Peglispro superior to Lantus in Phase III

Eli Lilly and Co. (NYSE:LLY) reported data on Monday from three Phase III trials evaluating basal insulin peglispro ( LY2605541) to treat Type II diabetes. Once-daily subcutaneous basal insulin peglispro met the primary endpoint of non-inferiority to Lantus insulin glargine in reducing HbA1c from baseline in each of the Phase III IMAGINE-2, IMAGINE-4 and IMAGINE-5 trials. Lilly also analyzed superiority for HbA1c reduction and basal insulin peglispro led to a significantly greater reduction in HbA1c vs. Lantus in all three trials.

IMAGINE-2 was a 52 -week trial in 1,538 insulin-naïve Type II diabetics. IMAGINE-4 was a 26-week trial in 1,369 Type II diabetics already taking a basal insulin with mealtime insulin and IMAGINE-5 was a 26-week trial in 466 Type II diabetics already taking a basal insulin. Top-line data from the Phase III IMAGINE-1 and IMAGINE-7 trials with basal insulin peglispro in Type I diabetics are expected next quarter. Based on Phase III data to date, Lilly plans to submit regulatory applications to FDA and EMA for basal insulin peglispro by the end of 1Q15. ...