Ertugliflozin Monotherapy Effective for Glycemic Control in Type 2 Diabetes

Used as monotherapy, ertugliflozin provides effective glycemic control for patients with type 2 diabetes inadequately treated by diet and exercise alone. 

Recent results of a first phase of a phase 3 study that evaluated the safety and efficacy of ertugliflozin monotherapy in 461 men and women with type 2 diabetes showed that patients treated with 5 mg or 15 mg ertugliflozin monotherapy had a significant reduction in glycated hemoglobin (HbA1c) after 26 weeks of therapy from baseline. Significant reductions in HbA1c were seen at both dose levels, with an average HbA1c reduction of 0.99% at 5 mg and 1.16% at 15 mg (P < 0.001).

Referred to as the VERTIS MONO, the multicenter, randomized trial included patients at least 18 years of age in whom glycemic control remained inadequate (HbA1c 7.0-10.5%) despite diet and exercise. In the 52-week trial, patients were randomized to a 26-week, placebo-controlled treatment period (phase A) followed by an additional 26-week
active-controlled treatment period (phase B).

According to the study results from the first phase (A) of the trial at 26 weeks, patients treated with ertugliflozin at 5 mg and 15 mg doses had significantly greater odds of attaining an HbA1c <7% than patients on placebo (28.2% and 35.8% vs 13.1%, respectively). 

At 26 weeks, the researchers also found that fasting plasma glucose, 2-hour post-prandial glucose, and body weight were all significantly lowered in patients treated with either doses of ertugliflozin. Results showed that changes to systolic blood pressure at 26 weeks from baseline were similar between the treatment and placebo groups.

In terms of safety, the researchers found that study participants treated with ertugliflozin had a higher incidence of genital mycotic infections when compared to placebo. The researchers also noted that no significant differences were found in the proportion of patients with symptomatic hypoglycemia or adverse events linked to urinary tract infection or hypovolemia. —Mary Beth Nierengarten