Disclosures: H.E.B. has received research grants and has served on advisory panels for Janssen, as well as several other pharmaceutical companies. R.W. has received research grants to his institution from Janssen. G.L. is an employee of Janssen Research and Development, LLC. W.C. is an employee of Janssen Global Services, LLC.
Canagliflozin: Effects in overweight and obese subjects without diabetes mellitus
Version of Record online: 9 DEC 2013
© 2013 The Authors Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS)
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
Volume 22, Issue 4, pages 1042–1049, April 2014
How to Cite
Bays, H. E., Weinstein, R., Law, G. and Canovatchel, W. (2014), Canagliflozin: Effects in overweight and obese subjects without diabetes mellitus. Obesity, 22: 1042–1049. doi: 10.1002/oby.20663
Author Contributions: H.E.B and R.W. contributed to the conduct of the study and the acquisition, analysis, and interpretation of data, and reviewed and approved the manuscript. G.L. contributed to the analysis and interpretation of data, and reviewed and approved the manuscript. W.C. contributed to the design and conduct of the study, and the acquisition, analysis, and interpretation of data, and reviewed and approved the manuscript.
- Issue online: 26 MAR 2014
- Version of Record online: 9 DEC 2013
- Accepted manuscript online: 13 NOV 2013 04:07AM EST
- Manuscript Accepted: 24 OCT 2013
- Manuscript Received: 3 JUL 2013
To evaluate the effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on body weight in overweight and obese subjects (body mass index [BMI] ≥27 and <50 kg/m2).
This 12-week, Phase 2b, randomized, double-blind study enrolled 376 subjects without diabetes mellitus who received canagliflozin 50, 100, or 300 mg or placebo once daily. The primary endpoint was the percent change in body weight from baseline through Week 12.
Canagliflozin increased urinary glucose excretion in a dose-dependent manner and produced statistically significant reductions in body weight compared with placebo (least squares mean percent changes from baseline of −2.2%, −2.9%, −2.7%, and −1.3% with canagliflozin 50, 100, and 300 mg and placebo; P < 0.05 for all comparisons). Overall adverse event (AE) rates were similar across groups. Canagliflozin was associated with higher rates of genital mycotic infections in women, which were generally mild and led to few study discontinuations. Osmotic diuresis-related AE rates were low and similar across groups.
In overweight and obese subjects without diabetes mellitus, canagliflozin significantly reduced body weight compared with placebo and was generally well tolerated.