Bristol-Myers Squibb, Route 206 & Province Line Road, Princeton, NJ, 08543, USA.
Diabetol Metab Syndr. 2012 Jul 24;4(1):36. doi: 10.1186/1758-5996-4-36.
The aim of this study was to assess efficacy and safety of saxagliptin monotherapy for up to 76 weeks in patients with type 2 diabetes mellitus (T2DM) and inadequate glycemic control, with main efficacy assessment at 24 weeks.
365 treatment-naïve patients with T2DM (HbA1c 7.0%-10.0%) were treated with saxagliptin 2.5 mg q.A.M., saxagliptin 2.5 mg q.A.M. with possible titration to saxagliptin 5 mg, saxagliptin 5 mg q.A.M., saxagliptin 5 mg q.P.M., or placebo. After week 24, patients in all groups were eligible for titration to saxagliptin 10 mg based on HbA1c ≥7%, and all unrescued placebo patients began blinded metformin 500 mg/day. Rescue with open-label metformin was available for patients with inadequate glycemic control.
At week 24, placebo-subtracted mean HbA1c reduction from baseline (LOCF) was significantly greater in the saxagliptin treatment groups vs placebo, and remained greater through week 76. Serious adverse events (AEs) and discontinuations due to AEs were similar in saxagliptin and control groups; incidence of confirmed hypoglycemia was low across all treatment groups (saxagliptin-treated, 2 [0.7]; control, 1 [1.4]).
In treatment-naïve patients with T2DM, saxagliptin monotherapy demonstrated statistically significant improvement in HbA1c compared with placebo at 24 weeks and was generally well tolerated for up to 76 weeks.
ClinicalTrials.gov Identifier: NCT00316082.
本研究旨在评估沙格列汀单药治疗 76 周对血糖控制不佳的 2 型糖尿病（T2DM）患者的疗效和安全性，主要疗效评估在 24 周。
365 例初治 T2DM 患者（HbA1c 7.0%-10.0%）接受沙格列汀 2.5mg 每日一次（q.A.M.）治疗，根据 HbA1c≥7%，所有患者可滴定至沙格列汀 5mg 每日一次（q.A.M.）、沙格列汀 5mg 每日一次（q.P.M.）或安慰剂治疗。第 24 周后，所有组患者均符合根据 HbA1c 滴定至沙格列汀 10mg 的条件，所有未挽救的安慰剂患者开始接受二甲双胍 500mg/天的盲法治疗。对于血糖控制不佳的患者，可加用开放标签的二甲双胍进行挽救治疗。
第 24 周时，与安慰剂相比，沙格列汀治疗组的基线（LOCF）时 HbA1c 降低的安慰剂校正平均差异显著更大，并且在第 76 周时仍保持更大。沙格列汀组和对照组的严重不良事件（AE）和因 AE 停药的发生率相似；所有治疗组的确诊低血糖发生率均较低（沙格列汀治疗组，2 [0.7%]；对照组，1 [1.4%]）。
在初治的 T2DM 患者中，与安慰剂相比，沙格列汀单药治疗在 24 周时 HbA1c 有统计学意义的改善，并且在长达 76 周的时间内通常具有良好的耐受性。
ClinicalTrials.gov 标识符：NCT00316082。
