PMID- 23782594
OWN - NLM
STAT- MEDLINE
DCOM- 20140522
LR  - 20221207
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Print)
IS  - 1462-8902 (Linking)
VI  - 15
IP  - 12
DP  - 2013 Dec
TI  - Efficacy and safety of canagliflozin in Japanese patients with type 2 diabetes: a 
      randomized, double-blind, placebo-controlled, 12-week study.
PG  - 1136-45
LID - 10.1111/dom.12149 [doi]
AB  - AIMS: We examined the efficacy, safety and tolerability of canagliflozin, a 
      sodium glucose co-transporter 2 inhibitor, in Japanese patients with type 2 
      diabetes (T2DM) undergoing diet and exercise therapy. METHODS: Patients aged 
      20-80 years with T2DM diagnosed >/=3 months previously, and HbA1c of 6.9-9.9% were 
      randomized to 50, 100, 200 or 300 mg canagliflozin or placebo once daily for 
      12 weeks. The primary and secondary endpoints were changes in HbA1c, fasting 
      plasma glucose (FPG), urinary glucose/creatinine and postprandial glycaemic 
      parameters following a meal test. The safety assessments included adverse events 
      (AEs) and clinical laboratory tests. RESULTS: Overall, 383 patients were 
      randomized to receive either placebo (n = 75), or 50 mg (n = 82), 100 mg 
      (n = 74), 200 mg (n = 77) or 300 mg canagliflozin (n = 75). At week 12, 
      significant reductions in HbA1c were observed in all canagliflozin groups 
      relative to placebo (-0.61, -0.80, -0.79 and -0.88% for 50, 100, 200 and 300 mg, 
      respectively, versus +0.11% for placebo; all, p < 0.01). FPG and postprandial 
      glycaemic parameters improved significantly in the canagliflozin groups. Body 
      weight was significantly decreased by canagliflozin. No deaths or drug-related 
      serious AEs were reported. There was no dose-dependent increase in the incidence 
      of AEs in the canagliflozin groups. The incidence of hypoglycaemia was low; 
      episodes were not severe or dose dependent. Canagliflozin did not affect serum 
      creatinine levels or the urinary albumin/creatinine ratio. CONCLUSIONS: Treatment 
      with canagliflozin for 12 weeks significantly improved glycaemic control and 
      reduced body weight in Japanese patients with T2DM. Canagliflozin was well 
      tolerated.
CI  - (c) 2013 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & 
      Sons Ltd.
FAU - Inagaki, N
AU  - Inagaki N
AD  - Department of Diabetes and Clinical Nutrition, Kyoto University Graduate School 
      of Medicine, Kyoto, Japan.
FAU - Kondo, K
AU  - Kondo K
FAU - Yoshinari, T
AU  - Yoshinari T
FAU - Maruyama, N
AU  - Maruyama N
FAU - Susuta, Y
AU  - Susuta Y
FAU - Kuki, H
AU  - Kuki H
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130714
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Blood Glucose)
RN  - 0 (Glucosides)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Thiophenes)
RN  - 0SAC974Z85 (Canagliflozin)
SB  - IM
CIN - Expert Opin Pharmacother. 2014 Feb;15(3):437-41. PMID: 24377759
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Blood Glucose/metabolism
MH  - Canagliflozin
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Glucosides/*administration & dosage/adverse effects
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Thiophenes/*administration & dosage/adverse effects
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC3906835
OTO - NOTNLM
OT  - SGLT2 inhibitor
EDAT- 2013/06/21 06:00
MHDA- 2014/05/23 06:00
CRDT- 2013/06/21 06:00
PHST- 2012/12/18 00:00 [received]
PHST- 2013/02/04 00:00 [revised]
PHST- 2013/06/11 00:00 [accepted]
PHST- 2013/06/21 06:00 [entrez]
PHST- 2013/06/21 06:00 [pubmed]
PHST- 2014/05/23 06:00 [medline]
AID - 10.1111/dom.12149 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2013 Dec;15(12):1136-45. doi: 10.1111/dom.12149. Epub 2013 
      Jul 14.