Home | About us | Editorial board | Search | Ahead of print | Current issue | Archives | Submit article | Instructions | Subscribe | Contacts | Advertise | Login 
 
Search Article 
  
Advanced search 
  Users Online: 1040 Home Print this page Email this page Small font sizeDefault font sizeIncrease font size  
ORIGINAL ARTICLE
Year : 2016  |  Volume : 20  |  Issue : 3  |  Page : 372-380

Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from India


1 Bangalore Diabetes Hospital, Bengaluru, Karnataka, India
2 Dr. Mohan's Diabetes Specialties Centre and Madras Diabetes Research Foundation, Chennai, Tamil Nadu, India
3 CARE Hospitals, Hyderabad, Telangana, India
4 Gandhi Research Institute, Nagpur, Maharashtra, India
5 Department of Endocrinology, St. John's Medical College and Hospital, Bengaluru, Karnataka, India
6 Janssen Research and Development, LLC, Raritan, NJ, USA

Correspondence Address:
K M Prasanna Kumar
Bangalore Diabetes Hospital, 16/M, Thimmaiah Road, Bengaluru - 560 052, Karnataka
India
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2230-8210.179996

Rights and Permissions

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 HbA1cwith 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. Conclusion: Canagliflozin provided glycemic control, body weight reduction, and was generally well tolerated in patients with T2DM from India.


[FULL TEXT] [PDF]*
Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)
 

 Article Access Statistics
    Viewed1545    
    Printed6    
    Emailed1    
    PDF Downloaded401    
    Comments [Add]    
    Cited by others 6    

Recommend this journal