Date: 2012-06-09
Type of information:
phase: 2
Announcement: Results presented during a late-breaking session at the American Diabetes Association's (ADA's) 72nd Scientific Sessions®.
Company: Boehringer Ingelheim (Germany) - Eli Lilly (USA)
Product: empagliflozin (BI 10773)
Action
mechanism: Empagliflozin inhibits SGLT-2 (sodium-dependent glucose co-transporter-2), which blocks glucose reuptake in the kidney, thereby removing excess glucose through the urine.
Disease: type 2 diabetes
Therapeutic area: Metabolic diseases
Country:
Trial
details: In this extension study, patients treated with 10 mg or 25 mg of empagliflozin (monotherapy or add-on to metformin), metformin alone, or sitagliptin as add-on to metformin in one of two 12-week trials continued on the same treatment for an additional 78 weeks. Patients in the 12-week trial who had received 1, 5 or 50 mg of empagliflozin or placebo were randomized to 78 weeks of treatment with either 10 mg or 25 mg of empagliflozin (monotherapy [106 on 10 mg; 109 on 25 mg] or add-on to metformin [166 on 10 mg and 166 on 25 mg]), metformin only (56) or sitagliptin (56). Results for empagliflozin monotherapy were compared with those of patients treated with metformin alone, while data among patients on empagliflozin plus metformin were compared with those of patients on sitagliptin plus metformin.
Latest
news: Boehringer Ingelheim and Eli Lilly have presented results that showed 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.
A1C is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months.
At week 90, decreases in average A1C levels (percent), FPG levels (mg/dL), and body weight (kg, weight) were observed with empagliflozin 10 mg alone (-0.34; -30.4; -2.24, respectively) and 25 mg alone (-0.47; -27.8; -2.61, respectively), versus metformin (-0.56; -26.0; -1.28, respectively).
When used as an add-on to metformin, empagliflozin showed reductions versus sitagliptin on A1C levels (-0.34 EMPA 10 mg; -0.63 EMPA 25 mg; and -0.40 sitagliptin); FPG levels (-21.3 EMPA 10 mg; -31.8 EMPA 25 mg; and -15.6 sitagliptin); and body weight (-3.14 EMPA 10 mg; -4.03 EMPA 25 mg; and -0.41 sitagliptin).
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.
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centers on four pipeline compounds, including empagliflozin (BI 10773) (See http://biopharmanalyses.fr/agreements/?pageid=204).
