(HealthDay News) — For adults with inadequately controlled type 2 diabetes, ertugliflozin treatment is associated with improved glycemic control over 52 weeks, according to a study published online in Diabetes, Obesity and Metabolism.

Ronnie Aronson, MD, from LMC Diabetes & Endocrinology in Ontario, and colleagues conducted a phase III randomized trial to examine the efficacy and safety of ertugliflozin monotherapy in adults with inadequately controlled type 2 diabetes despite diet and exercise. The study comprised a 26-week placebo-controlled period where 461 participants received placebo or ertugliflozin (5 or 15 mg/day) and a second 26-week period in which participants in the placebo group had blinded metformin added.

The researchers found that the mean change in glycated hemoglobin (HbA1c) from baseline to week 52 was −0.9 and −1% in the ertugliflozin 5- and 15-mg groups, respectively; the proportion of patients with HbA1c <7% was 25.6 and 28.5%, respectively, at week 52. Ertugliflozin was correlated with a reduction in fasting plasma glucose, body weight, and systolic blood pressure. In females, the incidence of genital mycotic infections (GMIs) was significantly higher in both the 5- and 15-mg ertugliflozin groups versus placebo/metformin (26.9 and 29 vs 9.9%); males had significantly higher GMI incidence in the 15-mg group (7.8 versus 1.2%).

“Ertugliflozin treatment over 52 weeks improved glycemic control and reduced body weight and systolic blood pressure but increased GMIs,” the authors write.

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Several authors disclosed financial ties to pharmaceutical companies, including Pfizer and Merck & Co., which funded the study.

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Aronson R, Frias J, Goldman A, et al. Long-term efficacy and safety of ertugliflozin monotherapy in patients with inadequately controlled T2DM despite diet and exercise: VERTIS MONO extension study. Diab Obes Metab. DOI: 10.1111/dom.13251