In two Phase 3 clinical trials, Eli Lilly's (NYSE:LLY) basal insulin peglispro (BIL) demonstrated a statistically significant lower hemoglobin A1c (HbA1c) compared to Sanofi's (NYSE:SNY) Lantus (insulin glargine) at 26 and 52 weeks in patients with Type 1 diabetes.
Both trials showed the rate of nocturnal hypoglycemia was significantly lower in patients taking BIL than those taking insulin glargine. In the open-label IMAGINE-1 trial, patients taking BIL reported a statistically significant higher rate of severe hypoglycemic events, however. In the the larger blinded IMAGINE-3 trial, the rate of severe hypoglycemic events in patients taking BIL was numerically lower that the insulin glargine arm but it was not statistically significant.
Both trials showed a statistically significant difference in weight. The BIL cohort experienced weight loss with lower HbA1c compared to weight gain in the insulin glargine cohort.
In IMAGINE-3, the BIL cohort showed statistically significant changes compared to insulin glargine in certain parameters: an increase in triglycerides and LDL cholesterol, a decrease in HDL cholesterol and increases in systolic and diastolic blood pressure. Some of these changes were not observed in IMAGINE-1.
Lilly intends to submit its marketing application with regulators in Q1 2015.