PMID- 36515221
OWN - NLM
STAT- MEDLINE
DCOM- 20221227
LR  - 20221230
IS  - 1753-0407 (Electronic)
IS  - 1753-0393 (Print)
IS  - 1753-0407 (Linking)
VI  - 14
IP  - 12
DP  - 2022 Dec
TI  - Yogliptin monotherapy in type 2 diabetes: A 12-week randomized, double-blind, 
      placebo-controlled phase II study.
PG  - 822-830
LID - 10.1111/1753-0407.13337 [doi]
AB  - BACKGROUND: The new xanthine dipeptidyl peptidase-4 inhibitor yogliptin has 
      exhibited excellent hypoglycemic activity in experimental disease models. The 
      present work aimed to assess the efficacy of yogliptin as a monotherapy in 
      individuals with type 2 diabetes mellitus (T2DM). METHODS: A 12-week, 
      double-blind, placebo-controlled phase II study was performed. T2DM patients (new 
      diagnosis or inadequately controlled) were randomly divided into groups (1:1:1:1) 
      and administered either a placebo or weekly doses of 200, 300, or 400 mg 
      yogliptin, respectively. The primary efficacy end point in this analysis was 
      hemoglobin A1c (HbA1c) change at 12 weeks relative to baseline. Relevant 
      secondary outcomes were also examined, including fasting plasma glucose (FPG), 
      2 h-postprandial plasma glucose (PPG), body weight, and the rate of individuals 
      who achieved the treatment goal of HbA1c </= 7% at 12 weeks from baseline. RESULTS: 
      A total of 81 cases who received either the placebo (20 cases) or 200 (20 cases), 
      300 (20 cases), or 400 (21 cases) mg yogliptin were examined in the full analysis 
      set. At 12 weeks, changes in HbA1c levels from baseline were 0.17 (-0.22, 0.57) 
      in the placebo group, and -0.75 (-1.15, -0.35), -0.52 (-0.93, -0.11) and -1.02 
      (-1.41, -0.64) (mean % [95% confidence interval], p < .001 vs. placebo) in the 
      200, 300, and 400 mg yogliptin groups, respectively. From week four, significant 
      improvements in secondary efficacy outcomes among patients administered the 
      yogliptin monotherapy were observed. FPG showed markedly more pronounced 
      reduction after treatment with yogliptin at 200, 300, and 400 mg in comparison 
      with placebo patients at 4, 8, and 12 weeks. At 12 weeks, goal attainment 
      (HbA1c </= 7%) was reached in 0%, 20.00%, 15.80%, and 33.33% of the placebo and 
      three Yogliptin dosage groups, respectively. Adverse events were comparable in 
      all groups. CONCLUSIONS: This study demonstrated that yogliptin controlled 
      glycemia in Chinese T2DM cases, with a great safety profile. The current findings 
      supported that any of the three doses of yogliptin, administered once a week, 
      could be used for phase III clinical studies.
CI  - (c) 2022 The Authors. Journal of Diabetes published by Ruijin Hospital, Shanghai 
      JiaoTong University School of Medicine and John Wiley & Sons Australia, Ltd.
FAU - Wang, Xin
AU  - Wang X
AUID- ORCID: 0000-0003-3176-1243
AD  - China-Japan Friendship Hospital, Beijing, China.
FAU - Wang, Ying
AU  - Wang Y
AD  - Chengdu Easton Biopharmaceuticals Co., Ltd, Chengdu, China.
FAU - Yong, Xiaolan
AU  - Yong X
AD  - Chengdu Xinhua Hospital, Chengdu, China.
FAU - Wu, Bojun
AU  - Wu B
AD  - Chengdu Xinhua Hospital, Chengdu, China.
FAU - Sun, Zilin
AU  - Sun Z
AUID- ORCID: 0000-0001-5357-5332
AD  - Zhongda Hospital Affiliated to Southeast University, Nanjing, China.
FAU - Lou, Ning
AU  - Lou N
AD  - Jinan Central Hospital, Jinan, China.
FAU - Wen, Qing
AU  - Wen Q
AD  - Jinan Central Hospital, Jinan, China.
FAU - Zhang, Yufang
AU  - Zhang Y
AD  - Chongqing Red Cross Hospital, Chongqing, China.
FAU - Li, Shiyun
AU  - Li S
AD  - Affiliated Hospital of Chengdu University, Chengdu, China.
FAU - Li, Jiarui
AU  - Li J
AD  - Cangzhou Central Hospital, Cangzhou, China.
FAU - He, Yan
AU  - He Y
AD  - Affiliated Hospital of Guizhou Medical University, Guizhou, China.
FAU - Cheng, Jinluo
AU  - Cheng J
AD  - Changzhou Second People's Hospital, Changzhou, People's Republic of China.
FAU - Zhong, Xiangdong
AU  - Zhong X
AD  - Changzhou Second People's Hospital, Changzhou, People's Republic of China.
FAU - Shen, Jing
AU  - Shen J
AD  - Chengdu Fifth People's Hospital, Chengdu, People's Republic of China.
FAU - Yang, Wenying
AU  - Yang W
AUID- ORCID: 0000-0002-7997-9404
AD  - China-Japan Friendship Hospital, Beijing, China.
LA  - eng
GR  - Easton Biopharmaceuticals/
GR  - 2020YFS0459/Scientific and technological project in Sichuan Province/
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20221214
PL  - Australia
TA  - J Diabetes
JT  - Journal of diabetes
JID - 101504326
RN  - 0 (Glycated Hemoglobin)
RN  - 0 (Blood Glucose)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
SB  - IM
MH  - Humans
MH  - *Diabetes Mellitus, Type 2
MH  - Glycated Hemoglobin
MH  - Blood Glucose
MH  - Hypoglycemic Agents/adverse effects
MH  - *Dipeptidyl-Peptidase IV Inhibitors/therapeutic use
MH  - Double-Blind Method
MH  - Treatment Outcome
MH  - Drug Therapy, Combination
PMC - PMC9789391
OTO - NOTNLM
OT  - 2型糖尿病
OT  - DPP-4抑制剂
OT  - monotherapy
OT  - type 2 diabetes mellitus
OT  - xanthine dipeptidyl peptidase-4 inhibitor
OT  - yogliptin
OT  - 优格列汀
OT  - 单药疗法
EDAT- 2022/12/15 06:00
MHDA- 2022/12/28 06:00
PMCR- 2022/12/14
CRDT- 2022/12/14 06:22
PHST- 2022/10/20 00:00 [revised]
PHST- 2021/12/20 00:00 [received]
PHST- 2022/11/14 00:00 [accepted]
PHST- 2022/12/15 06:00 [pubmed]
PHST- 2022/12/28 06:00 [medline]
PHST- 2022/12/14 06:22 [entrez]
PHST- 2022/12/14 00:00 [pmc-release]
AID - JDB13337 [pii]
AID - 10.1111/1753-0407.13337 [doi]
PST - ppublish
SO  - J Diabetes. 2022 Dec;14(12):822-830. doi: 10.1111/1753-0407.13337. Epub 2022 Dec 
      14.