂相比）。从基线到终点体重变化（kg）为-0.47±0.39（安慰剂）、-0.39±0.28（艾塞那肽 5μg）和-1.54±0.27（艾塞那肽 10μg；P=0.026，艾塞那肽 10μg与安慰剂相比）。报告了 8.6%（安慰剂）、25.0%（艾塞那肽 5μg）和 36.1%（艾塞那肽 10μg）的患者出现一般为轻度至中度的恶心。报告了 22.9%（安慰剂）、51.4%（艾塞那肽 5μg）和 58.3%（艾塞那肽 10μg）的患者出现轻度至中度低血糖。

结论

在 24 周内，与安慰剂相比，艾塞那肽改善了血糖控制，减轻了体重（10μg），并在接受磺酰脲类药物联合其他口服药物治疗的血糖控制不理想的日本 2 型糖尿病患者中具有良好的耐受性。该试验在 ClinicalTrials.gov 注册（编号：NCT00577824）。（《糖尿病研究与临床实践》，doi:10.1111/j.2040-1124.2010.00084.x，2011）。