[The design and baseline characteristics of a phase III study to evaluate the efficacy and safety of alogliptin versus placebo in type 2 diabetes mellitus in Mainland China].
OBJECTIVE
To assess the design and the Mainland China subgroup baseline characteristics of the study to evaluate the efficacy and safety of alogliptin versus placebo in subjects with type 2 diabetes (T2DM) as monotherapy, add-on to metformin or add-on to pioglitazone.


METHODS
This was a multi-center, randomized, double-blind, placebo-controlled, 16-week study comparing alogliptin (ALO, 25 mg, 1/d) versus placebo (PLA) as monotherapy (A), add-on to metformin (B) or add-on to pioglitazone ± metformin (C). The T2DM subjects with glycosylated hemoglobin A1c(HbA1c) between 7% and 10% and aged between 18 years and 75 years were enrolled and randomized to the alogliptin group and the placebo group in 1: 1 ratio with 16 weeks treatment. All patients were followed up every 4 weeks. The safety endpoints consisted of the incidence of hypoglycemia and other adverse events.


RESULTS
A total of 491 patients were enrolled in the Mainland China subgroup of the study (181 in group A, 186 in group B and 124 in group C). In each treatment group, the baseline characteristics including age, gender, body mass index, diabetes duration, HbA1c, fasting plasma glucose, body weight, daily dosage of metformin and daily dosage of pioglitazone were all well balanced.


CONCLUSIONS
The demographic data, medical history, glycemic profile and treatment regimen at baseline in Mainland China subgroup are well balanced. The result of this study will provide the clinical evidence for the use of alogliptin in Chinese T2DM patients.
Department of Endocrinology, Chinese PLA General Hospital, Beijing 100853, China. Email: panchy301@aliyun.com.
Chang-yu
CY
Pan
Wen-hui
WH
Li
Jiao-e
JE
Zeng
Cheng-jiang
CJ
Li
Jin-kui
JK
Yang
Qiu-he
QH
Ji
Ju-ming
JM
Lu
Xiao-feng
XF
Lü
Xue-feng
XF
Li
Shen
S
Qu
Xiang-jin
XJ
Xu
Yao-ming
YM
Xue
Ling
L
Li
Zhao-shun
ZS
Jiang
Bao-zhong
BZ
Zheng
Rui-fang
RF
Bu
Ping
P
Han
Yu
Y
Liu
Jing-dong
JD
Liu
Yong-de
YD
Peng
Xiao-min
XM
Liu
Zhi-min
ZM
Liu
Li
L
Yan
Min-xiang
MX
Lei
Xue-jun
XJ
Li
Qin-hua
QH
Song
Bing-yin
BY
Shi
Wei
W
Gu
Zheng-fang
ZF
Li
D000328:Adult; D002681:China; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000009:adverse effects* / Q000627:therapeutic use*; D011446:Prospective Studies; D012107:Research Design; D016896:Treatment Outcome; D014498:Uracil / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
D010880:Piperidines; D014498:Uracil; C520853:alogliptin