Federal University of São Paulo, Diabetes Center, Brazil.
Diab Vasc Dis Res. 2011 Apr;8(2):150-9. doi: 10.1177/1479164111404574.
To assess the long-term efficacy and safety of saxagliptin in patients with type 2 diabetes mellitus inadequately controlled on sulphonylurea monotherapy, 768 patients were randomised to saxagliptin 2.5 or 5 mg in combination with glyburide 7.5 mg versus placebo added to up-titrated glyburide over 76 weeks (24 weeks plus 52-week extension) in this phase 3, double-blind, placebo-controlled trial; 557 patients completed the study, 142 without being rescued. At 76 weeks, adjusted mean changes from baseline HbA(1C) (repeated measures model) (95% confidence interval) for saxagliptin 2.5 mg, saxagliptin 5 mg, and up-titrated glyburide were 0.11% (-0.05, 0.27), 0.03% (-0.14, 0.19), and 0.69% (0.47, 0.92), respectively (post hoc and nominal p < 0.0001 for saxagliptin 2.5 and 5 mg vs. up-titrated glyburide). Adverse event frequency was similar in all treatment groups; reported hypoglycaemia event rates were 24.2%, 22.9%, and 20.6% with saxagliptin 2.5 mg, saxagliptin 5 mg, and up-titrated glyburide, respectively. Saxagliptin plus glyburide provided sustained incremental efficacy compared with up-titrated glyburide over 76 weeks, and was generally well tolerated.
为评估在磺酰脲类单药治疗控制不佳的 2 型糖尿病患者中沙格列汀的长期疗效和安全性，768 例患者被随机分为沙格列汀 2.5mg 或 5mg 联合格列吡嗪 7.5mg 组与安慰剂组，后者在 76 周（24 周加 52 周延伸）内加到逐步增加的格列吡嗪剂量中；在这项 3 期、双盲、安慰剂对照试验中，557 例患者完成了研究，142 例未进行挽救治疗。在 76 周时，沙格列汀 2.5mg、沙格列汀 5mg 和逐步增加的格列吡嗪组从基线 HbA1c（重复测量模型）的调整平均变化（95%置信区间）分别为 0.11%（-0.05，0.27）、0.03%（-0.14，0.19）和 0.69%（0.47，0.92）（事后和名义 p<0.0001 比较沙格列汀 2.5mg 和 5mg 与逐步增加的格列吡嗪）。所有治疗组的不良事件发生率相似；报告的低血糖事件发生率分别为沙格列汀 2.5mg 组 24.2%、沙格列汀 5mg 组 22.9%和逐步增加的格列吡嗪组 20.6%。沙格列汀加格列吡嗪与逐步增加的格列吡嗪相比，在 76 周时提供了持续的疗效递增，且通常具有良好的耐受性。
