title: Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from India.
abstract: BACKGROUND
  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 India.
  
  
  METHODS
  Changes from baseline in HbA1c, fasting plasma glucose (FPG), body weight, and blood pressure (BP) with canagliflozin 100 and 300 mg were evaluated in a subgroup of patients from India (n = 124) from 4 randomized, double-blind, placebo- and active-controlled, Phase 3 studies (N = 2313; Population 1). Safety was assessed based on adverse event (AE) reports in these patients and in a broader subgroup of patients from India (n = 1038) from 8 randomized, double-blind, placebo- and active-controlled, Phase 3 studies (N = 9439; Population 2).
  
  
  RESULTS
  Reductions in HbA1c with canagliflozin 100 and 300 mg were -0.74% and -0.88%, respectively, in patients from India, and -0.81% and -1.00%, respectively, in the 4 pooled Phase 3 studies. In the Indian subgroup, both canagliflozin doses provided reductions in FPG, body weight, and BP that were consistent with findings in the overall population. The incidence of overall AEs in patients from India was generally similar with canagliflozin 100 and 300 mg and noncanagliflozin. The AE profile in patients from India was generally similar to the overall population, with higher rates of genital mycotic infections and osmotic diuresis-related and volume depletion-related AEs with canagliflozin versus noncanagliflozin.
  
  
  CONCLUSIONS
  Canagliflozin provided glycemic control, body weight reduction, and was generally well tolerated in patients with T2DM from India.
authors.affiliation: Bangalore Diabetes Hospital, Bengaluru, Karnataka, India.
authors.forename: K M
authors.initials: KM
authors.lastname: Prasanna Kumar
authors.affiliation: Dr. Mohan's Diabetes Specialties Centre and Madras Diabetes Research Foundation, Chennai, Tamil Nadu, India.
authors.forename: Viswanathan
authors.initials: V
authors.lastname: Mohan
authors.affiliation: CARE Hospitals, Hyderabad, Telangana, India.
authors.forename: Bipin
authors.initials: B
authors.lastname: Sethi
authors.affiliation: Gandhi Research Institute, Nagpur, Maharashtra, India.
authors.forename: Pramod
authors.initials: P
authors.lastname: Gandhi
authors.affiliation: Department of Endocrinology, St. John's Medical College and Hospital, Bengaluru, Karnataka, India.
authors.forename: Ganapathi
authors.initials: G
authors.lastname: Bantwal
authors.affiliation: Janssen Research and Development, LLC, Raritan, NJ, USA.
authors.forename: John
authors.initials: J
authors.lastname: Xie
authors.affiliation: Janssen Research and Development, LLC, Raritan, NJ, USA.
authors.forename: Gary
authors.initials: G
authors.lastname: Meininger
authors.affiliation: Janssen Research and Development, LLC, Raritan, NJ, USA.
authors.forename: Rong
authors.initials: R
authors.lastname: Qiu
keywords: Fasting blood glucose; HbA1c; hyperglycemia; oral medications; type 2 diabetes