Background: This pooled analysis assessed the efficacy of ertugliflozin versus placebo as monotherapy or with other antihyperglycaemic agents across patient subgroups defined by demographic and disease characteristics.
Methods: Data from three phase III randomised, placebo-controlled, double-blind studies (NCT01958671, NCT02033889 and NCT02036515) with similar designs and populations were pooled (N = 1544).
Results: At Week 26, placebo-adjusted least squares mean changes from baseline in glycated haemoglobin with ertugliflozin 5 and 15 mg were -0.8% (95% confidence interval: -0.9, -0.7) and -0.9% (-1.0, -0.8), respectively. Reductions were consistent across subgroups. Placebo-adjusted least squares mean changes in body weight were -1.8 kg (-2.2, -1.4) for both ertugliflozin doses; for systolic blood pressure, these were -3.4 mmHg (-4.8, -2.0) and -3.5 mmHg (-4.9, -2.0) for ertugliflozin 5 and 15 mg, respectively. Higher proportions of patients receiving ertugliflozin had glycated haemoglobin <7.0%, weight loss ⩾5% and systolic blood pressure <130 mmHg versus placebo. Ertugliflozin and placebo safety profiles were similar, including incidences of hypoglycaemia, urinary tract infection and hypovolaemia. Genital mycotic infection and adverse events related to osmotic diuresis were more common with ertugliflozin.
Conclusion: Ertugliflozin demonstrated efficacy as monotherapy or with other antihyperglycaemic agents in patients with different demographic and disease characteristics and was generally well tolerated.
Keywords: Ertugliflozin; blood pressure; body weight; glycaemic control; sodium-glucose cotransporter 2 inhibitor; type 2 diabetes mellitus.