Eli Lilly and Boehringer Ingelheim presented new data from a phase 2b open-label extension study, showing empagliflozin (BI 10773), alone or as an add-on to metformin, reduced hemoglobin A1c (HbA1c or A1c) levels, fasting plasma glucose (FPG) levels and body weight when given to adults with type 2 diabetes for up to 90 weeks.
The study showed empagliflozin (10 mg or 25 mg) was generally well-tolerated. When given for a treatment duration of at least 78 weeks and for up to 90 weeks, adverse events (AEs) were reported in 63.2 to 74.1 percent of patients on empagliflozin and in 69.6 percent of patients on metformin alone or sitagliptin plus metformin. More than 90 percent of these AEs were of mild or moderate severity. Between 0.9 and 3.6 percent of patients on empagliflozin reported hypoglycemic events, versus 7.1 percent on metformin only and 5.4 percent on sitagliptin. AEs related to urinary tract infections were reported in 3.8 to 12.7 percent of patients on empagliflozin, 3.6 percent of patients on metformin only, and 12.5 percent of patients on sitagliptin. AEs related to genital infections were reported in 3.0 to 5.5 percent of patients on empagliflozin, 1.8 percent of patients on metformin only, and none of the patients on sitagliptin.
Empagliflozin is currently in phase 3 clinical development with over 14,500 patients planned to be enrolled.
