Poxel SA, Lyon, France
Paul Stradins Clinical University Hospital, Riga, Latvia.
Diabetes Care. 2014 Jul;37(7):1924-30. doi: 10.2337/dc13-2349. Epub 2014 Apr 10.
This 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.
In 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.
Imeglimin 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 ≤7% compared with subjects receiving placebo (1.1%) (P = 0.004). Imeglimin was generally well tolerated, with a safety profile comparable to placebo and no related treatment-emergent adverse events.
Imeglimin demonstrated incremental efficacy benefits as add-on therapy to sitagliptin, with comparable tolerability to placebo, highlighting the potential for imeglimin to complement other oral antihyperglycemic therapies.
这项为期 12 周的研究评估了伊格列净作为二肽基肽酶-4 抑制剂西他列汀的附加治疗在单独使用西他列汀治疗未能充分控制的 2 型糖尿病患者中的疗效和耐受性。
在一项多中心、随机、双盲、安慰剂对照、平行分组研究中，170 例 2 型糖尿病患者（平均年龄 56.8 岁；BMI 32.2kg/m2）在 12 周的导入期内单独使用西他列汀（100mg，qd）未能充分控制（A1C≥7.5%），在此期间，患者接受伊格列净（1500mg，bid）或安慰剂治疗，为期 12 周。主要疗效终点为与安慰剂相比，从基线到 A1C 的变化；次要终点包括空腹血糖（FPG）水平的相应变化、按基线 A1C 分层以及 A1C 应答者的百分比。
与安慰剂相比，伊格列净使 A1C 水平从基线（8.5%）下降了 0.60%（最小二乘均值差异），而安慰剂则增加了 0.12%（组间差异 0.72%，P<0.001）。FPG 的相应变化为伊格列净组-0.93mmol/L，安慰剂组-0.11mmol/L（P=0.014）。伊格列净组有 54.3%的受试者 A1C 下降≥0.5%，而安慰剂组为 21.6%（P<0.001），19.8%接受伊格列净治疗的受试者 A1C 水平下降至≤7%，而安慰剂组为 1.1%（P=0.004）。伊格列净总体耐受性良好，安全性与安慰剂相当，无相关治疗引起的不良事件。
伊格列净作为西他列汀的附加治疗，具有额外的疗效优势，与安慰剂的耐受性相当，突出了伊格列净作为其他口服抗高血糖药物治疗补充的潜力。
