The Efficacy and Safety of Imeglimin as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Sitagliptin Monotherapy
The Efficacy and Safety of Imeglimin as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Sitagliptin Monotherapy
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DOI：
10.2337/dc13-2349
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发表时间：
2014-07-01
期刊：
影响因子：
16.2
通讯作者：
Bailey, Clifford J.
中科院分区：
文献类型：
--
作者：
Fouqueray, Pascale;Pirags, Valdis;Bailey, Clifford J.
目的 这项为期 12 周的研究评估了伊格列明作为二肽基肽酶 4 抑制剂西他列汀的附加疗法对西他列汀单药治疗控制不佳的 2 型糖尿病患者的疗效和耐受性。 研究设计和方法在一项多中心、随机、双盲、安慰剂对照、平行组研究中，伊格列明（1,500 mg b.i.d.）或在 170 名 2 型糖尿病患者（平均年龄 56.8 岁；BMI 32.2 kg/m(2)）中，在西他列汀（100 mg q.d.）的基础上添加安慰剂，为期 12 周，在 12 周的磨合期，单独使用西他列汀（A1C >= 7.5%）无法充分控制这些患者的病情。主要疗效终点是与安慰剂相比 A1C 相对于基线的变化；次要终点包括空腹血糖 (FPG) 水平的相应变化、基线 A1C 分层和 A1C 应答者百分比。 结果 与安慰剂相比，A1C 水平（最小二乘均差）较基线 (8.5%) 降低 0.60%，而安慰剂则增加 0.12%（组间差异 0.72%，P < 0.001）。伊格列明组的 FPG 相应变化为 -0.93 mmol/L，而安慰剂组为 -0.11 mmol/L（P = 0.014）。使用 imeglimin 时，54.3% 的受试者 A1C 水平下降≥ 0.5%，而安慰剂组为 21.6% (P < 0.001)，接受 imeglimin 的受试者中 19.8% 的 A1C 水平下降
OBJECTIVEThis 12-week study assessed the efficacy and tolerability of imeglimin as add-on therapy to the dipeptidyl peptidase-4 inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled with sitagliptin monotherapy.RESEARCH DESIGN AND METHODSIn a multicenter, randomized, double-blind, placebo-controlled, parallel-group study, imeglimin (1,500 mg b.i.d.) or placebo was added to sitagliptin (100 mg q.d.) over 12 weeks in 170 patients with type 2 diabetes (mean age 56.8 years; BMI 32.2 kg/m(2)) that was inadequately controlled with sitagliptin alone (A1C >= 7.5%) during a 12-week run-in period. The primary efficacy end point was the change in A1C from baseline versus placebo; secondary end points included corresponding changes in fasting plasma glucose (FPG) levels, stratification by baseline A1C, and percentage of A1C responders.RESULTSImeglimin reduced A1C levels (least-squares mean difference) from baseline (8.5%) by 0.60% compared with an increase of 0.12% with placebo (between-group difference 0.72%, P < 0.001). The corresponding changes in FPG were -0.93 mmol/L with imeglimin vs. -0.11 mmol/L with placebo (P = 0.014). With imeglimin, the A1C level decreased by >= 0.5% in 54.3% of subjects vs. 21.6% with placebo (P < 0.001), and 19.8% of subjects receiving imeglimin achieved a decrease in A1C level of