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. 2016 May-Jun;20(3):372-80.
doi: 10.4103/2230-8210.179996.

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

K M Prasanna Kumar  1 , Viswanathan Mohan  2 , Bipin Sethi  3 , Pramod Gandhi  4 , Ganapathi Bantwal  5 , John Xie  6 , Gary Meininger  6 , Rong Qiu  6
Affiliations

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

K M Prasanna Kumar et al. Indian J Endocrinol Metab. 2016 May-Jun.

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.

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

Keywords: Fasting blood glucose; HbA1c; hyperglycemia; oral medications; type 2 diabetes.

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Figures

Figure 1
Figure 1
Changes from baseline in (a) HbA1c, (b) FPG, (c) body weight, (d) systolic BP, and (e) diastolic BP in the overall population and in the Indian subgroup at week 52 (Population 1). FPG: Fasting plasma glucose, BP: Blood pressure, CANA: Canagliflozin, LS: Least squares, SE: Standard error
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