title: Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
abstract: 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.
  
  
  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]).
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  Canagliflozin improved glycemic control, reduced body weight and systolic BP, and was generally well tolerated in patients with T2DM from Latin America.
  
  
  BACKGROUND
  NCT01081834; NCT01106677; NCT01106625; NCT00968812; NCT01137812.
authors.affiliation: a a Universidad Autonoma de Nuevo Leon , Monterrey , Mexico.
authors.forename: Fernando J
authors.initials: FJ
authors.lastname: Lavalle-González
authors.affiliation: b b Hospital Israelita Albert Einstein and CPClin Clinical Research Center , São Paulo , Brazil.
authors.forename: Freddy G
authors.initials: FG
authors.lastname: Eliaschewitz
authors.affiliation: c c Hospital Cima, Centro de Investigacíon Clínica San Agustín , San José , Costa Rica.
authors.forename: Sonia
authors.initials: S
authors.lastname: Cerdas
authors.affiliation: d d Endocrinología, Medicina Interna , Bogota , Colombia.
authors.forename: Maria Del Pilar
authors.initials: Mdel P
authors.lastname: Chacon
authors.affiliation: e e Janssen Research & Development, LLC , Raritan, NJ , USA.
authors.forename: Cindy
authors.initials: C
authors.lastname: Tong
authors.affiliation: e e Janssen Research & Development, LLC , Raritan, NJ , USA.
authors.forename: Maria
authors.initials: M
authors.lastname: Alba
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000187:drug effects; D001794:Blood Pressure; D001835:Body Weight; D000068896:Canagliflozin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007843:Latin America; D008297:Male; D008687:Metformin / Q000008:administration & dosage; D008875:Middle Aged; D000068900:Sitagliptin Phosphate / Q000008:administration & dosage; D013453:Sulfonylurea Compounds / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D013453:Sulfonylurea Compounds; D000068896:Canagliflozin; C057619:glimepiride; D008687:Metformin; D000068900:Sitagliptin Phosphate
keywords: Antihyperglycemic agent; Canagliflozin; Latin America; Phase 3 study; SGLT2 inhibitor; Type 2 diabetes