Basal insulin peglispro superior to Lantus in Type 1 Diabetes- Eli Lilly

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 primary efficacy endpoint of non-inferior HbA1c at the primary study endpoint compared with insulin glargine was met in both the IMAGINE-1 and IMAGINE-3 trials, and superiority was demonstrated. In addition, significantly more patients taking BIL versus those taking insulin glargine achieved an HbA1c of less than 7 percent, a target for glycemic control established by the American Diabetes Association. Both trials also showed the rate of nocturnal hypoglycemia was significantly lower in patients taking BIL than in those taking insulin glargine. In both trials � in which patients were taking both mealtime and basal insulin � there was a statistically significant increase in the rate of total hypoglycemia for patients taking BIL compared with those taking insulin glargine due to a higher rate of daytime hypoglycemic events. In the open-label IMAGINE-1 trial, patients taking BIL reported a statistically significant higher rate of severe hypoglycemic events. However, in the larger, blinded IMAGINE-3 trial the rate of severe hypoglycemic events for treatment with BIL was numerically lower compared with insulin glargine, but was not statistically significant.

Additionally, both trials showed a statistically significant difference in weight. Patients taking BIL experienced weight loss�even with lower HbA1c�compared with weight gain in patients taking insulin glargine. 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.