PMID- 36594724
OWN - NLM
STAT- MEDLINE
DCOM- 20230404
LR  - 20230406
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 25
IP  - 5
DP  - 2023 May
TI  - Efficacy and safety of janagliflozin monotherapy in Chinese patients with type 2 
      diabetes mellitus inadequately controlled on diet and exercise: A multicentre, 
      randomized, double-blind, placebo-controlled, Phase 3 trial.
PG  - 1229-1240
LID - 10.1111/dom.14971 [doi]
AB  - AIMS: To evaluate the efficacy and safety of janagliflozin, a selective renal 
      sodium-glucose cotransporter-2 inhibitor, as monotherapy in drug-naive Chinese 
      patients with type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS: This Phase 
      3 trial included a 24-week, multicentre, randomized, double-blind, 
      placebo-controlled period, followed by a 28-week extension period. A total of 432 
      patients with glycated haemoglobin (HbA1c) levels >/=7.0% (53 mmol/mol) and </=10.5% 
      (91 mmol/mol) were randomized (1:1:1) to receive once-daily placebo, 25 mg or 
      50 mg janagliflozin. After 24 weeks, patients on placebo were switched and 
      re-randomized (1:1) to 25 mg or 50 mg janagliflozin, whereas patients on 
      janagliflozin maintained the initial therapy. The primary endpoint was change 
      from baseline in HbA1c after 24 weeks. RESULTS: At Week 24, the placebo-adjusted 
      least squares mean changes in HbA1c were -0.80% (95% confidence interval [CI] 
      -0.98% to -0.62%)/-8.7 mmol/mol (95% CI -10.7 mmol/mol to -6.8 mmol/mol) and 
      -0.88% (95% CI -1.06% to -0.70%)/-9.6 mmol/mol (95% CI 
      -11.6 mmol/mol to -7.7 mmol/mol), respectively (P < 0.001 for both). A higher 
      proportion of patients achieved HbA1c <7.0% (53 mmol/mol) with janagliflozin 
      25 mg and janagliflozin 50 mg compared with placebo (47.2%, 49.3%, and 23.5%, 
      respectively). Both janagliflozin doses significantly decreased fasting plasma 
      glucose, 2-hour postprandial glucose, body weight and systolic blood pressure, as 
      well as increased high-density lipoprotein (HDL) cholesterol and insulin 
      sensitivity compared with placebo (P < 0.05 for all). The trends in improvement 
      of these variables were sustained during the 28-week extension period. Overall 
      incidences of adverse events were 67.8%, 71.5% and 60.7% with janagliflozin 
      25 mg, janagliflozin 50 mg and placebo, respectively. The incidence of urinary 
      tract infections and genital fungal infections was low. No severe hypoglycaemia 
      or ketoacidosis occurred. CONCLUSIONS: Janagliflozin 25 mg and 50 mg monotherapy 
      once-daily effectively improved glycaemic control, reduced body weight and blood 
      pressure, improved HDL cholesterol and insulin sensitivity, and was generally 
      well tolerated.
CI  - (c) 2023 John Wiley & Sons Ltd.
FAU - Ji, Linong
AU  - Ji L
AUID- ORCID: 0000-0003-1305-1598
AD  - Department of Endocrinology and Metabolism, Peking University People's Hospital, 
      Beijing, China.
FAU - Jiang, Xiaozhen
AU  - Jiang X
AD  - Shanghai Pudong New Area People's Hospital, Shanghai, China.
FAU - Hao, Qingshun
AU  - Hao Q
AD  - Zaozhuang Municipal Hospital, Zaozhuang, China.
FAU - Cheng, Zhifeng
AU  - Cheng Z
AD  - Fourth Affiliated Hospital of Harbin Medical University, Harbin, China.
FAU - Wang, Kun
AU  - Wang K
AD  - Nanjing Jiangning Hospital, Nanjing, China.
FAU - Pang, Shuguang
AU  - Pang S
AD  - Jinan Central Hospital Affiliated to Shandong University, Jinan, China.
FAU - Liu, Meiying
AU  - Liu M
AD  - Inner Mongolia BaoGang Hospital, Baotou, China.
FAU - Guo, Yushan
AU  - Guo Y
AD  - The Affiliated Hospital of Beihua University, Jilin, China.
FAU - Chen, Xiaowen
AU  - Chen X
AD  - Huangshi Central Hospital, Huangshi, China.
FAU - Su, Xiuhai
AU  - Su X
AD  - Cangzhou Hospital of Integrated TCM-WM . Hebei, Cangzhou, China.
FAU - Ning, Tao
AU  - Ning T
AD  - Baotou Central Hospital, Baotou, China.
FAU - Liu, Jie
AU  - Liu J
AD  - First Affiliated Hospital of Henan University of Science and Technology, Luoyang, 
      China.
FAU - Bian, Fang
AU  - Bian F
AD  - Cangzhou People's Hospital, Cangzhou, China.
FAU - Li, Yulan
AU  - Li Y
AD  - Liuzhou People's Hospital, Liuzhou, China.
FAU - Zhang, Zhinong
AU  - Zhang Z
AD  - The First Hospital of Qiqihar, Qiaihar, China.
FAU - Song, Weihong
AU  - Song W
AD  - Chenzhou First People's Hospital, Chenzhou, China.
FAU - Sun, Jingfang
AU  - Sun J
AD  - Jilin Huisheng Bio-pharmaceutical Co., Ltd, Beijing, China.
LA  - eng
GR  - Jilin Huisheng Bio-pharmaceutical Co., Ltd./
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20230120
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Glycated Hemoglobin)
RN  - 0 (Sodium-Glucose Transporter 2 Inhibitors)
RN  - IY9XDZ35W2 (Glucose)
RN  - 0 (Blood Glucose)
SB  - IM
MH  - Humans
MH  - *Diabetes Mellitus, Type 2
MH  - Hypoglycemic Agents/therapeutic use
MH  - Glycated Hemoglobin
MH  - *Insulin Resistance
MH  - East Asian People
MH  - *Sodium-Glucose Transporter 2 Inhibitors/adverse effects
MH  - Treatment Outcome
MH  - Diet
MH  - Body Weight
MH  - Drug Therapy, Combination
MH  - Glucose/therapeutic use
MH  - Double-Blind Method
MH  - Blood Glucose
OTO - NOTNLM
OT  - janagliflozin
OT  - renal sodium-glucose cotransporter-2 inhibitor
OT  - type 2 diabetes mellitus
EDAT- 2023/01/04 06:00
MHDA- 2023/04/04 06:42
CRDT- 2023/01/03 08:52
PHST- 2022/12/22 00:00 [revised]
PHST- 2022/09/06 00:00 [received]
PHST- 2022/12/30 00:00 [accepted]
PHST- 2023/04/04 06:42 [medline]
PHST- 2023/01/04 06:00 [pubmed]
PHST- 2023/01/03 08:52 [entrez]
AID - 10.1111/dom.14971 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2023 May;25(5):1229-1240. doi: 10.1111/dom.14971. Epub 2023 
      Jan 20.