PMID- 27734320
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231104
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 7
IP  - 4
DP  - 2016 Dec
TI  - Canagliflozin: Efficacy and Safety in Combination with Metformin Alone or with 
      Other Antihyperglycemic Agents in Type 2 Diabetes.
PG  - 659-678
AB  - Metformin is typically the first pharmacologic treatment recommended for type 2 
      diabetes mellitus (T2DM), but many patients do not achieve glycemic control with 
      metformin alone and eventually require combination therapy with other agents. 
      Canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, was assessed 
      in a comprehensive Phase 3 clinical development program consisting of ~10,000 
      participants, of which ~80% were on background therapy that consisted of 
      metformin alone or in combination with other antihyperglycemic agents (AHAs; 
      e.g., pioglitazone, sulfonylurea, and insulin). In addition, the efficacy and 
      safety of canagliflozin and metformin as the initial combination therapy and 
      canagliflozin monotherapy were assessed versus metformin in treatment-naive 
      patients with T2DM. Across studies in patients with T2DM who were on metformin 
      alone or in combination with other AHAs, canagliflozin 100 and 300 mg provided 
      improvements in glycated hemoglobin for up to 104 weeks. Canagliflozin was also 
      associated with reductions in body weight and systolic blood pressure when added 
      to background therapy consisting of metformin alone or with other AHAs. 
      Canagliflozin was generally well tolerated, with increased incidence of adverse 
      events (AEs) related to the mechanism of SGLT2 inhibition (i.e., genital mycotic 
      infections, urinary tract infections, and osmotic diuresis-related AEs). 
      Consistent with its insulin-independent mechanism of action, canagliflozin was 
      associated with low rates of hypoglycemia when background therapy did not include 
      sulfonylurea or insulin. Due to its favorable efficacy and safety profile, these 
      results suggest that adding canagliflozin to a background regimen consisting of 
      metformin or implementing treatment with a fixed-dose regimen of canagliflozin 
      and metformin would provide an effective and safe treatment regimen for T2DM 
      management. FUNDING: Janssen Global Services, LLC.
FAU - Qiu, Rong
AU  - Qiu R
AD  - Janssen Research & Development, LLC, 920 Route 202 South, Raritan, NJ, 08869, 
      USA. rqiu17@its.jnj.com.
FAU - Balis, Dainius
AU  - Balis D
AD  - Janssen Research & Development, LLC, 920 Route 202 South, Raritan, NJ, 08869, 
      USA.
FAU - Capuano, George
AU  - Capuano G
AD  - Janssen Research & Development, LLC, 920 Route 202 South, Raritan, NJ, 08869, 
      USA.
FAU - Xie, John
AU  - Xie J
AD  - Janssen Research & Development, LLC, 920 Route 202 South, Raritan, NJ, 08869, 
      USA.
FAU - Meininger, Gary
AU  - Meininger G
AD  - Janssen Research & Development, LLC, 920 Route 202 South, Raritan, NJ, 08869, 
      USA.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20161012
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
PMC - PMC5118239
OTO - NOTNLM
OT  - Canagliflozin
OT  - Efficacy
OT  - Metformin
OT  - Safety
OT  - Sodium glucose co-transporter 2 inhibitor
OT  - Type 2 diabetes mellitus
EDAT- 2016/10/14 06:00
MHDA- 2016/10/14 06:01
PMCR- 2016/10/12
CRDT- 2016/10/14 06:00
PHST- 2016/08/01 00:00 [received]
PHST- 2016/10/14 06:00 [pubmed]
PHST- 2016/10/14 06:01 [medline]
PHST- 2016/10/14 06:00 [entrez]
PHST- 2016/10/12 00:00 [pmc-release]
AID - 10.1007/s13300-016-0201-z [pii]
AID - 201 [pii]
AID - 10.1007/s13300-016-0201-z [doi]
PST - ppublish
SO  - Diabetes Ther. 2016 Dec;7(4):659-678. doi: 10.1007/s13300-016-0201-z. Epub 2016 
      Oct 12.