Long-term Efficacy and Safety of Canagliflozin Over 104 Weeks in Patients
Accepted Article
Aged 55 to 80 Years With Type 2 Diabetes
Bruce Bode,1 Kaj Stenlöf,2 Stewart Harris,3 Daniel Sullivan,4 Albert Fung,4 Keith Usiskin,4 Gary Meininger4
1
Atlanta Diabetes Associates, Atlanta, GA, USA; 2Clinical Trial Center, Sahlgrenska University
Hospital, Gothenburg, Sweden; 3University of Western Ontario, London, Ontario, Canada, USA; 4
Janssen Research & Development, LLC, Raritan, NJ, USA.
Corresponding author: Bruce Bode, MD, FACE Atlanta Diabetes Associates 1800 Howell Mill Rd. Suite 450 Atlanta, GA 30318, USA Phone: 404-355-4393 Email: [email protected]
This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/dom.12428
This article is protected by copyright. All rights reserved.
Abstract Aim: The long-term efficacy and safety of canagliflozin, a sodium glucose co-transporter 2
Accepted Article
inhibitor, was evaluated over 104 weeks in patients aged 55-80 years with type 2 diabetes mellitus (T2DM) inadequately controlled on a stable antihyperglycaemic agent regimen. Methods: In this randomized, double-blind, phase 3 study, patients (N=714) received canagliflozin 100 or 300 mg or placebo once daily during a 26-week core period and a 78-week extension (n=624). Efficacy endpoints at Week 104 included change from baseline in haemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and systolic blood pressure (BP), and percent change from baseline in body weight and fasting plasma lipids. Safety was assessed by adverse event (AE) reports. Results: At Week 104, canagliflozin 100 and 300 mg were associated with reductions in HbA1c versus placebo (–0.32%,–0.43%, 0.17%, respectively; overall mean baseline, 7.7%); more patients achieved HbA1c
Accepted Article
Aged 55 to 80 Years With Type 2 Diabetes
Bruce Bode,1 Kaj Stenlöf,2 Stewart Harris,3 Daniel Sullivan,4 Albert Fung,4 Keith Usiskin,4 Gary Meininger4
1
Atlanta Diabetes Associates, Atlanta, GA, USA; 2Clinical Trial Center, Sahlgrenska University
Hospital, Gothenburg, Sweden; 3University of Western Ontario, London, Ontario, Canada, USA; 4
Janssen Research & Development, LLC, Raritan, NJ, USA.
Corresponding author: Bruce Bode, MD, FACE Atlanta Diabetes Associates 1800 Howell Mill Rd. Suite 450 Atlanta, GA 30318, USA Phone: 404-355-4393 Email: [email protected]
This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/dom.12428
This article is protected by copyright. All rights reserved.
Abstract Aim: The long-term efficacy and safety of canagliflozin, a sodium glucose co-transporter 2
Accepted Article
inhibitor, was evaluated over 104 weeks in patients aged 55-80 years with type 2 diabetes mellitus (T2DM) inadequately controlled on a stable antihyperglycaemic agent regimen. Methods: In this randomized, double-blind, phase 3 study, patients (N=714) received canagliflozin 100 or 300 mg or placebo once daily during a 26-week core period and a 78-week extension (n=624). Efficacy endpoints at Week 104 included change from baseline in haemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and systolic blood pressure (BP), and percent change from baseline in body weight and fasting plasma lipids. Safety was assessed by adverse event (AE) reports. Results: At Week 104, canagliflozin 100 and 300 mg were associated with reductions in HbA1c versus placebo (–0.32%,–0.43%, 0.17%, respectively; overall mean baseline, 7.7%); more patients achieved HbA1c
