PMID- 26579834
OWN - NLM
STAT- MEDLINE
DCOM- 20160929
LR  - 20181202
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 32
IP  - 3
DP  - 2016
TI  - Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus 
      from Latin America.
PG  - 427-39
LID - 10.1185/03007995.2015.1121865 [doi]
AB  - OBJECTIVE: This post hoc analysis evaluated the efficacy and safety of 
      canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 
      2 diabetes mellitus (T2DM) from Latin America. RESEARCH DESIGN AND METHODS: 
      Analyses were performed in subgroups of patients from Latin America based on data 
      from three individual, 26-week, placebo-controlled studies of canagliflozin 
      (monotherapy [n = 116/584], add-on to metformin [n = 199/918], and add-on to 
      metformin plus sulfonylurea [n = 76/469]) and three individual, 52-week, 
      active-controlled studies of canagliflozin (add-on to metformin versus 
      sitagliptin [n = 240/1101], add-on to metformin versus glimepiride 
      [n = 155/1450], and add-on to metformin plus sulfonylurea versus sitagliptin 
      [n = 156/755]). MAIN OUTCOME MEASURES: Changes from baseline in HbA1c, body 
      weight, and systolic blood pressure (BP) with canagliflozin 100 and 300 mg versus 
      placebo or active comparator (i.e., sitagliptin or glimepiride) were evaluated in 
      the overall study populations and Latin American subgroups. Safety was assessed 
      based on adverse event (AE) reports. RESULTS: Canagliflozin 100 and 300 mg 
      provided reductions in HbA1c, body weight, and systolic BP across studies in 
      patients from Latin America that were generally similar to those seen in the 
      overall populations of patients with T2DM. The AE profile in patients from Latin 
      America was equivalent to that in the overall populations; higher rates of 
      genital mycotic infections and osmotic diuresis-related AEs were seen with 
      canagliflozin versus comparators. Limitations of this study include the post hoc 
      analysis of data and the small sample size of patients from Latin America. 
      CONCLUSION: Canagliflozin improved glycemic control, reduced body weight and 
      systolic BP, and was generally well tolerated in patients with T2DM from Latin 
      America. CLINICAL TRIAL REGISTRATION: NCT01081834; NCT01106677; NCT01106625; 
      NCT00968812; NCT01137812.
FAU - Lavalle-Gonzalez, Fernando J
AU  - Lavalle-Gonzalez FJ
AD  - a a Universidad Autonoma de Nuevo Leon , Monterrey , Mexico.
FAU - Eliaschewitz, Freddy G
AU  - Eliaschewitz FG
AD  - b b Hospital Israelita Albert Einstein and CPClin Clinical Research Center , Sao 
      Paulo , Brazil.
FAU - Cerdas, Sonia
AU  - Cerdas S
AD  - c c Hospital Cima, Centro de Investigacion Clinica San Agustin , San Jose , Costa 
      Rica.
FAU - Chacon, Maria Del Pilar
AU  - Chacon Mdel P
AD  - d d Endocrinologia, Medicina Interna , Bogota , Colombia.
FAU - Tong, Cindy
AU  - Tong C
AD  - e e Janssen Research & Development, LLC , Raritan, NJ , USA.
FAU - Alba, Maria
AU  - Alba M
AD  - e e Janssen Research & Development, LLC , Raritan, NJ , USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT00968812
SI  - ClinicalTrials.gov/NCT01081834
SI  - ClinicalTrials.gov/NCT01106625
SI  - ClinicalTrials.gov/NCT01106677
SI  - ClinicalTrials.gov/NCT01137812
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20160114
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Blood Glucose)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Sulfonylurea Compounds)
RN  - 0SAC974Z85 (Canagliflozin)
RN  - 6KY687524K (glimepiride)
RN  - 9100L32L2N (Metformin)
RN  - TS63EW8X6F (Sitagliptin Phosphate)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Blood Glucose/drug effects
MH  - Blood Pressure
MH  - Body Weight
MH  - Canagliflozin/administration & dosage/adverse effects/*therapeutic use
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Latin America
MH  - Male
MH  - Metformin/administration & dosage
MH  - Middle Aged
MH  - Sitagliptin Phosphate/administration & dosage
MH  - Sulfonylurea Compounds/administration & dosage
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Antihyperglycemic agent
OT  - Canagliflozin
OT  - Latin America
OT  - Phase 3 study
OT  - SGLT2 inhibitor
OT  - Type 2 diabetes
EDAT- 2015/11/19 06:00
MHDA- 2016/09/30 06:00
CRDT- 2015/11/19 06:00
PHST- 2015/11/19 06:00 [entrez]
PHST- 2015/11/19 06:00 [pubmed]
PHST- 2016/09/30 06:00 [medline]
AID - 10.1185/03007995.2015.1121865 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2016;32(3):427-39. doi: 10.1185/03007995.2015.1121865. Epub 
      2016 Jan 14.