Efficacy and safety of canagliflozin as add-on therapy to a glucagon-like peptide-1 receptor agonist in Japanese patients with type 2 diabetes mellitus: A 52-week, open-label, phase IV study

Diabetes, Obesity & Metabolism
Shin-Ichi HarashimaYumi Watanabe

Abstract

Sodium-glucose co-transporter-2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP-1RAs) are antihyperglycaemic agents with weight-lowering effects. The efficacy and safety of the SGLT2 inhibitor canagliflozin as add-on therapy in Japanese patients with type 2 diabetes mellitus (T2DM) and inadequate glycaemic control with a GLP-1RA (≥12 weeks) were evaluated in this phase IV study. Patients received canagliflozin 100 mg once daily for 52 weeks. Efficacy endpoints included change in glycated haemoglobin (HbA1c), fasting plasma glucose (FPG), body weight, systolic blood pressure (SBP) and HDL cholesterol from baseline to week 52. Safety endpoints included adverse events (AEs), hypoglycaemia and laboratory tests. Of the 71 patients treated with canagliflozin, 63 completed the study. At 52 weeks, HbA1c was significantly reduced from baseline (-0.70%; paired t test, P < .001). Significant changes were also observed in FPG (-34.7 mg/dL), body weight (-4.46%), SBP (-7.90 mm Hg), and HDL cholesterol (7.60%; all P < .001). The incidence of AEs, adverse drug reactions and hypoglycaemia was 71.8%, 32.4% and 9.9%, respectively. All hypoglycaemic events were mild. These findings suggest that the long-term combination of c...Continue Reading

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Citations

Nov 2, 2019·Current Drug Targets·Ping WuHao Fang
May 26, 2018·Expert Opinion on Pharmacotherapy·Nobuya InagakiHiroaki Iijima
Aug 24, 2019·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Taichi Nagahisa, Yoshifumi Saisho
Aug 14, 2021·Expert Opinion on Pharmacotherapy·Maka Siamashvili, Stephen N Davis
May 20, 2020·Diabetes Spectrum : a Publication of the American Diabetes Association·John E Anderson

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Clinical Trials Mentioned

NCT02227849

Software Mentioned

CANVAS

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