Long-term efficacy and safety of ertugliflozin monotherapy in patients with inadequately controlled T2DM despite diet and exercise: VERTIS MONO extension study
Diabetes, Obesity and Metabolism May 31, 2018
Aronson R, et al. - In this phase III, multicentre, randomized study, the researchers intended to assess the efficacy and safety of ertugliflozin monotherapy in adults with inadequately controlled type 2 diabetes (glycated haemoglobin [HbA1c], 7.0% to 10.5% [53-91 mmol/mol]) despite diet and exercise. The 52-week study included a 26-week, double-blind, placebo-controlled period (Phase A) during which four hundred sixty-one members received placebo, ertugliflozin 5 mg/d or ertugliflozin 15 mg/d. Results revealed that ertugliflozin was not correlated with increased incidence of urinary tract infections, symptomatic hypoglycaemia or hypovolaemia adverse events compared with placebo/metformin. It was observed in the findings that ertugliflozin treatment over 52 weeks improved glycaemic control and decreased body weight and systolic blood pressure (SBP), but increased genital mycotic infections (GMIs).
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