TY - JOUR
T1 - Rationale, design and baseline characteristics of the effect of canagliflozin in patients with type 2 diabetes and microalbuminuria in the Japanese population
T2 - The CANPIONE study
AU - the CANPIONE study Investigators
AU - Miyamoto, Satoshi
AU - Heerspink, Hiddo J.L.
AU - de Zeeuw, Dick
AU - Toyoda, Masao
AU - Suzuki, Daisuke
AU - Hatanaka, Takashi
AU - Nakamura, Tohru
AU - Kamei, Shinji
AU - Murao, Satoshi
AU - Hida, Kazuyuki
AU - Ando, Shinichiro
AU - Akai, Hiroaki
AU - Takahashi, Yasushi
AU - Koya, Daisuke
AU - Kitada, Munehiro
AU - Sugano, Hisashi
AU - Nunoue, Tomokazu
AU - Nakamura, Akihiko
AU - Sasaki, Motofumi
AU - Nakatou, Tatsuaki
AU - Fujimoto, Kei
AU - Kawanami, Daiji
AU - Wada, Takashi
AU - Miyatake, Nobuyuki
AU - Yoshida, Michihiro
AU - Shikata, Kenichi
N1 - Funding Information:
information Mitsubishi Tanabe Pharma Corporation, JapanWe would like to express our gratitude to Prof. Kunihisa Kamikawa and Mr. Yoshihiro Satou, Center for Innovative Clinical Medicine, Okayama University Hospital, for management of the study; Mr. Masayoshi Nakabayashi, Center for Innovative Clinical Medicine, Okayama University Hospital, for conducting site audits; Ms. Hiromi Kuramoto, Center for Innovative Clinical Medicine, Okayama University Hospital, for data management of the study; Ms. Naomi Kondo, Center for Innovative Clinical Medicine, Okayama University Hospital, for monitoring the study; Ms. Satoko Fujio, Diabetes Center, Okayama University Hospital, for management of the study and performing measurements of cytokines and chemokines; and Mr. Kota Sakamoto, Center for Innovative Clinical Medicine, Okayama University Hospital, for statistical data analysis. This study is funded by Mitsubishi Tanabe Pharma Corporation, Japan.
Funding Information:
S. Miyamoto reports honoraria for speaking from Daiichi Sankyo, Mitsubishi Tanabe and Taisho. HJLH has served as a consultant for AbbVie, AstraZeneca, Bayer, Boehringer Ingelheim, Chinook, CSL Pharma, Gilead, Janssen, Merck, Mundi Pharma, Mitsubishi Tanabe, Novo Nordisk and Retrophin. He has received research support from AbbVie, AstraZeneca, Boehringer Ingelheim and Janssen. DdZ has served as a member of advisory boards and/or as a speaker for Bayer, Boehringer Ingelheim, Fresenius, Mitsubishi Tanabe and Travere; as a member of Steering Committees and/or speaker for AbbVie and Janssen; and as a member of Data Safety and Monitoring Committees for Bayer. MT reports honoraria for speaking from Kissei, Medtronic, Terumo, Abbott, MSD, Eli Lilly, Novartis, Takeda, Sumitomo Dainippon, Sanofi, Novo Nordisk, Daiich Sankyo, Mitsubishi Tanabe, Ono, Boehringer Ingelheim, AstraZeneca and Astellas; and research grants from LifeScan Japan, Mitsubishi Tanabe, Daiich Sankyo, Novo Nordisk, Sanofi, Takeda, Eli Lilly and MSD. DS reports honoraria for speaking from MSD, Eli Lilly Japan and Nippon Boehringer Ingelheim. T. Nakamura reports a manuscript fee from Takeda. KH reports honoraria for speaking from Takeda and Eli Lilly; and research grants from Eli Lilly, AstraZeneca, Mitsubishi Tanabe, Sanofi and Boehringer Ingelheim. HA reports honoraria for speaking from Eli Lilly, MSD, Arkray, Sumitomo Dainippon, Ono, Kracie, Astellas, Kowa, Becton Dickinson, Kyowa Hakko Kirin, LifeScan Japan, Sanofi, Takeda, Taisho, Chugai, Novo Nordisk, Boehringer Ingelheim, Mitsubishi Tanabe, Daiichi Sankyo, Novartis, Sanwa Chemistry, Kissei, Abbot and Kowa; and research grants from Boehringer Ingelheim, Kyowa Hakko Kirin, Ono, Eli Lilly, Takeda, Sanofi, Kowa and Taisho. D. Koya reports honoraria for speaking from MSD, Astellas, AstraZeneca, Mitsubishi Tanabe, Eli Lilly, Boehringer Ingelheim, Novo Nordisk and Sumitomo Dainippon; and research grants from Mitsubishi Tanabe and AstraZeneca. D. Koya and MK belong to the endowed department sponsored by Boehringer Ingelheim, Mitsubishi Tanabe, Ono and Taisho Toyama. MK reports research grants from Mitsubishi Tanabe, AstraZeneca, Sanwa Kagaku Kenkyusho and Kyowa Kirin. AN reports honoraria for speaking from Mitsubishi Tanabe, Fukuda Denshi, Astellas, Chugai, Novartis, MSD, Takeda, Kissei, Kyowa Hakko Kirin, Sanofi, Bristol‐Myers, Kowa, Sanwa Kagaku Kenkyusho and Ono. T. Nakatou reports honoraria for speaking from Eli Lilly, Novo Nordisk and Sumitomo Dainippon. KF reports honoraria for speaking from Sanofi, Merck Sharpe & Dohme, Taisho, Eli Lilly, Terumo, Arkray, Astellas, AstraZeneca, Boehringer Ingelheim, Mitsubishi Tanabe, Ono, Novo Nordisk, Kissei, Sumitomo Dainippon, Kowa, Takeda, Daiichi Sankyo, Chugai, Abbot, Otsuka and Kyowa Hakko Kirin. D. Kawanami reports honoraria for speaking from Novo Nordisk, Sanofi, Böehringer Ingelheim, Kyowa Kirin, Sumitomo Dainippon, Ono, Kowa, Taisho, Mitsubishi Tanabe, Daiichi Sankyo, MSD, Kowa, AstraZeneca, Teijin and Takeda; and research grants from Novo Nordisk, Mitsubishi Tanabe, Daiichi Sankyo, Terumo, Nipro, Eli Lilly, Böehringer Ingelheim, Kyowa Kirin, Sumitomo Dainippon, Taisho, Teijin and Takeda. TW reports a consulting fee from Mitsubishi Tanabe; honoraria for speaking from Astellas, Bayer, Chugai, Kowa, Kyowa Kirin, Mitsubishi Tanabe, Miyarisan, MSD, Boehringer Ingelheim, Ono, Sanofi, Sanwa Chemistry and Sysmex; and research grants from Astellas, Bayer, Chugai, Eli Lilly, Kissei, Kowa, Kyowa Kirin, Mitsubishi Tanabe, Asahi Kasei, Mochida, Takeda, Otsuka, Sanofi, Terumo, Torii and Fuji Yakuhin. NM reports honorarium for speaking from Sumitomo Dainippon. MY has received stock dividends from Takeda. KS reports honoraria for speaking from MSD, Eli Lilly, Boehringer Ingelheim, Novo Nordisk, Mitsubishi Tanabe and Kyowa Hakko Kirin; research support from Takeda, MSD, Kyowa Hakko Kirin and Mitsubishi Tanabe; and a consulting fee from Daiichi Sankyo. TH, SK, S. Murao, SA, YT, HS, T. Nunoue and MS have no conflicts of interest to declare.
Publisher Copyright:
© 2022 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
PY - 2022/8
Y1 - 2022/8
N2 - Aim: To evaluate the effect of canagliflozin, a sodium-glucose co-transporter-2 (SGLT2) inhibitor, on albuminuria and the decline of estimated glomerular filtration rate (eGFR) in participants with type 2 diabetes and microalbuminuria. Methods: The CANPIONE study is a multicentre, randomized, parallel-group and open-labelled study consisting of a unique 24-week preintervention period, during which the rate of eGFR decline before intervention is estimated, followed by a 52-week intervention and a 4-week washout period. Participants with a geometric mean urinary albumin-to-creatinine ratio (UACR) of 50 and higher and less than 300 mg/g in two consecutive first-morning voids at two different time points, and an eGFR of 45 ml/min/1.73m2 or higher, are randomly assigned to receive canagliflozin 100 mg daily or to continue guideline-recommended treatment, except for SGLT2 inhibitors. The first primary outcome is the change in UACR, and the second primary outcome is the change in eGFR slope. Results: A total of 258 participants were screened and 98 were randomized at 21 sites in Japan from August 2018 to May 2021. The mean baseline age was 61.4 years and 25.8% were female. The mean HbA1c was 7.9%, mean eGFR was 74.1 ml/min/1.73m2 and median UACR was 104.2 mg/g. Conclusions: The CANPIONE study will determine whether the SGLT2 inhibitor canagliflozin can reduce albuminuria and slow eGFR decline in participants with type 2 diabetes and microalbuminuria.
AB - Aim: To evaluate the effect of canagliflozin, a sodium-glucose co-transporter-2 (SGLT2) inhibitor, on albuminuria and the decline of estimated glomerular filtration rate (eGFR) in participants with type 2 diabetes and microalbuminuria. Methods: The CANPIONE study is a multicentre, randomized, parallel-group and open-labelled study consisting of a unique 24-week preintervention period, during which the rate of eGFR decline before intervention is estimated, followed by a 52-week intervention and a 4-week washout period. Participants with a geometric mean urinary albumin-to-creatinine ratio (UACR) of 50 and higher and less than 300 mg/g in two consecutive first-morning voids at two different time points, and an eGFR of 45 ml/min/1.73m2 or higher, are randomly assigned to receive canagliflozin 100 mg daily or to continue guideline-recommended treatment, except for SGLT2 inhibitors. The first primary outcome is the change in UACR, and the second primary outcome is the change in eGFR slope. Results: A total of 258 participants were screened and 98 were randomized at 21 sites in Japan from August 2018 to May 2021. The mean baseline age was 61.4 years and 25.8% were female. The mean HbA1c was 7.9%, mean eGFR was 74.1 ml/min/1.73m2 and median UACR was 104.2 mg/g. Conclusions: The CANPIONE study will determine whether the SGLT2 inhibitor canagliflozin can reduce albuminuria and slow eGFR decline in participants with type 2 diabetes and microalbuminuria.
KW - canagliflozin
KW - CANPIONE study
KW - diabetic kidney disease
KW - eGFR slope
KW - SGLT2 inhibitor
KW - urinary albumin-to-creatinine ratio
UR - http://www.scopus.com/inward/record.url?scp=85131856790&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85131856790&partnerID=8YFLogxK
U2 - 10.1111/dom.14731
DO - 10.1111/dom.14731
M3 - Article
C2 - 35491532
AN - SCOPUS:85131856790
VL - 24
SP - 1429
EP - 1438
JO - Diabetes, Obesity and Metabolism
JF - Diabetes, Obesity and Metabolism
SN - 1462-8902
IS - 8
ER -