Ruth Collins Diabetes Center, Baylor University Medical Center, Department of Endocrinology, Dallas, Texas, USA.
Diab Vasc Dis Res. 2011 Apr;8(2):125-35. doi: 10.1177/1479164111404575.
To assess the long-term efficacy and safety of saxagliptin in patients with type 2 diabetes mellitus inadequately controlled with thiazolidinedione monotherapy, 565 patients were randomised to saxagliptin (2.5 mg or 5 mg) or placebo added to thiazolidinedione over 76 weeks (24-week short-term + 52-week long-term extension period) in this phase 3, double-blind, placebo-controlled trial; 360 patients completed the study. At 76 weeks, adjusted mean changes from baseline HbA(1C) (repeated measures model; 95% CI) for saxagliptin 2.5 mg, 5 mg, and placebo were -0.59% (-0.75, -0.43), -1.09% (-1.26, -0.93), and -0.20% (-0.39, -0.01), respectively (post hoc and nominal p=0.0019 and p<0.0001 for saxagliptin 2.5 mg and 5 mg vs. placebo, respectively). Adverse event frequency was similar between groups. Confirmed hypoglycaemic events were 1.0% and 0% vs. 0.5% for saxagliptin 2.5 mg and 5 mg vs. placebo, respectively. Results should be interpreted with caution given the proportion of patients who discontinued or required glycaemic rescue therapy during the 76-week course of study. Saxagliptin added to thiazolidinedione provided sustained incremental efficacy vs. placebo with little hypoglycaemia for up to 76 weeks and was generally well tolerated.
为评估沙格列汀在单用噻唑烷二酮治疗血糖控制不佳的 2 型糖尿病患者中的长期疗效和安全性，565 例患者被随机分为沙格列汀（2.5mg 或 5mg）或安慰剂组，联合噻唑烷二酮治疗 76 周（24 周短期+52 周长期扩展期）。这是一项 3 期、双盲、安慰剂对照试验；360 例患者完成了研究。76 周时，沙格列汀 2.5mg、5mg 和安慰剂组的 HbA1c 较基线的平均调整变化（重复测量模型；95%CI）分别为-0.59%（-0.75，-0.43）、-1.09%（-1.26，-0.93）和-0.20%（-0.39，-0.01）（事后检验和名义 p=0.0019 和 p<0.0001，沙格列汀 2.5mg 和 5mg 组与安慰剂组相比）。两组的不良反应发生率相似。确认的低血糖事件分别为 1.0%和 0%，安慰剂组为 0.5%。鉴于研究期间有相当比例的患者停止或需要血糖补救治疗，因此应谨慎解释结果。沙格列汀联合噻唑烷二酮治疗可提供持续的疗效增加，低血糖发生率低，76 周内血糖控制良好，且总体耐受性良好。
