title: Diabetic Ketoacidosis and Related Events in the Canagliflozin Type 2 Diabetes Clinical Program.
abstract: OBJECTIVE
  This study assessed the incidence of serious adverse events of diabetic ketoacidosis (DKA) among patients with type 2 diabetes treated with canagliflozin.
  
  
  METHODS
  All serious adverse events of DKA and related events (ketoacidosis, metabolic acidosis, and acidosis) from 17,596 patients from randomized studies of canagliflozin through 11 May 2015 were analyzed.
  
  
  RESULTS
  Serious adverse events of DKA and related events were reported in 12 patients (0.07%), including 4 (0.07%), 6 (0.11%), and 2 (0.03%) treated with canagliflozin 100 and 300 mg and comparator, respectively; corresponding incidence rates were 0.522, 0.763, and 0.238 per 1,000 patient-years, respectively. Most patients with DKA and related events had a blood glucose >300 mg/dL (16.7 mmol/L) at presentation of DKA, were on insulin, and had DKA-precipitating factors, including some with type 1 diabetes/latent autoimmune diabetes of adulthood.
  
  
  CONCLUSIONS
  DKA and related events occurred at a low frequency in the canagliflozin type 2 diabetes program, with an incidence consistent with limited existing observational data in the general population with type 2 diabetes.
authors.affiliation: Janssen Research & Development, LLC, Raritan, NJ.
authors.forename: Ngozi
authors.initials: N
authors.lastname: Erondu
authors.affiliation: Janssen Research & Development, LLC, Raritan, NJ.
authors.forename: Mehul
authors.initials: M
authors.lastname: Desai
authors.affiliation: Janssen Research & Development, LLC, Raritan, NJ.
authors.forename: Kirk
authors.initials: K
authors.lastname: Ways
authors.affiliation: Janssen Research & Development, LLC, Raritan, NJ gmeining@its.jnj.com.
authors.forename: Gary
authors.initials: G
authors.lastname: Meininger
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000187:drug effects; D000068896:Canagliflozin / Q000008:administration & dosage / Q000009:adverse effects*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D016883:Diabetic Ketoacidosis / Q000139:chemically induced* / Q000453:epidemiology; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D015994:Incidence; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D012107:Research Design
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D000068896:Canagliflozin