PMID- 28608617
OWN - NLM
STAT- MEDLINE
DCOM- 20180727
LR  - 20210109
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Print)
IS  - 1462-8902 (Linking)
VI  - 20
IP  - 1
DP  - 2018 Jan
TI  - Long-term safety and efficacy of canagliflozin as add-on therapy to teneligliptin 
      in Japanese patients with type 2 diabetes.
PG  - 77-84
LID - 10.1111/dom.13038 [doi]
AB  - AIM: To evaluate the long-term safety and efficacy of canagliflozin as add-on 
      therapy in patients with type 2 diabetes mellitus (T2DM) who had inadequate 
      glycaemic control with teneligliptin monotherapy. METHODS: This open-label 
      52-week study was conducted in Japan. Patients received canagliflozin 100 mg 
      added to teneligliptin 20 mg orally once daily for 52 weeks. The safety endpoint 
      was the incidence of adverse events (AEs). The efficacy endpoints included 
      changes in glycated haemoglobin (HbA1c), fasting plasma glucose (FPG) and body 
      weight from baseline to week 52 (with last observation carried forward). RESULTS: 
      Overall, 153 patients entered the treatment period and 142 completed the study. 
      The overall incidence rates of AEs and drug-related AEs were 69.9% and 22.9%, 
      respectively. Most AEs and drug-related AEs were mild or moderate in severity. 
      There were no previously undescribed safety signals. The mean changes in HbA1c, 
      FPG and body weight were -0.99% (95% confidence interval [CI] -1.12 to -0.85), 
      -38.6 mg/dL (95% CI -43.4 to -33.9) and -3.92% (95% CI -4.53 to -3.31), 
      respectively. These effects were maintained for 52 weeks without attenuation. 
      HbA1c and body weight were both decreased in 82.24% of patients at the end of the 
      treatment period. Reductions in postprandial glucose were observed at weeks 24 
      and 52. CONCLUSIONS: No new safety risks with this combination were identified, 
      and sustained improvements in HbA1c, FPG and body weight were observed. The 
      findings suggest that long-term co-administration of canagliflozin with 
      teneligliptin is well tolerated and effective in Japanese patients with T2DM who 
      have inadequate glycaemic control on teneligliptin alone.
CI  - (c) 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & 
      Sons Ltd.
FAU - Kadowaki, Takashi
AU  - Kadowaki T
AD  - Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The 
      University of Tokyo, Tokyo, Japan.
FAU - Inagaki, Nobuya
AU  - Inagaki N
AD  - Department of Diabetes, Endocrinology, and Nutrition, Graduate School of 
      Medicine, Kyoto University, Kyoto, Japan.
FAU - Kondo, Kazuoki
AU  - Kondo K
AD  - Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma 
      Corporation, Tokyo, Japan.
FAU - Nishimura, Kenichi
AU  - Nishimura K
AD  - Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma 
      Corporation, Tokyo, Japan.
FAU - Kaneko, Genki
AU  - Kaneko G
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 - Nakanishi, Nobuhiro
AU  - Nakanishi N
AD  - Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma 
      Corporation, Tokyo, Japan.
FAU - Watanabe, Yumi
AU  - Watanabe Y
AD  - Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma 
      Corporation, Tokyo, Japan.
FAU - Gouda, Maki
AU  - Gouda M
AD  - Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma 
      Corporation, Tokyo, Japan.
FAU - Iijima, Hiroaki
AU  - Iijima H
AUID- ORCID: 0000-0003-4621-2394
AD  - Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma 
      Corporation, Tokyo, Japan.
LA  - eng
SI  - ClinicalTrials.gov/NCT02220907
PT  - Journal Article
PT  - Multicenter Study
DEP - 20170731
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 
      (3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine)
RN  - 0 (Anti-Obesity Agents)
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Membrane Transport Modulators)
RN  - 0 (Pyrazoles)
RN  - 0 (SLC5A2 protein, human)
RN  - 0 (Sodium-Glucose Transporter 2)
RN  - 0 (Sodium-Glucose Transporter 2 Inhibitors)
RN  - 0 (Thiazolidines)
RN  - 0SAC974Z85 (Canagliflozin)
SB  - IM
MH  - Aged
MH  - Anti-Obesity Agents/adverse effects/therapeutic use
MH  - Body Mass Index
MH  - Canagliflozin/adverse effects/*therapeutic use
MH  - Cohort Studies
MH  - Combined Modality Therapy/adverse effects
MH  - Diabetes Mellitus, Type 2/complications/*drug therapy/metabolism/therapy
MH  - Diet, Diabetic
MH  - Diet, Reducing
MH  - Dipeptidyl-Peptidase IV Inhibitors/adverse effects/*therapeutic use
MH  - Drug Resistance
MH  - Drug Therapy, Combination/adverse effects
MH  - Exercise
MH  - Female
MH  - Humans
MH  - Hyperglycemia/*prevention & control
MH  - Hypoglycemia/chemically induced/prevention & control
MH  - Hypoglycemic Agents/adverse effects/*therapeutic use
MH  - Japan
MH  - Male
MH  - Membrane Transport Modulators/adverse effects/therapeutic use
MH  - Middle Aged
MH  - Overweight/complications/metabolism/prevention & control/therapy
MH  - Pyrazoles/adverse effects/*therapeutic use
MH  - Sodium-Glucose Transporter 2/metabolism
MH  - *Sodium-Glucose Transporter 2 Inhibitors
MH  - Thiazolidines/adverse effects/*therapeutic use
PMC - PMC5724659
OTO - NOTNLM
OT  - DPP-4 inhibitor
OT  - SGLT2 inhibitor
OT  - canagliflozin
OT  - teneligliptin
OT  - type 2 diabetes mellitus
COIS- T. K. has received consulting fees and/or speakers' bureau fees from Astellas 
      Pharma Inc., AstraZeneca K.K., MSD K.K., Mitsubishi Tanabe Pharma Corp., Novo 
      Nordisk Pharma Ltd, Ono Pharmaceutical Co., Ltd, Sanofi K.K. and Takeda 
      Pharmaceutical Co., Ltd, research support from Daiichi Sankyo Co., Ltd and Takeda 
      Pharmaceutical Co., Ltd, scholarship grants from Astellas Pharma Inc., Daiichi 
      Sankyo Co., Ltd, Mitsubishi Tanabe Pharma Corp., Sumitomo Dainippon Pharma Co., 
      Ltd, Taisho Toyama Pharmaceutical Co., Ltd and Takeda Pharmaceutical Co., Ltd, 
      and belongs to courses endowed by MSD K.K., Nippon Boehringer Ingelheim Co., Ltd, 
      Novo Nordisk Pharma Ltd, and Takeda Pharmaceutical Co., Ltd. N. I. has received 
      consulting fees and/or speakers' bureau fees from Astellas Pharma Inc., MSD K.K., 
      Nippon Boehringer Ingelheim Co., Ltd, Sanofi K.K. and Takeda Pharmaceutical Co., 
      Ltd, research support from Eli Lilly Japan K.K., MSD K.K. and Mitsubishi Tanabe 
      Pharma Corp., and scholarship grants from Astellas Pharma Inc., AstraZeneca K.K., 
      Daiichi Sankyo Co., Ltd, Japan Diabetes Foundation, Japan Tobacco Inc., Kissei 
      Pharmaceutical Co., Ltd, Kyowa Hakko Kirin Co., Ltd, MSD K.K., Mitsubishi Tanabe 
      Pharma Corp., Nippon Boehringer Ingelheim Co., Ltd, Novartis Pharma K.K., Novo 
      Nordisk Pharma Ltd, Ono Pharmaceutical Co., Ltd, Pfizer Japan Inc., Sanwa Kagaku 
      Kenkyusho Co., Ltd, Sanofi K.K., Sumitomo Dainippon Pharma Co., Ltd, Takeda 
      Pharmaceutical Co., Ltd and Taisho Toyama Pharmaceutical Co., Ltd. K. K., K. N., 
      G. K., N. M., N. N., Y. W., M. G. and H. I. are employees of Mitsubishi Tanabe 
      Pharma Corp.
EDAT- 2017/06/14 06:00
MHDA- 2018/07/28 06:00
PMCR- 2017/12/11
CRDT- 2017/06/14 06:00
PHST- 2017/04/05 00:00 [received]
PHST- 2017/06/08 00:00 [revised]
PHST- 2017/06/09 00:00 [accepted]
PHST- 2017/06/14 06:00 [pubmed]
PHST- 2018/07/28 06:00 [medline]
PHST- 2017/06/14 06:00 [entrez]
PHST- 2017/12/11 00:00 [pmc-release]
AID - DOM13038 [pii]
AID - 10.1111/dom.13038 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2018 Jan;20(1):77-84. doi: 10.1111/dom.13038. Epub 2017 Jul 
      31.