Two Phase III trials of Jardiance show benefits for T2D-Boehringer/Eli Lilly

A Phase III clinical trial studying the efficacy and safety of Jardiance (empagliflozin), from Boehringer and Eli Lilly, in Type 2 Diabetes (T2D) demonstrated significantly greater decreases in hemoglobin A1C, body weight and blood pressure compared with glimepiride as add-on to metformin. In a 52-week study, adding empagliflozin to daily insulin significantly reduced blood glucose and body weight with lower insulin doses compared with placebo. The study showed a mean reduction in A1C levels of 0.66 percent for empagliflozin compared with 0.55 percent for glimepiride, mean change in body weight was a loss of 3.1 kg for empagliflozin vs a gain of 1.3 kg for glimepiride, a mean change in systolic blood pressure was a reduction of 3.1 mmHg for empagliflozin vs an increase of 2.5 mmHg for glimepiride and a mean change in diastolic blood pressure was a reduction of 1.8 mmHg for empagliflozin vs an increase of 0.9 mmHg for glimepiride. Significantly fewer confirmed hypoglycemic events were reported for empagliflozin (2.5 percent vs. 24.2 percent, respectively). Overall adverse event rates in the two arms were 86.4 percent and 86.3 percent for empagliflozin and glimepiride, respectively.

In a second 52-week, placebo-controlled study, the safety and efficacy of empagliflozin 10 mg or 25 mg added onto multiple daily insulin injections, with or without metformin, was studied in obese adults with T2D and inadequately controlled blood glucose levels. After 18 weeks, empagliflozin 10 mg and 25 mg significantly reduced A1C levels by 0.94 percent and 1.02 percent from baseline, respectively, compared with 0.50 percent with placebo. After 52 weeks, empagliflozin significantly reduced A1C by 1.18 percent and 1.27 percent, respectively, compared with 0.81 percent with placebo. Patients in each of the empagliflozin arms had an average body weight loss of 2 kg, vs a gain of 0.4 kg for those in the placebo arm. Hypoglycemia was reported in 51.1 percent, 57.7 percent and 58.0 percent of patients in the empagliflozin 10 mg, 25 mg and placebo arms, respectively. Data were presented at the American Diabetes Association 74th Scientific Sessions.