Long‐term efficacy and safety of canagliflozin over 104 weeks in patients aged 55–80 years with type 2 diabetes

Diabetes, Obesity and Metabolism - Tập 17 Số 3 - Trang 294-303 - 2015
Bruce W. Bode1, Kaj Stenlöf2, Stewart B. Harris3, Daniel J. Sullivan4, Albert Fung4, Keith Usiskin4, Gary Meininger4
1Atlanta Diabetes Associates, Atlanta, GA, USA
2Clinical Trial Centre, Sahlgrenska University Hospital Gothenburg Sweden
3Department of Family Medicine, University of Western Ontario, London, Ontario, Canada
4Janssen Research & Development, LLC Raritan NJ USA

Tóm tắt

AimsThe long‐term efficacy and safety of canagliflozin, a sodium glucose co‐transporter 2 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.MethodsIn this randomized, double‐blind, phase III study, patients received canagliflozin 100 or 300 mg or placebo once daily during a 26‐week core period (N = 714) and a 78‐week extension period (n = 624). Efficacy endpoints at week 104 included change from baseline in glycated haemoglobin (HbA1c), fasting plasma glucose (FPG) and systolic blood pressure, and percent change from baseline in body weight and fasting plasma lipids. Safety was assessed by adverse event (AE) reports.ResultsAt week 104, canagliflozin 100 and 300 mg were associated with reductions in HbA1c versus placebo (−0.32 and −0.43% vs 0.17%, respectively; overall mean baseline, 7.7%) and more patients achieved HbA1c <7.0% with canagliflozin 100 and 300 mg than with placebo (35.8 and 41.9% vs 20.3%, respectively). Reductions in FPG, body weight and systolic blood pressure, and increases in high‐density lipoprotein cholesterol (HDL‐C) and low‐density lipoprotein cholesterol (LDL‐C) were seen with canagliflozin compared with placebo. The overall incidence rates of AEs over 104 weeks were 88.0, 89.8 and 86.1% with canagliflozin 100 and 300 mg and placebo, respectively; serious AE rates were low across treatment groups. The incidence rates of urinary tract infections, genital mycotic infections and osmotic diuresis– and volume depletion–related AEs were higher with canagliflozin than with placebo.ConclusionCanagliflozin improved glycaemic control, reduced body weight and systolic blood pressure, and was generally well tolerated in patients aged 55–80 years with T2DM over 104 weeks.

Từ khóa


Tài liệu tham khảo

10.1016/S0140-6736(06)68967-8

Centers for Disease Control and Prevention.National diabetes fact sheet.2011. Available from URL:http://www.cdc.gov/diabetes/pubs/factsheet11.htm. Accessed 7 February 2012.

10.2337/diaclin.26.2.77

10.1186/1475-2840-11-122

10.2337/dc12-0413

10.2337/dc14-S014

10.1016/j.jamda.2012.04.012

10.2337/dc11-1926

10.1111/dom.12054

10.2337/dc12-2491

10.1111/dom.12090

10.3810/hp.2013.04.1020

10.1016/S0140-6736(13)60683-2

10.1007/s00125-013-3039-1

10.1111/ijcp.12322

10.1111/dom.12273

10.1186/1472-6823-14-37

10.1111/j.1463-1326.2012.01558.x

10.1111/j.1463-1326.2011.01406.x

10.1210/jc.2012-4205

10.3810/pgm.2014.05.2753

10.2337/diacare.25.10.1737

10.1016/j.arr.2009.08.002

10.2337/dc13-2762

10.2337/dc11-1693

Hach T, 2013, Empagliflozin improves glycemic parameters and cardiovascular risk factors in patients with type 2 diabetes (T2DM): pooled data from four pivotal phase III trials (Abstract 69‐LB), Diabetes, 62, LB19

10.1016/j.ahj.2013.05.007

Food and Drug Administration. FDA Briefing Document. NDA 204042. Invokana (canagliflozin) Tablets. Applicant: Janssen Pharmaceuticals Inc.Endocrinologic and Metabolic Drugs Advisory Committee Meeting. Silver Spring MD. 10 January 2013.

10.1111/dom.12187

10.1016/S2213-8587(14)70120-2

10.1111/j.1742-1241.2010.02353.x

10.1185/03007995.2014.890925

10.1111/dom.12385

10.1111/dom.12149

10.1111/j.1463-1326.2007.00744.x

10.1111/j.1464-5491.2009.02666.x

10.1111/j.1463-1326.2011.01434.x

Thông tin
Thông tin xuất bản

Diabetes, Obesity and Metabolism

Tập 17 Số 3

294-303

Thông tin tác giả