Efficacy and safety of canagliflozin in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, 12-week study
Aims We examined the efficacy, safety and tolerability of canagliflozin, a sodium glucose co‐transporter 2 inhibitor, in Japanese patients with type 2 diabetes (T2DM) undergoing diet and exercise therapy. Methods Patients aged 20–80 years with T2DM diagnosed ≥3 months previously, and HbA1c of 6.9–9....
Saved in:
Published in | Diabetes, obesity & metabolism Vol. 15; no. 12; pp. 1136 - 1145 |
---|---|
Main Authors | , , , , , |
Format | Journal Article |
Language | English |
Published |
Oxford, UK
Blackwell Publishing Ltd
01.12.2013
Wiley Subscription Services, Inc John Wiley & Sons Ltd |
Subjects | |
Online Access | Get full text |
Cover
Loading…
Summary: | Aims
We examined the efficacy, safety and tolerability of canagliflozin, a sodium glucose co‐transporter 2 inhibitor, in Japanese patients with type 2 diabetes (T2DM) undergoing diet and exercise therapy.
Methods
Patients aged 20–80 years with T2DM diagnosed ≥3 months previously, and HbA1c of 6.9–9.9% were randomized to 50, 100, 200 or 300 mg canagliflozin or placebo once daily for 12 weeks. The primary and secondary endpoints were changes in HbA1c, fasting plasma glucose (FPG), urinary glucose/creatinine and postprandial glycaemic parameters following a meal test. The safety assessments included adverse events (AEs) and clinical laboratory tests.
Results
Overall, 383 patients were randomized to receive either placebo (n = 75), or 50 mg (n = 82), 100 mg (n = 74), 200 mg (n = 77) or 300 mg canagliflozin (n = 75). At week 12, significant reductions in HbA1c were observed in all canagliflozin groups relative to placebo (−0.61, –0.80, –0.79 and −0.88% for 50, 100, 200 and 300 mg, respectively, versus +0.11% for placebo; all, p < 0.01). FPG and postprandial glycaemic parameters improved significantly in the canagliflozin groups. Body weight was significantly decreased by canagliflozin. No deaths or drug‐related serious AEs were reported. There was no dose‐dependent increase in the incidence of AEs in the canagliflozin groups. The incidence of hypoglycaemia was low; episodes were not severe or dose dependent. Canagliflozin did not affect serum creatinine levels or the urinary albumin/creatinine ratio.
Conclusions
Treatment with canagliflozin for 12 weeks significantly improved glycaemic control and reduced body weight in Japanese patients with T2DM. Canagliflozin was well tolerated. |
---|---|
Bibliography: | ArticleID:DOM12149 ark:/67375/WNG-6ZMBWRLS-6 istex:7CD01016BA2B7C47AEB2F9A2E917D042FC65156C Parts of this study were previously presented as a poster presentation at the 71st Scientific Sessions of the American Diabetes Association, San Diego, CA, USA, 24-28 June, 2011, and at the 9th International Diabetes Federation Western Pacific Region Congress, Kyoto, Japan, November 24-27, 2012. Mitsubishi Tanabe Pharma Corporation Appendix S1. Eligibility criteria and the method for sample size calculation are provided in the Supporting Information.Figure S1. HbA1c (A), FPG (B), urinary glucose/creatinine ratio (C) and body weight (D) measured at the start (except for urinary glucose/creatinine ratio and body weight) and end of the run-in period and during the 12-week treatment period. HbA1c, haemoglobin A1c; NGSP, National Glycohemoglobin Standardization Program; FPG, fasting plasma glucose; UGE, urinary glucose excretion; CRE, creatinine.Figure S2. Plasma glucose levels measured during the meal tolerance tests performed at baseline (end of the run-in period) and at week 12 in the treatment period in the placebo (A), 50 mg (B), 100 mg (C), 200 mg (D) and 300 mg (E) canagliflozin groups. The meal was consumed at 0 min. Parts of this study were previously presented as a poster presentation at the 71st Scientific Sessions of the American Diabetes Association, San Diego, CA, USA, 24–28 June, 2011, and at the 9th International Diabetes Federation Western Pacific Region Congress, Kyoto, Japan, November 24–27, 2012 |
ISSN: | 1462-8902 1463-1326 |
DOI: | 10.1111/dom.12149 |