PMID- 25495720
OWN - NLM
STAT- MEDLINE
DCOM- 20150924
LR  - 20221207
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 17
IP  - 3
DP  - 2015 Mar
TI  - Long-term efficacy and safety of canagliflozin over 104 weeks in patients aged 
      55-80 years with type 2 diabetes.
PG  - 294-303
LID - 10.1111/dom.12428 [doi]
AB  - AIMS: The long-term efficacy and safety of canagliflozin, a sodium glucose 
      co-transporter 2 inhibitor, was evaluated over 104 weeks in patients aged 
      55-80 years with type 2 diabetes mellitus (T2DM) inadequately controlled on a 
      stable antihyperglycaemic agent regimen. METHODS: In this randomized, 
      double-blind, phase III study, patients received canagliflozin 100 or 300 mg or 
      placebo once daily during a 26-week core period (N = 714) and a 78-week extension 
      period (n = 624). Efficacy endpoints at week 104 included change from baseline in 
      glycated haemoglobin (HbA1c), fasting plasma glucose (FPG) and systolic blood 
      pressure, and percent change from baseline in body weight and fasting plasma 
      lipids. Safety was assessed by adverse event (AE) reports. RESULTS: At week 104, 
      canagliflozin 100 and 300 mg were associated with reductions in HbA1c versus 
      placebo (-0.32 and -0.43% vs 0.17%, respectively; overall mean baseline, 7.7%) 
      and more patients achieved HbA1c <7.0% with canagliflozin 100 and 300 mg than 
      with placebo (35.8 and 41.9% vs 20.3%, respectively). Reductions in FPG, body 
      weight and systolic blood pressure, and increases in high-density lipoprotein 
      cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) were seen 
      with canagliflozin compared with placebo. The overall incidence rates of AEs over 
      104 weeks were 88.0, 89.8 and 86.1% with canagliflozin 100 and 300 mg and 
      placebo, respectively; serious AE rates were low across treatment groups. The 
      incidence rates of urinary tract infections, genital mycotic infections and 
      osmotic diuresis- and volume depletion-related AEs were higher with canagliflozin 
      than with placebo. CONCLUSION: Canagliflozin improved glycaemic control, reduced 
      body weight and systolic blood pressure, and was generally well tolerated in 
      patients aged 55-80 years with T2DM over 104 weeks.
CI  - (c) 2014 John Wiley & Sons Ltd.
FAU - Bode, B
AU  - Bode B
AD  - Atlanta Diabetes Associates, Atlanta, GA, USA.
FAU - Stenlof, K
AU  - Stenlof K
FAU - Harris, S
AU  - Harris S
FAU - Sullivan, D
AU  - Sullivan D
FAU - Fung, A
AU  - Fung A
FAU - Usiskin, K
AU  - Usiskin K
FAU - Meininger, G
AU  - Meininger G
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150112
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Blood Glucose)
RN  - 0 (Cholesterol, HDL)
RN  - 0 (Cholesterol, LDL)
RN  - 0 (Glucosides)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Thiophenes)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 0SAC974Z85 (Canagliflozin)
RN  - 9100L32L2N (Metformin)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Blood Glucose/drug effects
MH  - Blood Pressure/drug effects
MH  - Body Weight/drug effects
MH  - Canagliflozin
MH  - Cholesterol, HDL/blood/drug effects
MH  - Cholesterol, LDL/blood/drug effects
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Diuresis/drug effects
MH  - Double-Blind Method
MH  - Fasting
MH  - Female
MH  - Glucosides/adverse effects/*therapeutic use
MH  - Glycated Hemoglobin/drug effects
MH  - Humans
MH  - Hypoglycemic Agents/adverse effects/*therapeutic use
MH  - Male
MH  - Metformin/administration & dosage
MH  - Middle Aged
MH  - Mycoses/chemically induced
MH  - Osmolar Concentration
MH  - Thiophenes/adverse effects/*therapeutic use
MH  - Urinary Tract Infections/chemically induced
OTO - NOTNLM
OT  - SGLT2 inhibitor
OT  - canagliflozin
OT  - phase III study
OT  - type 2 diabetes
EDAT- 2014/12/17 06:00
MHDA- 2015/09/25 06:00
CRDT- 2014/12/16 06:00
PHST- 2014/09/22 00:00 [received]
PHST- 2014/11/21 00:00 [revised]
PHST- 2014/12/10 00:00 [accepted]
PHST- 2014/12/16 06:00 [entrez]
PHST- 2014/12/17 06:00 [pubmed]
PHST- 2015/09/25 06:00 [medline]
AID - 10.1111/dom.12428 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2015 Mar;17(3):294-303. doi: 10.1111/dom.12428. Epub 2015 
      Jan 12.