New Data Shows Empagliflozin Improves Blood Glucose Levels in Type 2 Diabetes Patients

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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. 
 
Empagliflozin inhibits SGLT-2, which blocks glucose reuptake in the kidney, thereby removing excess glucose through the urine.
 
In the open-label study, adults with type 2 diabetes who participated in one of two 12-week, blinded, dose-finding empagliflozin trials, were treated for an additional 78 weeks with open-label empagliflozin 10 mg or 25 mg (monotherapy or add-on to metformin), metformin alone, or sitagliptin as add-on to metformin. At week 90, decreases in average A1c levels, FPG levels and body weight were observed with empagliflozin 10 mg and 25 mg alone and as an add-on to metformin.

 

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. 

 

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