title: [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].
abstract: 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% 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.
  
  
  CONCLUSIONS
  Alogliptin 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.
authors.affiliation: Department of Endocrinology, Chinese PLA General Hospital, Beijing 100853, China; Email: panchy301@126.com.
authors.forename: Changyu
authors.initials: C
authors.lastname: Pan
authors.forename: Wenhui
authors.initials: W
authors.lastname: Li
authors.forename: Jiaoe
authors.initials: J
authors.lastname: Zeng
authors.forename: Chengjiang
authors.initials: C
authors.lastname: Li
authors.forename: Jinkui
authors.initials: J
authors.lastname: Yang
authors.forename: Qiuhe
authors.initials: Q
authors.lastname: Ji
authors.forename: Juming
authors.initials: J
authors.lastname: Lu
authors.forename: Xiaofeng
authors.initials: X
authors.lastname: Lyu
authors.forename: Xuefeng
authors.initials: X
authors.lastname: Li
authors.forename: Shen
authors.initials: S
authors.lastname: Qu
authors.forename: Xiangjin
authors.initials: X
authors.lastname: Xu
authors.forename: Yaoming
authors.initials: Y
authors.lastname: Xue
authors.forename: Ling
authors.initials: L
authors.lastname: Li
authors.forename: Zhaoshun
authors.initials: Z
authors.lastname: Jiang
authors.forename: Baozhong
authors.initials: B
authors.lastname: Zheng
authors.forename: Ruifang
authors.initials: R
authors.lastname: Bu
authors.forename: Ping
authors.initials: P
authors.lastname: Han
authors.forename: Yu
authors.initials: Y
authors.lastname: Liu
authors.forename: Jingdong
authors.initials: J
authors.lastname: Liu
authors.forename: Yongde
authors.initials: Y
authors.lastname: Peng
authors.forename: Xiaomin
authors.initials: X
authors.lastname: Liu
authors.forename: Zhimin
authors.initials: Z
authors.lastname: Liu
authors.forename: Li
authors.initials: L
authors.lastname: Yan
authors.forename: Minxiang
authors.initials: M
authors.lastname: Lei
authors.forename: Xuejun
authors.initials: X
authors.lastname: Li
authors.forename: Qinhua
authors.initials: Q
authors.lastname: Song
authors.forename: Bingyin
authors.initials: B
authors.lastname: Shi
authors.forename: Wei
authors.initials: W
authors.lastname: Gu
authors.forename: Zhengfang
authors.initials: Z
authors.lastname: Li
mesh_terms: D044466:Asian People; D001786:Blood Glucose; D002681:China; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D006442:Glycated Hemoglobin / Q000737:chemistry; D006801:Humans; D007003:Hypoglycemia; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008687:Metformin / Q000627:therapeutic use; D000077205:Pioglitazone; D010880:Piperidines / Q000627:therapeutic use*; D012449:Safety; D045162:Thiazolidinediones / Q000627:therapeutic use; D014498:Uracil / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D000077205:Pioglitazone; D010880:Piperidines; D045162:Thiazolidinediones; D014498:Uracil; C520853:alogliptin