LY 2605541 meets endpoints in 3 Phase III trials for T2D - Eli Lilly

Eli Lilly announced positive top-line results of three completed Phase III clinical trials in patients with Type 2 Diabetes for LY 2605541 (basal insulin peglispro or BIL), which is being studied as a once-daily treatment for both Type 1 and Type 2 Diabetes. The primary efficacy endpoint of non-inferior reduction in hemoglobin A1c (HbA1c) compared to insulin glargine was met in all three trials. Having met the primary endpoints, superiority for HbA1c lowering was examined and, in all three trials, BIL showed a statistically superior reduction in HbA1c compared with insulin glargine.

The clinical trials evaluated three specific populations of patients with Type 2 Diabetes: those who were not previously taking insulin (IMAGINE-2); those taking basal insulin with mealtime insulin (IMAGINE-4); and those currently taking a basal insulin (IMAGINE-5). All three clinical trials compared BIL, an investigational basal insulin, with insulin glargine. These clinical studies also evaluated the secondary endpoints of nocturnal hypoglycemia rates and changes in weight. In all three clinical trials, patients taking BIL experienced statistically significant lower rates of nocturnal hypoglycemia than those taking insulin glargine. In addition, patients taking BIL had comparable to statistically significant less weight gain. The additional safety findings in these Phase III clinical trials were generally consistent with findings reported in the BIL Phase II clinical trial.

Top-line results for the Phase III clinical trials of patients with Type 1 Diabetes are planned for release by the end of Q3 this year at the time when both Phase III clinical trials are complete. Detailed study results for Phase III Type 1 and Type 2 Diabetes clinical trials are expected to be disclosed at major medical conferences in 2015. At an upcoming medical meeting in 2014, Lilly will present new data regarding BIL's mechanism of action. Based on Phase III clinical trial results to date, Lilly expects to submit BIL for regulatory review to the FDA and EMA by the end of Q1 2015.