Eli Lilly and Company's basal insulin peglispro (BIL) demonstrated a statistically significant lower hemoglobin A1c (HbA1c) compared with insulin glargine (Lantus) at 26 weeks and 52 weeks, respectively, in the IMAGINE-1 and IMAGINE-3 Phase III clinical trials in patients with type 1 diabetes. Patients in these trials were also taking mealtime insulin. Notably, patients in IMAGINE-1 continued treatment beyond 26 weeks, and the HbA1c superiority for BIL was maintained at 52 and 78 weeks.
The Phase III trials needed for submission are now complete. The trials, in both type 1 and type 2 diabetes, showed consistent superiority of HbA1c for BIL against comparators. Lilly is on track to file a submission with regulators by the end of the first quarter in 2015.
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