PMID- 32744380
OWN - NLM
STAT- MEDLINE
DCOM- 20210624
LR  - 20220531
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 22
IP  - 12
DP  - 2020 Dec
TI  - Pharmacokinetics, pharmacodynamics and tolerability of single and multiple doses 
      of janagliflozin, a sodium-glucose co-transporter-2 inhibitor, in Chinese people 
      with type 2 diabetes mellitus.
PG  - 2316-2324
LID - 10.1111/dom.14156 [doi]
AB  - AIMS: To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) 
      characteristics, and tolerability of janagliflozin, a novel sodium-glucose 
      co-transporter-2 inhibitor, in Chinese people with type 2 diabetes mellitus 
      (T2DM). MATERIALS AND METHODS: In this study, 36 people with T2DM were randomly 
      assigned in a 1:1:1:1 ratio to receive janagliflozin 25 mg, janagliflozin 50 mg, 
      dapagliflozin 10 mg or placebo. Participants received a single dose on day 1, and 
      were treated once daily from day 4 to day 17. RESULTS: Following oral 
      administration, janagliflozin was rapidly absorbed, reaching C(max) at 2 hours. 
      The mean half-life (t(1/2) ) at steady state was approximately 21 to 23 hours. 
      There was no significant accumulation with multiple doses (accumulation 
      factor < 2). In participants treated with janagliflozin 25 mg, janagliflozin 
      50 mg, dapagliflozin 10 mg or placebo, change in mean 24-hour urinary glucose 
      excretion from baseline was 92.35, 94.17, 87.61 and 6.26 g after multiple doses, 
      and change in mean fasting plasma glucose level from baseline to day 17 was 
      -2.18, -2.66, -2.79 and 1.70%, respectively. Most adverse events (AEs) were mild 
      or moderate with no deaths, serious AEs, or discontinuations due to AEs. 
      CONCLUSIONS: Single and multiple oral administration (14 days) of janagliflozin 
      25 mg and 50 mg exhibited favourable PK, PD and tolerability profiles in Chinese 
      people with T2DM, which were comparable to those of dapagliflozin 10 mg. 
      Janagliflozin 25 mg and 50 mg are recommended for further clinical investigation.
CI  - (c) 2020 John Wiley & Sons Ltd.
FAU - Li, Xiaojiao
AU  - Li X
AUID- ORCID: 0000-0001-5999-0035
AD  - Phase I Clinical Trial Unit, First Hospital, Jilin University, Jilin, China.
FAU - Zhu, Xiaoxue
AU  - Zhu X
AD  - Phase I Clinical Trial Unit, First Hospital, Jilin University, Jilin, China.
FAU - Liu, Jingrui
AU  - Liu J
AD  - Phase I Clinical Trial Unit, First Hospital, Jilin University, Jilin, China.
FAU - Li, Qianqian
AU  - Li Q
AD  - Phase I Clinical Trial Unit, First Hospital, Jilin University, Jilin, China.
FAU - Zhang, Hong
AU  - Zhang H
AUID- ORCID: 0000-0002-8546-8555
AD  - Phase I Clinical Trial Unit, First Hospital, Jilin University, Jilin, China.
FAU - Li, Cuiyun
AU  - Li C
AD  - Phase I Clinical Trial Unit, First Hospital, Jilin University, Jilin, China.
FAU - Wu, Min
AU  - Wu M
AD  - Phase I Clinical Trial Unit, First Hospital, Jilin University, Jilin, China.
FAU - Gao, Lei
AU  - Gao L
AD  - Phase I Clinical Trial Unit, First Hospital, Jilin University, Jilin, China.
FAU - Wen, He
AU  - Wen H
AD  - Sihuan Pharmaceutical Holdings Group Ltd., Beijing, China.
FAU - Li, Xixi
AU  - Li X
AD  - Sihuan Pharmaceutical Holdings Group Ltd., Beijing, China.
FAU - Tang, Xinran
AU  - Tang X
AD  - Sihuan Pharmaceutical Holdings Group Ltd., Beijing, China.
FAU - Liu, Li
AU  - Liu L
AD  - Department of Pediatrics, First Hospital, Jilin University, Jilin, China.
FAU - Ding, Yanhua
AU  - Ding Y
AD  - Phase I Clinical Trial Unit, First Hospital, Jilin University, Jilin, China.
LA  - eng
GR  - 2017ZX09101001-002-004/National Major Scientific and Technological Special 
      Project for Significant New Drug Development during the Thirteenth Five-Year Plan 
      Period of China/
GR  - Project: 2017ZX09304004/National Major Scientific and Technological Special 
      Project for Significant New Drug Development during the Thirteenth Five-Year Plan 
      Period of China/
GR  - 81602897/National Natural Science Foundation of China/
GR  - 2017TD-08/The program for JLU Science and Technology Innovative Research Team and 
      the Fundamental Research Funds for the Central Universities./
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20200902
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Sodium-Glucose Transporter 2 Inhibitors)
RN  - 0 (Symporters)
RN  - 9NEZ333N27 (Sodium)
RN  - IY9XDZ35W2 (Glucose)
SB  - IM
MH  - China/epidemiology
MH  - *Diabetes Mellitus, Type 2/drug therapy
MH  - Dose-Response Relationship, Drug
MH  - Glucose
MH  - Humans
MH  - Sodium
MH  - *Sodium-Glucose Transporter 2 Inhibitors
MH  - *Symporters
OTO - NOTNLM
OT  - SGLT2 inhibitors
OT  - dapagliflozin
OT  - janagliflozin
OT  - pharmacokinetics and pharmacodynamics
OT  - type 2 diabetes mellitus
EDAT- 2020/08/04 06:00
MHDA- 2021/06/25 06:00
CRDT- 2020/08/04 06:00
PHST- 2020/05/08 00:00 [received]
PHST- 2020/07/13 00:00 [revised]
PHST- 2020/07/27 00:00 [accepted]
PHST- 2020/08/04 06:00 [pubmed]
PHST- 2021/06/25 06:00 [medline]
PHST- 2020/08/04 06:00 [entrez]
AID - 10.1111/dom.14156 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2020 Dec;22(12):2316-2324. doi: 10.1111/dom.14156. Epub 2020 
      Sep 2.