ABSTRACT
Objectives: To evaluate the proportion of patients with type 2 diabetes mellitus (T2DM) achieving reductions in both glycated hemoglobin (HbA1c) and body weight with canagliflozin, a sodium glucose co-transporter 2 inhibitor, versus sitagliptin over 52 weeks.
Methods: Data were pooled from two, randomized, Phase 3 studies of canagliflozin 100 and 300 mg versus sitagliptin 100 mg as add-on to metformin, and canagliflozin 300 mg versus sitagliptin 100 mg as add-on to metformin plus sulfonylurea (N = 1856). The composite end points of change from baseline in both HbA1c <0% and body weight <0 kg, and attainment of HbA1c <7.0% and body weight reduction ≥5% at Week 52 were evaluated. Safety was assessed based on adverse event reports.
Results: Canagliflozin provided reductions in HbA1c and body weight over 52 weeks versus sitagliptin. A greater proportion of patients had both HbA1c and body weight reductions with canagliflozin 100 and 300 mg versus sitagliptin 100 mg (67.7%, 72.6%, and 44.1%, respectively). Among patients with HbA1c and body weight reductions, more patients achieved the composite end point of HbA1c <7.0% and body weight reduction ≥5% with canagliflozin 100 and 300 mg versus sitagliptin 100 mg (18.9%, 18.3%, and 5.7%, respectively). Canagliflozin was generally well tolerated.
Conclusions: A greater proportion of patients with T2DM achieved reductions in both HbA1c and body weight, and more patients with HbA1c and body weight reductions achieved HbA1c <7.0% and body weight reduction ≥5% with canagliflozin versus sitagliptin over 52 weeks.
Clinical trial registration: www.ClinicalTrials.gov identifiers are NCT01106677; NCT01137812.
Acknowledgments
The authors acknowledge Cindy Tong, MS, of Janssen Research & Development, LLC for her contribution to the data analyses. The authors thank all investigators, study teams, and patients for participating in these studies. Canagliflozin was developed by Janssen Research & Development, LLC, in collaboration with Mitsubishi Tanabe Pharma Corporation.
Declaration of interest
Medical writing support was provided by Kimberly Fuller, PhD, of MedErgy, and was funded by Janssen Global Services, LLC. G Schernthaner has served on advisory boards for Eli Lilly, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Takeda, and Johnson & Johnson and is a speaker for Eli Lilly, Boehringer Ingelheim, Takeda, AstraZeneca, Bristol-Myers Squibb, Sanofi, Merck, and Novo Nordisk. FJ Lavalle-González has served on advisory boards for Merck Sharp & Dohme, Sanofi, Novo Nordisk, Janssen-Cilag, Eli Lilly, Bristol-Myers Squibb/AstraZeneca, and Takeda; has participated in speakers bureaus for Merck Sharp & Dohme, Sanofi, Novo Nordisk, Janssen-Cilag, Eli Lilly, Bristol-Myers Squibb/AstraZeneca, GlaxoSmithKline, Pfizer, Merck Serono, Silanes, and Novartis; and has received research support from Merck Sharp & Dohme, Boehringer Ingelheim, GlaxoSmithKline, Sanofi, Pfizer, Janssen-Cilag, Novartis, and Novo Nordisk. JA Davidson has served on advisory boards or as a consultant for Amgen, AstraZeneca, Eli Lilly, Janssen, Merck, Novo Nordisk, and Aspire Bariatrics and serves on speakers bureaus for AstraZeneca, Janssen, and Novo Nordisk. H Jodon serves on a speakers bureau for Janssen, is a consultant for AstraZeneca and Sanofi, and has served on an advisory board for Novo Nordisk. U Vijapurkar, R Qiu, and W Canovatchel are full-time employees of Janssen Research & Development, LLC. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.