Exenatide Exhibits Dose-Dependent Effects on Glycemic Control over 12 Weeks in Japanese Patients with Suboptimally Controlled Type 2 Diabetes
Exenatide Exhibits Dose-Dependent Effects on Glycemic Control over 12 Weeks in Japanese Patients with Suboptimally Controlled Type 2 Diabetes
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DOI：
10.1507/endocrj.k08e-296
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发表时间：
2009-06-01
影响因子：
2
通讯作者：
Brodows, Robert G.
中科院分区：
文献类型：
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作者：
Kadowaki, Takashi;Namba, Mitsuyoshi;Brodows, Robert G.
本研究评估了艾塞那肽在日本2型糖尿病患者中12周的剂量依赖性疗效和安全性，尽管磺酰脲类（SU）、SU+双胍或SU+噻唑烷二酮治疗剂量控制不佳。患者被随机分配至安慰剂组（N = 40）、2.5 μ g（N = 38）、5 μ g（N = 37）或10 μ g（N = 38）艾塞那肽组，每日两次（BID）皮下给药。随机分配至10 μ g艾塞那肽组的患者在前4周接受5 μ g BID，在最后8周剂量递增至10 μ g BID。患者年龄为60.3 ± 9.7岁，体重指数为25.3 ± 4.3 kg/m2，血红蛋白A1 c（HbA 1c）为8.0 ± 0.8%。基线至终点HbA 1c变化（%）为+0.02 +/- 0.1（安慰剂）、-0.9 +/- 0.1（2.5 μ g）、-1.2 +/- 0.1（5 μ g）和-1.4 +/- 0.1（10 μ g）（与安慰剂相比，所有p均< 0.001）。在基线HbA 1c ≥ 7%的患者中，5.1%（安慰剂）、50.0%（2.5 μ g）、71.4%（5 μ g）和79.4%（10 μ g）达到HbA 1c
This study assessed the dose-dependent efficacy and safety of exenatide over 12 weeks in Japanese patients with type 2 diabetes suboptimally controlled despite therapeutic doses of sulfonylurea (SU), SU plus biguanide, or SU plus thiazolidinedione. Patients were randomly assigned to placebo (N = 40), 2.5 mu g (N = 38), 5 mu g (N = 37), or 10 mu g (N = 38) exenatide administered subcutaneously twice daily (BID). Patients randomly assigned to 10 mu g exenatide received 5 mu g BID for the first 4 weeks, with the dose escalated to 10 mu g BID for the final 8 weeks. Patients were 60.3 +/- 9.7 years old, with body mass index 25.3 +/- 4.3 kg/m(2) and hemoglobin A1c (HbA1c) 8.0 +/- 0.8%. Baseline-to-endpoint HbA1c changes (%) were +0.02 +/- 0.1 (placebo), -0.9 +/- 0.1 (2.5 mu g), - 1.2 +/- 0.1 (5 mu g), and - 1.4 +/- 0.1 (10 mu g) (all p < 0.001 vs. placebo). Of patients with baseline HbA1c >= 7%, 5.1 % (placebo), 50.0% (2.5 mu g), 71.4% (5 mu g), and 79.4% (10 mu g) achieved H bA1c