Eli Lilly and Company have announced positive top-line results of three completed Phase III clinical trials in patients with type 2 diabetes for basal insulin peglispro (BIL). Peglispro 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 (Lantus) 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 in patients with type 2 diabetes.
Lilly expects U.S. and European regulatory submissions by Q1 2015