主页 > 医学文档 >
【文摘发布】二肽基肽酶IV (DPP4)抑制剂 Sitaglipt
DOI: 10.2337/dc07-0627
标题： Effect of Initial Combination Therapy with Sitagliptin, a Dipeptidyl Peptidase-4 Inhibitor, and Metformin on Glycemic Control in Patients with Type 2 Diabetes
作者： Barry J. Goldstein, Mark N. Feinglos, et.al. Williams-Herman for the Sitagliptin 036 Study Group
ABSTRACT
Objective:To assess the efficacy and safety of initial combination therapy with sitagliptin and metformin in patients with type 2 diabetes (T2DM) and inadequate glycemic control on diet and exercise.
Research Design and Methods: In a 24-week, randomized, double-blind, placebo-controlled, parallel-group study, 1091 patients with T2DM and HbA1c 7.5% to 11% were randomized to one of six daily treatments: sitagliptin 100-mg/metformin 1000-mg (S100/M1000), sitagliptin 100-mg/metformin 2000-mg (S100/M2000), metformin 1000-mg (M1000), metformin 2000-mg (M2000) (all as divided doses administered b.i.d.), sitagliptin 100-mg q.d. (S100), or placebo. Patients who had an HbA1c >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 sub-study and were treated with S100/M2000 for 24 weeks.
Results:The mean baseline HbA1c was 8.8% in the randomized patients. The placebo-subtracted HbA1c 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 vs. placebo and for co-administration vs. respective monotherapies). The proportion of patients achieving an HbA1c <7% and <6.5% was 66% and 44%, respectively, in the S100/M2000 group (p<0.001 vs. S100 or M2000). For the open-label cohort (n=117; baseline HbA1c=11.2%) treated with S100/M2000, the within-group mean HbA1c change from baseline was -2.9%. The incidence of hypoglycemia was low (0.5%-2.2%) across active treatment groups and not significantly different from placebo (0.6%). The incidence of gastrointestinal adverse experiences was similar for co-administration therapies compared with their respective metformin monotherapy.
Conclusions:The initial combination of sitagliptin and metformin provided substantial and additive glycemic improvement and was generally well-tolerated in patients with T2DM. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领
阅读本文的人还阅读：
作者:admin@医学,生命科学 2010-10-13 17:11
医学,生命科学网