Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin on glycemic control in patients with type 2 diabetes
Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin on glycemic control in patients with type 2 diabetes
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DOI：
10.2337/dc07-0627
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发表时间：
2007-08-01
期刊：
影响因子：
16.2
通讯作者：
Williams-Herman, Debora E.
中科院分区：
文献类型：
--
作者：
Goldstein, Barry J.;Feinglos, Mark N.;Williams-Herman, Debora E.
目的-评估西格列汀和二甲双胍初始联合治疗在饮食和运动血糖控制不佳的2型糖尿病患者中的疗效和安全性-研究设计和方法-在一项为期24周的随机、双盲、安慰剂对照、平行组研究中，1，09 1例AIC 7.5-110/0的2型糖尿病患者随机接受6种每日治疗之一：西格列汀100 mg/二甲双胍1，000 mg（S100/M1000组），西他汀100 mg/二甲双胍2,000 mg（S100/M2000组），二甲双胍1，000 mg M1000组），二甲双胍2，000环（M2000组）（均为分次给药，每日两次[b.i.d.]），西格列汀100 mg q.d. (S100组）或安慰剂。导入期后AIC >11%或空腹血糖值>280 mg/dl的患者不符合随机化条件，这些患者可参加开放标签子研究，并接受S1008/M2000治疗24周。结果：随机分组患者的平均基线AIC为8.8%。减去安慰剂的AIC较基线的变化为-2.07%（S100/M2000）、-1.57%（S100/M1000）、-1.30%（M2000）、-0.99%（M1000）和-0.83%（S100）（P < 0.001）。对于与安慰剂的比较以及对于联合给药与各自的单药治疗的比较），
OBJECTIVE - To assess the efficacy and safety Of initial combination therapy with sitagliptin and metformin in patients with type 2 diabetes and inadequate glycemic control on diet and exercise- RESEARCH DESIGN AND METHODS - in a 24-week, randomized, double-blind, placebo-controlled, parallel-group study, 1,09 1 patients with type 2 diabetes and AIC 7.5-110/0 were randomized to one of six daily treatments: sitagliptin 100 mg/metformin 1,000 mg (S100/M1000 group), sitagiptin 100 mg/metformin 2,000 mg (S100/M2000 group), metformin 1,000 mg M1000 group), metformin 2,000 ring (M2000 group) (all as divided doses administered twice daily [b.i.d.]), sitagliptin 100 mg q.d. (S100 group), or placebo. Patients who had an AIC >11% or a fasting glucose value >280 mg/dl after the run-in period were not eligible to be randomized, these patients could participate in an open-label substudy and were treated with S1008/M2000 for 24 weeks. RESULTS - The mean baseline AIC was 8.8% in the randomized patients. The placebo-subtracted AIC change from baseline was -2.07% (S100/M2000), -1.57% (S100/M1000), - 1.30% (M2000) -0.99% (M1000), and -0.83% (S100) (P < 0.001. for comparisons versus placebo and for coadministration versus respective monotherapies), The proportion of patients h achieving an AlC