IMAGINE-1 is a 78-week, open-label study designed to compare BIL (n=295) with insulin glargine (n=160) in combination with mealtime insulin in patients with type 1 diabetes. IMAGINE-3 is a 52-week, double-blind randomized study designed to compare BIL (n=664) with insulin glargine (n=450) in combination with mealtime insulin in patients with type 1 diabetes. The primary efficacy endpoint was of non-inferior hemoglobin A1c (HbA1c) at the primary study endpoint compared with insulin glargine.
The primary efficacy endpoint was met in both the IMAGINE-1 and IMAGINE-3 trials. Results showed that BIL demonstrated a statistically significant lower HbA1c compared to Lantus (insulin glargine; Sanofi Aventis) at 26 weeks and 52 weeks, respectively, in IMAGINE-1 and IMAGINE-3. In IMAGINE-1, patients continued treatment beyond 26 weeks, and the HbA1c superiority for BIL was maintained at 52 and 78 weeks. In addition, significantly more patients taking BIL vs. those taking insulin glargine achieved an HbA1c of <7%.
The core Phase 3 clinical trial program of BIL, consisting of seven IMAGINE trials in patients with type 1 and type 2 diabetes has been completed and superiority in HbA1c for BIL was seen in all six of the trials that were conducted against active comparators. IMAGINE-7 showed there was no statistically significant difference in HbA1c between BIL dosed at the same time every day vs. BIL dosed at variable times. IMAGINE-6 met its primary efficacy endpoint of non-inferior reduction in HbA1c compared with NPH insulin at 26 weeks and also demonstrated HbA1c superiority of BIL compared to NPH insulin.
Lilly plans to submit basal insulin peglispro for regulatory review to the FDA by the end of the first quarter in 2015.
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