摘要
目的 评价阿格列汀在中国大陆人群中治疗2型糖尿病的有效性和安全性.方法 多中心、随机、双盲、安慰剂对照的Ⅲ期临床研究,入组491例2型糖尿病患者,1：1随机接受阿格列汀（25 mg,每天1次）或相应安慰剂进行为期16周的治疗,其中单药治疗组（A组）181例,联合二甲双胍组（B组）186例,联合吡格列酮组（C组）124例.结果 第16周时,A、B、C3组中阿格列汀和安慰剂分别使糖化血红蛋白（HbA1c）降低1.00％和0.43％,0.91％和0.23％,0.76％和0.25％（P值均＜0.001）.与安慰剂相比,阿格列汀可显著降低空腹血糖（FPG）,并提高患者HbA1c≤6.5％和≤7.0％的达标比例.阿格列汀与安慰剂的全部不良反应,包括低血糖发生率差异均无统计学意义.结论 在中国大陆2型糖尿病患者中,与安慰剂相比,无论单药或联用二甲双胍或联用吡格列酮,阿格列汀均可显著降低HbA1c与FPG,提高HbA1c达标率.同时,阿格列汀与安慰剂的低血糖发生率和总体安全性类似.
Objective To evaluate the efficacy and safety of alogliptin in Chinese patients with type 2 diabetes （T2DM）.Methods This was a multicenter, randomized, double-blind, placebo-controlled phase Ⅲ trial.A total of 491 subjects with T2DM were randomized in a 1：1 ratio to receive alogliptin （25 mg once daily） or placebo for 16 weeks.Among them, 181 were in the monotherapy group （group A）, 186 were in the add-on to metformin group （group B）, and 124 were in the add-on to pioglitazone group （group C）.Results After 16 weeks of therapy, glycosylated hemoglobin A1c （HbA1c） levels decreased in both alogliptin and placebo groups.The mean changes in HbA1c for alogliptin and placebo were 1.00%and0.43% （P〈0.001）, 0.91% and0.23% （P〈0.001）, and0.76% and0.25% （P〈0.001） in group A, B and C, respectively.Compared with placebo, alogliptin treatment led to a greater decrease in fasting plasma glucose （FPG） and a higher percentage of subjects who achieved HbA1 c targets of ≤ 6.5% and ≤ 7.0%.The percentage of subjects who experienced all adverse events including hypoglycemia with alogliptin were comparable to those with placebo.Conclusions Alogliptin 25 mg once daily reduced HbA1 c and FPG, and increased a greater proportion of subjects achieving HbA1c goals of ≤6.5% and ≤7.0% compared with placebo when used as a monotherapy, add-on to metformin, or add-on to pioglitazone.The hypoglycemia rates and safety profiles with alogliptin were similar to those with placebo.
出处
《中华内科杂志》
CAS
CSCD
北大核心
2015年第11期949-953,共5页
Chinese Journal of Internal Medicine
关键词
糖尿病
2型
阿格列汀
临床试验
Ⅲ期
Diabetes mellitus,type 2＇ - Alogliptin
Clinical trials,phase Ⅲ
