Add-On Ertugliflozin Improves Outcomes in Poorly Controlled Diabetes
Adding ertugliflozin to metformin and sitagliptin improved glycemic control for patients with inadequately controlled type 2 diabetes, according to a recent study.
The double-blind, randomized study included 464 patients with type 2 diabetes who were receiving 1500 mg or more of metformin per day and 100 mg of sitagliptin per day but had glycated hemoglobin (HbA1c) between 7% and 10.5%. Patients were randomly assigned to receive either once-daily 5 mg of ertugliflozin, once-daily 15 mg of ertugliflozin, or placebo for 51 weeks. Changes in HbA1c from baseline to week 26 were assessed as the primary endpoint.
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The placebo-adjusted least squares (LS) mean change in HbA1c from baseline to 26 weeks was -0.7% for patients who received 5 mg of ertugliflozin and -0.8% for those who received 15 mg of ertugliflozin. In addition, 17% of patients who received placebo, 32.1% of patients who received 5 mg of ertugliflozin, and 39.9% of patients who received 15 mg of ertugliflozin had HbA1c below 7% after 26 weeks of treatment.
Ertugliflozin was associated with significant reductions in fasting plasma glucose, body weight, and systolic blood pressure (SBP) compared with placebo. These positive effects were maintained through 52 weeks.
While ertugliflozin was associated with a higher incidence of genital mycotic infections, the incidence of urinary tract infections, symptomatic hypoglycemia, and hypovolemia adverse events were not meaningfully different across groups.
“Ertugliflozin added to metformin and sitagliptin was well-tolerated, and provided clinically meaningful, durable glycemic control, [body weight] and SBP reductions versus placebo over 52 weeks,” the researchers concluded.
—Melissa Weiss
Reference:
Dagogo-Jack S, Liu J, Eldor R, et al. Efficacy and safety of the addition of ertugliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sitagliptin: the VERTIS SITA2 placebo-controlled randomized study [published online September 17, 2017]. Diabetes Obes Metab. doi:10.1111/dom.13116.