This article is part of Endocrinology Advisor’s coverage of the American Diabetes Association’s 77th Scientific Sessions (ADA 2017), taking place in San Diego, CA. Our staff will report on medical research and technological advances in diabetes and diabetes education, conducted by experts in the field. Check back regularly for more news from ADA 2017.
Ertugliflozin may be added to metformin monotherapy for inadequately controlled type 2 diabetes, but patients should be monitored for a variety of adverse effects, according to research presented at the American Diabetes Association 77th Scientific Sessions, held June 9-13 in San Diego, California.
Study investigators shared results from the phase 3 VERTIS MET (Safety and Efficacy of Ertugliflozin in the Treatment of Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin [MK-8835-006]; ClinicalTrials.gov Identifier NCT02036515) trial, which examined the safety and efficacy of added ertugliflozin vs placebo in adults with type 2 diabetes already on metformin monotherapy (≥1500 mg/d for 8 weeks or longer). More than 600 patients (n=621) were included in the randomized double-blind 26-week (ongoing 78-week extension) multicenter study.
Baseline characteristics were collected for all participants, including mean age, 56.6±8.8 years; duration of type 2 diabetes, 8±6 years; body mass index, 30.9±4.7 kg/m2; and glycated hemoglobin A1c (HbA1c), 8.1%±0.9%. Participants received either placebo, ertugliflozin 5 mg/day, or ertugliflozin 15 mg/day at a 1:1:1 ratio.
By week 26, both groups receiving ertugliflozin had “significantly reduced” HbA1c, fasting blood glucose, body weight, and blood pressure; the researchers noted that “significantly higher proportions had [HbA1c] <7%” compared with the placebo group.
Adverse events occurred in all groups (45.0%, 42.5%, and 50.2% in ertugliflozin 5 mg/d and 15 mg/d and placebo groups, respectively), including genital mycotic infection (GMI), urinary tract infection, symptomatic hypoglycemia, and hypovolemia.
GMI rates increased in patients who received ertugliflozin vs placebo (women: 0.9% vs 5.5% vs 6.3%; men: 0% vs 3.1% vs 3.2%, in placebo vs ertugliflozin 5 mg vs ertugliflozin 15 mg, respectively). Urinary tract infections were most common in the ertugliflozin 15 mg group (3.4%), while symptomatic hypoglycemia and hypovolemia were similar among groups. No adverse effect on bone mineral density (BMD) was noted in the ertugliflozin groups.
“[Ertugliflozin] added to [metformin] in inadequately controlled [type 2 diabetes] improved glycemic control, reduced body weight and [blood pressure] without impacting BMD, but with increased incidence of GMI,” the researchers concluded.
Disclosures: All authors report disclosures, including consultant, advisory panel, and shareholder positions with pharmaceutical companies including Boehringer Ingelheim, Janssen, Eli Lilly and Company, Novo Nordisk, Sanofi, AstraZeneca, and Merck & Co. For a full list of author disclosures, please see Abstract 1168-P.
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Rosenstock J, Frias J, Pall D, et al. Effect of ertugliflozin on glycemic control, body weight, blood pressure, and bone mineral density in T2DM inadequately controlled with metformin monotherapy: VERTIS MET trial. Presented at: American Diabetes Association 77th Scientific Sessions; June 9-13, 2017; San Diego, California. Abstract 1168-P.