PMID- 27600862
OWN - NLM
STAT- MEDLINE
DCOM- 20170807
LR  - 20221207
IS  - 1742-1241 (Electronic)
IS  - 1368-5031 (Print)
IS  - 1368-5031 (Linking)
VI  - 70
IP  - 9
DP  - 2016 Sep
TI  - Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus 
      living in hot climates.
PG  - 775-85
LID - 10.1111/ijcp.12868 [doi]
AB  - AIMS: Patients with type 2 diabetes mellitus (T2DM) have increased risk of 
      adverse events (AEs; e.g. dehydration, hypoglycaemia) in hot weather. This 
      analysis assessed the efficacy and safety of canagliflozin, a sodium glucose 
      co-transporter 2 (SGLT2) inhibitor, in patients with T2DM who live in hot 
      climates. METHODS: This post hoc analysis evaluated patients with T2DM using 
      pooled data from four 26-week, placebo-controlled studies (N=2,313) and data from 
      a 104-week, active-controlled study (add-on to metformin vs glimepiride; 
      N=1,450). Changes in HbA1c, fasting plasma glucose (FPG), body weight and blood 
      pressure (BP) were assessed in subsets of patients living in hot climates 
      (pooled, placebo-controlled studies, n=611; active-controlled study, n=307) and 
      those living in other climates (i.e. other climate subset; pooled, 
      placebo-controlled studies, n=1,702; active-controlled study, n=1,143). Safety 
      was assessed based on AE reports. RESULTS: Canagliflozin 100 and 300 mg lowered 
      HbA1c, FPG, body weight and BP vs placebo over 26 weeks and glimepiride over 
      104 weeks in the hot climate subsets. Canagliflozin was generally well tolerated 
      in the hot climate subsets, with a higher incidence of AEs related to the 
      mechanism of SGLT2 inhibition (i.e. genital mycotic infections). Volume 
      depletion-related AEs were low across groups. CONCLUSION: Canagliflozin improved 
      glycaemic control, lowered body weight and BP, and was generally well tolerated 
      in patients with T2DM living in hot climates compared with placebo over 26 weeks 
      or glimepiride over 104 weeks. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov 
      NCT01081834, NCT01106677, NCT01106625, NCT01106690, NCT00968812.
CI  - (c) 2016 The Authors. International Journal of Clinical Practice published by John 
      Wiley & Sons Ltd.
FAU - John, Mathew
AU  - John M
AD  - Providence Endocrine & Diabetes Specialty Centre, Trivandrum, Kerala, India. 
      drmathewjohn@yahoo.com.
FAU - Cerdas, Sonia
AU  - Cerdas S
AD  - Hospital Cima, Centro de Investigacion Clinica San Agustin, San Jose, Costa Rica.
FAU - Violante, Rafael
AU  - Violante R
AD  - Centro de Estudios de Investigacion Metabolicos y Cardiovasculares S.C., Tampico, 
      Mexico.
FAU - Deerochanawong, Chaicharn
AU  - Deerochanawong C
AD  - Rajavithi Hospital, Rangsit Medical School, Bangkok, Thailand.
FAU - Hassanein, Mohamed
AU  - Hassanein M
AD  - Dubai Hospital, Dubai Health Authority, Dubai, United Arab Emirates.
FAU - Slee, April
AU  - Slee A
AD  - Axio Research, Seattle, WA, USA.
FAU - Canovatchel, William
AU  - Canovatchel W
AD  - Janssen Global Services, LLC, Raritan, NJ, USA.
FAU - Hamilton, Gill
AU  - Hamilton G
AD  - Janssen-Cilag Ltd, High Wycombe, UK.
LA  - eng
SI  - ClinicalTrials.gov/NCT00968812
SI  - ClinicalTrials.gov/NCT01081834
SI  - ClinicalTrials.gov/NCT01106677
SI  - ClinicalTrials.gov/NCT01106625
SI  - ClinicalTrials.gov/NCT01106690
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - India
TA  - Int J Clin Pract
JT  - International journal of clinical practice
JID - 9712381
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0SAC974Z85 (Canagliflozin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Blood Pressure/drug effects
MH  - Canagliflozin/*administration & dosage/adverse effects
MH  - Diabetes Complications/complications
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Genital Diseases, Female/chemically induced
MH  - Genital Diseases, Male/chemically induced
MH  - Glycated Hemoglobin/metabolism
MH  - Hot Temperature
MH  - Humans
MH  - Hypoglycemia/chemically induced
MH  - Hypoglycemic Agents/*administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Mycoses/chemically induced
MH  - Residence Characteristics
MH  - Treatment Outcome
MH  - Urination Disorders/chemically induced
MH  - Weight Loss/drug effects
MH  - Young Adult
PMC - PMC5129493
EDAT- 2016/09/08 06:00
MHDA- 2017/08/08 06:00
PMCR- 2016/11/30
CRDT- 2016/09/08 06:00
PHST- 2016/02/25 00:00 [received]
PHST- 2016/07/11 00:00 [accepted]
PHST- 2016/09/08 06:00 [entrez]
PHST- 2016/09/08 06:00 [pubmed]
PHST- 2017/08/08 06:00 [medline]
PHST- 2016/11/30 00:00 [pmc-release]
AID - IJCP12868 [pii]
AID - 10.1111/ijcp.12868 [doi]
PST - ppublish
SO  - Int J Clin Pract. 2016 Sep;70(9):775-85. doi: 10.1111/ijcp.12868.