PMID- 29473709
OWN - NLM
STAT- MEDLINE
DCOM- 20190124
LR  - 20230926
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Print)
IS  - 1462-8902 (Linking)
VI  - 20
IP  - 7
DP  - 2018 Jul
TI  - Efficacy and safety of canagliflozin as add-on therapy to a glucagon-like 
      peptide-1 receptor agonist in Japanese patients with type 2 diabetes mellitus: A 
      52-week, open-label, phase IV study.
PG  - 1770-1775
LID - 10.1111/dom.13267 [doi]
AB  - Sodium-glucose co-transporter-2 (SGLT2) inhibitors and glucagon-like peptide-1 
      receptor agonists (GLP-1RAs) are antihyperglycaemic agents with weight-lowering 
      effects. The efficacy and safety of the SGLT2 inhibitor canagliflozin as add-on 
      therapy in Japanese patients with type 2 diabetes mellitus (T2DM) and inadequate 
      glycaemic control with a GLP-1RA (>/=12 weeks) were evaluated in this phase IV 
      study. Patients received canagliflozin 100 mg once daily for 52 weeks. Efficacy 
      endpoints included change in glycated haemoglobin (HbA1c), fasting plasma glucose 
      (FPG), body weight, systolic blood pressure (SBP) and HDL cholesterol from 
      baseline to week 52. Safety endpoints included adverse events (AEs), 
      hypoglycaemia and laboratory tests. Of the 71 patients treated with 
      canagliflozin, 63 completed the study. At 52 weeks, HbA1c was significantly 
      reduced from baseline (-0.70%; paired t test, P < .001). Significant changes were 
      also observed in FPG (-34.7 mg/dL), body weight (-4.46%), SBP (-7.90 mm Hg), and 
      HDL cholesterol (7.60%; all P < .001). The incidence of AEs, adverse drug 
      reactions and hypoglycaemia was 71.8%, 32.4% and 9.9%, respectively. All 
      hypoglycaemic events were mild. These findings suggest that the long-term 
      combination of canagliflozin with a GLP-1RA is effective and well tolerated in 
      Japanese patients with T2DM.
CI  - (c) 2018 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & 
      Sons Ltd.
FAU - Harashima, Shin-Ichi
AU  - Harashima SI
AD  - Department of Diabetes, Endocrinology and Nutrition, Kyoto University Graduate 
      School of Medicine, Kyoto, Japan.
FAU - Inagaki, Nobuya
AU  - Inagaki N
AD  - Department of Diabetes, Endocrinology and Nutrition, Kyoto University Graduate 
      School of Medicine, Kyoto, Japan.
FAU - Kondo, Kazuoki
AU  - Kondo K
AD  - Ikuyaku Integrated Value Development Division, Mitsubishi Tanabe Pharma 
      Corporation, Tokyo, Japan.
FAU - Maruyama, Nobuko
AU  - Maruyama N
AD  - Ikuyaku Integrated Value Development Division, Mitsubishi Tanabe Pharma 
      Corporation, Tokyo, Japan.
FAU - Otsuka, Makiko
AU  - Otsuka M
AD  - Ikuyaku Integrated Value Development Division, Mitsubishi Tanabe Pharma 
      Corporation, Tokyo, Japan.
FAU - Kawaguchi, Yutaka
AU  - Kawaguchi Y
AD  - Ikuyaku Integrated Value Development Division, Mitsubishi Tanabe Pharma 
      Corporation, Tokyo, Japan.
FAU - Watanabe, Yumi
AU  - Watanabe Y
AUID- ORCID: 0000-0002-8875-7598
AD  - Ikuyaku Integrated Value Development Division, Mitsubishi Tanabe Pharma 
      Corporation, Tokyo, Japan.
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20180324
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Blood Glucose)
RN  - 0 (Cholesterol, HDL)
RN  - 0 (Glucagon-Like Peptide-1 Receptor)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Incretins)
RN  - 0 (Sodium-Glucose Transporter 2 Inhibitors)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 0SAC974Z85 (Canagliflozin)
SB  - IM
MH  - Aged
MH  - Blood Glucose/metabolism
MH  - Blood Pressure
MH  - Body Weight
MH  - Canagliflozin/*therapeutic use
MH  - Cholesterol, HDL/metabolism
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Drug Therapy, Combination
MH  - Female
MH  - Glucagon-Like Peptide-1 Receptor/agonists
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemia/chemically induced
MH  - Incretins/*therapeutic use
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Sodium-Glucose Transporter 2 Inhibitors/*therapeutic use
MH  - Treatment Outcome
PMC - PMC6033027
OTO - NOTNLM
OT  - GLP-1 receptor agonist
OT  - SGLT2 inhibitor
OT  - canagliflozin
OT  - phase IV
OT  - type 2 diabetes
COIS- S.H. has received consulting fees and/or speakers' bureau fees from Eli Lilly 
      Japan KK, Mitsubishi Tanabe Pharma Corp., MSD KK, Novo Nordisk Pharma Ltd and 
      Sanofi KK. N.I. has received consulting fees and/or speakers' bureau fees from 
      Astellas Pharma Inc., MSD KK, Nippon Boehringer Ingelheim Co., Ltd, Sanofi KK and 
      Takeda Pharmaceutical Co., Ltd, research support from AstraZeneca KK, Daiichi 
      Sankyo Co., Ltd, Eli Lilly Japan KK, MSD KK and Mitsubishi Tanabe Pharma Corp., 
      and scholarship grants from Astellas Pharma Inc., AstraZeneca K.K., Daiichi 
      Sankyo Co., Ltd., Japan Tobacco Inc., Kissei Pharmaceutical Co., Ltd., Kyowa 
      Hakko Kirin Co., Ltd., MSD KK, Mitsubishi Tanabe Pharma Corp., Nippon Boehringer 
      Ingelheim Co., Ltd, Novartis Pharma KK, Novo Nordisk Pharma Ltd, Ono 
      Pharmaceutical Co., Ltd, Pfizer Japan Inc., Sanwa Kagaku Kenkyusho Co., Ltd, 
      Sanofi KK, Sumitomo Dainippon Pharma Co., Ltd, Takeda Pharmaceutical Co., Ltd and 
      Taisho Toyama Pharmaceutical Co., Ltd. K.K., N.M., M.O., Y.K. and Y.W. are 
      employees of Mitsubishi Tanabe Pharma Corp.
EDAT- 2018/02/24 06:00
MHDA- 2019/01/25 06:00
PMCR- 2018/07/05
CRDT- 2018/02/24 06:00
PHST- 2017/11/03 00:00 [received]
PHST- 2018/02/16 00:00 [revised]
PHST- 2018/02/19 00:00 [accepted]
PHST- 2018/02/24 06:00 [pubmed]
PHST- 2019/01/25 06:00 [medline]
PHST- 2018/02/24 06:00 [entrez]
PHST- 2018/07/05 00:00 [pmc-release]
AID - DOM13267 [pii]
AID - 10.1111/dom.13267 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2018 Jul;20(7):1770-1775. doi: 10.1111/dom.13267. Epub 2018 
      Mar 24.