Original Article
Efficacy and safety of alogliptin in treatment of type 2 diabetes mellitus
a multicenter, randomized, double-blind, placebo-controlled phase Ⅲ clinical trial in mainland China
Pan Changyu, Li Wenhui, Zeng Jiaoe, Li Chengjiang, Yang Jinkui, Ji Qiuhe, Lu Juming, Lyu Xiaofeng, Li Xuefeng, Qu Shen, Xu Xiangjin, Xue Yaoming, Li Ling, Jiang Zhaoshun, Zheng Baozhong, Bu Ruifang, Han Ping, Liu Yu, Liu Jingdong, Peng Yongde, Liu Xiaomin, Liu Zhimin, Yan Li, Lei Minxiang, Li Xuejun, Song Qinhua, Shi Bingyin, Gu Wei, Li Zhengfang
Published 2015-11-01
Cite as Chin J Intern Med, 2015, 54(11): 949-953. DOI: 10.3760/cma.j.issn.0578-1426.2015.11.010
Abstract
ObjectiveTo evaluate the efficacy and safety of alogliptin in Chinese patients with type 2 diabetes(T2DM).
MethodsThis 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).
ResultsAfter 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% and 0.43%(P<0.001), 0.91% and 0.23%(P<0.001), and 0.76% and 0.25%(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 HbA1c 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.
ConclusionsAlogliptin 25 mg once daily reduced HbA1c 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.
Key words:
Diabetes mellitus, type 2; Alogliptin; Clinical trials, phase Ⅲ
Contributor Information
Pan Changyu
Department of Endocrinology, Chinese PLA General Hospital, Beijing 100853, China
Li Wenhui
Zeng Jiaoe
Li Chengjiang
Yang Jinkui
Ji Qiuhe
Lu Juming
Lyu Xiaofeng
Li Xuefeng
Qu Shen
Xu Xiangjin
Xue Yaoming
Li Ling
Jiang Zhaoshun
Zheng Baozhong
Bu Ruifang
Han Ping
Liu Yu
Liu Jingdong
Peng Yongde
Liu Xiaomin
Liu Zhimin
Yan Li
Lei Minxiang
Li Xuejun
Song Qinhua
Shi Bingyin
Gu Wei
Li Zhengfang
