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

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 the change in glycated haemoglobin (HbA1c), fasting plasma glucose (FPG), bodyweight, systolic blood pressure (SBP), and high‐density lipoprotein cholesterol (HDL‐C) from baseline to Week 52. Safety endpoints included adverse events (AEs), hypoglycaemia and laboratory tests. Of the 71 patients treated with canagliflozin, 63 patients completed the study. At 52 weeks, HbA1c was significantly reduced from baseline (−0.70%; paired t‐test, p <0.001). Significant changes were also observed in FPG (−34.7 mg/dL), bodyweight (−4.46%), SBP (−7.90 mmHg), and HDL‐C (7.60%; all p<0.001). 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 canagliflozin with a GLP‐1RA is effective and well tolerated in Japanese patients with T2DM.
Source: Diabetes, Obesity and Metabolism - Category: Endocrinology Authors: Tags: BRIEF REPORT Source Type: research