PMID- 26121561
OWN - NLM
STAT- MEDLINE
DCOM- 20160512
LR  - 20221207
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 31
IP  - 9
DP  - 2015
TI  - The efficacy and safety of canagliflozin across racial groups in patients with 
      type 2 diabetes mellitus.
PG  - 1693-702
LID - 10.1185/03007995.2015.1067192 [doi]
AB  - OBJECTIVE: Canagliflozin, a sodium-glucose co-transporter 2 inhibitor, enhances 
      urinary glucose excretion through an insulin-independent mode of action, and 
      improves glycemic control in patients with type 2 diabetes mellitus (T2DM). This 
      study assessed the efficacy and safety of canagliflozin across racial groups. 
      METHODS: The efficacy of canagliflozin 100 mg and 300 mg was evaluated by racial 
      group using data pooled from four placebo-controlled phase 3 studies and two 
      placebo-controlled sub-studies of a population of patients with inadequately 
      controlled T2DM (N = 4158). Least-squares mean changes from baseline were 
      calculated for hemoglobin A1c (HbA1c), systolic blood pressure (SBP), body weight 
      (BW), cholesterol, and triglycerides. Safety/tolerability evaluation included 
      reporting of general and prespecified adverse events (AEs). RESULTS: A total of 
      75% of patients were White, 13% were Asian, 4% were Black/African American, and 
      8% were 'Other' (American Indian, Alaskan Native, mixed race, Native Hawaiian or 
      other Pacific Islander, not reported, and unknown). Baseline demographics were 
      similar for these groups. Dose-related reductions in HbA1c, BW, and SBP were 
      observed with both canagliflozin doses in all racial groups. Canagliflozin was 
      generally safe and well tolerated. Treatment with canagliflozin was associated 
      with an increased rate of genital mycotic infections (GMIs) and urinary tract 
      infections (UTIs) in all racial groups. GMIs were observed more often in 
      Black/African American males and males from the 'Other' racial group, whereas 
      UTIs and osmotic diuresis-related AEs were less common in Asians. Key study 
      limitations include the high proportion of White patients compared with other 
      racial groups and the fact that included studies were not powered to evaluate 
      racial differences. CONCLUSION: Canagliflozin was generally well tolerated and 
      consistently associated with reductions in HbA1c, BW, and SBP in patients with 
      T2DM independent of racial background. (ClinicalTrials.gov numbers: NCT01081834; 
      NCT01106677; NCT01106625; NCT01106690; and NCT01032629.).
FAU - Gavin, James R 3rd
AU  - Gavin JR 3rd
AD  - a a Emory University School of Medicine , Atlanta , GA , USA.
FAU - Davies, Melanie J
AU  - Davies MJ
AD  - b b Diabetes Research Centre, University of Leicester , Leicester , UK.
FAU - Davies, Michael
AU  - Davies M
AD  - c c Janssen Scientific Affairs LLC , Raritan , NJ , USA.
FAU - Vijapurkar, Ujjwala
AU  - Vijapurkar U
AD  - d d Janssen Research & Development LLC , Raritan , NJ , USA.
FAU - Alba, Maria
AU  - Alba M
AD  - d d Janssen Research & Development LLC , Raritan , NJ , USA.
FAU - Meininger, Gary
AU  - Meininger G
AD  - d d Janssen Research & Development LLC , Raritan , NJ , USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01032629
SI  - ClinicalTrials.gov/NCT01081834
SI  - ClinicalTrials.gov/NCT01106625
SI  - ClinicalTrials.gov/NCT01106677
SI  - ClinicalTrials.gov/NCT01106690
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150904
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Sodium-Glucose Transporter 2 Inhibitors)
RN  - 0 (Triglycerides)
RN  - 0SAC974Z85 (Canagliflozin)
RN  - 97C5T2UQ7J (Cholesterol)
SB  - IM
MH  - Aged
MH  - Blood Glucose/analysis
MH  - Body Weight/drug effects
MH  - *Canagliflozin/administration & dosage/adverse effects
MH  - Cholesterol/blood
MH  - Diabetes Mellitus, Type 2/blood/diagnosis/drug therapy/ethnology
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Ethnicity/statistics & numerical data
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemic Agents/administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Sodium-Glucose Transporter 2 Inhibitors
MH  - Treatment Outcome
MH  - Triglycerides/blood
OTO - NOTNLM
OT  - Canagliflozin
OT  - Efficacy
OT  - Race
OT  - Safety
OT  - Type 2 diabetes mellitus
EDAT- 2015/06/30 06:00
MHDA- 2016/05/14 06:00
CRDT- 2015/06/30 06:00
PHST- 2015/06/30 06:00 [entrez]
PHST- 2015/06/30 06:00 [pubmed]
PHST- 2016/05/14 06:00 [medline]
AID - 10.1185/03007995.2015.1067192 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2015;31(9):1693-702. doi: 10.1185/03007995.2015.1067192. Epub 
      2015 Sep 4.